The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
Device Story
Senhance Surgical System is a robotically-assisted platform for laparoscopic surgery. Surgeon operates from a cockpit outside the sterile field, using hand/eye movements to control manipulator arms. System includes cockpit, manipulator arms, and Intelligent Surgical Unit (ISU). New articulating platform adds motorized adapter and single-use articulating instruments (Bipolar Atraumatic Grasper, Needle Driver) to provide additional degrees of freedom (up to 65-degree bend) at the distal tip, simulating human wrist motion. Adapter uses RFID for instrument identification and display on cockpit monitor. System integrates with third-party electrosurgical units (ESUs) via direct cable connection to instruments. Output is real-time endoscopic visualization and precise instrument control, enabling complex tasks like suturing and dissection. Benefits include enhanced range of motion and dexterity for minimally invasive procedures.
Clinical Evidence
No clinical data. Evidence consists of bench testing (mechanical integrity, jaw actuation, ESU compatibility), biocompatibility (ISO 10993-1), sterilization validation (ISO 11137, ISO 17665), electrical safety (IEC 60601 series), and a simulated-use design validation study with surgical teams to confirm usability and risk mitigation.
Technological Characteristics
System comprises cockpit, manipulator arms, and ISU. Articulating platform uses motorized adapter with RFID identification. Instruments: 5mm diameter, 310mm shaft, stainless steel/biocompatible plastics. Connectivity: Networked components, ESU integration via bipolar cables. Software: Version 2.5.3.14, major level of concern. Sterilization: Gamma irradiation (instruments), steam (coupler). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-2, ISO 10993, ISO 11137, ISO 17665.
Indications for Use
Indicated for adult patients undergoing general laparoscopic or laparoscopic gynecological surgical procedures requiring tissue manipulation, visualization, and endoscopic instrument control.
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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Asensus Surgical, Inc. Taylor Fisher Program Manager 1 TW Alexander Drive, Suite 160 Durham, North Carolina 27703
#### Re: K211325
Trade/Device Name: Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: April 30, 2021 Received: April 30, 2021
#### Dear Taylor Fisher:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark Trumbore Ph.D. Acting Assistant Director THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known)
Device Name Senhance® Surgical System
#### Indications for Use (Describe)
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
Type of Use (Select one or both, as applicable)
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K211325
## 510(k) Summary
[In accordance with 21CFR 807.92]
## 1. Submitter
Reference Device:
| 510(k) Sponsor: | Asensus Surgical, Inc. |
|------------------------------------|------------------------------------------------------------------------------------|
| Address: | 1 TW Alexander Drive, Suite 160<br>Durham, NC 27703 USA |
| Contact Person: | Taylor Fisher<br>Program Manager |
| Contact Information: | Email: tfisher@asensus.com<br>Phone: +1 919.765.8400<br>Facsimile: +1 919.765.8459 |
| Date Summary Prepared: | 7/12/2021 |
| 2. Device | |
| Proprietary (Trade) Name: | Senhance® Surgical System |
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Classification: | Class II |
| Classification Advisory Committee: | General and Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument |
| 3. Predicate and Reference Devices | |
| Predicate Device: | Senhance® Surgical System (K202166) |
Intuitive Surgical EndoWrist Instruments (K081137)
{4}------------------------------------------------
### 4. Device Description:
The Senhance Articulating platform is intended as an addition to the suite of instruments and adapters previously cleared for use with the Senhance® Surgical System ("Senhance system"). These instruments add degrees of freedom near the instrument end effector to allow for additional range of motion for the surgeon when performing laparoscopic tissue manipulations. Two articulating instruments are being added to the suite of instruments –Bipolar Atraumatic Grasper and Needle Driver. The instruments are single use and provided sterile to the end user. The instruments connect to a coupler which in turn connects to the articulating adapter which attaches to the Senhance Manipulator Arm.
## 5. Intended Use/ Indications for Use:
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic qynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
## Comparison with Predicate Device Intended Use/ Indications for Use:
The Senhance Articulating platform has the identical intended use and indications for use as predicate Senhance Surgical System (K202166).
