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 in laparoscopic colorectal surgery 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 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 which 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 document is a 510(k) summary for the Senhance Surgical System (K171120), comparing it to the predicate device, the Intuitive Surgical da Vinci Si Surgical System IS3000 (K081137). The device is an endoscopic instrument control system.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific metrics like sensitivity, specificity, or AUC, as would be typical for diagnostic AI devices. Instead, the substantial equivalence is determined by comparing procedural endpoints of the Senhance System's clinical data to published literature data of the predicate device. The general acceptance criterion seems to be that the Senhance System is "as safe and effective as the predicate device for its intended use" based on these comparisons.

Here's a summary of the performance data presented, compared implicitly to the predicate device's published literature:

Metric (Procedural Endpoints)	Senhance - Gynecological Study (150 patients)	Senhance - Colorectal Study (45 patients)	Implicit Acceptance Criteria / Comparison to Predicate (via published literature)
Safety
Intraoperative Complications	10 conversions to manual laparoscopy (2 associated with serious adverse events), no blood transfusions. Overall: 2 (Total Hysterectomy group)	0 (all groups)	Similar or better than predicate
Post-operative Complications	6 serious adverse events (4%), including wound dehiscence, infections, suspected pleurisy, rapid onset anemia. None device-related.	2 (4.4%) serious complications (anastomotic leak, intraluminal bleed). None device-related.	Similar or better than predicate
Mortality	0% (all groups)	0% (all groups)	Similar or better than predicate
Conversion Rates (to open/manual)	5 (3.3%) for Total Hysterectomy group	1 (2.2%) for Right Hemicolectomy, 2 (4.4%) for Left Hemicolectomy. No conversions to laparotomy.	Similar or better than predicate
Reoperation Rates	2 (1.3%) for Total Hysterectomy group	0% (all groups)	Similar or better than predicate
Readmission Rates	3 (2%) for Total Hysterectomy group	1 (2.2%) for Right Hemicolectomy, 0% for others	Similar or better than predicate
Estimated Blood Loss	<63 mL to <144 mL depending on procedure. 0 transfusions.	<20 mL to <50 mL depending on procedure. 0 transfusions.	Similar or better than predicate
Anastomotic Leak Rate	(Not explicitly reported for gynecology)	1 in Right Hemicolectomy group (part of serious complication)	Similar or better than predicate
Effectiveness/Efficiency
Operative Time	Mean 26.1 min (Mono/Bilateral salpingo-oophorectomy) to 221 min (radical Hysterectomy)	Mean 222 min (Right Hemicolectomy) to 359 min (LAR/TME)	Similar or within acceptable range to predicate
Hospital Length of Stay	Median 1-2 days (range 1-5 days)	Median 5-6 days (range 3-19 days)	Similar or within acceptable range to predicate
Surgical Margins R0 (%)	(Not applicable for most gynecological procedures)	100% (all groups)	Similar or better than predicate (for cancer resections)

2. Sample Sizes and Data Provenance

Test Set (Clinical Data):
- Gynecological Laparoscopic Surgery: 150 patients. Prospective, non-randomized clinical trial. The country of origin is not explicitly stated, but clinical trials for FDA submissions are often multinational or US-based.
- Colorectal Laparoscopic Surgery: 45 patients. Retrospective chart review (referred to as Real World Evidence or RWE). The country of origin is not explicitly stated.
Training Set: The document does not mention separate "training sets" for an AI algorithm. The Senhance Surgical System is a robotic surgical system, not a diagnostic AI device requiring a machine learning training set in the typical sense. The development of the system itself involved various engineering tests, including software verification and validation, human factors/usability testing, bench testing, and animal testing.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The clinical studies involved investigators/surgeons who performed the procedures and assessed adverse events. However, no specific number of experts used to establish a ground truth for a test set (e.g., for image annotations or diagnoses) is mentioned because this is a surgical system, not a diagnostic AI. The "ground truth" for the clinical studies was derived from the actual surgical outcomes, investigator assessments of device-related events, and standard clinical endpoints (e.g., blood loss, hospital stay, complications, reoperation).

