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.

Device Description

The Senhance Surgical System is a console-based, multi-arm surgical system, which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows:

. Cockpit - The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field.
. Manipulator Arms - Independent mechanized support arms that interface with the endoscope and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms.
Node A relay unit that connects the cockpit inputs to the manipulator arms in the system as configured, ● and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.

AI/ML Overview

The provided text describes the TransEnterix Senhance Surgical System and its 510(k) submission (K180163) for expanding its indications for use to include inguinal hernia repair and cholecystectomy procedures. The document aims to demonstrate substantial equivalence to a predicate device (Senhance Surgical System, K171120) and reference devices (Intuitive Surgical da Vinci Xi Surgical System).

However, the provided document does not contain information about acceptance criteria in the form of a table or specific metrics for device performance (e.g., sensitivity, specificity, accuracy, or any quantifiable clinical endpoints with associated thresholds). Instead, it presents comparative clinical data from case series for the new indications against published literature data for predicate and reference devices, and standard laparoscopic techniques. The "acceptance criteria" appear to be implicit in the comparative study outcomes, where the Senhance System's performance is deemed "similar," "comparable," or "as safe and effective" as the comparators.

Therefore, I cannot generate a table of acceptance criteria and reported device performance as requested, because specific, quantitative acceptance criteria are not explicitly stated in the provided text for these procedures for the Senhance Surgical System.

I will, however, provide the available information regarding the studies and ground truth, addressing as many points of your request as possible based only on the provided text.

Here's a summary of the study information based on the provided text:

Study Information for TransEnterix Senhance Surgical System (K180163) - Expansion for Cholecystectomy and Inguinal Hernia Repair

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, specific quantitative acceptance criteria are not explicitly stated in the provided document. The document describes a comparative approach where the Senhance System's clinical outcomes are compared to published literature data from predicate/reference robotic systems and traditional laparoscopic techniques. The "acceptance" is implicitly based on achieving "comparable" or "similar" outcomes, indicating "as safe and effective."

Below are the outcomes reported for the Senhance System and comparators, which form the basis of the substantial equivalence claim.

Outcome Measure	Senhance - Cholecystectomy (Imperial College, N=20)	Senhance - Cholecystectomy (Hamburg University, N=20)	Reference da Vinci System - Cholecystectomy (N=1435)	Laparoscopic arm from meta-analysis (Huang et al) - Cholecystectomy (N=921)
Complication Non-serious (Clavien Dindo I-II)	6, 30%	0	0-25%	Not Reported
Serious Complication (Clavien Dindo III)	0	0	0-4%	0-10%
Estimated Blood Loss (mL)	Minimal	Not Reported	Not Reported	12-14 mL
Intra-op Adverse Events / Complications	1 (intraop bleeding), 5%	0	0-5%	0-33.3%
Transfusions (%)	0	0	0-2%	0
Mortality (%)	0	0	0-0.5%	0
Conversion to Laparoscopy (%)	1, 5%	1, 5%	0-12.5%	N/A
Conversion to Open (%)	0	0	unknown	0-15.7%
Reoperation rates (%)	0	0	0-4%	Not Reported
Readmission rates (%)	3, 15%	0	0-4%	0-4.3%
Median Operative Time in min (range)	86.5 (44-129)	71.5 (34-197)	91.7 (50-152)	115.3 (65-141)
Hospital Length of Stay (days)	0 (1 pt remained overnight)	2**	1-5	2.2 (range 1.0-5.1)

