HandX Instrument - Monopolar Spatula

K222011 · Human Xtensions , Ltd. · GCJ · Jan 12, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K222011
• Device Name: HandX Instrument - Monopolar Spatula
• Applicant: Human Xtensions , Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 12, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

HandX Monopolar Spatula is a single-use sterile electrosurgical electrode accessory for the HandX laparoscopic system. Device connects to HandX system, which translates motor rotation into articulation of the spatula end effector. Connects to standard electrosurgical generators via standard cable for monopolar diathermy. Used by trained physicians in operating rooms for tissue manipulation, cutting, and coagulation. Provides surgeons with articulated control of electrosurgical energy delivery during laparoscopy. Benefits include enhanced maneuverability and precision in tissue management compared to rigid instruments.

Clinical Evidence

Bench testing included dimensional verification, seal testing, and tip pull-to-failure. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity) showed negligible risk. Electrical safety/EMC testing complied with IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-18, and 60601-1-6. Thermal effects evaluated via ex-vivo and in-vivo porcine models, demonstrating equivalent thermal behavior to predicate. Human factors summative evaluation per IEC 62366-1 confirmed safe and effective use.

Technological Characteristics

Single-use sterile electrosurgical electrode. Articulated end effector driven by HandX system motors. Connects to standard electrosurgical units. Complies with IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-18, and 60601-1-6. Biocompatibility per ISO 10993-1:2018.

Indications for Use

Indicated for trained physicians performing laparoscopic surgical procedures requiring tissue manipulation (grasping, approximation, ligation, suturing) and electrosurgical cutting or coagulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Monopolar Hook, Human Xtensions (K203603)

Reference Devices

• ENDOPATH Electrosurgery PROBE PLUS II (K160128)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 510(k) SUMMARY

#### Human Xtensions Ltd.'s HandX

| Submitter: | Human Xtensions Ltd.<br>4 Meir Ariel Street<br>Grand Netter Building<br>Netanya, 4250574, Israel<br>Telephone: + (972) 77 36 30 300 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Randy J Prebula<br>Hogan Lovells US LLP<br>Columbia Square<br>555 Thirteenth Street, NW<br>Washington, DC 20004<br>Telephone: [phone]<br>Direct: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | January 11, 2023 |
| Subject Device: | |
| Device Name:<br>Common Name: | HandX™ Monopolar Spatula<br>Electrosurgical electrode |
| Classification Name:<br>Product Codes: | Laparoscope, General & Plastic Surgery<br>GCJ, GEI |
| Product Class:<br>Regulation Number: | Class II<br>21 CFR Part 876.1500<br>21 CFR Part 878.4400 |
| Predicate Device:<br>Reference Device: | Monopolar Hook, Human Xtensions (K203603)<br>ENDOPATH Electrosurgery PROBE PLUS II<br>(K160128) |

#### Intended Use / 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.

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## 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.

## 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.