The HX Device is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.

Device Description

The Human Extensions HX Device is a hand held powered laparoscopic device. The device enables, by its attached instruments grasper and needle holder, the surgeon to perform a variety of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension", enhancing maneuverability and control. The HX Device is electromechanically controlled and includes both hardware and software and comprises of two major parts, the Handpiece and the Instrument. The HX Device Handpiece consists of a reusable Control Interface (CI) handle held by the surgeon and a Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip (grasper/needle holder). Prior to use, a set of single use, disposable, sterile Power Cable, Arc, Finger Pads, and strap-adapting Spacer are assembled on the Handpiece and the CI unit. In addition, prior to use, the Handpiece is covered with a standard, sterile cover (e.g., endoscopic camera cover) of at least 8.5 cm inner diameter. The sterile cover is not provided with the HX device. After each use, the Handpiece is cleaned and disinfected according to the specifications detailed in the Instructions For Use.

AI/ML Overview

The provided text describes the regulatory clearance for the HX Device, a handheld powered laparoscopic device. It details the device's intended use, comparison to predicate devices, and the performance data submitted to support its substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "All tests met the predefined acceptance criteria" for various bench tests and an animal study. However, the specific quantitative acceptance criteria values and the quantitative results of the device performance against these criteria are not explicitly stated in the provided text.

The text broadly lists the types of tests conducted and states their successful completion:

Acceptance Criteria Category	Reported Device Performance
Risk analysis per ISO 14971	Performed
Biocompatibility testing per ISO 10993	All tests completed and passed
Sterilization validation per ISO 11135-1	Performed to demonstrate compliance
Cleaning validation (re-use of handle)	Validated
Shelf life and packaging testing	Performed to support labeled shelf life; All tests successfully completed
Bench Testing (HX Device Performance Evaluation, Instrument Corrosion Test, Needle Holder Instrument Reliability Evaluation, Arc and Pads Reliability Evaluation, Dimensional Attributes Verification, Tissue Grasping Force Test, Needle Holding Strength, Grasper Instrument Reliability Evaluation, Device Motion Performance Test, Motor Drive Chain Durability, Liquid Permeability, Bacterial Permeability)	All tests met the predefined acceptance criteria
Animal Study	Devices performed well without malfunction to users' satisfaction. Users were able to perform tissue manipulation tasks (grasping different tissues, continuous or interrupted sutures). Test met predefined acceptance criteria.
Software Validation	Verification and validation tests conducted; documentation provided as recommended by FDA guidance.
Electrical Safety per IEC 60601-1	Conducted
Electromagnetic Compatibility (EMC) per IEC 60601-1-2	Conducted

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

Bench Testing: The text does not specify the exact sample sizes (number of devices, instruments, or tests) used for the various bench tests. It only states that these tests were conducted.
Animal Study: The text does not specify the sample size (number of animals or procedures) used for the GLP animal study.
Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a regulatory submission for a new device, it's highly probable that the studies were prospective and conducted to generate data for this submission. The manufacturer, Human Extensions Ltd., is based in Israel, so the studies were likely conducted there or in a region that supports GLP standards.

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

Bench Testing: Not applicable in the context of "ground truth" established by experts in the same way as clinical imagery interpretation. These tests evaluate quantifiable physical properties and performance.
Animal Study: The text states, "GLP Animal Study was performed by several users." It then mentions, "Users were able to perform tissue manipulation tasks such as grasping different tissues, and to perform continues or interrupted sutures tasks." These "users" are implicitly the experts who performed the procedures and evaluated the device's performance, but their specific number or qualifications (e.g., "veterinarian with X years of experience," or "surgeon with Y years of experience") are not detailed.

4. Adjudication Method for the Test Set

Bench Testing: Adjudication is not typically relevant here, as results are usually objective measurements against defined specifications.
Animal Study: The text mentions that the study was performed by "several users" and that the "devices performed well without malfunction to users' satisfaction." This suggests a subjective assessment by the users, but no formal adjudication method (like 2+1 or 3+1 consensus) is described among these users.