Outcome Measure	Senhance System - Inguinal Hernia Repair (N=64)	Reference da Vinci System - Inguinal Hernia Repair (N=652)	Laparoscopic Cohort - Inguinal Hernia Repair (N=3457)
Mean age, (y ± SD or range)	54.5 ± 16.3	55.8 ± 15.6	34.91 - 62.3
Female, n (%) or % range	10 (15.6%)	64 (9.8%)	0 - 6.1%
Mean BMI, kg/m2 (± SD) or range	25.9 ± 3.1	27.3 ± 5.1	22.4 - 26.8
Length of Stay - Inpatient (days)	1.04 ± 0.2 days†	3.01 ± 4.65 (n=52)	0.8 - 5 days
Length of Stay - Outpatient (hours)	n/a	7.16 ± 3.01
Intraoperative Complications, n (%)	0 (0%)	2 (0.3%)	0 - 8%
Transfusions - Intraoperative	0	0	Not Reported
Transfusions - Perioperative	0	2 (0.3%)
Postoperative Complications, n (%)	1 (1.6%)	15 (2.3%)	0-36% (reported as total time period)
Readmission Rates, n (%)	0	23 (3.5%)	Not Reported
Reoperation Rates, n (%)	0 (Postop to discharge) / 0 (Post discharge to 30 days)	3 (0.5%) (Postop to discharge) / 0 (Post discharge to 30 days)	0-2.5% (reported as total time period)
Mortality, n	0	0	0
Operative Time, min, avg ± SD/range (Unilateral)	44 ± 17.4	79.7 ± 31.7	32.6 - 110
Operative Time, min, avg ± SD/range (Bilateral)	79 ± 23.7
All Complications, n (%)	1 (1.6%)	45 (6.9%)	7.9 – 8.7%

2. Sample Sizes and Data Provenance:

Cholecystectomy Test Set:
- Senhance System: 40 patients (20 from Imperial College, 20 from Hamburg University). Data provenance: Retrospective chart reviews. Country of origin for the Senhance data is not explicitly stated beyond "Imperial College" and "Hamburg University," implying data from UK and Germany, respectively.
- Reference da Vinci System: 1435 patients (data compiled from 19 papers from a PubMed literature search, years 2000-2018). Provenance: Literature.
- Laparoscopic arm (Huang et al meta-analysis): 921 patients (summarized from 13 trials). Provenance: Literature (meta-analysis).
Inguinal Hernia Repair Test Set:
- Senhance System: 64 patients who underwent 76 transabdominal preperitoneal (TAPP) inguinal hernia repairs. Data provenance: Retrospective chart review. Country of origin not explicitly stated.
- Reference da Vinci System: 652 patients (data from 510(k) summary K170713). Provenance: Literature (previous 510(k) submission).
- Laparoscopic Cohort: 3457 patients (data from 11 publications referenced in Bittner, et al.). Provenance: Literature.

3. Number of Experts and Qualifications for Ground Truth:

Not Applicable. The studies are clinical case series and comparisons to published literature, not evaluations of an AI's diagnostic performance based on expert-labeled ground truth annotations on medical images. The "ground truth" here is the actual clinical outcome of surgical procedures.

4. Adjudication Method for the Test Set:

Not Applicable explicitly. As these are retrospective chart reviews and literature comparisons of surgical outcomes (not image interpretation or diagnostic tasks), an adjudication method in the context of expert consensus for ground truth establishment is not described or relevant. For intraoperative complications or conversions, these would have been recorded by the operating room staff and surgeons at the time of the procedure and subsequently extracted from patient charts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This was not an MRMC study comparing human readers with and without AI assistance. This was a study comparing the clinical outcomes of a robotic surgical system (Senhance) to other surgical methods (other robotic systems, traditional laparoscopy). The Senhance System is a surgical tool, not a diagnostic AI system assisting human readers.

6. Standalone (Algorithm Only) Performance:

Not Applicable. The Senhance System is a surgical device operated by a human surgeon; it is not a standalone algorithm without human-in-the-loop performance. Its performance is human-in-the-loop.

7. Type of Ground Truth Used:

Clinical Outcomes Data: The ground truth for this device's performance is derived from real-world clinical outcomes of surgical procedures (e.g., complications, operative time, length of stay, conversions, reoperation, readmission), as documented in patient charts and published literature.

8. Sample Size for the Training Set:

Not Applicable / Not Explicitly Stated. The Senhance System is a mechanical and software-controlled surgical device, not a machine learning model that undergoes "training" in the conventional sense of machine learning algorithms for diagnostic tasks. The "training" of the device (i.e., its development and refinement) would involve engineering, bench testing, and pre-clinical studies, not a "training set" of patient data for learning algorithms. The software updates mentioned (Software Compatibility Check Feature, R&D Mode, Service function for Automated Instrument Calibration) were subject to software V&V testing, not machine learning training.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As per point 8, there isn't a "training set" with established ground truth in the context of machine learning model development. The safety and effectiveness of the device's design and software were established through traditional engineering and software verification and validation methods, and then confirmed clinically through the comparative case series.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.

