REALHAND HIGH DEXTERITY (HD) INSTRUMENTS

K071488 · Novare Surgical Systems, Inc. · GCJ · Jun 29, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071488
• Device Name: REALHAND HIGH DEXTERITY (HD) INSTRUMENTS
• Applicant: Novare Surgical Systems, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RealHand™ High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.

Device Story

RealHand HD Instruments are single-use, sterile surgical tools designed for grasping, mobilization, dissection, transection, and suturing of tissue. The device comprises a handle, shaft, and jaws, featuring distal and proximal articulating sections to provide high dexterity. Operated by a surgeon during endoscopic or open procedures, the device is inserted through incisions or surgical trocars. The surgeon activates the jaws or scissor blades by compressing and releasing the handle. The handle includes a rotation control wheel, an articulation lock, and a ratchet mechanism to lock jaws in place. The device provides enhanced maneuverability compared to standard rigid instruments, assisting the surgeon in complex tissue manipulation tasks.

Clinical Evidence

Bench testing only. Testing evaluated conformance to product specifications, including grasping, manipulating, cutting, and suturing of tissue. Comparative testing against the predicate device confirmed equivalent performance.

Technological Characteristics

Single-use, sterile surgical instrument. Features handle, shaft, and jaws with distal and proximal articulation. Mechanical actuation via handle compression/release. Includes ratchet, ratchet release, rotation control wheel, and articulation lock. Materials are biocompatible and used in previously cleared devices. Designed for use through standard surgical trocars/ports.

Indications for Use

Indicated for grasping, mobilization, dissection, transection, and suturing of tissue during surgical procedures under direct or endoscopic visualization.

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

• Endolink TM True Movement System™ (K043541)

Submission Summary (Full Text)

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JUN 29 2007

510(k) Summary

General Information

| Classification | Class II |
|----------------|---------------------------------------------------------|
| Trade Name | RealHand ^TM High Dexterity (HD) Instruments. |
| Submitter | Novare Surgical Systems, Inc. |
| | 10440 Bubb Road |
| | Suite A |
| | Cupertino, CA 95014 |
| | Tel: [phone] |
| Contact | Kerry Pope |
| | President & CEO |

#### Intended Use

The RealHand™ High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.

## Predicate Devices

Endolink TM True Movement System™ K043541 Novare Surgical Systems, Inc.

### Device Description

The RealHand Instruments are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissor blades) are activated by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place, a rotation control wheel and articulation lock.

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## Materials

All materials used in the manufacture of the RealHand Instruments are suitable for this use and have been used in numerous previously cleared products.

## Testing

Product testing was conducted to evaluate conformance to product specification. Testing included grasping, manipulating, cutting and suturing of tissue.

Testing comparing the RealHand Instruments to a commercially available predicate product was conducted. The products were used per their respective Instructions for Use. The results showed the RealHand Instruments were equivalent to the predicate device.

## Summary of Substantial Equivalence

The RealHand Instruments are equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007

Novare Surgical Systems % Regulatory Strategies, Inc. Mr. Gregory Mathison President 3924 Cascade Beach Road Lutsen, Minnesota 55612

Re: K071488

Trade/Device Name: RealHand" High Dexterity (HD) Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: May 24, 2007 Received: May 30, 2007

Dear Mr. Mathison:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Gregory Mathison

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Anastacia M. Bilek

Image /page/3/Picture/5 description: The image shows a handwritten letter. The letter is written in cursive and the text is not fully visible. The visible text includes the letters 'for' on the left side of the image, followed by the words 'Director' and 'Director' on the right side of the image. The letter appears to be a formal document.

ം Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

This application

Device Name:

Indications for Use:

RealHand™ High Dexterity (HD) Instruments

The RealHand™ High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Anastasia M. Bilek

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

OR

**510(k) Number** K071488

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