4. Adjudication Method (Test Set)

The document mentions that adverse events were considered "device related according to the investigator's assessment." This suggests that the investigators (surgeons/clinicians) made the primary determination. There is no mention of a formal multi-expert adjudication method (e.g., 2+1, 3+1 consensus) for the clinical outcomes or adverse events in the clinical data section.

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

No MRMC comparative effectiveness study was done. This type of study is typically for diagnostic aids or image interpretation AI where multiple human readers interpret cases with and without AI assistance. The Senhance System is a surgical tool, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study, in the sense of a diagnostic AI operating independently without human interaction, was performed. The Senhance System is designed to be a human-in-the-loop robotic surgical assistant, where the surgeon controls the system. Its performance is intrinsically tied to human interaction.
However, various non-clinical tests essentially establish the "standalone" engineering performance of the system components, such as:
- Bench testing (mechanical performance, system latency, motion accuracy, force feedback, eye sensing)
- Electrical safety and EMC testing
- Software Verification and Validation
- Biocompatibility testing
- Cleaning, Disinfection, and Sterilization validation

7. Type of Ground Truth Used (Test Set)

The "ground truth" for the clinical studies was clinical outcomes data and investigator assessments. This includes:
- Surgical success (successful completion of procedures)
- Intraoperative and post-operative complications
- Adverse events (and investigator's assessment of device relatedness)
- Blood loss, operative time, hospital length of stay
- Conversion rates
- Reoperation rates, readmission rates, mortality
- Surgical margins (for colorectal cancer cases)

8. Sample Size for the Training Set

As explained in Point 2, there isn't a traditional "training set" for an AI algorithm in this context. The system development and validation involved various engineering, preclinical (animal), and human factors studies. The sample sizes for these are:
- Human Factors/Usability Engineering: 16 teams of 3 users (surgeon, surgical assistant, nurse) in a porcine wet lab environment.
- Animal Testing (Pre-clinical Design Validation): 4 teams of trained subjects (surgeon, surgical assistant) performed tasks on a live porcine model.

9. How Ground Truth for Training Set was Established

Again, no traditional "training set" ground truth. For the human factors and animal testing, the "ground truth" was established by:
- Successful completion of use tasks in the simulated (human factors) and live porcine (animal) environments.
- Observation by independent usability investigators to ensure use tasks were completed without preventable errors causing harm (human factors).
- Assessment of essential user requirements and successful completion of surgical procedures (animal testing).
- For the engineering tests (bench, electrical, software), the "ground truth" was established by compliance with established standards, specifications, and verified functionality (e.g., IEC standards, FDA guidance for software, mechanical performance specs).

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, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

October 13, 2017 TransEnterix, Inc. Stephanie Fitts, Ph.D. VP, Clinical, Quality and Regulatory Affairs, Chief Compliance Officer 635 Davis Drive, Suite 300 Morrisville. North Carolina 27560

Re: K171120

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: September 15, 2017 Received: September 15, 2017

Dear Dr. 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 practice, 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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) K171120

Device Name 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

[In accordance with 21CFR 807.92] Submitter -510(k) Submitter: TransEnterix, Inc. Address: 635 Davis Drive, Suite 300 Morrisville, NC 27560 Contact Person: Stephanie M. Fitts. PhD Vice President, RA/QA, Clinical and Compliance Contact Information: Email: sfitts@transenterix.com Phone: 919.765.8400 Facsimile: 919.765.8549 Date Summary Prepared: October 13, 2017 II. Device Senhance™ Surgical System Name of Device: Common or Usual Name: Endoscopic Instrument Control System Endoscopic Instruments and Accessories Classification Name: Endoscope and Accessories (21 CFR 876.1500) Requlatory Class: ll Product Code: NAY (System, Surgical, Computer Controlled Instrument) Intuitive Surgical da Vinci Si Surgical System IS3000 III. Predicate Device (K081137) This predicate has not been subject to a design-related recall Stryker (MAKO) RIO Robotic Arm Assisted System Reference Devices (K093425) Stryker Surgical Instruments (K150127) GIMMI GmbH Surgical Instruments (K012660) Bissinger GmbH POWERGRIP Coagulation Forceps (K033177 and K970968)

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IV. 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 which 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.

Figure 1, below, is a graphical depiction of the main Senhance system components.

Image /page/4/Figure/6 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, while the node is used to control the arms. The cockpit is where the surgeon sits and controls the system.

