The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (≥22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
Device Story
Flex Robotic Colorectal System is an operator-controlled flexible endoscope providing benefits of rigid endoscope and computer-assisted controller. System inputs: digital camera video at distal end of endoscope. Operation: physician uses console-based joystick to control electromechanical steering of multi-segmented endoscope; system provides visualization and access to anus, rectum, and distal colon. Output: video display for surgeon. Used in hospital setting by surgeons and nurses/technicians. System includes Flex Drive (endoscope), Flex Console (monitor/joystick), Flex Base, Flex Cart, Flex Camera, Flex Rectoscope, and Instrument Support Arm. Rectoscope seals anatomy for insufflation. Provides two accessory channels for flexible instruments and auxiliary port for laparoscopic instruments. Benefits: stable platform for trans-anal tissue resection and closure; facilitates two-handed surgery.
Clinical Evidence
No human clinical trials. Evidence includes three GLP animal studies (porcine model) evaluating abrasion, visualization, and surgical performance (excision, suturing, bleeding control). One human cadaveric study demonstrated successful trans-anal entry, insufflation, and tissue resection/closure. Bench testing confirmed reliability, software V&V, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993).
Technological Characteristics
Multi-segmented, cable-steered, CMOS-based video endoscope. Electromechanical control via console-based joystick. Components: Flex Drive, Console, Base, Cart, Camera, Rectoscope. Materials: Biocompatible. Energy: AC powered. Sterilization: EtO (single-use drive) and validated cleaning/sterilization for reusable components. Connectivity: Standalone system. Software: Moderate level of concern.
Indications for Use
Indicated for robot-assisted visualization and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age).
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2017
Medrobotics Corporation John D. Bonasera Director of Regulatory Affairs 475 Paramount Drive Raynham, MA 02767
Re: K162330
Trade/Device Name: Flex Robotic System and Flex Colorectal Drive Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: April 7, 2017 Received: April 7, 2017
Dear John D. Bonasera:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K162330
Device Name Flex Robotic System and Flex Colorectal Drive
Indications for Use (Describe)
The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, recturn and distal colon. The Flex Robotic System is intended for use in adults (≥22 years of age).
The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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## TRADITIONAL 510(K) SUMMARY
## Flex® Robotic System and Flex® Colorectal Drive
This Summary of the Traditional 510(k) Substantial Equivalence Information is being submitted in accordance with the requirements of 21 CFR 807.92. All data included in this document is accurate and complete to the best of Medrobotics' knowledge.
| 510(k) Number | K162330 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name | Medrobotics Corporation |
| Submitter Address | 475 Paramount Drive<br>Raynham, MA 02767 |
| Contact Person | John D. Bonasera<br>Vice President of Clinical, Regulatory, and Quality Affairs |
| Phone Number | 508-692-6460 |
| Fax Number | 508-823-1703 |
| Date Prepared | April 6, 2017 |
| Device Trade Name | Flex® Robotic System and Flex® Colorectal Drive |
| Device Common Name | Flexible Colonoscope and Accessories |
| Device Classification Name | Endoscope and accessories |
| Product Code | FDF |
| Classification | Class II |
| Predicate Device | The NeoGuide Navigator Endoscopy System, K070622 |
| Reference Device | The Flex® Robotic System and Flex® Colorectal Drive were also<br>compared to the Medrobotics Flex® System, K150776 and the<br>Storz TEO System, K945209. The proposed system is a modified<br>version of the cleared Flex System, K150776. The proposed<br>system includes the Flex® Rectoscope, which, like the Storz<br>reference device facilitates access to the colorectal anatomy and<br>allows sealing of the anatomy for insufflation. |
| Device Description | The Flex® Robotic System and Flex® Colorectal Drive make up<br>the Flex Robotic Colorectal System. The Flex Robotic Colorectal |
| | System is an operator-controlled flexible endoscope that provides<br>the benefits of both a rigid endoscope and a computer assisted<br>controller. The Flex Robotic Colorectal System is a software-<br>controlled device. The Flex® Robotic Colorectal System allows<br>for the endoscope to be introduced via an operator-controlled user<br>interface easily providing visualization and access of structures in<br>the anus, rectum, and distal colon. Visualization is provided by a<br>digital camera attached at the distal end of the endoscope. The<br>Flex Robotic Colorectal System's endoscope also provides two<br>accessory channels for use of varied flexible instruments. The<br>Flex Robotic Colorectal System is intended for professional use<br>only in a hospital setting. The Flex Robotic System is provided<br>non-sterile and reusable. The Flex Robotic Colorectal Drive is<br>provided sterile through EtO sterilization and is intended for single<br>patient use. The patient contacting components of the proposed<br>system are all composed of biocompatible materials. |
