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 Monopolar Scissors is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Monopolar Scissors is connected to the HandX and transmits the motors' rotations to articulate the movement of the Monopolar Scissors' end effector. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.

AI/ML Overview

The provided text describes the HandXTM Monopolar Scissors, a single-use, disposable, ETO sterilized instrument. The device is intended to assist in the control of Human Xtensions laparoscopic instruments for endoscopic manipulation of tissue in various surgical procedures involving grasping, approximation, ligation, suturing, cutting, and/or coagulation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document broadly states that "All tests met the predefined acceptance criteria" for various bench tests. However, it does not explicitly list specific numerical acceptance criteria or quantitative performance results for each test. Instead, it confirms that the device passed these tests.

Test Category	Specific Tests	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity	Not explicitly defined, but based on ISO 10993-1:2018, ISO 14971:2019, and FDA guidance documents, the materials should not cause unacceptable biological reactions or risks when in limited (≤24 hours) contact with tissue or bone.	"Based upon the biological risk assessment and the results of biocompatibility testing performed on the device, it can be concluded that the device can be considered biocompatible for use as intended."
Electrical Safety and EMC	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6.	The device must meet the electrical safety and electromagnetic compatibility requirements of the specified IEC standards to ensure safe operation and prevent interference with other equipment.	"The Monopolar Scissors 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	Instrument Dimensional Attribute, Articulation Angle and Roll Range Measurement, Roll and Grasp Torque Measurement Method, Instrument Articulation latency, Impedance Test, Dielectric Strength, Insulation Integrity test, Generator Cable Compatibility with Extension Cables, Proximal Seal Test, Tip Integrity, Deflection Integrity, Cutting Integrity, Performance Test (instrument integrity following simulated use), Human Factors Summative Evaluation, Human Factors Labeling Validation, Instrument Corrosion Test	Predefined acceptance criteria for each test to demonstrate that design outputs meet design input requirements and that the device is safe and effective for its intended use. These would typically include specific ranges or thresholds for dimensions, angles, torques, electrical properties, structural integrity after use, and user interaction.	"All tests met the predefined acceptance criteria. The testing identified no new questions of safety and effectiveness."
Performance Testing - Animal (Swine Model)	Safety (thermal damage evaluation using temperature probes and histopathology evaluation) and functional performance and usability comparison with a reference device.	For safety, thermal damage and histopathology results should be acceptable and comparable to the reference device. For performance and usability, the device should function effectively and be usable by qualified personnel, as assessed by questionnaires.	"It can be concluded that the Monopolar Scissors instrument passed all the per-defined acceptance criteria for safety, performance and usability." "Temperature and histopathology evaluations were performed following slits formation on porcine tissue... as compared to the reference device ENDOPATH® Scissors... in various working modes... and in different energy levels."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Bench Testing: The sample size for each specific bench test is not provided. The data provenance is implied to be from internal laboratory testing.
Performance Testing - Animal (Swine Model): The number of animals used is not specified. The study involved qualified personnel performing tasks with both the subject and reference device. This appears to be a prospective study conducted in a controlled environment (animal lab). The country of origin for the data is not explicitly mentioned.

3. 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)

Bench Testing: The document does not mention the use of external experts to establish ground truth for bench tests. These tests are typically evaluated against engineering specifications and validated test methods.
Performance Testing - Animal: "Qualified personnel with appropriate experience" executed the evaluation and filled out questionnaires. The specific number or detailed qualifications (e.g., years of experience, specialty) of these personnel are not provided. For thermal damage and histopathology, it is implied that experts (e.g., a pathologist) evaluated the tissue, but their number and specific qualifications are not stated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for reconciling varying opinions, as no multiple expert readings of the test results are mentioned. For bench tests, it's typically a direct comparison to predefined criteria. For the animal study, it appears to be based on observations, measurements, and questionnaires by the "qualified personnel."

5. 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

No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers interpreting results. The animal study did compare the device to a reference device, but this was a functional comparison, not an assessment of human reader performance with or without AI assistance.

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

No, this question doesn't apply directly to the HandXTM Monopolar Scissors. It is a physical surgical instrument, not an algorithm. Its performance is always with a human-in-the-loop (the surgeon).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Biocompatibility: Ground truth was established by adherence to recognized international standards (ISO 10993-1, ISO 14971) and FDA guidance, with testing for specific biological endpoints (cytotoxicity, sensitization, etc.).
Electrical Safety and EMC: Ground truth was established by compliance with international electrical safety and EMC standards (IEC 60601 series).
Bench Testing: Ground truth was based on engineering design input requirements and validated test methods, with established predefined acceptance criteria.
Performance Testing - Animal: Ground truth for safety was assessed by "thermal damage evaluation using temperature probes and histopathology evaluation according to FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff." For functional performance and usability, it was through direct observation during surgical tasks and post-procedure questionnaires completed by "qualified personnel." This combines objective measurements (temperature, histopathology) with subjective assessment (usability questionnaires).