Figure 1. Senhance System

The following are the device safety features:

Manipulator Arm Brakes ●
. Indicator Lights
Audible Alerts ●
. Trocar Fulcrum
Hierarchv 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 .

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RFID surgical instrument ●
Power loss stoppage ●

The Senhance system includes a series of surgical instruments (Table 1), which are attached to the manipulator arms by way of corresponding 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 Grasper	Mixter Dissector
Kocher Grasper	Needle Holder, Left
Allis Grasper	Needle Holder, Right
Strong Grasper	Fundus Grasper
MONOPOLAR INSTRUMENTS
Maryland Dissector	Curved Metzenbaum Scissors Short Tip
Curved Metzenbaum Scissors	L-Hook Electrode
BIPOLAR INSTRUMENTS
Large Grasping Forceps	Maryland Dissector
Curved Scissors

	TABLE 1. Senhance Surgical Instruments

V. Indications for Use:

VI. Summary of Technological Characteristics:

Robotically-assisted tele-operation is the primary technological principle for both the subject and predicate devices. 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 tissues and vessels in the insufflated body cavity. At a high level, the subject and predicate devices are based on the following same technological elements: surgeon console which provides remote manipulators or handles to allow the surgeon to maneuver the surqical instruments and a video monitor for the endoscopic signal, manipulator arms which hold the instruments and endoscope based on inputs from the surgeon, and instruments which manipulate the tissue of interest.

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The eye sensing feature provides the surgeon an optional alternate method to control the endoscope other than using their hands. This feature is similar to the Class II exempt device, the Tobii CEve System Augmentative and Alternative Communication Devices with ISO 15004-2: 2007-02-15 and IEC 62471: 2006-07. Force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. This feature is similar to that of the reference device Stryker (MAKO) RIO Robotic Arm Assisted System (K093425).

The Senhance Surgical System differs from the predicate in the instrumentation. The predicate utilizes wristed instruments with an additional degree of freedom. The Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation. The instrument reference devices listed (Stryker Surgical Instruments (K150127), GIMMI GmbH Surgical Instruments (K012660), and Bissinger GmbH POWERGRIP Coagulation Forceps (K033177 and K970968)) all have instrument designs and materials which have a long history of safe clinical use.

Table 2 lists the differences between the subject device and the predicate device features.

Feature	Senhance	Predicate
Surgeon Console	Open Cockpit design	Head-in cockpit
Surgeon Controls	Laparoscopic style grip and motion	Three-finger grip with open surgery motion
Instrument	Dual surgeon inputs for manipulator arm	Dual surgeon inputs for manipulator arm
Activation	motion (fingers in handles plus clutchpedal)	motion (forehead sensor plus finger gripactivation)
Endoscope Control	Hand or optional Infrared Eye sensor	Clutch pedal selection and hand control
Force Feedback	Yes	No
Surgeon Display	Active instruments shown	Similar
Robotic Arms	Three separate carts with one arm eachManual brake and wheelsExceeding Force Stop -arms stop whenexcessive force is detectedEmergency Stop button	One cart with 3-4 armsPowered brake and wheelsArms stop after collision when joints aremoved from original positionSimilar
SurgicalInstruments	Fulcrum set by force sensorStraight stick standard laparoscopy	Fulcrum set by remote center function usingpotentiometersWristed instruments
Third Party	Reusable instruments	Reusable instruments
EndoscopeAdapters	Yes	No
Drapes	Third party sterile equipment covers	Same

TABLE 2. Differences between Senhance and Predicate, da Vinci Si (K081137)

To establish the substantial equivalence (SE) with the predicate device and address the above listed differences, the subject device was tested in preclinical, usability, and in-vivo testing as summarized in Section VII of this document.

Table 3 lists some of the Senhance technological features along with a reference device which includes a similar feature.

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TABLE 3. Senhance Features and Reference Devices with Similar Feature.