## 6. Summary of Technological Characteristics:
The substantial equivalence comparison below shows that the subject Senhance Articulating platform is very similar to the predicate Senhance Surgical System. Many of the subject device's technological characteristics and principles of operation are identical or similar to those of the predicate. Furthermore, a comparison of the subject articulating instruments to a reference device (Intuitive Surgical EndoWrist Instruments, K081137) shows that both the subject and reference devices have similarities in their dimensions and design. Any differences in technological characteristics between the subject and predicate devices have been addressed through a comprehensive set of testing using established test methods and do not raise any different questions of safety and effectiveness.
| Characteristic | Subject Device | Predicate Device |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Senhance Articulating Platform for use<br>with the Senhance Surgical System | Senhance Surgical System<br>K202166 |
| Capital<br>Equipment | The subject Senhance system is<br>comprised of three main components:<br>cockpit, manipulator arms, and ISU. | The subject Senhance system is<br>comprised of three main components:<br>cockpit, manipulator arms, and ISU. |
| Characteristic | Subject Device | Predicate Device |
| | Cockpit – positioned outside the sterile<br>field, is where the surgeon inputs<br>information through hand and eye<br>movements to direct the motion of the<br>manipulator arms in the surgical field.<br>The surgeon manipulates two cockpit<br>handles to transmit position and jaw<br>actuation movements to the manipulator<br>arms. | Cockpit - positioned outside the sterile<br>field, is where the surgeon inputs<br>information through hand and eye<br>movements to direct the motion of the<br>manipulator arms in the surgical field.<br>The surgeon manipulates two cockpit<br>handles to transmit position and jaw<br>actuation movements to the manipulator<br>arms. |
| | Manipulator Arms - the independent,<br>mechanical support arms that interface<br>with the endoscope and surgical<br>instruments. The manipulator arms<br>produce output movements based on the<br>input movement from the surgeon at the<br>cockpit. The Senhance system is<br>configurable with up to three manipulator<br>arms. Each manipulator arm has a total<br>of six joints: three joints that allow the<br>surgical team to grossly position each<br>manipulator arm above the operating<br>table and three joints for positioning of<br>the instrument interface.<br>The connector in the center of the<br>instrument interface has been removed<br>and a connection port was added to<br>power the new articulating motorized<br>adapter while maintaining the sterile field. | Manipulator Arms - the independent,<br>mechanical support arms that interface<br>with the endoscope and surgical<br>instruments. The manipulator arms<br>produce output movements based on the<br>input movement from the surgeon at the<br>cockpit. The Senhance system is<br>configurable with up to three manipulator<br>arms. Each manipulator arm has a total<br>of six joints: three joints that allow the<br>surgical team to grossly position each<br>manipulator arm above the operating<br>table and three joints for positioning of<br>the instrument interface. |
| | ISU - the communication hub that<br>connects the cockpit inputs to the<br>manipulator arms. The Smart Node<br>contains a high-performance PC that<br>enables the surgeon to command<br>endoscopic motion using software<br>features that apply image processing<br>algorithms to the endoscope video signal. | ISU - the communication hub that<br>connects the cockpit inputs to the<br>manipulator arms. The Smart Node<br>contains a high-performance PC that<br>enables the surgeon to command<br>endoscopic motion using software<br>features that apply image processing<br>algorithms to the endoscope video signal. |
| Surgeon Controls | Touchpad, keyboard, clutch pedal,<br>handles, eye tracker.<br>The trigger/tilt button on the cockpit<br>handle is used to activate articulation of<br>the instrument. The instrument is<br>articulated by rotating the handles about<br>the yaw axis. | Touchpad, keyboard, clutch pedal,<br>handles, eye tracker |
| Software<br>Architecture | Four software subsystems: LTM, ARM,<br>RHMI, SNIP | Four software subsystems: LTM, ARM,<br>RHMI, SNIP |
| Software Version | Senhance Software Version 2.5.3.14 | Senhance Software Version 2.5.0.22 |
| Characteristic | Subject Device | Predicate Device |
| Instrument<br>Adapters | A new motorized articulating adapter that<br>attaches to the manipulator arm and<br>drives articulation (or "tilt") and rotation of<br>the instrument tip ("roll"). Jaw actuation is<br>the same as the predicate. The<br>articulating adapter is covered by a<br>sterile, disposable drape before each use<br>like the Senhance capital equipment.<br><br>A new reusable articulating coupler that<br>connects the articulating instruments to<br>the articulating adapter.<br><br>The articulating adapter is uniquely<br>matched to the articulating instruments.<br>The adapter has an embedded RFID tag<br>which is used by the manipulator arm to<br>identify which adapter is attached to the<br>instrument interface. This allows the icon<br>representing the instrument type to be<br>displayed to the surgeon on the functions<br>area of the cockpit monitor. | Five (5) different types of reusable<br>instrument adapters that connect to the<br>Senhance Surgical Instruments and<br>attach to the manipulator arm(s): passive<br>(non-energized), monopolar, bipolar,<br>ultrasonic, and endoscope.<br><br>Each adapter is uniquely matched to<br>each instrument or endoscope. Each<br>adapter has an embedded RFID tag<br>which is used by the manipulator arm to<br>identify which adapter is attached to the<br>instrument interface. This allows the icon<br>representing the instrument type or<br>endoscope to be displayed to the<br>surgeon on the functions area of the<br>cockpit monitor. |
