K131422 · Endochoice, Inc. · FDS · Oct 10, 2013 · Gastroenterology, Urology
Device Facts
Record ID
K131422
Device Name
PEERSCOPE SYSTEM
Applicant
Endochoice, Inc.
Product Code
FDS · Gastroenterology, Urology
Decision Date
Oct 10, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). The PeerScope System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
Device Story
The PeerScope System (Model HG) is a flexible video gastroscope platform used in healthcare facilities by GI physicians for diagnostic visualization and therapeutic intervention in the upper digestive tract. The system comprises a Main Control Unit (MCU) videoprocessor and a PeerScope GS flexible video gastroscope. It captures visual data via an integral LED-illuminated camera head and processes the signal through the MCU to provide two viewing modes: a standard 160° front field of view and a 210° wide field of view. The system interfaces with standard endoscopy tools for therapeutic procedures. Physicians view the output on a display connected to the MCU to guide navigation and perform interventions. The device benefits patients by providing enhanced visualization capabilities compared to standard front-view-only endoscopes, facilitating diagnostic and therapeutic access to the upper GI tract.
Clinical Evidence
No clinical trials were performed. Evidence consists of bench testing and a usability study. Bench testing verified design requirements against ISO 14971, IEC 60601-1, IEC 60601-2-18, ISO 10993, and ISO 8600 series standards. Usability testing was conducted in a US medical center with five experienced GI physicians to confirm device performance in a clinical environment.
Technological Characteristics
Flexible video gastroscope with integral LED illumination. Features front and side viewing capabilities with 160° standard and 210° wide fields of view. Distal tip diameter 10.5mm; working length 1050mm. Connectivity via MCU videoprocessor. Biocompatibility per ISO 10993. Electrical safety per AAMI/ANSI ES 60601-1 and IEC 60601-1-2. Reprocessing validated per FDA guidance.
Indications for Use
Indicated for diagnostic visualization and therapeutic intervention in the upper digestive tract (esophagus, stomach, duodenum) in a healthcare facility setting.
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 EndoChoice. The logo consists of a circular swirl design on the left, followed by the word "ENDOCHOICE" in a stylized font. The font appears to be sans-serif and the letters are spaced closely together.
EndoChoice, Inc., 11810 Wills Road Alpharetta, GA 30009
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92
#### Submitter Details
EndoChoice Inc. 11810 Wills Road OCT 1 0 2013 Alpharetta, GA 30009 Phone: 678-534-6012 866-567-8218 Fax: Date prepared: June 18, 2013 Submission Contact: Tamar Fuerst EndoChoice Innovation Center Ltd. Caesarea, 38900, Israel. Phone: +972-46327731, Fax: +972-46327743
#### Device Details
Proprietary Name: Classification Name Product Code: Committee/Panel: Device Class:
PeerScope System (Model HG) Endoscope and Accessories, 21 CFR 876.1500 FDS Gastroenterology/Urology II
Reason for 510(k) Submission: New Device
#### Identification of Legally Marketed Predicates Devices:
EVIS EXERA II 180 System (K100584) by Olympus. PeerScope System Model H (K130718) - by PeerMedical Ltd.
## Device Description
The PeerScope System Model HG is a G1 platform for diagnostic visualization and therapeutic intervention of the digestive tract for use in healthcare facility/hospital. The system consists of the Main Control Unit (MCU) Videoprocessor that provides the device controls, user interfaces, image processing, pneumatic controls and interfaces with various external accessories, and of the PeerScope GS flexible video Gastroscope labeled for repeatable clinical usage within the upper digestive tract. The operation principles of the PeerScope System are similar to those of other legally marketed standard Gastroscopic systems. The system also provides the physicians with two viewing capabilities: Standard 160° front field of view, and 210° wide field of view.