| Intended Use | The Medrobotics Flex Robotic System is intended to provide<br>robot-assisted control of the Flex Colorectal Drive during<br>visualization of and surgical site access to the anus, rectum and<br>distal colon. The Flex Robotic System is intended for use in adults<br>(≥22 years of age). |
| | The Flex Colorectal Drive is intended for robot-assisted<br>visualization of and surgical site access to the anus, rectum, and<br>distal colon in adults (≥22 years of age). The Flex Colorectal<br>Drive also provides accessory channels for compatible flexible<br>instruments used in surgery. |
| Substantial Equivalence | The Flex® Robotic System and Flex® Colorectal Drive are<br>substantially equivalent to the NeoGuide Navigator Endoscopy<br>System (NeoGuide System). As shown in the comparison table at<br>the end of this section, the Flex® Robotic System and Flex®<br>Colorectal Drive have very similar functionality and intended use<br>as the predicate device. |
| Summary of Performance<br>Testing | The Flex® Robotic System and Flex® Colorectal Drive have been<br>subjected to and successfully tested for function, performance, and<br>safety as per FDA-recognized standards IEC 60601-1 and IEC<br>60601-1-2, and biocompatibility and toxicity of the patient<br>contacting materials per ISO-10993-1. It has been tested and met<br>acceptance criteria per FDA-recognized standards for the<br>establishment of shelf life, shipping, and validated for sterility by<br>ETO and moist heat to a SAL of 10-6. Processes by which the user<br>may clean and sterilize certain reusable components have been |
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validated in accordance with FDA-recognized standards. Summaries of this testing are provided below.
#### Bench Testing
The following verification and/or validation testing was performed to confirm that the Flex Colorectal System, as a whole, and its components met their performance specifications:
- Reliability Testing
- Vision and Video Subsystem and System Testing ●
- Subsystem and System Software Verification and Validation Testing ●
- Reusable Camera Testing ●
- . Ship Testing
- Mechanical Requirements Testing
- Safety Subsystem Testing
- System Electrical and Board Requirements Testing ●
## Software
Medrobotics followed the FDA guidance document, "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005." to classify the Flex Colorectal System software as a "moderate level of concern." The software was verified and validated, and the software verification and validation documents were prepared and presented in accordance with FDA's guidance document.
## Ship Testing
Testing was performed per applicable ISTA standards to demonstrate that all modified components of the Flex Colorectal System could withstand anticipated shipping conditions.
## Usability/Human Factors Testing
Medrobotics performed usability and human factors testing of the Flex Colorectal System. Such testing was performed in accordance with FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016). In addition, Wiklund's Usability Testing of Medical Devices was used as a reference.
This testing assessed the performance of the Flex® Robotic System and Flex® Colorectal Drive when used by representative end users (i.e., surgeons and nurses/technicians) in accordance with the instructions for use after having been trained on how to use the system. The testing demonstrated that the Flex® Robotic System and Flex® Colorectal Drive design meets the intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors.
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#### Animal and Cadaver Testing
Medrobotics performed three animal studies to evaluate the safety of the Flex® Robotic System and Flex® Colorectal Drive for transanal access to the colorectal anatomy. The studies were conducted in accordance with Good Laboratory Practice (GLP).
One study evaluated abrasion caused by the Flex® Colorectal Drive (the patient contacting portion of the Flex® Robotic System). The study concluded that the Flex® Colorectal Drive does not cause an increased level of abrasion during visualization and access of the anus and rectum in a porcine model when compared to a colonoscope control.
The other study demonstrated that the Flex® Robotic System and Flex® Colorectal Drive provided acceptable visualization of and access to the colorectal space and served as a stable platform that enabled the surgeon to perform full thickness surgical procedures (excision, suturing, and bleeding control) on live (porcine) rectal tissue.
The third study demonstrated that the Flex® Robotic System and Flex® Colorectal Drive provided acceptable visualization of and access to the colorectal space and served as a stable platform that enabled the surgeon to perform submucosal surgical procedures (excision, suturing, and bleeding control) on live (porcine) rectal tissue.
Finally, a study of the use of the Flex® Robotic System and Flex® Colorectal Drive was conducted in six human cadaveric specimens. The results of the study demonstrated that the Flex Robotic System and Flex Colorectal Drive enabled trans-anal entry, maintained insufflation of the colon, and provided visualization and access to perform trans-anal tissue resection and resection closure in human anatomy with a high degree of success.
