AMS SOFT-TISSUE APPROXIMATION SYSTEM

K012342 · American Medical Systems, Inc. · FZP · Sep 5, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012342
• Device Name: AMS SOFT-TISSUE APPROXIMATION SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Sep 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMS soft tissue approximation system ("ASTA") is intended for use as a general use suture retention device. The ASTA system provides a method to deploy and anchor suture internally from a single access point, which may be used to grasp, manipulate, or affix the attached tissue.

Device Story

AMS Soft Tissue Approximation System (ASTA) comprises a rod-shaped clip and a stainless steel applicator; used for internal suture retention. Applicator features straight or curved tube with handle and release button for clip deployment. Clinician inserts clip through single access point to anchor non-absorbable suture (up to size No. 1). Device facilitates grasping, manipulation, or affixing of soft tissue. Used in clinical settings by physicians. Benefits include minimally invasive internal suture anchoring.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Components: stainless steel applicator, rod-shaped clip. Materials are biocompatible. Manual mechanical deployment via handle-actuated release button. No software or electronic components.

Indications for Use

Indicated for use as a general suture retention device to grasp, manipulate, or affix soft tissue internally via a single access point.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Acufex Microsurgical's T-Fix (K942442)
• Acufex Microsurgical's T-Bar (K925573)
• AMS Inc's Fascial-Anchoring System (K010277)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness American Medical Systems, Inc.'s Soft Tissue Approximation System 510(k) Number ________________________________________________________________________________________________________________________________________________________________ KO12342

SEP - 5 2001

July 23, 2001

# Submitter/Contact Name:

Avraham Biran / Elsa Linke American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 Tel: [phone] Fax: [phone]

## Trade Name:

AMS Soft Tissue Approximation System

## Classification Name:

Implantable Clip and Applicator

# Predicate Devices:

Acufex Microsurgical's T-Fix and T-Bar (K942442 and K925573, respectively) and AMS Inc's Fascial-Anchoring System (K010277).

### Indication for Use:

The AMS soft tissue approximation system ("ASTA") is intended for use as a general use suture retention device. The ASTA system provides a method to deploy and anchor suture internally from a single access point, which may be used to grasp, manipulate, or affix the attached tissue.

# Device Description:

The AMS soft tissue approximation system has two components: a clip and an applicator. The clip is shaped as a rod and is available in two different sizes. Each clip has a central hole through which non-absorbable suture up to and including size No. I may be threaded. The applicator is composed of a straight or curved stainless steel tube in which the tip of the clip is positioned and has a handle with a release button for clip deployment. The choice of shaft configuration and clip size depends upon the desired application.

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K∅12342

# Technological Characteristics and Performance:

All materials used in the AMS soft tissue approximation system are either commonly used in medical applications or have been proven to be biocompatible through biocompatibility testing. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k)-cleared device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2001

Ms. Elsa A. Linke Regulatory Affairs American Medical Systems, Inc. 10700 Bren Road West Minnetonka, Minnesota 55343

Re: K012342

Trade/Device Name: AMS Soft Tissue Approximation System Regulation Number: 878.4300, 878.4930 Regulatory Class: II Product Code: FZP, KGS Dated: July 23, 2001 Received: July 24, 2001

Dear Ms. Linke:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use above and we nave acterially 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). 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 precistion, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarter rippe valy, was found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Elsa A. Linke

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Susan Walker, MD
for

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012342

## INDICATIONS FOR USE

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

Device Name:

Indications for Use:

AMS Soft Tissue Approximation system, consisting of Applicators and Clips.

The AMS Soft Tissue Approximation system is intended for use as a general use suture retention device. The ASTA system provides a method to deploy and anchor suture internally from a single access point, which may be used to grasp, manipulate, or affix the attached tissue.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use _ ﮯ (Per 21 CFR 801.109)

OR

Over the Counter Use_ ________________________________________________________________________________________________________________________________________________________

Susa Walk

(Division Sign-Off) (Division biggeneral, Restorative and Neurological Devices

510(k) Number K012342

510(k) Notification for the AMS Soft Tissue Approximation System

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