| Equipment<br>Drapes | Single use, sterile equipment drapes<br>cover the manipulator arm and<br>instrument interface. The drapes are<br>classified as Class 2, 510(k)-exempt<br>devices under product code PUI.<br><br>A new single use, sterile, articulating<br>adapter drape pack is provided to cover<br>and connect the instrument interface and<br>articulating adapter during use. The<br>drapes are classified as Class 2, 510(k)-<br>exempt devices under product code PUI. | Single use, sterile equipment drapes<br>cover the manipulator arm and<br>instrument interface. The drapes are<br>classified as Class 2, 510(k)-exempt<br>devices under product code PUI. |
| Surgical<br>Instruments | Two new single use, sterile, laparoscopic<br>articulating instruments with an<br>articulating design at the distal tip that<br>simulates the human wrist. The<br>articulating instruments can bend up to<br>65 degrees when fully articulated.<br><br>Bipolar Atraumatic Grasper,<br>Articulating - 5mm diameter x<br>310mm shaft length Needle Driver, Articulating - 5mm<br>diameter x 310mm shaft length | A suite of reusable, laparoscopic<br>Senhance Surgical Instruments available<br>in a variety of sizes (diameters and<br>lengths), end effector designs, and<br>energy (passive, monopolar, bipolar,<br>ultrasonic) including:<br><br>Bipolar Large Grasping Forceps -<br>5mm diameter x 310mm shaft length Needle Holder Left/Right - 5mm<br>diameter x 310mm shaft length |
| Biocompatibility | The instruments are made from<br>biocompatible metals and plastics with a<br>long history of safe use and<br>demonstrated to be non-toxic, non- | The instruments are made from<br>biocompatible metals and plastics with a<br>long history of safe use and<br>demonstrated to be non-toxic, non- |
| Characteristic | Subject Device | Predicate Device |
| | irritating, non-sensitizing, and non-pyrogenic. | irritating, non-sensitizing, and non-pyrogenic. |
| Instruments<br>Rated Voltage | 5mm Bipolar Articulating Instrument @ 250 Vpeak | 5mm Bipolar Instruments @ 500 Vpeak |
| Compatible<br>Electrosurgical<br>Units (ESUs) | Compatible third-party ESUs include: Erbe VIO® 300 D Covidien ForceTriad™ Covidien/Valleylab Force FX™ CONMED System 5000™ The ESU connects directly to the articulating instrument using a bipolar ESU accessory cable, rather than to the adapter like with the predicate. The ESU is operated in the usual manner by the ESU's foot pedal positioned near the surgeon at the cockpit. There is no communication between the Senhance system and any ESU. | Compatible third-party ESUs include: Erbe VIO® 300 D Covidien ForceTriad™ Covidien/Valleylab Force FX™ CONMED System 5000™ ESUs connect to the adapters through monopolar or bipolar cables and provide energy directly to the instruments. The ESU is operated in the usual manner by the ESU's foot pedal positioned near the surgeon at the cockpit. There is no communication between the Senhance system and any ESU. |
#### Table 1. Substantial Equivalence Comparison
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
| | | Table 2. Reference Device Comparison | | | |
|--|--|--------------------------------------|--|--|--|
|--|--|--------------------------------------|--|--|--|
| Characteristic | Subject Device | Reference Device |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Senhance Articulating Instruments | Intuitive Surgical EndoWrist Instruments<br>for use with da Vinci Si Surgical System/<br>IS3000 (K081137) |
| Instrument<br>Classification | Single Use Disposable (Gamma<br>Sterilization) | Reusable, programmed with a maximum<br>number of surgical procedures. They<br>must be cleaned, and steam sterilized by<br>the end user between uses. |
| Articulated<br>Instrument Types<br>and Dimensions | Two laparoscopic articulating instruments<br>with an articulating design at the distal tip<br>that simulates the human wrist:<br>Bipolar Atraumatic Grasper,<br>Articulating - 5mm diameter x<br>310mm shaft length Needle Driver, Articulating - 5mm<br>diameter x 310mm shaft length | A variety of articulating instruments<br>consisting of graspers, dissectors,<br>needle drivers, scissors, monopolar<br>energy, bipolar energy, and clip appliers.<br>The EndoWrist instruments have an<br>articulating design at the distal tip that<br>simulates the human wrist and include:<br>Bipolar grasper – 8mm diameter x<br>~310mm shaft length) Need driver – 8mm diameter x<br>~310mm shaft length |
| Degrees of<br>Articulation | 0 degrees (straight) to 65 degrees (fully<br>articulated) | 0 degrees (straight) to 90 degrees (fully<br>articulated) |
{8}------------------------------------------------
#### 7. Performance Data:
The following performance testing of the Senhance Articulating platform was conducted to demonstrate substantial equivalence of the device to the predicate.
