The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

Device Description

The Senhance Articulating platform is intended as an addition to the suite of instruments and adapters previously cleared for use with the Senhance® Surgical System ("Senhance system"). These instruments add degrees of freedom near the instrument end effector to allow for additional range of motion for the surgeon when performing laparoscopic tissue manipulations. Two articulating instruments are being added to the suite of instruments –Bipolar Atraumatic Grasper and Needle Driver. The instruments are single use and provided sterile to the end user. The instruments connect to a coupler which in turn connects to the articulating adapter which attaches to the Senhance Manipulator Arm.

AI/ML Overview

The provided text, a 510(k) summary for the Senhance Surgical System, describes the device, its intended use, and substantial equivalence to predicate devices, supported by various performance tests. However, it does not contain the specific information required to complete a table of acceptance criteria and the detailed study results as requested in the prompt.

Specifically, the document does NOT include:

A table of acceptance criteria with reported device performance (quantitative metrics are absent). The document mentions various performance tests (Biocompatibility, Reprocessing, Bench Testing, Electrical Safety, Software V&V, Pre-Clinical Design Validation, Usability Testing) but provides only qualitative statements about their success (e.g., "demonstrated that the patient-contacting portions... are non-toxic," "confirmed that the articulating instruments perform as intended," "Software verification and validation were successfully conducted," "All applicable user level requirements were assessed and found to be met," "The surgical teams were able to independently perform all critical tasks without use errors that would lead to harm"). It does not list specific numerical acceptance thresholds or the measured device performance against those thresholds.
Sample sizes used for a "test set" in the context of AI/ML performance. While "Pre-Clinical Design Validation" involved a "simulated use design validation evaluation" with "users who represented the intended primary user population," and "Usability Testing" involved "surgical teams," these are not described as conventional "test sets" for evaluating an AI/ML algorithm's analytical performance (e.g., in terms of sensitivity/specificity).
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications for establishing ground truth.
Adjudication method for a test set.
Details on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or effect size of human reader improvement with AI assistance. The device described is a surgical system with articulating instruments, not an AI software intended to assist human readers in, for example, diagnostic image interpretation.
Details on a standalone (algorithm only) performance study. Again, this is a surgical system, not an AI algorithm evaluated in isolation.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Conclusion:

The provided document describes the regulatory submission for a surgical system, focusing on its substantial equivalence to a predicate device through various engineering and usability validations. It does not provide the specific type of information requested, which pertains more to the rigorous testing and validation of an Artificial Intelligence/Machine Learning (AI/ML) based medical device, particularly in a diagnostic or assistive interpretive role, where concepts like acceptance criteria for sensitivity/specificity, ground truth establishment by experts, and MRMC studies are common. The device described, the "Senhance Surgical System," is a robotically-assisted surgical tool with new articulating instruments, not an AI/ML diagnostic or predictive software.

Summary

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Asensus Surgical, Inc. Taylor Fisher Program Manager 1 TW Alexander Drive, Suite 160 Durham, North Carolina 27703

Re: K211325

Trade/Device Name: Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: April 30, 2021 Received: April 30, 2021

Dear Taylor Fisher:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark Trumbore Ph.D. Acting Assistant Director THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

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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K211325

510(k) Summary

[In accordance with 21CFR 807.92]

1. Submitter

Reference Device:

510(k) Sponsor:	Asensus Surgical, Inc.
Address:	1 TW Alexander Drive, Suite 160Durham, NC 27703 USA
Contact Person:	Taylor FisherProgram Manager
Contact Information:	Email: tfisher@asensus.comPhone: +1 919.765.8400Facsimile: +1 919.765.8459
Date Summary Prepared:	7/12/2021
2. Device
Proprietary (Trade) Name:	Senhance® Surgical System
Common Name:	System, Surgical, Computer Controlled Instrument
Classification:	Class II
Classification Advisory Committee:	General and Plastic Surgery
Regulation Number:	21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument
3. Predicate and Reference Devices
Predicate Device:	Senhance® Surgical System (K202166)

Intuitive Surgical EndoWrist Instruments (K081137)

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4. Device Description:

5. Intended Use/ Indications for Use:

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic qynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

Comparison with Predicate Device Intended Use/ Indications for Use:

The Senhance Articulating platform has the identical intended use and indications for use as predicate Senhance Surgical System (K202166).

