G-LIX TISSUE GRASPER

K061268 · Usgi Medical · HET · Jul 31, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K061268
• Device Name: G-LIX TISSUE GRASPER
• Applicant: Usgi Medical
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Jul 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.

Device Story

The g-Lix Tissue Grasper is a sterile, single-patient-use manual surgical instrument. It consists of a proximal rotation knob, a flexible or rigid shaft, and a distal helix tip. The device is used by surgeons during minimally invasive procedures to grasp and mobilize tissue, specifically tissue targeted for removal, such as the gall bladder. The surgeon manually operates the device to engage the helix tip with the target tissue, facilitating manipulation and mobilization within the surgical field.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual surgical instrument; proximal rotation knob, shaft (flexible or rigid), and distal helix tip. Sterile, single-patient-use. No software or electronic components.

Indications for Use

Indicated for use in minimally invasive surgical procedures to facilitate tissue grasping and mobilization, particularly for tissue intended for removal, such as the gall bladder.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• EndoPATH Tissue Grasper (K930933)
• FG Grasping Forcep (K962474)

Submission Summary (Full Text)

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510(k) Premarket Notification g-Lix Tissue Grasper

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92

#### 1 . SUBMITTER INFORMATION

- a. Company Name: USGI Medical b. Company Address: 1140 Calle Cordillera San Clemente, CA 92673 c. Telephone: [phone] Fax: [phone]
- d. Contact Person:
- e. Date Summary Prepared:

### DEVICE IDENTIFICATION 2.

- a. Trade/Proprietary Name: g-I.ixTM Tissue Grasper
- b. Common Name: Grasper

c. Classification Name:

Manual surgical instrument for general use, 878.4800

ﮯ

4.410.

### ನ್ನೆ IDENTIFICATION OF PREDICATE DEVICES

| EndoPATH Tissue Grasper | Ethicon Endo-Surgery |
|-------------------------|----------------------|
| | (K930933) |

FG Grasping Forcep

Olympus America (K962474)

## JUL 3 1 2006

JUL 31 2006

KO61268

ical

40 Calle Cordillera

Clemente, CA 92673

Mary Lou Mooney Vice President of Clinical, Regulatory & Quality

May 4, 2006

-l ix
Tissue Grasper

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### DESCRIPTION OF THE DEVICE 4.

The g-Lix Tissue Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is comprised of a proximal rotation knob, flexible or rigid shaft and distal helix tip.

### STATEMENT OF INTENDED USE પં

The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.

### COMPARISON WITH PREDICATE DEVICES 6.

The g-Lix Tissue Grasper is comparable to the predicate devices in terms of intended use, technology, and materials.

Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2006

USGI Medical % Ms. Mary Lou Mooney Vice President of Clinical, Regulatory & Quality l 140 Calle Cordillera San Clemente, California 92673

Re: K061268

Trade/Device Name: G-Lix Tissue Grasper Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: I Product Code: HET Dated: July 18, 2006 Received: July 19. 2006

Dear Ms. Mooney:

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 Mav 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 vour 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

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Page 2 - Ms. Mary Lou Mooney

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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/cdrl/industry/support/index.html.

Sincerely yours,

Herbert Lewandrow

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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CONFIDENTIAL USGI Medical May, 2006

510(k) Premarket Notification g-Lix Tissue Grasper

# Indications for Use

KOb 510(k) Number (if known):

Device Name: g-Lix Tissue Grasper

Indications For Use:

The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Remmer

(Division Division of General, Restorative, and Neurological Devices

510(k) Number K012668

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