#### Electrical Safety
The Flex® Robotic System and Flex® Colorectal Drive have been tested to demonstrate electrical safety and compliance with:
- IEC 60601-1 Ed: 3.1, Medical Electrical Equipment, Part 1: General Req. for Safety
- ANSI/AAMI ES60601-1:2005/(R)2012, Issued: 2012/01/17, Medical electrical ● equipment - Part 1: General requirements for basic safety and essential performance with C1:2009/(R)2012 and A2:2010/(R)2012
- . IEC 60601-1-6: 2010, Edition 3.0, Version: 2010/01/27, Medical electrical equipment - Part 1- 6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366: 2007, Edition 1.0, Issued: 2007/10/18, Ed. 1, Medical Devices -Application Of Usability Engineering To Medical Devices
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- IEC 60601-1-4: 2000, Edition 1.1, Issued 2000/04/01, Medical electrical systems -Part 1- 4: General requirements for safety - Collateral standard: Programmable electrical medical systems
#### Electromagnetic Compatibility Testing
The Flex® Robotic System and Flex® Colorectal Drive were tested and determined to be in compliance with:
- EN 60601-1-2:2007/AC:2010, Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment, Class A for non-life supporting equipment
- IEC 60601-1-2, Ed. 3.0, Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment, Class A for non-life supporting equipment
- Common emitter immunity testing, for cell phones, Wi-Fi, Bluetooth, and some RFID frequencies was performed per the latest edition 60601-1-2:2014 (4th Ed.) Table 9, Section 8.10. Some of the frequencies in Table 9 are tested per 60601-1-2:2007, but power levels are higher and dwell times are longer in Table 9 testing.
- . RFID immunity ad hoc testing was performed for two common RFID emitters not included in Table 9 testing, 125kHz (low frequency RFID, or LF RFID) and 13.56MHz (high frequency RFID, or HF RFID). The testing was based on standard 60601-1-2 conducted EMI testing (modulation) conditions at these frequencies, with increased field strength and longer dwell times.
- Electro-Surgical Unit (ESU) immunity testing was based on IEC 60601-2-27:2011 Particular Requirements for ECG, Section 202.6.2.101.
## Biocompatibility
The Flex® Colorectal Drive, including Flex Camera and Flex Rectoscope, contains the patient contacting portions of the Flex® Colorectal System. In accordance with ANSI/AAMI/ISO/EN 10993-1:2009, and the modified matrix in FDA Guidance Document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 2016), the Flex Colorectal Drive is classified as "external communicating device," in contact with "tissue/bone/dentin" and "limited exposure" (≤24 hours). Biocompatibility testing was performed in accordance with the standard and guidance or a rationale for not testing was provided for all patient contacting components. The results of these tests demonstrate that the patient contacting portions of the device, as intended for use, are biocompatible and nontoxic.
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## Sterilization, Packaging, and Shelf Life for Single Use Flex® Colorectal Drive
The Flex® Colorectal Drive is supplied sterile and is a single use device. The Flex® Colorectal Drive is sterilized via ethylene oxide (EtO). The EtO cycle has been validated to a sterility assurance level (SAL) of 10th, in accordance with the following standards:
- ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products Ethylene ● Oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO TIR 11135-2:2008, Sterilization of health care products -Ethylene Oxide - Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
- AAMI TIR 28:2009, Product adoption and process equivalence for ethylene oxide sterilization
- ANSI/AAMI/ISO/EN 10993-7:2008, Biological evaluation of medical devices Part ● 7: Ethylene oxide sterilization residuals
Functional testing has been performed to demonstrate the Flex Colorectal Drive is stable over the labeled shelf life.
## Cleaning and Sterilization of Reusable System Components
The Flex Colorectal System includes reusable components, the Flex® Camera, Flex® Colorectal Instrument Support and Flex® Rectoscope, which are provided non-sterile. These components are intended to be cleaned and sterilized before each use. The recommended cleaning and sterilization instructions were validated in accordance with the following standards:
- AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30:2011, A compendium of processes, materials, test methods, and . acceptance criteria for cleaning reusable medical devices
- EN ISO 17664:2004. Sterilization of medical devices Information to be provided ● by the manufacturer for the processing of resterilizable medical devices
- . ANSI/AAMI ST81:2004/(R)2010. Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
- ISO TS 15883-5:2005, Washers-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy
- ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization
- ANSI/AAMI ST79:2010, A1:2010, A2:2011, A3:2012, A4: 2013, (R)2014 . Comprehensive guide to steam sterilization and sterility assurance in health care facilities
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- ANSI/AAMI/ISO 14937:2009, Sterilization of health care products General ● requirements for characterization of sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
- . ANSI/AAMI/ISO 17665-1:2006. Sterilization of health care products - Moist heat -Requirements for the development, validation and routine control of sterilization process for medical devices
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Document issued on March 17, 2015, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluations
- . ISO 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance of the application of ISO 17665-1
The Flex System also consists of reusable capital equipment supplied non-sterile. The Flex Base, Flex Cart, Stand, and Flex Console, with the exception of the monitor, are intended to be cleaned and disinfected before each use. None of these components have direct patient contact during a surgical procedure. The Monitor is intended to be cleaned before each use. These pieces of equipment are intended to be covered prior to each use with sterile drapes.