May 25, 2018

TransEnterix, Inc. Stephanie Fitts VP, Clinical, Quality and Regulatory Affairs, Chief Compliance Officer 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560

Re: K180163

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, GCJ Dated: April 23, 2018 Received: April 24, 2018

Dear Stephanie Fitts:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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Page 2 - Stephanie Fitts

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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. Jennifer R. Stevenson -S 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) K180163

Device Name

TransEnterix Senhance Surgical System

Indications for Use (Describe)

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

K180163

	[In accordance with 21 CFR 807.92]
510(k) Sponsor:Address:	TransEnterix, Inc.635 Davis Drive, Suite 300Morrisville, NC 27560
Contact Person:	Stephanie Fitts, Ph.D.Vice President, RA/QA, and Clinical
Contact Information:	Email: sfitts@transenterix.comPhone: 919.765.8400Facsimile: 919.765.8549
Date Summary Prepared:	May 14, 2018
Proprietary (Trade) Name:	TransEnterix® Senhance™ Surgical System
Common Name:	Endoscopic Instrument Control SystemEndoscopic 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 Device:	Senhance™ Surgical System (K171120)
Reference Devices:	Intuitive Surgical da Vinci Xi Surgical System (K170713 andK172643)

I. Device Description

. Cockpit - The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field.
. Manipulator Arms - Independent mechanized support arms that interface with the endoscope and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms.
Node A relay unit that connects the cockpit inputs to the manipulator arms in the system as configured, ● and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.

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The figure below is a graphical depiction of the main Senhance system components.

Image /page/4/Picture/1 description: The image shows a robotic surgery system. The system includes manipulator arms, a node, and a cockpit. The manipulator arms are used to perform the surgery, the node is used to control the arms, and the cockpit is where the surgeon sits to control the system.

Senhance System

The following are the device safety features:

Manipulator Arm Brakes ●
. Indicator Lights
Audible Alerts ●
. Trocar Fulcrum
Hierarchy of Control ●
Exceeding Force
Multiple inputs required at cockpit to initiate motion
. Emergency Stop
Surgeon presence
Eye tracking lost gaze stop ●
. Jog mode velocity restriction
RFID surgical instrument ●
Power loss stoppage ●

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The Senhance system includes a series of surgical instruments (Table 1), which are attached to the manipulator arms by way of corresponding adapters. All adapters and instruments are multi-use components that are steam sterilized by the end user before the first and each subsequent use. The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter.

PASSIVE INSTRUMENTS
Johan Grasping Forceps	Mixter
Kocher	Needle Holder, Left
Allis Atraumatic Grasper	Needle Holder, Right
Strong Grasper	Fundus/ Universal Grasping Forceps
MONOPOLAR INSTRUMENTS
Maryland Dissector	Metzenbaum Short Tip
Metzenbaum Curved	L-Hook
BIPOLAR INSTRUMENTS
Large Grasping Forceps	Maryland Dissector
Curved Scissors

Table 1. Senhance Surgical Instruments

II. 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, 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.

III. Summary of Technological Characteristics

This 510(k) is for a labeling modification only, to include inguinal hernia repair and cholecystectomy procedures under the cleared list of procedures for the Senhance Surgical System. There are no changes to the technological characteristics of the cleared Senhance Surgical System proposed in this submission. The comparison of the subject device technological characteristics to the predicate device is provided in Table 2 below.

