(60 days)
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 laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. 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.
The purpose of this submission is to seek clearance for an alternate Node component called the Smart Node (to be marketed as the Intelligent Surgical Unit (ISU)), which introduces enhanced image processing features and augments the endoscope movement capabilities of the TransEnterix® Senhance® Surgical System. The Smart Node adds three new methods of camera control for the surgeon operating at the Senhance Cockpit.
The provided text describes a 510(k) submission for the TransEnterix Senhance Surgical System with an alternate Node component called the Smart Node (marketed as the Intelligent Surgical Unit or ISU). This submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K192877).
However, the document does not contain the following information regarding acceptance criteria and a study proving the device meets those criteria:
- A table of acceptance criteria and the reported device performance: The document lists types of testing performed (Bench Testing, Electrical Safety and Compatibility, Software Verification and Validation, Pre-Clinical Design Validation, Usability Testing) and states that performance was evaluated and requirements were met, but it does not provide specific quantitative acceptance criteria or detailed reported performance values in a table.
- Sample size used for the test set and the data provenance: For the pre-clinical design validation and usability testing, it mentions "a single-center" and "users who represented the intended primary user population," but specific sample sizes for the test set are not provided. Data provenance is not explicitly mentioned beyond the type of model used (live porcine model for pre-clinical, simulated use for usability).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method: This information is not provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned. The device is a surgical system, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable in this context.
- Standalone performance: The document focuses on the integrated performance of the "Senhance Surgical System with Smart Node" and its comparison to the predicate device. It does not describe a standalone performance study of the Smart Node component in isolation, outside of specific functional tests.
- Type of ground truth used: For the pre-clinical design validation, it states it was conducted in a live porcine model, which "most closely represents the human anatomy," implying the physiological outcomes in this model served as validation. For usability, "user level requirements were assessed and found to be met," suggesting user feedback and task completion were the ground truth.
- Sample size for the training set: The document describes performance testing to support substantial equivalence for a new component (Smart Node) of an existing surgical system. It does not mention a "training set" in the context of machine learning model development. The software verification and validation are for "software modifications to support the subject Smart Node," not the training of a new AI model with a distinct training set.
- How the ground truth for the training set was established: As no training set is described for a machine learning model, this information is not applicable.
Summary of available information related to performance testing:
- Device: TransEnterix® Senhance® Surgical System with Smart Node (Intelligent Surgical Unit (ISU))
- Purpose of Submission: Seek clearance for an alternate Node component (Smart Node) that introduces enhanced image processing features and augments endoscope movement capabilities.
- Performance Tests Conducted:
- Bench Testing: Evaluated the performance of the Smart Node and the overall system, confirming compatibility, reliability, functionality, safety, and efficacy. (Specific criteria/results not provided).
- Electrical Safety and Compatibility: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18. (No specific numerical results/acceptance criteria given, just compliance statement).
- Software Verification and Validation Testing: Conducted on software modifications for the Smart Node, following FDA guidance for "major" level of concern software. (No specific test results/acceptance criteria given).
- Pre-Clinical Design Validation:
- Environment: Single-center, un-blinded, observational, simulated use design validation.
- Model: Live porcine model.
- Users: Users representing the intended primary user population.
- Ground Truth: Assessed user-level requirements; all found to be met.
- Sample Size/Provenance: Not specified beyond "single-center" and "live porcine model."
- Usability Testing:
- Modifications: Based on new Smart Node features.
- Study Type: Confirmatory summative study.
- Users: Performed by users in a simulated use environment.
- Ground Truth: Users were able to independently perform all critical tasks without use errors that would lead to harm.
- Sample Size/Provenance: Not specified.
Conclusion stated by the submitter: The performance testing supported the safety and functionality of the device and demonstrated that the device is substantially equivalent to the predicate device.
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March 9, 2020
TransEnterix, Inc. Kaitlyn Alexander Regulatory Affairs Manager 635 Davis Drive, Suite 300 Morrisville, North Carolina 27650
Re: K200049
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: January 9, 2020 Received: January 9, 2020
Dear Kaitlyn Alexander:
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
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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 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.
