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 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.

Device Description

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

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

AI/ML Overview

This document is a 510(k) summary for the HandX Monopolar Spatula, a medical device. It describes the device's intended use, comparison to a predicate device, and performance data.

Here's an analysis of the provided text in relation to acceptance criteria and study proving device meets those:

The provided text describes a 510(k) premarket notification for a medical device called the "HandX Monopolar Spatula". This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing acceptance criteria and conducting a study to prove the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning device.

The HandX Monopolar Spatula is an electrosurgical electrode, not an AI or machine learning device. Therefore, many of the typical criteria and study elements associated with AI device performance validation (like sensitivity, specificity, MRMC studies, ground truth establishment with experts, training set size, etc.) are not applicable to this submission.

The "acceptance criteria" for this device are primarily related to its physical, electrical, and biological performance, demonstrating it's as safe and effective as existing similar devices.

However, I will extract relevant information from the document that touches upon "acceptance criteria" and "studies" as best as possible, interpreting them within the context of a traditional medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" are implied by successful completion of various tests, demonstrating compliance with standards and equivalence to the predicate. The "reported device performance" is the statement that these tests were passed successfully.

Category / Test Type	Implied Acceptance Criteria	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, demonstrating negligible risk of toxicity (cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity).	"The device was deemed to pose a negligible risk of toxicity and is considered to have met the requirements of ISO 10993-1:2018 and FDA's corresponding guidance and to be safe for use as intended."
Electrical Safety & EMC	Full compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6.	"The Monopolar Spatula was found to fully comply with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6."
Bench Testing	Design outputs meet design input requirements; device is safe and effective for intended use; all tests meet predefined acceptance criteria.	"All tests [Dimensional attributes, Seal Test, Tip Pull to Failure] met the predefined acceptance criteria, and testing identified no new questions of safety and effectiveness."
Thermal Effects Testing	Substantially equivalent thermal behavior compared to predicate and reference devices.	"The results supported the substantially equivalent thermal behavior of the Monopolar Spatula compared to the predicate and reference devices." (Based on ex-vivo and in-vivo studies using a porcine model to evaluate thermal behavior and lateral thermal spread).
Human Factors/Usability	Device can be used safely and effectively in accordance with its labeling.	"A summative evaluation study (per IEC 62366-1) confirmed that the device can be used safely and effectively in accordance with its labeling."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for most tests. For Thermal Effects Testing, it mentions a "porcine model," implying animal subjects, but no specific number of animals or trials. For Human Factors/Usability, a "summative evaluation study" was done, but the number of participants is not provided.
Data Provenance: The document does not specify the country of origin for the data. The studies appear to be pre-market validation studies conducted by the manufacturer, rather than retrospective or prospective clinical data from a specific patient population.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable in the context of an AI device. For this physical device, "ground truth" generally refers to design specifications, validated measurement techniques, and established safety standards. There is no mention of "experts" establishing a "ground truth" as would be done for diagnostic AI. The "Human Factors/Usability" study would likely involve trained medical professionals, but their role is to test usability, not establish a diagnostic ground truth.

4. Adjudication Method for the Test Set

Not Applicable. As there is no "ground truth" being established by multiple readers/experts in a diagnostic sense, no adjudication method (like 2+1, 3+1) is mentioned or relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/diagnostic device. An MRMC study is not relevant to demonstrating the safety and effectiveness of a surgical instrument of this type. The comparison is primarily against a predicate device based on physical, electrical, and biological performance characteristics, rather than diagnostic accuracy or human reader performance.

