G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333

K100251 · Usgi Medical · GAT · Feb 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100251
• Device Name: G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333
• Applicant: Usgi Medical
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Feb 17, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The USGI g-Cath Tissue Anchor Delivery Catheter is intended for soft tissue approximation in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.

Device Story

The g-Cath Tissue Anchor Delivery Catheter is a sterile, single-patient-use device designed for soft tissue approximation. It contains a nitinol/polyester tissue anchor pair within its lumen. During minimally invasive gastroenterology procedures, the clinician deploys the anchor pair through the catheter to compress and approximate tissue. The device is used to address clinical conditions such as fistulas, perforations, leaks, and gastric tissue dilation. It functions as a mechanical delivery system for tissue anchors.

Technological Characteristics

Sterile, single-patient-use catheter. Contains nitinol/polyester tissue anchor pair. Mechanical deployment mechanism. No electronic components or software.

Indications for Use

Indicated for soft tissue approximation in patients undergoing minimally invasive gastroenterology procedures, including fistula closure, perforation/leak closure, and repair of dilated gastric tissue.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• g-Cath Tissue Anchor Delivery Catheter (K061276)

Submission Summary (Full Text)

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K100251

USGI Medical

[phone]

[phone]

Mary Lou Mooney

January 25, 2010

Catheter

Vice President of Clinical, Regulatory & Quality

1140 Calle Cordillera San Clemente, CA 92673

USGI Medical Special 510(k) Device Modification USGI g-Cath Tissue Anchor Delivery Catheter

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FEB 1 7 2010

# 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:

b. Company Address:

c. Telephone: Fax:

d. Contact Person:

e. Date Summary Prepared:

#### DEVICE IDENTIFICATION 2.

a. Trade/Proprietary Name:

b. Common Name:

c. Classification Name:

Nonabsorbable (PET) surgical sutur, 878.5000

Nonabsorbable surgical suture

g-Cath Tissue Anchor Delivery

#### IDENTIFICATION OF PREDICATE DEVICES 3.

g-Cath Tissue Anchor Delivery Catheter

USGI Medical (K061276)

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USGI Medical Special 510(k) Device Modification USGI g-Cath Tissue Anchor Delivery Catheter

K100251 page 2/2

## 4. DESCRIPTION OF THE DEVICE

The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.

# STATEMENT OF INTENDED USE ડ.

The USGI g-Cath Tissue Anchor Delivery Catheter is intended for soft tissue approximation in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.

## COMPARISON WITH PREDICATE DEVICES 6.

The g- Cath Tissue Anchor Delivery Catheter is comparable to the predicate device in terms of intended use, technology, and materials.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 1 7 2010

USGI Medical % Ms. Mary Lou Mooney VP, Clinical, Regulatory & Quality 1140 Calle Cordillera San Clemente, California 92673

Re: K100251

Trade/Device Name: g-Cath Tissue Anchor Delivery Catheter Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, GDW, HET Dated: January 25, 2010 Received: January 28, 2010

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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Mary Lou Mooney

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.1.5809.html far the Center for Devices and Kadiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofire no ber [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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# Indications for Use

510(k) Number (if known): K10025|

Device Name: g-Cath Tissue Anchor Delivery Catheter

Indications For Use:

The USGI g- Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Daniel Kaine for MXM
(Division Sign-Off)

Division of Surgical, Cathopedie, and Restorative Devices

510(k) Number K100251 Page 1 of *_*_

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