The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures.

The HandX monopolar instruments are connected by a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.

Device Description

The Monopolar Hook is a single use sterile electrosurgical electrode for use with the HandX™ device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors' rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.

The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for the "Monopolar Hook" device by Human Xtensions Ltd. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than describing a study proving the device meets acceptance criteria for an AI/algorithm-driven, diagnostic, or prognostic medical device.

Therefore, much of the requested information (acceptance criteria for an AI model, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided document, because the Monopolar Hook is a physical surgical instrument, not an AI or algorithm-based device.

The "Performance Data" section describes validation for a physical medical device, not an AI system. It mentions:

Biocompatibility testing: Catheterized as an externally communicating device in limited contact (≤24 hours) with tissue or bone. Endpoints considered: cytotoxicity, sensitization, acute systemic toxicity, and material mediated pyrogenicity.
Electrical Safety and ElectroMagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18, and IEC 60601-1-6.
Bench Testing: Evaluated device performance against design inputs, demonstrating safety and effectiveness.
- Tests included: Physical/Dimensional Inspection and Tip Measurements, Functional Test, Impedance Test, DC Hipot-Ramp to Failure, Generator Cable Pull Test, Seal Test, Sterile Barrier, Mechanical Strength – Pull to Failure, Passivation Verification Corrosion Test, Shaft's Insulation Integrity Test.
- Acceptance Criteria & Performance: "All tests met the predefined acceptance criteria." Specific quantitative criteria and detailed performance values are not provided in this summary document, only the statement of compliance.
Animal Study (Pre-clinical): Tested in a porcine model to evaluate safety, functional performance, and usability.
- Safety assessed via histopathology evaluation of slits performed by the Monopolar Hook compared to the predicate device.
- Performance: "The Monopolar Hook performed similarly when compared to the predicate device."

Based on the provided document, here's what can be extracted and what cannot:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria Description	Reported Device Performance (Summary)	Quantifiable Performance Data Provided?
Biocompatibility	Compliance with ISO 10993-1 for cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity.	No specific data, only "considered".
Electrical Safety / EMC	Full compliance with IEC 60601 series standards (IEC 60601-1, -1-2, -2-2, -2-18, -1-6).	No specific data, only "fully comply."
Bench Testing (Multiple aspects)	All predefined acceptance criteria were met for: - Physical/Dimensional Inspection & Tip Measurements - Functional Test - Impedance Test - DC Hipot-Ramp to Failure - Generator Cable Pull Test - Seal Test - Sterile Barrier - Mechanical Strength – Pull to Failure - Passivation Verification Corrosion Test - Shaft's Insulation Integrity Test	No specific quantitative acceptance criteria or performance values are detailed in this summary.
Animal Study (Safety/Similarity)	Device safety (histopathology of slits) and functional performance were evaluated. Performed similarly to the predicate device.	No specific histopathology results or quantitative performance metrics for "similarly."

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the tests. The animal study mentions a "porcine model" but not the number of animals used.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is a medical device clearance, not a clinical trial or AI validation study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not mentioned. The device is a surgical instrument, not an AI diagnostic tool requiring expert ground truth for image interpretation. The histopathology in the animal study would presumably be conducted by a pathologist, but details are not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal study, safety was assessed by a "histopathology evaluation" of lesions. This implies pathological assessment served as a form of ground truth for safety comparison.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI model.
How the ground truth for the training set was established:
- Not applicable. This is a physical device, not an AI model.

Summary

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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

February 1, 2021

Human Xtensions Ltd. % Randy Prebula Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004

Re: K203603

Trade/Device Name: Monopolar Hook Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, GEI Dated: December 9, 2020 Received: December 9, 2020

Dear Randy Prebula:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203603

Device Name Monopolar Hook

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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Premarket Notification 510(k) Summary – K203603

The Company's 510(k) Summary is provided below.

Submitter:	Human Xtensions Ltd.4 Meir Ariel StreetNetanya, 4250574, IsraelTelephone: + (972) 77 36 30 300
Contact:	Randy J PrebulaHogan Lovells US LLPColumbia Square555 Thirteenth Street, NWWashington, DC 20004Telephone: +1 202 637 5600Direct: +1 202 637 6548Fax: +1 202 637 5910Email: randy.prebula@hoganlovells.com
Date Prepared:	February 1, 2021
Subject Device:
Device Name:	Monopolar Hook
Common Name:	Electrosurgical electrode
Device Classification Name:	Laparoscope, General & Plastic Surgery
Product Codes:	GCJ, GEI
Product Class:	Class II
Regulation Numbers:	21 CFR Parts 876.1500, 878.4400
Predicate Devices:	HandXTM, Human Xtensions (K173919)SILS L-Hook, Covidien (K091869)
Device Description:

The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable.

Indications for Use:

The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of

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tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures.

The HandX monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.

Contraindications:

The HandX is not intended for contraceptive coagulation of fallopian tissue, but may be used to achieve homeostasis following transaction of the fallopian tube.

Comparison of Technological Characteristics With the Predicate Devices:

The Monopolar Hook is substantially equivalent to the predicate devices, Human Xtensions' HandX (K173919) and Covidien's SILS L-Hook (K091869), in its intended use, contraindications, fundamental technology, sterilization method and general characteristics. The Monopolar Hook's electrosurgical characteristics were compared for usability and safety to the predicate device, the SILS L-Hook (K091869), under animal study. The similarities of the technological characteristics of the Monopolar Hook compared to the predicate devices are further outlined in Table 1, below.