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

Not Applicable. This is a physical surgical instrument that always requires a human in the loop for its operation. It does not contain an "algorithm" in the sense of an AI/machine learning component that could operate standalone.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance validation is derived from:

Mechanical and Electrical Engineering Standards: Compliance with relevant IEC standards (e.g., IEC 60601 series).
Biocompatibility Standards: Compliance with ISO 10993-1.
Predefined Acceptance Criteria: Established internally by the manufacturer for bench tests (Dimensional attributes, Seal Test, Tip Pull to Failure).
Comparative Performance: Demonstrating substantial equivalence in thermal behavior to a predicate and reference device in animal models.
Usability Standards: Compliance with IEC 62366-1 for human factors/usability.

8. The Sample Size for the Training Set

Not Applicable. This device does not use an AI/machine learning component, so there is no concept of a "training set" for an algorithm.

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

Not Applicable. As per point 8, there is no training set for an algorithm.

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 12, 2023

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

Re: K222011

Trade/Device Name: HandX Instrument - Monopolar Spatula Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, GEI Dated: December 14, 2022 Received: December 14, 2022

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Colin K. Chen -S

for

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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222011

Device Name HandX™ Monopolar Spatula

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

Human Xtensions Ltd.'s HandX

Submitter:	Human Xtensions Ltd.4 Meir Ariel StreetGrand Netter BuildingNetanya, 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:	January 11, 2023
Subject Device:
Device Name:Common Name:	HandX™ Monopolar SpatulaElectrosurgical electrode
Classification Name:Product Codes:	Laparoscope, General & Plastic SurgeryGCJ, GEI
Product Class:Regulation Number:	Class II21 CFR Part 876.150021 CFR Part 878.4400
Predicate Device:Reference Device:	Monopolar Hook, Human Xtensions (K203603)ENDOPATH Electrosurgery PROBE PLUS II(K160128)

Intended Use / Indications for Use

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Device Description

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

Comparison of Technological Characteristics With Predicate Device:

The Monopolar Spatula is substantially equivalent to the predicate device, Human Xtensons' HandX™ Monopolar Hook (K203603), in its intended use, contraindications, fundamental technology, mechanical performance characteristics and sterilization method. The Monopolar Spatula is an alternative electrode for the Monopolar Hook for surgical tasks that require monopolar cutting and/or coagulation during surgeries. It differs from the Monopolar Hook only in the end effector's tip shape and material; all other components and assembly configuration are identical.

The electrical functionality of the Monopolar Spatula is equivalent to that of the cleared Monopolar Hook. The MonopolarSpatula's usability and safety aspects were compared to the predicate device in Human Factors Summative Evaluation, bench tests, and in vivo testing,

Performance Data

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

Biocompatibility Testing:

The Monopolar Spatula is categorized per ISO 10993-1 as an externally communicating device in limited (≤24 hours) contact with tissue or bone. Accordingly, the following endpoints were considered: cytotoxicity, sensitization, acute systemic toxicity, and material mediated pyrogenicity. The device was deemed to pose a negligible risk of toxicity and is considered to have met the requirements of ISO 10993-1:2018 and FDA's corresponding guidance and to be safe for use as intended.

Electrical Safety and Electromagnetic Compatibility (EMC):

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

Bench Testing:

Bench testing was conducted to evaluate device performance and to 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:

· Verification of Dimensional attributes
· Seal Test
Tip Pull to Failure

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

Thermal Effects Testing:

Ex-vivo and in-vivo studies were conducted using a porcine model to evaluate the thermal behavior and the lateral thermal spread of the Monopolar Spatula compared to its predicate and reference

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devices. The results supported the substantially equivalent thermal behavior of the Monopolar Spatula compared to the predicate and reference devices.

Human Factors/Usability:

A summative evaluation study (per IEC 62366-1) confirmed that the device can be used safely and effectively in accordance with its labeling.

Conclusion

Based upon the intended use, technological characteristics, safety and performance testing, as well as comparison to the predicate device, it can be concluded that the HandX™ Monopolar Spatula is substantially equivalent to its predicate device. The minor differences between the subject and predicate device do not raise any different questions of safety and effectiveness, and the design controls and data collected ensure no adverse impact on safety or effectiveness.

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.