The cleaning instructions for the Flex Base, Flex Cart, Stand, Flex Console, and Monitor were validated in accordance with the following standards:
- AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for . reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance ● criteria for cleaning reusable medical devices
The disinfection instructions for the Flex Base, Flex Cart, Stand, and Flex Console (excluding the Monitor) were validated in accordance with the following standards:
- AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for ● reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
## Conclusion
Based on the indications for use, performance testing, pre-clinical study data and technological characteristics, the Medrobotics modified Flex® Robotic System and Flex® Colorectal Drive have been shown to be as safe and effective for its stated intended use as the predicate device to which substantial equivalence is claimed.
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| Device Name | PROPOSED<br>Flex Robotic Colorectal<br>System<br>[K162330] | PREDICATE NeoGuide<br>System [K070622] | REFERENCE<br>Flex System [K150776] | REFERENCE<br>Karl Storz Proctoscope/<br>TEO System [K945209] |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For endoscopic access and<br>visualization of patient<br>anatomy through a natural<br>orifice. | For endoscopic access and<br>visualization of patient<br>anatomy through a natural<br>orifice. | For endoscopic access and<br>visualization of patient<br>anatomy through a natural<br>orifice. | For endoscopic access and<br>visualization of patient<br>anatomy through a natural<br>orifice. |
| Indications for Use | The Medrobotics Flex<br>Robotic System is intended<br>to provide robot-assisted<br>control of the Flex<br>Colorectal Drive during<br>visualization of and surgical<br>site access to the anus,<br>rectum and distal colon.<br>The Flex Robotic System is<br>intended for use in adults<br>(≥22 years of age).<br>The Flex Colorectal Drive<br>is intended for robot-<br>assisted visualization of and<br>surgical site access to the<br>anus, rectum and distal<br>colon in adults (≥22 years<br>of age). The Flex<br>Colorectal Drive also<br>provides accessory channels<br>for compatible flexible<br>instruments used in surgery. | The NeoGuide Endoscopy<br>System is intended to<br>provide visualization and<br>diagnostic / therapeutic<br>access to the adult lower<br>gastrointestinal tract<br>(including, but not limited<br>to, the anus, rectum,<br>sigmoid colon, colon,<br>cecum and ileocecal valve)<br>for endoscopy and<br>endoscopic surgery. | The Medrobotics Flex<br>System is a device that is<br>intended for robot-assisted<br>visualization and surgical<br>site access to the<br>oropharynx, hypopharynx,<br>and larynx in adults (≥ 22<br>years of age). The Flex<br>System also provides<br>accessory channels for<br>compatible flexible<br>instruments used in surgery. | The Karl Storz Endoscopy<br>Proctoscopes,<br>Sigmoidoscopes,<br>Accessories, and<br>Proctosigmoidoscopy<br>Instruments are manually<br>operated, reusable devices<br>which are designed for use<br>by qualified surgeons<br>during gastroenterological<br>endoscopic procedures.<br>The instruments are<br>designed to facilitate the<br>introduction or removal of<br>instruments, telescopes, and<br>light during<br>gastroenterological<br>endoscopic surgery. |
| Device Name | PROPOSED<br>Flex Robotic Colorectal<br>System<br>[K162330] | PREDICATE NeoGuide<br>System [K070622] | REFERENCE<br>Flex System [K150776] | REFERENCE<br>Karl Storz Proctoscope/<br>TEO System [K945209] |
| Operational<br>Principles | Cable steered CMOS based<br>video endoscope using<br>electromechanical controls<br>driven from a console based<br>computer controlled<br>physician handle | Cable steered endoscope<br>using electromechanical<br>controls on the handle distal<br>tip CCD camera and tool<br>channels for instrument<br>based therapeutic<br>procedures, valves for air<br>insufflation, water irrigation<br>and suction. | Cable steered CMOS based<br>video endoscope using<br>electromechanical controls<br>driven from a console based<br>computer controlled<br>physician handle | |