Senhance Feature	Reference Device with Similar Feature or Standard Used to TestSafety of the Given Feature
Handle to Instrument Movement,Straight shaft design and standardend effectors	Stryker Surgical Instruments (K150127)GIMMI GmbH Surgical Instruments (K012660)
Standard port placement and size	Bissinger GmbH POWERGRIP Coagulation Forceps (K033177 andK970968)
Haptic force feedback to handles	Stryker (MAKO) RIO Robotic Arm Assisted System (K093425)
Eye sensing camera control	Radiation safety testing per ISO 15004-2: 2007-02-15 and IEC 62471:2006-07

The compatibility of the features listed in the above table was established as a part of usability testing and during the design validation process.

VII. Performance Data

The following performance testing of the Senhance Surgical System was conducted to support substantial equivalence to the predicate device.

Biocompatibility testing: The biocompatibility evaluation for the Senhance Surgical System was conducted on all patient contacting instruments in accordance with the FDA Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1 , Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016 , and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

· Cytotoxicity
Sensitization ●
Irritation/Inflammatory Response (IR) ●
Acute Systemic toxicity
. Pyrogenicity

The instruments are considered tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone.

Cleaning, Disinfection (Reprocessing) and Sterilization: The capital equipment was validated through cleaning effectiveness, cleaning compatibility and low level disinfection testing. Cleaning effectiveness and low-level disinfection studies were conducted on non-draped areas of the Senhance manipulator arm. These studies were based on the quidelines outlined in AAMI TIR12:2010, ANSI/AAMI TIR30:2011, and ANSI/AAMI ST58:2013. The reusable instruments and adapters were the subject of a cleaning effectiveness study based on the guidelines outlined in AAMI TIR12:2010 and ANSI/AAMI TIR30:2011. A steam sterilization 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" issued on: March 17, 2015 and the FDA recognized consensus standards ANSI/AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013.

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Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Senhance Surgical System. The system complies with the IEC 60601-1:2012 standard for basic safety and essential performance of medical equipment and IEC 60601-1-2:2014 collateral standard for EMC. High frequency electrical safety requirements were evaluated per IEC 60601-2-2 2009/COR1:2014 and applicable safety requirements for the endoscopic equipment were evaluated per IEC 60601-2-18:2009.

Software Verification and Validation Testing: Software verification and validation testing were conducted and 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." The software for this device was considered as a "maior" level of concern.

Bench testing: Bench testing evaluated the mechanical performance of the system and included the following:

Instruments Dynamic Cantilever Testing .
Instruments Jaw Grasping Reliability and Force to Jaw Failure ●
Shears Reliability
Video Signal Verification ●
System Latency
Robotic arm and surgical instrument motion accuracy
Video Signal Latency
Force Feedback
Eye Sensing [ISO 15004-2:2007 Ophthalmic Instruments - Fundamental Requirements and Test Methods Part 2: Light Hazards Protection and IEC 62471:2006 Photobiological safety of lamps and lamp systems]
Transit and Packing Testing
Drape Compatibility
Endoscope Compatibility
ESU Compatibility

Human Factors/ Usability Enqineering Testing: The Senhance Surgical System underwent full summative human factors (usability) testing. The study was conducted in accordance with the FDA Guidance for Industry and FDA Staff "Applying Human Factors and Usability Engineering to Medical Devices" issued on February 3, 2016. In this study, realistic team-based scenarios were evaluated. Sixteen (16) teams of 3 users were evaluated in performing use tasks in a porcine wet lab environment which was simulated to reflect the actual intended conditions of use. The teams, which consisted of one surgeon, one surgical assistant and one nurse, were training program intended for use at market introduction which includes individual and team based training exercises. After a training decay period of between overnight and seven days, the team was evaluated by an independent usability investigator while performing surqical tasks in a porcine model. All study endpoints confirmed that the Senhance system can be used by surgeons, surgical assistants, and nurses in an operating room environment without patterns of preventable use errors that may cause harm when the system is in use during laparoscopic surgery.

Animal Testing: Pre-clinical Design Validation: A single-center, un-blinded, observational, simulated use study of the Senhance System was conducted with representative users. Four (4) teams of trained subjects (one surqeon and one surgical assistant per team) performed surgical tasks on a live porcine model. The teams performed serosal bladder incision with repair, oophorectomy, total laparoscopic hysterectomy, gastric serosal incision with repair, cholecystectomy, and nephrectomy.