Biocompatibility Testing: The Senhance Articulating instruments are considered tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone. The articulating instruments were assessed in accordance with the FDA Guidance for Industry and FDA Staff on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". Testing demonstrated that the patient-contacting portions of the Senhance Articulating instruments are non-toxic, non-irritating, non-sensitizing, and nonpyrogenic and do not result in an unacceptable adverse biological response resulting from contact of the devices' materials with the body.
Reprocessing, Cleaning, and Sterilization: The reusable coupler has cleaning instructions that were validated based on the quidelines outlined in AAMI TIR30:2011. A steam sterilization validation study was conducted in accordance with the FDA's Guidance for Industry and FDA Staff "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and the FDA recognized consensus standards ANSI/AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013. The coupler was validated to a Sterility Assurance Level of 10-6 using the half cycle testing validation method.
The articulating adapter is non-sterile capital equipment and is used with a sterile equipment drape. The drape remains intact throughout the procedure and thereby maintains a sterile barrier. A cleaning compatibility study confirmed that the agents used during cleaning/disinfection are compatible with the materials of construction and markings of the adapter.
The single use articulating instruments are provided sterile to the end user via gamma irradiation. Gamma irradiation at a minimum dose of 25 kGy was validated per FDA recognized consensus standards ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3:2017 and demonstrated a Sterility Assurance Level of 10°. The packaging has been validated to maintain sterility for the stated shelf life of the device.
Bench Testing: Bench testing evaluated the performance of the Senhance Articulating instruments as well as compatibility of the Senhance Articulating platform when used with the Senhance Surgical System. The following tests confirmed that the articulating instruments perform as intended after tests of mechanical integrity under conditions of simulated use and that the Senhance system performs as intended when used with the subject Senhance Articulating platform:
- Cantilever Bending Reliability .
- . Jaw Actuation Reliability
{9}------------------------------------------------
- . Jaw Compensation
- . Electrosurgical Unit (ESU) Compatibility
- Sterile Drape Reliability
Electrical Safety and Compatibility: The Senhance Articulating platform used in conjunction with the Senhance system comply with the current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-2-18 (Endoscopic equipment interactions), and IEC 60601-2-2 (High frequency surgical equipment).
Software Verification and Validation Testing: Software verification and validation were successfully conducted on the latest Senhance software version that supports the Senhance Articulating platform. Documentation was provided as recommended in FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software is considered as a "major" level of concern.
Pre-Clinical Design Validation: Design validation of the Senhance Articulating platform was conducted to ensure that the devices perform as intended according to defined user needs and intended uses when used with the Senhance system in a simulated use environment. A singlecenter, un-blinded, observational, simulated use design validation evaluation of the Senhance system used in conjunction with Senhance Articulating platform was conducted with users who represented the intended primary user population. The design validation was conducted in a simulated patient model. All applicable user level requirements were assessed and found to be met.
Usability Testing: Modifications to the existing Senhance system Usability Engineering file were made based on the addition of the new articulating platform. A summative usability validation study was performed with final instructions for use and training materials. In a simulated use environment, the surgical teams were able to independently perform all critical tasks without use errors that would lead to harm. This study demonstrated that the overall residual risk of use errors with the Senhance Articulating platform have been mitigated to an acceptable level. The Senhance Articulating platform used in conjunction with the Senhance system can be used without use errors or problems that could result in serious harm.
## Conclusions
The Senhance Articulating platform used with the Senhance Surgical System is as safe and effective as the predicate Senhance Surgical System (K202166). The subject device has the same intended use/ indications for use and either identical or very similar technological characteristics and principles of operation as the predicate device. Any differences in technological characteristics between the subject and predicate devices have been addressed through a comprehensive set of testing using established test methods and do not raise any new or different questions of safety or effectiveness. Thus, the equivalence assessment and testing results support a determination of substantial equivalence to the predicate in terms of safety, efficacy, and performance.
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
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.
