ACIER SUTURES

K991073 · Cardio Thoracic Systems · GAQ · Jul 30, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991073
• Device Name: ACIER SUTURES
• Applicant: Cardio Thoracic Systems
• Product Code: GAQ · General, Plastic Surgery
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Acier Steel Suture is indicated for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

Device Story

Acier is a nonabsorbable, sterile surgical suture composed of 316L stainless steel. Used by surgeons for tissue approximation in abdominal, intestinal, hernia, sternal, and orthopedic procedures. Device provides mechanical support to tissues during healing. Operates as a physical implant; no electronic or software components. Performance verified via bench testing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: 316L stainless steel. Form: Monofilament and multifilament surgical suture. Nonabsorbable. Sterile.

Indications for Use

Indicated for abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure, and orthopedic procedures including cerclage and tendon repair. Restricted to prescription use.

Regulatory Classification

Identification

A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

Special Controls

*Classification.* Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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

• Ethicon's Ethi-Pack Surgical Stainless Steel Suture (K931271)

Submission Summary (Full Text)

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# K991073

# 510(k) Summary CardioThoracic Systems, Inc. Acier Sutures 510(k) Notification K991073

#### GENERAL INFORMATION

Manufacturer: Peters Pharmaceutical Laboratory 42 Rue Benoit Frachon Bobigny, France 93000

#### Distributed By:

CardioThoracic Systems, Inc. 10600 North Tantau Avenue Cupertino, California 95014 Est. Registration No. 9027735 Contact Person:

Michael J. Billig Regulatory, Quality, and Clinical Vice President, Research

March 25, 1999 Date Prepared:

# DEVICE DESCRIPTION

| Classification: | Suture, Nonabsorbable, Steel, Monofilament<br>and Multifilament Surgical Suture |
|-----------------|---------------------------------------------------------------------------------|
|-----------------|---------------------------------------------------------------------------------|

Trade Name:

Acier

Generic/Common Name: Surgical Sutures

## PREDICATE DEVICES

Ethicon's Ethi-Pack Surgical Stainless Steel Suture; K931271

#### INTENDED USE

Acier Steel Suture is indicated for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

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# PRODUCT DESCRIPTION

Acier Steel Suture is a nonabsorbable sterile surgical suture composed of 316L stainless steel.

# SUBSTANTIAL EQUIVALENCE

The Peters Acier sutures are substantially equivalent to the predicate devices (Ethicon's Ethi-Pack Surgical Stainless Steel Suture; K931271) in regards to intended use, design, composition, function, indications, patient population and performance. Any differences between the Peters Acier sutures and its predicate device do not raise any new issues of safety and effectiveness.

Functional bench testing has been conducted on the Acier sutures and the results of the testing verified that the sutures perform as designed, are suitable for their intended use.

## SUMMARY

As contained in this 510(k) summary, the Peters Acier sutures are substantially equivalent to the predicate devices identified in that the sutures have the same intended use and are similar in design, composition, function, patient population and performance.

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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. Michael J. Billig Cardio Thoracic Systems, Inc. 10600 N. Tantau Avenue Cupertino, California 95014-0739

K991073 Re: Trade Name: Acier Stainless Steel Suture Regulatory Class: II Product Code: GAQ Dated: June 25, 1999 Received: June 28, 1999

Dear Mr. Billig:

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 stated in the enclosure) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification will be announced in a future Federal Register notice. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- The Acier Surgical Suture is indicated for use in abdominal wound closure, hernia repair, 1. sternal closure, and certain orthopedic procedures including cerclage and tendon repair.
- 2. This device may not be manufactured from any metal other than 316L stainless steel. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Acier surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.

The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.

The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and labeling, and prohibition against misbranding and adulteration.

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#### Page 2 - Mr. Michael J. Billig

Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (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 the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations.

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

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

Enclosure

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# 16991073

Page__________________________________________________________________________________________________________________________________________________________________________

k991073 5 10(k) Number (if known): _

Device Name:__________________________________________________________________________________________________________________________________________________________________ STAINLESS 57286 SUNRE

Indications For Use:

Surgical Suture is indicated for use in abdominal wound closure, hernia repair,
the supportunity artheredic procedures including cerclage and tendo Surgical Suture is indicated for use in abdominal wound closure, access of the course,
sternal closure, and certain orthopedic procedures including cerclage and tendon repair.

..

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K991073 |

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

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