MODIFICATION TO SUTURE CLINCH

K033024 · Applied Medical Resources Corp. · FZP · Oct 24, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033024
• Device Name: MODIFICATION TO SUTURE CLINCH
• Applicant: Applied Medical Resources Corp.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Oct 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation.

Device Story

Suture Clinch is a sterile, single-use implantable clip used during laparoscopic surgery. Device fastens non-absorbable sutures (0 to 4-0 USP) by crimping suture ends to secure soft tissue approximation. Operated by surgeons using a compatible clip applier. Device is manufactured from polyacetal plastic; supplied in Tyvek pouch; sterilized via ethylene oxide (EO). Provides mechanical fixation of sutures; replaces manual knot-tying; facilitates secure closure in minimally invasive procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Polyacetal plastic. Biocompatibility: ISO 10993-1 compliant. Sterilization: Ethylene oxide (EO) with SAL 10^-6. Form factor: Single-use cartridge for use with clip applier. Mechanical principle: Crimping/deformation of plastic clip to secure suture.

Indications for Use

Indicated for fastening sterile non-absorbable sutures (sizes 0 to 4-0 USP) during laparoscopic soft tissue approximation.

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

• Applied Medical Suture Clinch (K992852)

Submission Summary (Full Text)

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| OCT 2 4 2003 | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) SUMMARY |
| 510(k) NUMBER: | K033024 |
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA 92688<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| CONTACT PERSON: | Cheryl Blake<br>Director of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | October 16, 2003 |
| NAME OF DEVICE: | Suture Clinch |
| TRADE NAME: | Not Determined |
| COMMON OR USUAL NAME: | Suture Fixation Device |
| CLASSIFICATION NAME: | Implantable Clip (21 CFR 878.4300) |

SUMMARY STATEMENT:

Identification of the legally marketed: The Applied Medical Suture Clinch is substantially equivalent to the Applied Medical Suture Clinch cleared under Applied Medical's previous 510(k) filing number K992852.

## Description:

The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation. The Suture Clinch is manufactured from poly acetyl plastic. Its unique shape provides an optimum means of capturing and securing the suture. The unique shape of the Suture Clinch also allows the applicator (clip applier) to close the Suture Clinch completely around the suture. The single use Suture Clinch Cartridge is supplied sterile, packaged individually in a Tyvek® pouch. The method of sterilization is EO with a Sal of 10°.

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K032034 2/2

Intended Use: The Sunce Clinch is a sterile single use clip intended fasten suture during laparoscopic surgery.

Non-clinical Testing: Bench top testing was conducted and comparisons were made to the predicated device.

Summary of Technological Characteristics: The Technological characteristics are the same as or equivalent to the predicated device and introduce no new safety and effectiveness issues when used as instructed. The polyacetal material used in the clinch is shown to be biocompatible according to ISO 10993-1 requirements.

Design Control / Risk Analysis/Design Verification: Design control, risk analysis and design verification activities for the subject of this Special 510(k) have been conducted in accordance with all applicable internal Applied Medical Procedures. The design control process employed is inclusive of the elements stipulated by 21 CFR § 820.30. The risk analysis preformed identified the risks relative to the performance requirements, as specified by Applied Medical internal procedures for risk analysis. The Design Risk Assessment Profile was conducted in accordance to Applied Medical internal Stand Operating Procedures, EN 1441 standards, ISO 9001/ISO 13485, AAMI/ISO TIR 14971, and 21 CFR § 820.30, validation and verification activities addressed the profile. Based on the risk analysis, validation and verification activities were formally controlled and addressed by Applied Medical, the activities included the methods, tests used, and acceptance criteria applied.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2003

Ms. Cheryl Blake Director of Regulatory Affairs and Clinical Programs Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K033024

Trade/Device Name: Suture Cinch Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: September 23, 2003 Received: September 26, 2003

Dear Ms. Blake:

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 - Ms. Cheryl Blake

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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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KO33034

## INDICATIONS FOR USE

Applied Medical Resources is providing this separate cover page for the Suture Clinch "Indications for Use" as required.

510(k) Number: Unknown

Suture Clinch Device Name:

Indications for Use: The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation.

Signature: Title: *Director RA/Clinical Programs* Date: *9-23-03*

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K033024

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over-The -Counter Use

(Optional Format 1-2-96)