8. The sample size for the training set

The concept of a "training set" is not applicable here as the device is a physical surgical instrument, not an AI/ML algorithm that requires training data.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 10, 2023

Human Xtensions Ltd. Hani Rauch RA Manager Meir Ariel 4 Netanya, 4250574 Israel

Re: K230491

Trade/Device Name: HandXTM Monopolar Scissors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, GEI Dated: February 5, 2023 Received: February 23, 2023

Dear Hani Rauch:

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

{1}------------------------------------------------

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,

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2013.05.10
08:22:23 -04'00'

Mark Trumbore 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

{2}------------------------------------------------

Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

Device Name HandX(TM) Monopolar Scissors

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Premarket Notification 510(k) Summary

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

Submitter:	Human Xtensions Ltd.Grand Netter Building4 Meir Ariel StreetNetanya, 4250574,IsraelTelephone: + (972) 77 36 30 300
Contact:	Hani RauchHumanXtensions Ltd.4 Meir Ariel StreetNetanya, 4250574,IsraelTelephone: + (972) 77 36 30 300 Email:hani@human-x.com
Date Prepared:	May 7, 2023
Subject Device:
Device Name:Device Classification Name:Product Codes:Product Class:Regulation Numbers:	HandX™ Monopolar ScissorsLaparoscope, General & Plastic SurgeryGCJ, GEIClass II21 CFR Parts 876.1500, 878.4400
Predicate Devices:	Monopolar Hook, Human Xtensions Ltd.(K203603)
Reference device:	ENDOPATH® Scissors, curved, withmonopolar cautery, 5MM (K984240),Ethicon.

Device Description:

{4}------------------------------------------------

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 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.

Comparison of Technological Characteristics With the Predicate Devices:

The Monopolar Scissors is substantially equivalent to the predicate device. Human Xtensions' Monopolar Hook (K203603), in its intended use, contraindications, fundamental technology, packaging, sterilization method and general characteristics.

The main design characteristics of the instrument's effective length, diameter, materials and compatibility with commonly used 5mm trocars are similar to those of the Monopolar Hook.

The electrosurgical characteristics of the Monopolar Scissors are similar to its predicate device and similarly is connected to a standard Electrosurgical Unit (ESU) via a standard generator cable, which are generic Operating Room (OR) equipment.

Its dissection/cutting of organ/tissue function is comparable with the reference device Ethicon's ENDOPATH® 5MM Curved Scissors with Monopolar Cautery (K984240).

It can be concluded that the Monopolar Scissors is substantially equivalent to its predicate. No new questions of safety and effectiveness were raised.

Performance Data:

Bench testing, biocompatibility, electrical safety, human factors, and usability evaluations were performed to support a substantial equivalence determination. The results of the tests met the acceptance criteria and demonstrated the safety and substantial equivalency of the Monopolar Scissors. 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 Scissors is categorized according to ISO 10993-1 as an externally communicating device in limited (≤24 hours) contact with tissue or bone.

The materials of the Monopolar Scissors are similar to those of the previously cleared HandXTM instruments.

A full biological risk assessment for the Monopolar Scissors was performed according to the requirements of ISO 10993-1:2018, ISO 14971:2019 and FDA's guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Per the categorization, the following endpoints were considered: cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.

{5}------------------------------------------------

Based upon the biological risk assessment and the results of biocompatibility testing performed on the device, it can be concluded that the device can be considered biocompatible for use as intended.

Electrical Safety and ElectroMagnetic Compatibility (EMC):

The Monopolar Scissors 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 Scissors was subjected to bench testing to evaluate its 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 the following:

Instrument Dimensional Attribute
Articulation Angle and Roll Range Measurement
Roll and Grasp Torque Measurement Method ●
Instrument Articulation latency ●
Impedance Test
Dielectric Strength ●
Insulation Integrity test
Generator Cable Compatibility with Extension Cables
Proximal Seal Test
Tip Integrity
Deflection Integrity
Cutting Integrity ●
Performance Test (instrument integrity following simulated use) ●
Human Factors Summative Evaluation
Human Factors Labeling Validation ●
Instrument Corrosion Test ●

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

Performance Testing - Animal

The HandX Monopolar Scissors was tested in a swine model to evaluate the device's safety, functional performance and usability. The evaluation was executed by performing various surgical tasks, using both the subject device and the reference device, by qualified personnel with appropriate experience, followed by questionnaires filled out by the participants.

The device's safety was assessed by thermal damage evaluation using temperature probes and histopathology evaluation according to FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff. Temperature and histopathology evaluations were performed following slits formation on porcine tissue. Slits were performed by the Monopolar Scissors as compared to the reference device ENDOPATH® Scissors (curved, with monopolar cautery, 5MM) in various working modes (pure cut, blend cut, spray and coagulation) and in different energy levels.

It can be concluded that the Monopolar Scissors instrument passed all the per-defined acceptance criteria for safety, performance and usability.

{6}------------------------------------------------

Conclusion:

Based upon the intended use, indications, technological characteristics and performance testing, it can be concluded that the Monopolar Scissors is substantially equivalent to its predicate device. The differences between the subject and predicate devices do not raise any questions about safety and 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.