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The procedures were non-survival. The surgical teams performed tasks representing major user needs which included: Patient and Trocar Placement, Initial Endoscope and Instrument, Initial Endoscope and Instrument Insertion, Cockpit Setup, Communication, Laparoscopic Procedure, Feature-specific Laparoscopic Tasks, Instrument Removal and Detachment, Incision Site Evaluation, and Emergency Access. The surgical tasks from the Senhance system's indications for use were performed according to the demands of the specific surgical procedure. All surgical procedures were successfully completed, and all essential user requirements were assessed and found to be met by the system.

Clinical Data: The gynecological laparoscopic surqery data were from a prospective non-randomized clinical trial for 150 patients undergoing surgery with the Senhance system. The colorectal laparoscopic surgery data were from a retrospective chart review (referred to as real world evidence or RWE) of 45 patient's medical records of colorectal surgery.

The Gynecological Laparoscopic Surgery Data

The gynecological study enrolled 150 subjects with surgical indications that included ovarian cyst removal (39%), cancer prophylaxis (2%), uterine fibroids (3%), benign or early stage uterine and adnexal cancer (43%) and advanced uterine/adnexal cancer (13%). The majority (57%) of patients reported a previous abdominal/pelvic surgery with 33% specifically reporting a previous gynecological surgery. The patients enrolled had an average Body Mass Index (BMI) of 24.4 kg/m². Ten conversions to manual laparoscopy were reported and all were included as intraoperative complications in the results. Two conversions were associated with serious adverse events at the time of surgery: one patient converted to laparoscopy for bladder perforation requiring repair and one patient who developed subcutaneous emphysema due to the anesthetic technique. Neither of the events was device related according to the investigator's assessment. The remaining conversions were due to patient anatomy or surgeon preference. No blood transfusions or other complications were reported in the intra-operative timeframe. Post-operatively an additional six serious adverse events (4%) were reported including one wound dehiscence, two infections, one suspected pleurisy requiring hospitalization, and one rapid onset anemia. One patient returned to the operating room after pathology confirmed a cancer diagnosis was included conservatively as an adverse event, but was not a true re-operation. None of these serious adverse events was considered device related according to the investigators.

Data were extrapolated from two umbrella procedures: total laparoscopic radical hysterectorny and myomectomy. This allowed labeling for representative specific covered gynecological procedures (listed in Table 4) without the need to provide clinical data for the covered procedures.

Representative Procedures
Umbrella Procedures	Covered Procedures
Laparoscopic radical/totalhysterectomy, cyst removal,salpingectomy, oophorectomy	benign/ simple total laparoscopic hysterectomy,lymphadenectomy, endometriosis resection, adnexectomy,omentectomy, parametrectomy, lysis of adhesions
Myomectomy	Myomectomy

TABLE 4. Umbrella and Covered Procedures for Laparoscopic Gynecology

The data from the gynecology procedures are shown below in Table 5.

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	Mono/Bilateralsalpingo-oophorectomy,cyst removal	Myomectomy	TotalHysterectomy	Total Hysterectomyplus adjacentstructures (radical)
Number of pts	62	4	64	20
Complication Non-serious(Clavien Dindo I-II)*	16	0	14	15
Serious Complication(Clavien Dindo III)*	0	0	8	0
Estimated Blood Loss(mL)	<63	0 (minimal)	<144	<112
Intra-op Adverse Events /Complications	0	0	2	0
Transfusions*	0	0	0	0
Mortality*	0	0	0	0
Conversion to Lap (n, %)	0	0	5 (3.3%)	5 (3.3%)
Reoperation rates (n, %)	0	0	2 (1.3%)	0
Readmission rates (n, %)	0	0	3 (2%)	0
Operative Time (min) †	26.1 (26.3)	57.7 (15.5)	157 (61.1)	221 (86)
Hospital Length of Stay**(days)	1 (1-3)	1.5 (1-3)	2 (1-5)	2 (1-5)

TABLE 5. Gynecological Surgery Data with Senhance by Surgery Group

*through 30 days † Mean (SD) ** median (range)

Data from the gynecological study of 150 patients using the Senhance System were compared with the results from eight peer-reviewed research publications describing the clinical outcomes for more than 8000 gynecological operations using the predicate device. Substantial equivalence was determined by comparing the following procedural endpoints to the predicate device: length of hospital stay, intraoperative complications, estimated blood loss (transfusions), post-operative complications (through 30 days), readmission rates, reoperation rates, mortality, operative time, and conversion rates (from RASD to open or traditional laparoscopic). Overall, the comparison of the provided gynecological surgery clinical data with the predicate published literature data demonstrated that the Senhance system is as safe and effective as the predicate device for its intended use.

