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, cholecystectorny, 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.

Device Description

The Senhance 3 mm bipolar surgical instruments and adapters are additions to the suite of bipolar instruments and adapters previously cleared for use with the Senhance Surgical System (K181517). The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter. All instruments and adapters are multi-use devices that are steam sterilized by the end user before the first use and after each use. The Senhance 3 mm bipolar instruments include:

. Bipolar Maryland Dissector – diameter 3 mm / length 280 mm
. Bipolar Grasping Forceps - diameter 3 mm / length 280 mm

AI/ML Overview

This document describes the 510(k) summary for the TransEnterix Senhance Surgical System, focusing on the acceptance criteria and study proving its substantial equivalence to a predicate device. This is primarily a regulatory submission, so instead of typical "AI/ML model" performance metrics, the "acceptance criteria" here refer to meeting performance standards that demonstrate safety and effectiveness for a medical device, particularly in comparison to a previously cleared device.

Given the nature of the provided document, which is a 510(k) summary for a surgical instrument, many typical AI/ML study components (like expert consensus for ground truth, MRMC studies, training set details) are not applicable. The device is a surgical instrument system, not an AI diagnostic algorithm.

Here's an interpretation of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) for new instruments within an existing surgical system, the acceptance criteria are generally to demonstrate that the new instruments (3mm bipolar) perform as intended, are safe and effective, and do not raise new questions of safety or effectiveness compared to predicate devices. The performance is reported in terms of successful completion of various tests.

Acceptance Criteria (General Goal)	Reported Device Performance
Mechanical Integrity / Intended Performance (Simulated Use)	Demonstrated that the devices perform as intended when subjected to tests of mechanical integrity under conditions of simulated use, including: Cantilever Bending Reliability Testing Instrument Jaw Output Force Reliability Testing and Jaw Force to Failure Testing Bipolar Jaw Spreading Force
Electrosurgical Unit (ESU) Compatibility	Demonstrated that all third-party ESUs compatible with the Senhance Surgical System are also compatible with the 3mm bipolar instruments and adapters. Testing compared the rated voltage of the instruments with each ESU's manufacturer settings.
Reprocessing/Cleaning Effectiveness	A cleaning effectiveness validation study confirmed the overall effectiveness of the prescribed cleaning procedures. Test results demonstrated that cleaning procedures for the 3mm bipolar adapters allow them to be effectively cleaned according to instructions.
Sterilization Efficacy	Validation of the steam sterilization process for the 3mm bipolar adapters demonstrated a Sterility Assurance Level (SAL) of at least 10^-6.
Electrical Safety Compliance	The 3mm bipolar instruments and adapters fulfilled all applicable requirements to demonstrate compliance with the current electrical safety standard, IEC 60601-2-2:2017 (Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories).
Software Compatibility and Reliability (with new instruments)	Software testing demonstrated that the Senhance system software continues to reliably operate as designed with the addition of the new instruments and adapters.
Design Validation (Performance in Simulated Clinical Environment) / Substantial Equivalence to Predicate	Design Validation was conducted in a porcine model (simulating key human anatomy) using production-equivalent instruments and adapters in a simulated use environment. This supported that the instruments perform as intended according to defined user needs and intended uses, and are substantially equivalent to the predicate devices (K181517), not raising any new issues of safety or effectiveness. The intended use/indications for use are identical to the predicate.

2. Sample size used for the test set and the data provenance:

Sample size: The document does not specify a numerical sample size for individual tests like mechanical testing or ESU compatibility, but indicates "testing" was conducted. For "Design Validation," it states "a porcine model" was used, implying more than one animal or multiple procedures within one animal, but no specific count is provided.
Data Provenance: The origin of the data is from in-house testing conducted by TransEnterix, Inc. The studies appear to be prospective for the purpose of this 510(k) submission, specifically designed to test the new 3mm bipolar instruments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable in the context of this device and study type. The "ground truth" here is established by engineering and medical device performance standards (e.g., successful mechanical function, proper sterilization, electrical safety compliance) rather than expert interpretation of medical images or diagnoses. The "Design Validation" involved simulating use, implying evaluation by qualified personnel, but "experts" in the sense of clinical reviewers for ground truth is not relevant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This type of adjudication method is common in studies involving human interpretation (e.g., radiology reads), not for performance testing of a surgical instrument.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a surgical instrument, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device isn't an algorithm. Its performance is inherent to its mechanical, electrical, and material properties, and its interaction with the Senhance Surgical System.

7. The type of ground truth used:

The "ground truth" is based on:

Engineering specifications and performance standards (e.g., force measurements, voltage ratings, mechanical integrity).
Validated regulatory standards (e.g., IEC 60601-2-2 for electrical safety, established SAL for sterilization).
Demonstrated functionality in a simulated use environment (porcine model) comparing to the established performance of predicate devices.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML model that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. No training set for an AI/ML model.