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Feature	Senhance (Subject Device,K180163)	Senhance (PredicateDevice, K171120)	da Vinci Xi(Reference Devices,K170713 & K172543)
Surgeon ConsoleSurgeon Controls	Open Cockpit designLaparoscopic style grip andmotion	Open Cockpit designLaparoscopic style gripand motion	Head-in cockpitThree-finger grip withopen surgery motion
InstrumentActivation	Dual surgeon inputs formanipulator arm motion(fingers in handles plusclutch pedal)	Dual surgeon inputs formanipulator arm motion(fingers in handles plusclutch pedal)	Dual surgeon inputsfor manipulator armmotion (foreheadsensor plus finger gripactivation)
EndoscopeControl	Hand or optional InfraredEye sensor	Hand or optional InfraredEye sensor	Clutch pedal selectionand hand control
Force Feedback	Yes	Yes	No
Surgeon Display	Active instruments shown	Active instruments shown	Similar
Robotic Arms	Three separate carts withone arm each	Three separate carts withone arm each	One cart with 4 arms
	Manual brake and wheels	Manual brake and wheels	Powered brake andwheels
	Exceeding Force Stop –arms stop when excessiveforce is detected	Exceeding Force Stop –arms stop when excessiveforce is detected	Arms stop aftercollision when jointsare moved fromoriginal position
	Emergency Stop button	Emergency Stop button	Similar
SurgicalInstruments	Fulcrum set by force sensor	Fulcrum set by forcesensor	Fulcrum set by remotecenter function usingpotentiometers
	Straight stick standardlaparoscopy	Straight stick standardlaparoscopy	Wristed instruments
	Reusable instruments	Reusable instruments	Reusable instruments
Third PartyEndoscopeAdapters	Yes	Yes	No
Drapes	Third party sterileequipment covers	Third party sterileequipment covers	Same

The subject Senhance System has undergone software revision since the predicate Senhance System was cleared in K171120 to add the following 3 non-end user related features:

Software Compatibility Check Feature: This feature queries and retrieves all software component ● version levels for TransEnterix-created binary files. The gathered binary files are compared against expected versions, and if any discrepancies are found during the check, the system displays a version incompatibility error message on the cockpit monitor. The check is performed at system startup and any time an arm is newly connected to an active system.
R&D Mode: This function was added to allow the system to enable or disable specific features to facilitate . unrestricted continued software development of the system. The R&D Mode feature will only be enabled once a "development config" file is placed on a component of the system. This file can only be placed on a component through physically deconstructing the component and interacting with the PCs internal to the

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device, or through the Node's service port which is only accessible by authorized and trained personnel using a password protected interface.

. Service function for Automated Instrument Calibration: Instrument calibration is a time-consuming task that is normally performed by Field Service to calibrate the jaw open and close ranges for designated "grasping" surgical instruments. This feature automates that process to save time during a field service visit.
The subject device is substantially similar in technological characteristics to the predicate Senhance device. When used for the additional laparoscopic surgeries proposed, the substantial equivalence has been demonstrated through the clinical data, summary of which is included in this document.

The bench, usability, pre-clinical and in-vivo data provided for Senhance device under K171120 are applicable to the subject device since in terms of technology and intended use the remains similar to the predicate cleared under K171120. These data along with additional clinical data presented under the subject submission demonstrate the subject device is substantially equivalent to the predicate device. Moreover, the clinical data provided for subject device for laparoscopic inguinal hernia and cholecystectomy procedures had similar outcomes when compared with the reference device, da Vinci Xi Surgical System, and standard laparoscopic technique.

IV. Software Verification and Validation

The subject Senhance System has undergone software revision to add the following 3 non-end user related features: Software Compatibility Check Feature, R&D Mode, and Service function for Automated Instrument Calibration. These features are described above in Section III.

Software verification and validation testing were conducted for the architecture including regression testing and integration for the revised code. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" including re-presentation of unchanged specifications and test reports submitted with the predicate device submission K171120. The software for this device was considered as a "major" level of concern.

V. Clinical Data

In supplement to the previously submitted clinical data in K171120, the company has collected data on the Senhance Robotic System for cholecystectory and inguinal hernia procedures as part of three studies. In sum, data has been collected on 76 inguinal hernia repair procedures and 40 cholecystectomy procedures with the Senhance Robotic System. These data demonstrate results that support substantial equivalence to the predicates for the proposed indications.

Cholecystectomy Case Series

Two retrospective chart reviews were performed for 40 patients who underwent cholecystectomy procedures with the Senhance Robotic System. There were few intraoperative complications and two conversions to standard laparoscopy. No conversions to open technique, reoperations or readmissions related to the procedure were necessary.