Colorectal Laparoscopic Surgery Data

The colorectal surgery data from a retrospective chart review study on 45 patients undergoing colorectal surgeries were provided. Surgical indications were colorectal cancer (66%), endoscopically unresectable adenoma (4.4%), complicated inflammatory bowel disease (18%) and diverticular disease (11%). Twenty-three patients underwent right hemicolectomy. 9 left hemicolectomy. 12 lower anterior resection including Low Anterior Resection Total Mesorectal Excision (LAR/TME), and 1 colectomy.

Data was extrapolated from the umbrella procedure of LAR/TME. This allowed labeling for representative specific covered colorectal procedures (listed in Table 6) without the need to provide clinical data for the covered procedures.

TABLE 6. Umbrella and Covered Procedures for Laparoscopic Colorectal
Representative Procedures

Representative Procedures
Umbrella Procedure	Covered Procedures
Low Anterior Resection Total MesorectalExcision (LAR/TME), Colectomy (Right,Left, Total)	Colectomy (Transverse, Hemi & Sigmoidectomy), Small BowelResection, Rectopexy, Abdominoperineal Resection (APR),Appendectomy

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The data from the colorectal procedures are shown below in Table 7.

	RightHemicolectomy	LeftHemicolectomy	LAR includingLAR/TME	TotalColectomy
Number of pts	23	9	12	1
Complication Non-serious(Clavien Dindo I-II)	8	3	2	1
Serious Complication(Clavien Dindo III)	2	0	0	0
Estimated Blood Loss (mL)	<20	< 50	< 50	< 50
Intra-op Adverse Events /Complications	0	0	0	0
Transfusions	0	0	0	0
Mortality*	0	0	0	0
Conversion to Lap (n, %)	1 (2.2%)	2 (4.4%)	0	0
Reoperation rates (n, %)	0	0	0	0
Readmission rates (n, %)	1 (2.2%)	0	0	0
Anastomotic leak	1	0	0	0
Surgical Margins R0 (%)	100	100	100	100
Operative Time (min) †	222 (175-307)	247 (200-299)	359 (274-501)	279
Hospital Length of Stay(days) †	5 (3-13)	6 (4-14)	6 (3-19)	5

TABLE 7, Colorectal Surgery Data with Senhance by Surgery Type

*through 30 days † mean (range)

There were three conversions to standard laparoscopy. Two conversions were for complicated diverticular disease and one was secondary to mesocolic bleeding. No conversions to laparotomy or open surgery were reported. The post-operative serious complication rate for all patients was 4.4% (2 patients) which included an anastomotic leak leading to abscess reguiring a drain placement, and an intraluminal bleed requiring endoscopic clips. No patient underwent reoperation and none of the adverse events were considered device related by the investigators.

Data from the retrospective case series review of 45 (real world evidence) patients undergoing colorectal procedures in a real world setting using the Senhance system were compared with the results from 11 peer-reviewed research publications describing the clinical outcomes for more than 5000 colorectal operations performed using the predicate device. Substantial equivalence was determined by comparing the following procedural endpoints to the predicate device: length of hospital stay, conversion rates (from RASD to open or traditional laparoscopic), intraoperative complications, estimated blood loss (transfusions), adverse events / all complications, anastomotic leak rate, readmission rates, reoperation rates, mortality, operative time, and surgical margins. Overall, the comparison of the provided colorectal surgery clinical data with the predicate published literature data demonstrated that the Senhance system is as safe and effective as the predicate device for its intended use.

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 surqeon 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.

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VIII. Conclusions

The Senhance Surgical System has the same intended use as the predicate device. There are technological differences between the subject device and the predicate device, Intuitive Surgical da Vinci Si Surgical System IS3000 (K081137). The non-clinical testing supported the safety and functionality of the device. The clinical testing supported the indications for use. Overall, the performance testing data demonstrate the device is substantially equivalent to the predicate device.

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.