Summary

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December 6, 2018

TransEnterix, Inc. Michele Jans Sr. Manager, Regulatory Affairs 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560

Re: K183098

Trade/Device Name: TransEnterix Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: November 6, 2018 Received: November 7, 2018

Dear Michele Jans:

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 H. Chen Digitally signed by Long
H. Chen -S Date: 2018.12.06 12:49:08 -5 -05'00' for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183098

Device Name TransEnterix® SenhanceTM 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, cholecystectorny, 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 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Senhance 3 mm Bipolar Surgical Instruments and Adapters

[In accordance with 21CFR 807.92]

510(k) Sponsor:	TransEnterix, Inc.
Address:	635 Davis Drive, Suite 300Morrisville, NC 27713
Contact Person:	Michele JansSr. Manager, Regulatory Affairs
Contact Information:	Email: mjans@transenterix.comPhone: 919.765.8420Facsimile: 919.765.8459
Date Summary Prepared:	12/5/2018
Proprietary (Trade) Name:	TransEnterix® Senhance™ Surgical System
Common Name:	Endoscopic Instruments and Accessories
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)
Predicate Devices:	TransEnterix® Senhance™ Surgical System (K181517)
Reference Devices	Bissinger Powergrip Bipolar Coagulation Forceps (K033177)TransEnterix® Senhance™ Surgical System (K171120)

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Device Description:

. Bipolar Maryland Dissector – diameter 3 mm / length 280 mm
. Bipolar Grasping Forceps - diameter 3 mm / length 280 mm

Intended Use/ Indications for Use:

Comparison with Predicate Device Intended Use/ Indications for Use:

The Senhance 3 mm bipolar instruments and adapters have the same intended use/ indications for use as previously cleared for the Senhance system under K181517. There are no differences in how the 3mm bipolar devices are used that alter the Senhance system's therapeutic effect or raise different questions of safety or effectiveness.

Technological Characteristics:

The Senhance 3 mm bipolar instruments and adapters are very similar to the predicate devices cleared under K181517, with differences in diameter, length, and voltage ratings. The patient contacting instruments are made of the same biocompatible materials as the Reference devices.

Performance Data:

Performance testing of the Senhance 3 mm bipolar instruments and adapters was conducted to support substantial equivalence to the predicate device and demonstrated that the technological differences between the 3 mm bipolar instruments and adapters and the predicate devices did not raise any different questions of safety or effectiveness.

Testing and evaluation included mechanical verification of cleaning and sterilization, electrical safety, electrosurgical unit compatibility, software verification, and design validation.

The 3 mm bipolar devices are cleaned and sterilized in the same way as the predicate devices. Due to the similarity of the subject devices to the predicate devices, no other testing was necessary.

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The testing conducted for the devices in this submission is summarized below:

Bench Testing:

Test	Summary
Mechanical VerificationTesting for 3 mm BipolarInstruments and Adapter	Demonstrated that the devices perform as intended when subjected to tests ofmechanical integrity under conditions of simulated use.Cantilever Bending Reliability Testing Instrument Jaw Output Force Reliability Testing and Jaw Force toFailure Testing Bipolar Jaw Spreading Force
Verification of ESUCompatibility	Demonstrated that all third-party electrosurgical units (ESUs) that arecompatible with the Senhance Surgical System are also compatible with the 3mm bipolar instruments and adapters. Testing compared the rated voltage ofthe instruments with each ESU's manufacturer settings.

Reprocessing, Cleaning, and Sterilization:

Test	Summary
Reprocessing/ Cleaning	A cleaning effectiveness validation study was conducted consistent with theprocedures and protocols utilized for the previously cleared adapters used withthe Senhance Surgical System to confirm the overall effectiveness of theprescribed cleaning procedures. The test results demonstrated that thecleaning procedures for the 3 mm bipolar adapters allow them to be effectivelycleaned according to the processing instructions provided in the labeling.
Sterilization	A validation of the steam sterilization process for the 3 mm bipolar adapterswas conducted to demonstrate a Sterility Assurance Level (SAL) of at least $10^{-6}$ .

Test

Summary

Reprocessing/ Cleaning

A cleaning effectiveness validation study was conducted consistent with theprocedures and protocols utilized for the previously cleared adapters used withthe Senhance Surgical System to confirm the overall effectiveness of theprescribed cleaning procedures. The test results demonstrated that thecleaning procedures for the 3 mm bipolar adapters allow them to be effectivelycleaned according to the processing instructions provided in the labeling.

Sterilization

A validation of the steam sterilization process for the 3 mm bipolar adapterswas conducted to demonstrate a Sterility Assurance Level (SAL) of at least $10^{-6}$ .

Electrical Safety and Compatibility:

Test	Summary
Electrical Safety Testing	The 3 mm bipolar instruments and adapters fulfilled all applicable requirementsto demonstrate that the instruments are compliant with the current electricalsafety standard, IEC 60601-2-2:2017, Medical electrical equipment Part 2-2:Particular requirements for the basic safety and essential performance of highfrequency surgical equipment and high frequency surgical accessories.

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Software:

Test	Summary
Software	Software testing was conducted to demonstrate that the Senhance systemsoftware continues to reliably operate as designed with the addition of the newinstruments and adapters.

Design Validation:

Test	Summary
Design Validation	Design Validation was conducted to ensure that the subject 3 mm bipolarinstruments and adapters perform as intended according to defined user needsand intended uses, and to support substantial equivalence to the predicatedevices cleared under K181517. The design validation was conducted in aporcine model, which was used to simulate key human anatomy. This validationused production-equivalent instruments and adapters in a simulated useenvironment,

Test

Summary

Design Validation

Design Validation was conducted to ensure that the subject 3 mm bipolarinstruments and adapters perform as intended according to defined user needsand intended uses, and to support substantial equivalence to the predicatedevices cleared under K181517. The design validation was conducted in aporcine model, which was used to simulate key human anatomy. This validationused production-equivalent instruments and adapters in a simulated useenvironment,

Conclusions/ Substantial Equivalence:

The data acquired from the performance testing and software testing of the Senhance 3 mm bipolar instruments and adapters, as summarized herein, demonstrate that the devices are as safe and effective and perform similarly to the predicate devices cleared under K181517. The intended use/ indications for use for the subject devices are identical to those cleared under K181517. The Senhance 3 mm bipolar instruments and adapters do not raise any new issues of safety or effectiveness when compared to the predicate devices, thus, they are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.