STEELEX STERNUM SET

K023411 · Aesculap, Inc. · GAQ · Dec 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023411
• Device Name: STEELEX STERNUM SET
• Applicant: Aesculap, Inc.
• Product Code: GAQ · General, Plastic Surgery
• Decision Date: Dec 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Steelex Sternum Set is indicated in abdominal surgery, for orthopedic procedures (tendon operations and cerclages), hernia surgery and sternal closure. It is designed to remain inside the patient.

Device Story

Steelex Sternum Set consists of corrosion-resistant stainless steel monofilament sutures armed with specialized HRS needles; used for sternal closure, abdominal surgery, hernia repair, and orthopedic procedures (tendon operations/cerclages). Device remains inside patient post-procedure. Operated by surgeons in clinical/OR settings. Provides mechanical fixation of tissues/sternum. Benefits include secure closure using biocompatible materials.

Clinical Evidence

Bench testing only. Biomechanical testing performed per USP standards demonstrated performance equivalent to predicate suture systems.

Technological Characteristics

Stainless steel monofilament suture (316L, ASTM F138). Needles (302, 420, or 420F stainless steel, ASTM F899). USP sizes 3, 4, 5, 6, 7. Tapercut round-bodied needle geometry. Fixed or rotating needle attachment.

Indications for Use

Indicated for patients undergoing abdominal surgery, orthopedic procedures (tendon operations and cerclages), hernia surgery, and sternal closure.

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, Inc. Ethi-Pack Surgical Stainless Steel Suture (K931271)
• Stony Brook Surgical Innovations Sterna-Wire (K013059)
• CardioThoracic Systems, Inc. Acier Sutures (K991073)

Submission Summary (Full Text)

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K023411

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### VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [Accordance with SMDA of 1990]

#### Steelex Sternum Set

October 10, 2002

DEC 1 9 2002

Aesculap®, Inc. COMPANY: 3773 Corporate Parkwav Center Valley, PA 18034

Establishment Registration Number: 2916714

CONTACT: Georg Keller 800-258-1946 x 5073 (phone) 610-791-6882 (fax)

- TRADE NAME: Steelex Sternum Set
COMMON NAME: Stainless Steel Suture

DEVICE CLASS: Class II

PRODUCT CODE: 79GAQ

CLASSIFICATION: 878.4495 - Suture, Nonabsorbable, Steel, Monofilament And Multifilament

REVIEW PANEL: General and Plastic Surgery

## INDICATIONS FOR USE

The Steelex Sternum Set is indicated in abdominal surgery, for orthopedic procedures (tendon operations and cerclages), hernia surgery and sternal closure. It is designed to remain inside the patient.

## DEVICE DESCRIPTION

The Steelex Sternum Set consists of a corrosion resistant steel monofilament suture with a specially designed HRS needle for the sternum closure. The set consists of a combination of 2 or 4 steel wite monofilaments armed with a tapercut round bodied needle fixed or rotating. The wire for Steelex Sternum Set is made of stainless steel 316L (ASTMF138) and the needle is made of stainless steel 302, 420 or 420F (ASTMF899). The needle sizes for Steelex Sternum Set are available in the USP sizes 3, 4, 5, 6 and 7,

#### PURPOSE FOR SUBMISSION

This submission seeks marketing clearance for Aesculap's Steelex Sternum Set.

#### PERFORMANCE DATA

All required testing per USP for Steelex Sternum Set were completed Biomechanical testing results demonstrate the Steelex Sternum Set is substantially equivalent to other suture systems currently on the market.

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Steelex Sternum Set is substantially equivalent to:

- Ethicon, Inc. Ethi-Pack Surgical Stainless Steel Suture (K931271) .
- Stony Brook Surgical Innovations Sterna-Wire (K013059) ●
- CardioThoracic Systems, Inc. Acier Sutures (K991073) .

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Georg Keller Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K023411 · Steelex Sternum Set Regulation Number: 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: October 10, 2002 Received: October 11, 2002

Dear Mr. Keller:

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. Iisting 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 mav 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 - Mr. Georg Keller

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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.

Muriam C' Puritz

AW 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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510(K) Premarket Notifica

# B. INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number:

K023411

Device Name:

Steelex Sternum Set

Indication for Use:

The Steelex Sternum Set is indicated in abdominal surgery, for orthopedia procedures (tendon operations and cerclages), hernia surgery and sternal closure. It is designed to remain inside the patient.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use or Over-the-Counter Use (per 21 CFR 801.109)

Muriàm C. Provost

Restorative

K023411