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	Senhance -ImperialCollegeN=20	Senhance -HamburgUniversityN=20	Referenceda VinciSystemN=1435	Laparoscopicarm frommeta-analysis(Huang et al)*N=921
Complication Non-serious(Clavien Dindo I-II) (n, %)or % range	6, 30%	0	0-25%	Not Reported
Serious Complication(Clavien Dindo III) (%)	0	0	0-4%	0-10%
Estimated Blood Loss (mL)	Minimal	Not Reported	Not Reported	12-14 mL
Intra-op Adverse Events /Complications (n, %) or %range	1 (intraopbleeding),5%	0	0-5%	0-33.3%
Transfusions (%)	0	0	0-2%	0
Mortality (%)	0	0	0-0.5%	0
Conversion to Laparoscopy(n, %) or % range	1,5%	1,5%	0-12.5%	N/A
Conversion to Open (n, %)or % range	0	0	unknown	0-15.7%
Reoperation rates (n, %) or% range	0	0	0-4%	Not Reported
Readmission rates (n, %)	3, 15%	0	0-4%	0-4.3%
Median Operative Time inmin (range)	86.5 (44-129)	71.5 (34-197)	91.7 (50-152)	115.3 (65-141)
Hospital Length of Stay(days)	0 (1 ptremainedovernight)	2**	1-5	2.2 (range 1.0-5.1)

Table 3. Cholecystectomy Data - Senhance, Predicate Robotic and Laparoscopic

Reference da Vinci data compiled from 19 papers obtained from structured PubMed literature search years 2000-2018

Huang et al. Robotic cholecystectory versus conventional laparoscopic cholecystectomy: A metaanalysis. Surgery. 2017 Mar;161(3):628-636. doi: 10.1016/j.surg.2016.08.061

** 2-day hospital stay per protocol

For the data provided under the heading entitled "Reference da Vinci System" and a PubMed search was conducted using specific Medical Subject Heading (MeSH) terms for the years 2000-2018 which vielded 61 robotic papers of interest. A pre-determined excision criteria was used to filter the final set of 19 per-reviewed research publications describing the clinical outcomes for more than 1400 cholecystectomy robotically assisted surgery operations.

A meta-analysis publication (Huang et al) was used for the laparoscopic comparison. This publication summarized 13 trials for the outcomes of interest and reported on over 900 cholecystectomies performed by manual laparoscopic technique.

When comparing results from the Senhance System and the literature, all outcomes measures demonstrated comparable results. Overall, the comparison of the provided cholecystectomy surgery clinical data with the published literature data from other surgical techniques demonstrated that the Senhance System is as safe and effective as the predicate device for its intended use.

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Inguinal Hernia Repair Surgery Data

A retrospective chart review was performed for 64 patients who underwent inguinal hernia repair procedures with the Senhance Robotic System. These patients underwent 76 transabdominal preperitoneal (TAPP) inguinal hernia repairs, including bilateral hernias and recurrent hernia after previous surgical repair. No significant intraoperative or postoperative complications were observed in the 64 patients. Two cases had to be converted to standard laparoscopic technique. No reoperations or readmissions related to the procedure were necessary.

Outcome	Senhance System	Reference da Vinci	Laparoscopic Cohort
	N=64^	System N=652**	N=3457*
Patient Demographics
Mean age, (y ± SD or range)	54.5 ± 16.3	55.8 ± 15.6	34.91 - 62.3
Female, n (%) or % range	10 (15.6%)	64 (9.8%)	0 - 6.1%
Mean BMI, kg/m2 (± SD) or range	25.9 ± 3.1	27.3 ± 5.1	22.4 - 26.8
Length of Stay
Inpatient (days, mean ± SD or range)	1.04 ± 0.2 days†	3.01 ± 4.65 (n=52)	0.8 - 5 days
Outpatient (hours)	n/a	7.16 ± 3.01
Intraoperative Complications, n (%) or	0 (0%)	2 (0.3%)	0 - 8%
% range
Transfusions, n (%)
Intraoperative	0	0	Not Reported
Perioperative	0	2 (0.3%)
Postoperative Complications, n (%) or			0-36%
% range	1 (1.6%)	15 (2.3%)	(reported as total time
Postop to discharge	0	28 (4.3%)	period)
Post discharge to 30 days
Readmission Rates, n (%)	0	23 (3.5%)	Not Reported
Reoperation Rates, n (%) or % range			0-2.5%
Postop to discharge	0	3 (0.5%)	(reported as total time
Post discharge to 30 days	0	0	period)
Mortality, n	0	0	0
Operative Time, min, avg ± SD/range
Unilateral repair	44 ± 17.4	79.7 ± 31.7	32.6 - 110
Bilateral repair	79 ± 23.7
All Complications, n (%) or % range	1 (1.6%)	45 (6.9%)	7.9 – 8.7%