6. Summary of Technological Characteristics:

The substantial equivalence comparison below shows that the subject Senhance Articulating platform is very similar to the predicate Senhance Surgical System. Many of the subject device's technological characteristics and principles of operation are identical or similar to those of the predicate. Furthermore, a comparison of the subject articulating instruments to a reference device (Intuitive Surgical EndoWrist Instruments, K081137) shows that both the subject and reference devices have similarities in their dimensions and design. Any differences in technological characteristics between the subject and predicate devices have been addressed through a comprehensive set of testing using established test methods and do not raise any different questions of safety and effectiveness.

Characteristic	Subject Device	Predicate Device
Name	Senhance Articulating Platform for usewith the Senhance Surgical System	Senhance Surgical SystemK202166
CapitalEquipment	The subject Senhance system iscomprised of three main components:cockpit, manipulator arms, and ISU.	The subject Senhance system iscomprised of three main components:cockpit, manipulator arms, and ISU.
Characteristic	Subject Device	Predicate Device
	Cockpit – positioned outside the sterilefield, is where the surgeon inputsinformation through hand and eyemovements to direct the motion of themanipulator arms in the surgical field.The surgeon manipulates two cockpithandles to transmit position and jawactuation movements to the manipulatorarms.	Cockpit - positioned outside the sterilefield, is where the surgeon inputsinformation through hand and eyemovements to direct the motion of themanipulator arms in the surgical field.The surgeon manipulates two cockpithandles to transmit position and jawactuation movements to the manipulatorarms.
	Manipulator Arms - the independent,mechanical support arms that interfacewith the endoscope and surgicalinstruments. The manipulator armsproduce output movements based on theinput movement from the surgeon at thecockpit. The Senhance system isconfigurable with up to three manipulatorarms. Each manipulator arm has a totalof six joints: three joints that allow thesurgical team to grossly position eachmanipulator arm above the operatingtable and three joints for positioning ofthe instrument interface.The connector in the center of theinstrument interface has been removedand a connection port was added topower the new articulating motorizedadapter while maintaining the sterile field.	Manipulator Arms - the independent,mechanical support arms that interfacewith the endoscope and surgicalinstruments. The manipulator armsproduce output movements based on theinput movement from the surgeon at thecockpit. The Senhance system isconfigurable with up to three manipulatorarms. Each manipulator arm has a totalof six joints: three joints that allow thesurgical team to grossly position eachmanipulator arm above the operatingtable and three joints for positioning ofthe instrument interface.
	ISU - the communication hub thatconnects the cockpit inputs to themanipulator arms. The Smart Nodecontains a high-performance PC thatenables the surgeon to commandendoscopic motion using softwarefeatures that apply image processingalgorithms to the endoscope video signal.	ISU - the communication hub thatconnects the cockpit inputs to themanipulator arms. The Smart Nodecontains a high-performance PC thatenables the surgeon to commandendoscopic motion using softwarefeatures that apply image processingalgorithms to the endoscope video signal.
Surgeon Controls	Touchpad, keyboard, clutch pedal,handles, eye tracker.The trigger/tilt button on the cockpithandle is used to activate articulation ofthe instrument. The instrument isarticulated by rotating the handles aboutthe yaw axis.	Touchpad, keyboard, clutch pedal,handles, eye tracker
SoftwareArchitecture	Four software subsystems: LTM, ARM,RHMI, SNIP	Four software subsystems: LTM, ARM,RHMI, SNIP
Software Version	Senhance Software Version 2.5.3.14	Senhance Software Version 2.5.0.22
Characteristic	Subject Device	Predicate Device
InstrumentAdapters	A new motorized articulating adapter thatattaches to the manipulator arm anddrives articulation (or "tilt") and rotation ofthe instrument tip ("roll"). Jaw actuation isthe same as the predicate. Thearticulating adapter is covered by asterile, disposable drape before each uselike the Senhance capital equipment.A new reusable articulating coupler thatconnects the articulating instruments tothe articulating adapter.The articulating adapter is uniquelymatched to the articulating instruments.The adapter has an embedded RFID tagwhich is used by the manipulator arm toidentify which adapter is attached to theinstrument interface. This allows the iconrepresenting the instrument type to bedisplayed to the surgeon on the functionsarea of the cockpit monitor.	Five (5) different types of reusableinstrument adapters that connect to theSenhance Surgical Instruments andattach to the manipulator arm(s): passive(non-energized), monopolar, bipolar,ultrasonic, and endoscope.Each adapter is uniquely matched toeach instrument or endoscope. Eachadapter has an embedded RFID tagwhich is used by the manipulator arm toidentify which adapter is attached to theinstrument interface. This allows the iconrepresenting the instrument type orendoscope to be displayed to thesurgeon on the functions area of thecockpit monitor.
EquipmentDrapes	Single use, sterile equipment drapescover the manipulator arm andinstrument interface. The drapes areclassified as Class 2, 510(k)-exemptdevices under product code PUI.A new single use, sterile, articulatingadapter drape pack is provided to coverand connect the instrument interface andarticulating adapter during use. Thedrapes are classified as Class 2, 510(k)-exempt devices under product code PUI.	Single use, sterile equipment drapescover the manipulator arm andinstrument interface. The drapes areclassified as Class 2, 510(k)-exemptdevices under product code PUI.
SurgicalInstruments	Two new single use, sterile, laparoscopicarticulating instruments with anarticulating design at the distal tip thatsimulates the human wrist. Thearticulating instruments can bend up to65 degrees when fully articulated.Bipolar Atraumatic Grasper,Articulating - 5mm diameter x310mm shaft length Needle Driver, Articulating - 5mmdiameter x 310mm shaft length	A suite of reusable, laparoscopicSenhance Surgical Instruments availablein a variety of sizes (diameters andlengths), end effector designs, andenergy (passive, monopolar, bipolar,ultrasonic) including:Bipolar Large Grasping Forceps -5mm diameter x 310mm shaft length Needle Holder Left/Right - 5mmdiameter x 310mm shaft length
Biocompatibility	The instruments are made frombiocompatible metals and plastics with along history of safe use anddemonstrated to be non-toxic, non-	The instruments are made frombiocompatible metals and plastics with along history of safe use anddemonstrated to be non-toxic, non-
Characteristic	Subject Device	Predicate Device
	irritating, non-sensitizing, and non-pyrogenic.	irritating, non-sensitizing, and non-pyrogenic.
InstrumentsRated Voltage	5mm Bipolar Articulating Instrument @ 250 Vpeak	5mm Bipolar Instruments @ 500 Vpeak
CompatibleElectrosurgicalUnits (ESUs)	Compatible third-party ESUs include: Erbe VIO® 300 D Covidien ForceTriad™ Covidien/Valleylab Force FX™ CONMED System 5000™ The ESU connects directly to the articulating instrument using a bipolar ESU accessory cable, rather than to the adapter like with the predicate. The ESU is operated in the usual manner by the ESU's foot pedal positioned near the surgeon at the cockpit. There is no communication between the Senhance system and any ESU.	Compatible third-party ESUs include: Erbe VIO® 300 D Covidien ForceTriad™ Covidien/Valleylab Force FX™ CONMED System 5000™ ESUs connect to the adapters through monopolar or bipolar cables and provide energy directly to the instruments. The ESU is operated in the usual manner by the ESU's foot pedal positioned near the surgeon at the cockpit. There is no communication between the Senhance system and any ESU.