Performance Data:

Biocompatibility testing, bench testing and a pre-clinical study were performed to support a determination of substantial equivalence. The results of the tests met acceptance criteria and demonstrated the safety and substantial equivalency of the Monopolar Hook. No safety or performance issues were raised during the testing.

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility Testing:

The Monopolar Hook is categorized according to ISO 10993-1 as an externally communicating device in limited (≤24 hours) contact with tissue or bone. Per the categorization, the following endpoints were considered: cytotoxicity, sensitization, acute systemic toxicity, and material mediated pyrogenicity.

Electrical Safety and ElectroMagnetic Compatibility (EMC):

The Monopolar Hook was found to fully comply with the requirements of the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18, and IEC 60601-1-6.

Bench Testing:

The Monopolar Hook was subjected to bench testing to evaluate device performance and demonstrate that the design outputs meet the design input requirements and that the device is safe and effective for its intended use.

The verification bench testing included:

Physical / Dimensional Inspection and Tip Measurements ●
Functional Test ●

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Human Xtensions Ltd., Monopolar Hook, K203603

Impedance Test
DC Hipot-Ramp to Failure
Generator Cable Pull Test
Seal Test
. Sterile Barrier
Mechanical Strength – Pull to Failure
Passivation Verification Corrosion Test ●
Shaft's Insulation Integrity Test ●

All tests met the predefined acceptance criteria. The testing identified no new questions of safety and effectiveness.

Animal Study:

The Monopolar Hook was tested in a porcine model to evaluate the device's safety, functional performance, and usability. Device safety was assessed by a histopathology evaluation of slits performed by the Monopolar Hook in comparison to those performed by the predicate device (Covidien's, SILS L-Hook (K091869)). The Monopolar Hook performed similarly when compared to the predicate device.

Conclusion:

Based upon the intended use, technological characteristics, safety and performance testing, as well as comparison to the predicate devices, it can be concluded that the Monopolar Hook is substantially equivalent to its predicate devices. The minor differences between the subject and predicate devices do not raise any questions of safety and effectiveness.

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Description	Human XtensionsMonopolar Hook	Human XtensionsHandX (K173919)	Covidien SILSL-Hook (K091869)	SubstantialEquivalence
Product Code	GCJGEI	GCJ	GCJ	Same
CFR	876.1500878.4400	876.1500	876.1500	Same
Indications forUse	The HandX isintended to assist inthe control of HumanXtensionslaparoscopicinstruments includingneedle holder, grasperand monopolarinstruments, forendoscopicmanipulation of tissue,including grasping,approximation,ligation, suturing,cutting and/orcoagulation, duringlaparoscopic surgicalprocedures.The HandXmonopolar instrumentsare connected by astandard cable to astandardelectrosurgical powersource.It is intended to beused by trainedphysicians in anoperating roomenvironment inaccordance with itsInstructions for Use.	The HX Device isintended to assist inthe accurate controlof HX laparoscopicInstruments includingneedle holder andgrasper, forendoscopicmanipulation oftissue, includinggrasping,approximation,ligation, suturing,during laparoscopicsurgical procedures.It is intended to beused by trainedphysicians in anoperating roomenvironment, inaccordance with itsInstructions for Use.	The SILS™ L-Hook single usearticulating hook withmonopolar cautery hasapplication in endoscopic,gynecological, and generalabdominal and thoraciclaparoscopic procedures.When connected by a standardcable to an electrosurgicalpower source, the device maybe utilized for monopolarcautery.	Same
Contra-indications	Not intended forcontraceptivecoagulation offallopian tissue, butmay be used toachieve homeostasisfollowing transactionof the fallopian tube.	N/A	Not intended for contraceptivecoagulation of fallopian tissue,but may be used to achievehomeostasis followingtransaction of the fallopiantube.	Same
Technological Characteristics
Specialty	Laparoscopic	Laparoscopic	Laparoscopic	Same
Mode ofoperation	Electromechanicallyoperated, softwarecontrolled	Electromechanicallyoperated, softwarecontrolled	Manual, hand maneuvered	Same
InsertionMethod	Via Trocar	Via Trocar	Via Trocar	Same
Articulation	Yes	Yes	Yes	Same
Articulationrange	0 to 85°	0 to 85°	0 to 85°	Same
Articulationlocking feature	Yes	Yes	Yes	Same
Tip axialrotation feature	360°	360°	360°	Same
Shaft material	Stainless steel	Stainless steel	Stainless steel	Same
Electrosurgical Characteristics
ApplicationTechnology	Monopolar	N/A	Monopolar	Same
Instrument type	Monopolar L-shapedhook	N/A	Monopolar L-shaped hook	Same
Tip length	5.7 mm to 6.5 mm	N/A	6.0 mm	Similar
Tip width	4.6 mm	N/A	4.7 mm	Similar
Material forelectrode tip	Stainless steel	N/A	Stainless steel	Same
Energyactivation	Generator foot pedalswitch	N/A	Device finger-controlled switch	Both getenergy fromESU; usercontrols theactivation
Other Attributes
Sterilizationmethod	EtO	EtO	EtO	Same
Sterilityassurance level	10-6	10-6	10-6	Same

Table 1 – Substantial Equivalence Table

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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.