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

No MRMC study is mentioned or implied. The document focuses on demonstrating the device's basic performance, reliability, and safety attributes, and showing substantial equivalence to predicate devices, rather than a comparative effectiveness study involving human readers' diagnostic accuracy or changes in their performance with AI assistance. The HX Device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This concept is not directly applicable. The HX Device is a physical, electromechanically controlled surgical instrument that is always "human-in-the-loop," as it is "controlled by the surgeon's hand." While it has software, its performance is intrinsically tied to human operation. The software validation mentioned is for the functionality of the device's embedded software, not for a standalone diagnostic algorithm.

7. Type of Ground Truth Used

Bench Testing: Ground truth is established by the definitions of the physical and mechanical properties being measured and the predefined acceptance criteria for those measurements.
Animal Study: The ground truth for the animal study appears to be defined by the successful completion of specified surgical tasks (tissue manipulation, grasping, suturing) without device malfunction, and the "satisfaction" of the users (operators). This is an observational and performance-based ground truth within a controlled preclinical setting. It does not rely on pathology or outcomes data in the sense of long-term patient follow-up, but rather on immediate operational success and device reliability during simulated procedures.

8. Sample Size for the Training Set

The document addresses a regulatory submission for device performance and equivalence, not an AI model's training. Therefore, there is no mention of a "training set" in the context of machine learning. The device's design and engineering are based on principles of mechanical and electrical engineering, validated through the described tests.

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

As there is no training set for an AI model mentioned, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.

March 20, 2018

Human Extensions Ltd. % Orly Maor Regulatory Consultant Orly Maor 25 Sirkin Street Kfar Saba, Israel 44421

Re: K173919

Trade/Device Name: HX Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, NAY Dated: February 28, 2018 Received: March 5, 2018

Dear Orly Maor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, practice, 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K173919

Device Name HX Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
凶Prescription Use (Part 21 CFR 801 Subpart D)	i 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. '

FORM FDA 3881 (8/14)

Page 1 of 1 FDA

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Image /page/3/Picture/0 description: The image shows the alphanumeric string "K173919". The string is written in a clear, sans-serif font. The characters are uniformly sized and spaced, making the string easily readable. The image appears to be a close-up of the string, with no other discernible elements or background features.

Image /page/3/Picture/1 description: The image shows the logo for Human Extensions. The logo consists of a gray molecular structure graphic on the left, followed by the words "HumanExtensions" on the right. The word "Human" is in a gradient orange color, while the word "Extensions" is in gray.

Traditional Premarket Notification Submission - 510(k) HX Device 510(k) Number K173919/S001

Date Prepared: March 17, 2018

I. SUBMITTER

Human Extensions Ltd. 45 Hamada Street, Poleg Industrial Park, P.O.Box 8180 Netanya, 4250574, Israel Telephone: +(972) 9 766 9569

Contact Person

Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: +972-9-7453607 Fax: +972-153-9-7453607 oram.ma@gmail.com

II. DEVICE

Name of Device: HX Device Common or Usual Name: HX Device Classification Name: Laparoscope, General & Plastic Surgery (Regulation 876.1500) Regulatory Class: II Product Code: GCJ; NAY Panel: General & Plastic Surgery

III. PREDICATE DEVICE

Human Extensions Ltd. believes that the HX Device is substantially equivalent to the following predicate devices:

Cambridge Endoscopic Devices Inc. PureWrist™ cleated under K061425
Aesculap's Sovereign® mini system cleared under K123102

In addition, additional device the daVinci Surgical System (Intuitive Surgical Inc.) cleared under several clearances K131861 (product codes: NAY) and K170875 (product codes: NAY, GCJ) is being used as a reference device in respect to its technology and in particular its using sterile drape cover.

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Image /page/4/Picture/0 description: The image contains the logo for Human Extensions. The logo features a gray molecular structure graphic to the left of the text "HumanExtensions". The word "Human" is in a gradient orange color, while "Extensions" is in gray.

Traditional Premarket Notification Submission - 510(k) HX Device 510(k) Number K173919/S001

IV. DEVICE DESCRIPTION

The HX Device is electromechanically controlled and includes both hardware and software and comprises of two major parts, the Handpiece and the Instrument.