Table 1. Substantial Equivalence Comparison

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		Table 2. Reference Device Comparison
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Characteristic	Subject Device	Reference Device
Name	Senhance Articulating Instruments	Intuitive Surgical EndoWrist Instrumentsfor use with da Vinci Si Surgical System/IS3000 (K081137)
InstrumentClassification	Single Use Disposable (GammaSterilization)	Reusable, programmed with a maximumnumber of surgical procedures. Theymust be cleaned, and steam sterilized bythe end user between uses.
ArticulatedInstrument Typesand Dimensions	Two laparoscopic articulating instrumentswith an articulating design at the distal tipthat simulates the human wrist:Bipolar Atraumatic Grasper,Articulating - 5mm diameter x310mm shaft length Needle Driver, Articulating - 5mmdiameter x 310mm shaft length	A variety of articulating instrumentsconsisting of graspers, dissectors,needle drivers, scissors, monopolarenergy, bipolar energy, and clip appliers.The EndoWrist instruments have anarticulating design at the distal tip thatsimulates the human wrist and include:Bipolar grasper – 8mm diameter x~310mm shaft length) Need driver – 8mm diameter x~310mm shaft length
Degrees ofArticulation	0 degrees (straight) to 65 degrees (fullyarticulated)	0 degrees (straight) to 90 degrees (fullyarticulated)

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7. Performance Data:

The following performance testing of the Senhance Articulating platform was conducted to demonstrate substantial equivalence of the device to the predicate.

