Monopolar Hook

K203603 · Human Xtensions , Ltd. · GCJ · Feb 1, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K203603
• Device Name: Monopolar Hook
• Applicant: Human Xtensions , Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 1, 2021
• Decision: SESE
• Submission Type: Traditional
• 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

Monopolar Hook is a single-use, sterile electrosurgical electrode accessory for the HandX system; used in laparoscopic surgery. Device connects to HandX system; transmits motor rotation to articulate end-effector. Connects to standard electrosurgical unit (ESU) via cable for monopolar diathermy. Operated by trained physicians in OR. Provides tissue grasping, cutting, coagulation. Benefits include enhanced control and articulation during minimally invasive procedures. Surgeon controls energy activation via ESU foot pedal.

Clinical Evidence

No human clinical data. Safety and functional performance evaluated via porcine animal study comparing histopathology of tissue slits created by subject device versus SILS L-Hook predicate. Bench testing included physical/dimensional inspection, impedance, DC Hipot, pull-to-failure, seal, and insulation integrity tests. All tests met acceptance criteria.

Technological Characteristics

Stainless steel construction; electromechanically operated via HandX system; 0-85° articulation range; 360° tip rotation; EtO sterilized (SAL 10^-6). Complies with IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-18, and 60601-1-6. Monopolar energy delivery via standard ESU.

Indications for Use

Indicated for trained physicians performing laparoscopic surgical procedures requiring endoscopic tissue manipulation (grasping, approximation, ligation, suturing, cutting, coagulation). Contraindicated for contraceptive coagulation of fallopian tissue, though permitted for homeostasis following fallopian tube transaction.

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

• HandX, Human Xtensions (K173919)
• SILS L-Hook, Covidien (K091869)

Submission Summary (Full Text)

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

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-----------------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# Premarket Notification 510(k) Summary – K203603

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

| Submitter: | Human Xtensions Ltd.<br>4 Meir Ariel Street<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: | 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)<br>SILS L-Hook, Covidien (K091869) |
| 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.

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 Xtensions<br>Monopolar Hook | Human Xtensions<br>HandX (K173919) | Covidien SILS<br>L-Hook (K091869) | Substantial<br>Equivalence |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Product Code | GCJ<br>GEI | GCJ | GCJ | Same |
| CFR | 876.1500<br>878.4400 | 876.1500 | 876.1500 | Same |
| Indications for<br>Use | The HandX is<br>intended to assist in<br>the control of Human<br>Xtensions<br>laparoscopic<br>instruments including<br>needle holder, grasper<br>and monopolar<br>instruments, for<br>endoscopic<br>manipulation of tissue,<br>including grasping,<br>approximation,<br>ligation, suturing,<br>cutting and/or<br>coagulation, during<br>laparoscopic surgical<br>procedures.<br>The HandX<br>monopolar instruments<br>are connected by a<br>standard cable to a<br>standard<br>electrosurgical power<br>source.<br>It is intended to be<br>used by trained<br>physicians in an<br>operating room<br>environment in<br>accordance with its<br>Instructions for Use. | The HX Device is<br>intended to assist in<br>the accurate control<br>of HX laparoscopic<br>Instruments including<br>needle holder and<br>grasper, for<br>endoscopic<br>manipulation of<br>tissue, including<br>grasping,<br>approximation,<br>ligation, suturing,<br>during laparoscopic<br>surgical procedures.<br>It is intended to be<br>used by trained<br>physicians in an<br>operating room<br>environment, in<br>accordance with its<br>Instructions for Use. | The SILS™ L-Hook single use<br>articulating hook with<br>monopolar cautery has<br>application in endoscopic,<br>gynecological, and general<br>abdominal and thoracic<br>laparoscopic procedures.<br>When connected by a standard<br>cable to an electrosurgical<br>power source, the device may<br>be utilized for monopolar<br>cautery. | Same |
| Contra-<br>indications | Not intended for<br>contraceptive<br>coagulation of<br>fallopian tissue, but<br>may be used to<br>achieve homeostasis<br>following transaction<br>of the fallopian tube. | N/A | Not intended for contraceptive<br>coagulation of fallopian tissue,<br>but may be used to achieve<br>homeostasis following<br>transaction of the fallopian<br>tube. | Same |
| Technological Characteristics | | | | |
| Specialty | Laparoscopic | Laparoscopic | Laparoscopic | Same |
| Mode of<br>operation | Electromechanically<br>operated, software<br>controlled | Electromechanically<br>operated, software<br>controlled | Manual, hand maneuvered | Same |
| Insertion<br>Method | Via Trocar | Via Trocar | Via Trocar | Same |
| Articulation | Yes | Yes | Yes | Same |
| Articulation<br>range | 0 to 85° | 0 to 85° | 0 to 85° | Same |
| Articulation<br>locking feature | Yes | Yes | Yes | Same |
| Tip axial<br>rotation feature | 360° | 360° | 360° | Same |
| Shaft material | Stainless steel | Stainless steel | Stainless steel | Same |
| Electrosurgical Characteristics | | | | |
| Application<br>Technology | Monopolar | N/A | Monopolar | Same |
| Instrument type | Monopolar L-shaped<br>hook | 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 for<br>electrode tip | Stainless steel | N/A | Stainless steel | Same |
| Energy<br>activation | Generator foot pedal<br>switch | N/A | Device finger-controlled switch | Both get<br>energy from<br>ESU; user<br>controls the<br>activation |
| Other Attributes | | | | |
| Sterilization<br>method | EtO | EtO | EtO | Same |
| Sterility<br>assurance level | 10-6 | 10-6 | 10-6 | Same |

Table 1 – Substantial Equivalence Table

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