PeerScope System Model HG Submission Section 5_ 510(k) Summary
Page I of 4
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## Intended use and indications for Use
The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The PeerScope System consists of camera heads, endoscopes, video system, light source and other ancillary equipment. ·
## Technological characteristics
The PeerScope GS video Gastroscope incorporates the following additional features compared to the predicate device:
| Category | Subject Device:<br>PeerScope GS<br>Gastroscope | Predicate Device<br>Gastrointestinal<br>Videoscope GIF<br>Type H180-<br>(K100584) | Impact of the differences<br>on device performance |
|-------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Direction of Views | Front and left (side) | Front only | Both designs utilize<br>standard front view. |
| Standard Field Of<br>View [degrees] | 160 | 140 | Both designs utilize<br>industry accepted standard<br>for Field Of View. |
| Wide Field Of View<br>[degrees] | 210 | Not included | The Presentation of the<br>wide view option is a<br>unique feature of the<br>PeerScope System feature<br>of the PeerScope System,<br>which is not included<br>EVIS EXERA II 180<br>System specifications. |
| Depth Of Field [mm] | 3-100 | 2-100 | Both designs utilize<br>industry accepted standard<br>for Depth Of Field. |
| Working Length [mm] | 1050 | 1030 | Both designs utilize<br>industry accepted standard<br>for Working Length |
| Distal tip Outer<br>Diameter [mm] | 10.5 | 9.8 | Both designs utilize<br>industry accepted standard<br>for Distal tip Outer<br>Diameter |
| Illumination Type | Integral LED<br>illumination | Examination lamp | Both systems utilize<br>accepted industry standard<br>for illumination |
PeerScope System Model HG Submission Section 5 - 510(k) Summary
Page 2 of 4
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| Category | Subject Device:<br>PeerScope GS<br>Gastroscope | Predicate Device:<br>Gastrointestinal<br>Videoscope GIF<br>Type H180<br>(K100584) | Impact of the differences<br>on device performance |
|--------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Narrow band<br>illumination | Not Included | Included | The narrow band<br>illumination is a unique<br>feature of The EVIS<br>EXERA II 180 System,<br>which is not included in<br>the PeerScope System<br>specifications. |
| Water Flow rate - lens<br>irrigation | 1.25 cc/sec | 0.9 cc/sec | Both systems utilize<br>accepted industry standard<br>for lens irrigation |
| Angulation Range<br>[degrees] | Up 210, Down 120<br>Left 120, Right 120 | Up 210, Down 90<br>Left 100, Right 100 | Both systems utilize<br>accepted industry standard<br>for Angulation Range |
Based on the results of verification and performance testing, the impact of the above differences is insignificant in terms of the device safety and effectiveness for the device intended use.
#### Performance data
#### Bench data:
Risk analysis was conducted in accordance with ISO 14971. Design verification tests and their acceptance criteria were identified, preformed and met.
Software validation was carried out in accordance with FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)".
Reprocessing validation was carried out in accordance with FDA Guidance Document "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft Guidance (May 2011)".
Device safety and performance were verified by EndoChoice Innovation Center Ltd. and accredited third party laboratories.
The following standards were used / relied upon for testing:
AAMI / ANSI ES 60601-1:2005/(R) 2012 and C1:2009/(R) 2012 AAMI / ANSI ES60601-1:2005/A1:2012 IEC 60601-1-2:2007 IEC 60601-2-18 Edition 3.0 2009-08 IEC 62304:2006 ISO 10993:2009 Part #1 ISO 10993:2009 Part #5 ISO 10993:2010 Part #10 ISO 10993:2007 Part #12 ISO 8600-1 Second edition 2005-05-01
PeerScope System Model HG Submission Page 3 of 4 Section 5 - 510(k) Summary
Rev 02
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ISO 8600-3 First edition 1997-07-01 ISO 8600-4 First edition 1997-07-01 ISO 8600-6 First edition 2005-03-15 ASTM E 1837- 96 (reapproved 2007)
#### Usubility Data:
Device Usability was carried out by means of testing within a clinical environment in a US medical center by five experienced GI physicians.
The conclusions drawn from the bench and usability tests demonstrate that the device meets its specifications, and supports a determination that the device is at least as safe and effective for its intended use as the predicate device.
#### Substantial Equivalence
The above presented data demonstrate that:
- The PeerScope System Model HG and the predicate device, EVIS EXERA II 180 હો. System have the same intended use and indications for use in upper digestive tract.
- The PeerScope System Model HG uses the same technologies used by the predicate b. PeerScope System Model H.
- The PeerScope System Model HG does not raise different questions of safety and C. effectiveness.
- The data provided collected by scientific acceptable methods, thus demonstrating d. equivalence and support the indications.
Conclusion: It is the opinion of EndoChoice Innovation Center Ltd. that the PeerScope system Model HG is substantially equivalent to the predicate devices, in terms of safety and effectiveness.
Page 4 of 4
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Giff Silver Spring, MI) 20993-0002
#### October 10, 2013
EndoChoice, Inc. % Tamar Fuerst RA Manager EndoChoice Innovation Center Ltd. 2 Hatochen Street, Business and Industrial Park (North), POB 3161 Caesarea Israel 38900
Re: K131422
> Trade/Device Name: PeerScope System (Model HG) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: 11 Product Code: FDS Dated: August 29, 2013 Received: September 9. 2013
Dear Tamar Fuerst.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
# Glenn BiBell -S
Acting for: 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): K l 31422
Device Name: PeerScope System (Model HG)
Indications for Use:
The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The PeerScope System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/6/Picture/10 description: The image shows the name "Glenn Bell -S" in a bold, sans-serif font. The letters "enn B" and "Bell" are partially obscured by a decorative design. The design appears to be a stylized emblem or logo, possibly related to the name itself.
PeerScope System Model HG Submission Section 4_Indication for Use Statement
Confidential Page I of I
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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.
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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.
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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.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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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.