Biocompatibility Testing: The Senhance Articulating instruments are considered tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone. The articulating instruments were assessed in accordance with the FDA Guidance for Industry and FDA Staff on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". Testing demonstrated that the patient-contacting portions of the Senhance Articulating instruments are non-toxic, non-irritating, non-sensitizing, and nonpyrogenic and do not result in an unacceptable adverse biological response resulting from contact of the devices' materials with the body.

Reprocessing, Cleaning, and Sterilization: The reusable coupler has cleaning instructions that were validated based on the quidelines outlined in AAMI TIR30:2011. A steam sterilization validation study was conducted in accordance with the FDA's Guidance for Industry and FDA Staff "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and the FDA recognized consensus standards ANSI/AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013. The coupler was validated to a Sterility Assurance Level of 10-6 using the half cycle testing validation method.

The articulating adapter is non-sterile capital equipment and is used with a sterile equipment drape. The drape remains intact throughout the procedure and thereby maintains a sterile barrier. A cleaning compatibility study confirmed that the agents used during cleaning/disinfection are compatible with the materials of construction and markings of the adapter.

The single use articulating instruments are provided sterile to the end user via gamma irradiation. Gamma irradiation at a minimum dose of 25 kGy was validated per FDA recognized consensus standards ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3:2017 and demonstrated a Sterility Assurance Level of 10°. The packaging has been validated to maintain sterility for the stated shelf life of the device.

Bench Testing: Bench testing evaluated the performance of the Senhance Articulating instruments as well as compatibility of the Senhance Articulating platform when used with the Senhance Surgical System. The following tests confirmed that the articulating instruments perform as intended after tests of mechanical integrity under conditions of simulated use and that the Senhance system performs as intended when used with the subject Senhance Articulating platform:

Cantilever Bending Reliability .
. Jaw Actuation Reliability

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. Jaw Compensation
. Electrosurgical Unit (ESU) Compatibility
Sterile Drape Reliability

Electrical Safety and Compatibility: The Senhance Articulating platform used in conjunction with the Senhance system comply with the current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-2-18 (Endoscopic equipment interactions), and IEC 60601-2-2 (High frequency surgical equipment).

Software Verification and Validation Testing: Software verification and validation were successfully conducted on the latest Senhance software version that supports the Senhance Articulating platform. Documentation was provided as recommended in FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software is considered as a "major" level of concern.

Pre-Clinical Design Validation: Design validation of the Senhance Articulating platform was conducted to ensure that the devices perform as intended according to defined user needs and intended uses when used with the Senhance system in a simulated use environment. A singlecenter, un-blinded, observational, simulated use design validation evaluation of the Senhance system used in conjunction with Senhance Articulating platform was conducted with users who represented the intended primary user population. The design validation was conducted in a simulated patient model. All applicable user level requirements were assessed and found to be met.

Usability Testing: Modifications to the existing Senhance system Usability Engineering file were made based on the addition of the new articulating platform. A summative usability validation study was performed with final instructions for use and training materials. In a simulated use environment, the surgical teams were able to independently perform all critical tasks without use errors that would lead to harm. This study demonstrated that the overall residual risk of use errors with the Senhance Articulating platform have been mitigated to an acceptable level. The Senhance Articulating platform used in conjunction with the Senhance system can be used without use errors or problems that could result in serious harm.

Conclusions

The Senhance Articulating platform used with the Senhance Surgical System is as safe and effective as the predicate Senhance Surgical System (K202166). The subject device has the same intended use/ indications for use and either identical or very similar technological characteristics and principles of operation as the predicate device. Any differences in technological characteristics between the subject and predicate devices have been addressed through a comprehensive set of testing using established test methods and do not raise any new or different questions of safety or effectiveness. Thus, the equivalence assessment and testing results support a determination of substantial equivalence to the predicate in terms of safety, efficacy, and performance.

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.