Table 4. Inguinal Hernia Repair Surgery - Senhance, Reference da Vinci System and Laparoscopic

^ All performed via TAPP method

TOne patient in each group was hospitalized for 2 days. All other patients were admitted for 1 day.

Data from eleven (11) publications referenced in Bittner, et al., "Update of guidelines on laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia (International Endohernia Society", Chapter 4: "TEP versus TAPP: which is better?" Surg Endosc 29:289-321 (2015).

** Data from 510(k) summary K170713

Data from the inguinal hernia repair case series using the Senhance system were compared with the results from over 650 robotic surgeries using the reference da Vinci system and over 3400 inguinal hernia repair operations performed using standard laparoscopic technique.

Operative times and complication rates were similar between the Senhance System retrospective chart review and the literature. Longer term endpoints such as inguinal hernia repair recurrence and chronic pain were not assessed

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in this study, and thus no claims regarding these outcomes data should be inferred. Overall, the comparison of the provided inguinal hernia repair surgery clinical data with the published literature data demonstrated that the Senhance System is as safe and effective as the predicate device for its intended use.

Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided for the most complex/highest risk representative, specific procedures of Total Radical Hysterectorny, and Low Anterior Resection Total Mesorectal Excision (referred to as the "umbrella" procedures). The data on these "umbrella" procedures were extrapolated to cover the less complex/lower risk procedures (referred to as "covered" procedures) so published clinical data on the covered procedures were not provided. Clinical data were provided for Myomectomy, Cholecystectomy, and Inguinal Hernia Repair yet these data did not act as umbrella procedures to cover any other procedure. Thus, the Representative Procedures for the Senhance System are outlined in Table 5 below.

Representative Procedures
Surgical Specialties/Procedures	Umbrella Procedures	Covered Procedures
Laparoscopic GynecologicalProcedures	Laparoscopic radical/totalhysterectomy, cyst removal,salpingectomy, oophorectomy	benign/ simple total laparoscopichysterectomy, lymphadenectomy,endometriosis resection, adnexectomy,omentectomy, parametrectomy, lysis ofadhesions
	Myomectomy
Laparoscopic ColorectalProcedures	Low Anterior Resection TotalMesorectal Excision(LAR/TME), Colectomy (Right,Left, Total)	Colectomy (Transverse, Hemi &Sigmoidectomy), Small Bowel Resection,Rectopexy, Abdominoperineal Resection(APR), Appendectomy
Specific LaparoscopicProcedures	Cholecystectomy
	Inguinal Hernia Repair (Uni andbilateral)

Table 5. Umbrella and Covered Procedures

PRECAUTION: Clinical data for the representative specific labeled uses was based on evaluation of the device as a surgical tool that assists in the accurate control and performance of coordinated surgical tasks in the form of specific surgical procedures. Therefore, safety and effectiveness considerations were limited to validating the indications for use and do not imply that any outcomes related to surgeon training, skill or proficiency were considered. Outcomes related to the treatment of cancer (i.e., local recurrence, disease-free survival, overall survival), or any specific treatment for underlying disease or patient condition were not evaluated.

VI. Conclusions

The clinical analysis of the TransEnterix Senhance System, as summarized herein, demonstrates that the device is as safe and effective for the two additional umbrella procedures as the predicate Senhance System cleared in K171120.

The Senhance System has the same intended use and its expanded indications for cholecystectomy and inguinal hernia repair do not affect the safety or effectiveness of the device compared to predicate device. In addition, the Senhance System has identical technological characteristics and principles of operation as the predicate device.

TransEnterix, Inc.

Senhance Surgical System

{11}------------------------------------------------

Analysis and clinical performance of the device in these new procedures indicate that no new issues of safety or effectiveness have been raised for the expanded claim. Thus, the Senhance System is substantially equivalent.

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.