| Energy Source | AC powered | AC powered | AC powered | |
| Software | Yes. Software-driven<br>endoscope. | Yes. Software-driven<br>endoscope. | Yes. Software-driven<br>endoscope. | |
| Device Name | PROPOSED<br>Flex Robotic Colorectal<br>System<br>[K162330] | PREDICATE NeoGuide<br>System [K070622] | REFERENCE<br>Flex System [K150776] | REFERENCE<br>Karl Storz Proctoscope/<br>TEO System [K945209] |
| Hardware | Major hardware system<br>components:<br>- Flex Drive (endoscope)<br>- Flex Console (including<br>video monitor and joystick)<br>- Flex Base<br>- Flex Cart<br>- Flex Camera (with light<br>source)<br>- Flex Rectoscope<br>- Instrument Support Arm | Major hardware system<br>components:<br>- NeoGuide Colonoscope<br>(with integrated camera)<br>- Actuation Control Unit<br>- External Position Sensor<br>- Cart<br>- Colonoscope Support Arm<br>- Isolation Transformer<br>- Video Monitor<br>- Light source/insufflation<br>Unit | Major hardware system<br>components:<br>- Flex Scope (endoscope),<br>including camera and light<br>source<br>- Flex Console (including<br>video monitor and joystick)<br>- Flex Base<br>- Flex Cart<br>- Instrument Support Arm | Major hardware system<br>components:<br>- Proctoscope<br>- Sigmoidoscope<br>- Accessories<br>- Proctosigmoidoscopy<br>Instruments |
| Operating<br>Environment -<br>Temperature | 50° - 86° F (10° - 30° C) | 50° - 104° F (10° - 40° C) | 50° - 86° F (10° - 30° C) | |
| Operating<br>Environment -<br>Relative Humidity | 15 - 75% relative humidity,<br>non-condensing | 30 - 85% relative humidity | 15 - 75% relative humidity,<br>non-condensing | |
| Operating<br>Environment - Air<br>pressure | 700 - 1060 hPA | 700 - 1060 hPA | 700 - 1060 hPA | |
| Device Name | PROPOSED<br>Flex Robotic Colorectal<br>System<br>[K162330] | PREDICATE NeoGuide<br>System [K070622] | REFERENCE<br>Flex System [K150776] | REFERENCE<br>Karl Storz Proctoscope/<br>TEO System [K945209] |
| Lubrication | Yes. Lubricate using sterile<br>petroleum jelly. | Yes. Lubricate using<br>medical grade water-soluble<br>lubricant. | No. | |
| Insufflation | Insufflation is necessary for<br>procedure. | Insufflation is necessary for<br>procedure. | Not applicable. Insufflation<br>not used in ENT<br>procedures. | Insufflation is necessary for<br>procedure. |
| Insufflation<br>maintenance | Rectoscope seals the<br>flexible scope and anatomy<br>to maintain insufflation. | Rigid scope exterior is self-<br>sealing against the anus to<br>maintain insufflation | Not applicable. Insufflation<br>not used in ENT<br>procedures. | Rectoscope seals the<br>flexible scope and anatomy<br>to maintain insufflation. |
| Anatomical Access | Scope gains access through<br>entry of the Flex<br>Rectoscope | No access tools required | Scope gains access through<br>use of a retractor | Rigid scope gains entry to<br>the anatomy through this<br>rectoscope |
| | Obturator dilates the anus as<br>the rectoscope is inserted | | | Obturator dilates the anus as<br>the rectoscope is inserted |
| Device Name | PROPOSED<br>Flex Robotic Colorectal<br>System<br>[K162330] | PREDICATE NeoGuide<br>System [K070622] | REFERENCE<br>Flex System [K150776] | REFERENCE<br>Karl Storz Proctoscope/<br>TEO System [K945209] |
| Rectoscope Ports for<br>Compatible<br>Instruments | Yes. The system has both<br>left (1) and right (1)<br>instrument ports which seal<br>against specialized<br>compatible rigid<br>laparoscopic instruments to<br>facilitate two handed<br>surgery.<br>Also contains a third<br>auxiliary port to accept a<br>variety of laparoscopic<br>instruments. | Not applicable - does not<br>use a rectoscope | Not applicable - does not<br>use a rectoscope | Yes. The system has both<br>left (1) and right (1)<br>instrument ports which seal<br>against specialized<br>compatible rigid<br>laparoscopic instruments to<br>facilitate two handed<br>surgery.<br>Also contains a third<br>auxiliary port to accept a<br>variety of laparoscopic<br>instruments. |
| CO2 Port | Yes. 2 leur lock ports to<br>provide CO2 gas to the<br>surgical field for<br>insufflation.…
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