Long Chen, Ph.D. Assistant Director 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
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Indications for Use
510(k) Number (if known)
K200049
Device Name
TransEnterix® 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 laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. 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)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | □ Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
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510(K) SUMMARY
[In accordance with 21CFR 807.92]
| 1. Submitter | |
|---|---|
| 510(k) Sponsor: | TransEnterix, Inc. |
| Address: | 635 Davis Drive, Suite 300Morrisville, NC 27560 |
| Contact Person: | Kaitlyn AlexanderRegulatory Affairs Manager |
| Contact Information: | Email: kalexander@transenterix.comPhone: 919-765-8400 x8505Facsimile: 919.765.8459 |
| Date Summary Prepared: | 01/09/2020 |
| 2. Device | |
| Proprietary (Trade) Name: | Senhance® Surgical System |
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Classification: | Class II |
| Classification AdvisoryCommittee: | General and Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument) |
| 3. Predicate Device: | |
| Predicate Device | Senhance® Surgical System (K192877) |
| Reference Device | AutoLap System (K152848) |
4. Device Description:
The purpose of this submission is to seek clearance for an alternate Node component called the Smart Node (to be marketed as the Intelligent Surgical Unit (ISU)), which introduces enhanced image processing features and augments the endoscope movement capabilities of the
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TransEnterix® Senhance® Surgical System. The Smart Node adds three new methods of camera control for the surgeon operating at the Senhance Cockpit.
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 laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inquinal hernia repair. 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 Surgical System with Smart Node has the same intended use/ indications for use as previously cleared for the predicate Senhance Surgical System (K192877).
6. Summary of Technological Characteristics:
The subject device has the same basic technological characteristics as the predicate Senhance Surgical System (K192877). In sum, the subject and predicate devices involve roboticallyassisted tele-operation as the primary technological principle. It is based on the accurate translation of user input to a robotically assisted output. It involves the use of endoscopic instrumentation for manipulation of tissue and vessels in the insufflated body cavity. The device consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor to display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscope, based on inputs from the surgeon; node, which is the system communication hub, connecting the cockpit and manipulator arms: and instruments, which manipulate the tissue of interest. The Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation.
In addition, force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, other than using their hands. The Senhance Smart Node allows for three new optional methods of camera control, in addition to the optional eye tracking method.
Performance testing demonstrated that the technological differences between the Senhance Surgical System with Smart Node and the predicate device did not raise any different questions of safety or effectiveness.
7. Performance Data:
Performance testing of the Senhance system with Smart Node was conducted to support the substantial equivalence to the predicate device. The following performance tests were conducted:
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Bench Testing: Bench testing evaluated the performance of the Senhance Smart Node as well as the overall use of the Senhance Surgical System with Smart Node. The following tests confirmed that the Senhance system and the Smart Node perform as intended after tests of compatibility, reliability, functionality, safety, and efficacy.
Electrical Safety and Compatibility: The Senhance Surgical System with Smart Node comply with the current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), and IEC 60601-2-18 (Endoscopic equipment interactions).
Software Verification and Validation Testing: Software verification and validation were conducted on the Senhance system software modifications to support the subject Smart Node. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Controlled in Medical Devices" and "Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The software was considered as a "major" level of concern.
Pre-Clinical Design Validation: Design validation of the Senhance system with Smart Node was conducted to ensure that the device performs as intended according to defined user needs and intended use in a simulated use environment. A single-center, un-blinded, observational, simulated use design validation evaluation of the Senhance system was conducted with users who represented the intended primary user population. The design validation was conducted in a live porcine model, which most closely represents the human anatomy for the given procedures. All 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 new features and functionality of the Smart Node. A confirmatory summative study was performed with final instructions and training materials. In a simulated use environment, the users were able to independently perform all critical tasks without use errors that would lead to harm.
8. Conclusions
The Senhance Surgical System with Smart Node is as safe and effective as the predicate Senhance Surgical System (K192877). The subject device has the same intended uses/ indications for use and similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the subject device and predicate device raise no different questions of safety or effectiveness. The performance testing supported the safety and functionality of the device and demonstrate that the device is substantially equivalent to predicate device.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.