The HX Device Handpiece consists of a reusable Control Interface (CI) handle held by the surgeon and a Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip (grasper/needle holder). Prior to use, a set of single use, disposable, sterile Power Cable, Arc, Finger Pads, and strap-adapting Spacer are assembled on the Handpiece and the CI unit.

In addition, prior to use, the Handpiece is covered with a standard, sterile cover (e.g., endoscopic camera cover) of at least 8.5 cm inner diameter. The sterile cover is not provided with the HX device.

After each use, the Handpiece is cleaned and disinfected according to the specifications detailed in the Instructions For Use.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Human Extensions believes that the HX Device has the similar intended use and indications for use as the predicate devices and the reference device the da Vinci system. The instruments principles of operation and functionality characteristics are similar as well.

The HX Device Instrument, like the predicate, is inserted through a trocar to assist in procedures in which tissue grasping and suturing is needed under direct visualization. The Instruments for both devices have articulating design at the distal tip that mimics the human hand. The instruments of the HX Device are needle holder and grasper and performed the same tasks as the predicate devices.

Specifically, the use of electromechanical control systems, end-effectors, and degree of mechanical articulation, manipulation and mode of operation of the predicate device and the HX device are comparable.

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Image /page/5/Picture/0 description: The image contains the logo for Human Extensions. The logo features a gray molecular structure graphic to the left of the text "HumanExtensions". The word "Human" is in orange, while "Extensions" is in gray.

Traditional Premarket Notification Submission - 510(k) HX Device 510(k) Number K173919/S001

The daVinci reference device and the HX Device share the same risk/benefit profile in regards to the cover (sterile drape) and cleaning and disinfection method.

Based on the above analysis, Human Extensions Ltd. believes that the HX Device is substantially equivalent to the legally marketed predicate devices.

VII. PERFORMANCE DATA

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

Risk analysis per ISO 14971 -
Biocompatibility testing -

An evaluation of biocompatibility was performed in compliance with ISO 10993. All tests were completed and passed.

Sterilization, Cleaning, Packaging and Shelf Life Testing -
Sterilization validation testing of the single use parts was performed to demonstrate compliance with ISO 11135-1. The handle was validated for cleaning and re-use. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.

Bench Testing -

Bench testing included the following:

· HX Device Performance Evaluation
· Instrument Corrosion Test
· Needle Holder Instrument Reliability Evaluation
· Arc and Pads Reliability Evaluation
· Dimensional Attributes Verification
Tissue Grasping Force Test .
· Needle Holding Strength
· Grasper Instrument Reliability Evaluation
· Device Motion Performance Test
Motor Drive Chain Durability
· Liquid Permeability (Sterile Cover Non-Permeability Evaluation Report)
· Bacterial Permeability (aseptic barrier validation of a standard sterile covered HX Device Handpiece)

All tests met the predefined acceptance criteria.

Animal Study -

GLP Animal Study was performed by several users. Devices performed well without malfunction to users' satisfaction. The users were able to perform tissue manipulation tasks such as grasping different tissues, and to perform continues or interrupted sutures tasks. The test met the predefined acceptance criteria.

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Image /page/6/Picture/0 description: The image contains the logo for Human Extensions. The logo consists of a gray molecular structure graphic to the left of the text "HumanExtensions". The word "Human" is in a gradient orange color, while "Extensions" is in gray.

Traditional Premarket Notification Submission - 510(k) HX Device

510(k) Number K173919/S001

-Software Validation

Software verification and validation tests were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

-Electrical Safely and EMC Electrical Safety per IEC 60601-1 and Electromagnetic Compatibility (EMC) per IEC 60601-1-2 were conducted on the HX Device.

VIII. CONCLUSIONS

The HX Device has the same intended use as the predicate devices. The principal features of the device that were described, as well as the tests provided, show that the minor differences in the device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness.

Performance data. GLP animal study and software validation demonstrates that the HX Device performs as intended and, in a manner, that is substantially equivalent to the predicate.

Therefore, the device may be found substantially equivalent.

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.