AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE

K042897 · Ethicon Endo-Surgery, Inc. · GAL · Nov 19, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042897
• Device Name: AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GAL · General, Plastic Surgery
• Decision Date: Nov 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AUTOBAHN Tissue Closure Device and Disposable Cartridge is intended for soft tissue approximation and/ or ligation in general surgical procedures.

Device Story

AUTOBAHN Tissue Closure Device is a reusable instrument used with a sterile, single-use disposable cartridge. Cartridge contains a needle and suture (absorbable or non-absorbable). Device operates by driving the needle in a 360° arc within the cartridge; each cycle places a stitch through tissue located within the aperture. Used in general surgical procedures by surgeons and OR staff. Primary benefit is needle containment within the cartridge before, during, and after use, reducing risk of accidental needle sticks to clinical staff.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and design identity to the predicate device.

Technological Characteristics

Reusable tissue closure device with sterile, single-use disposable cartridge. Features a needle-driving mechanism capable of a 360° arc. Compatible with standard absorbable and non-absorbable sutures. Mechanical device; no software or electronic components.

Indications for Use

Indicated for soft tissue approximation and/or ligation in general surgical procedures for patients requiring such interventions.

Regulatory Classification

Identification

An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

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

• FASTCLOSE Fascia Closure Device (K011105)

Submission Summary (Full Text)

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Ethicon Endo-Surgery, Inc. 510(k) Premarket Notification for AUTOBAHN Tissue Closure Device and Disposable Cartridge

## AUTOBAHN Tissue Closure Device and Disposable Cartridge 510(k) Summary of Safety and Effectiveness

#### Company

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

#### Contact

Elizabeth Miller Regulatory Affairs Associate I

#### Date Prepared:

October 19, 2004

#### Name of Device

Trade Name: AUTOBAHN Tissue Closure Device AUTOBAHN Disposable Cartridge Classification Name: Suture, Absorbable, Natural (GAL), Class II, 878.4830

Predicate Device: FASTCLOSE Fascia Closure Device

Device Description: The AUTOBAHN Tissue Closure Device is a non-sterile, reusable device for use with the AUTOBAHN Disposable Cartridge. The AUTOBAHN Disposable Cartridge is a sterile; single-use disposable cartridge containing a standard type needle and standard, absorbable and non-absorbable, suture that is attached to the reusable AUTOBAHN Tissue Closure Device. The AUTOAHN Tissue Closure Device and Disposable Cartridge are indicated for soft tissue approximation and/ or ligation in general surgical procedures. The needle is contained within the AUTOBAHN Disposable Cartridge before, during, and after the case, aiding in the prevention of suture needle sticks to the surgeons, nurses, and OR staff. The AUTOBAHN tissue Closure Device needle is driven around inside the cartridge in a complete 360° arc. A completed stitch is placed each time the needle and suture are driven across the aperture and through tissue located within the aperture.

Intended Use: AUTOBAHN Tissue Closure Device and Disposable Cartridge is intended for soft tissue approximation and/ or ligation in general surgical procedures.

Technological Characteristics: The technological characteristics of the AUTOBAHN Tissue Closure Device and Disposable Cartridge are identical to those of the predicate device FASTCLOSE Fascia Closure Device K011105, cleared 5/30/01.

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K042777

# Section I

## Truthful and Accurate Statement

The Truthful and Accurate Statement, as required by 21 CFR 807.87(k) is provided below.

We, the undersigned, certify that, in our capacity as associates of Ethicon Endo-Surgery, Inc., believe, to the best of our knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact related to a substantial equivalence decision has been omitted.

Elizabeth Miller

Elizabeth Miller Regulatory Affairs Associate I

Vam Sachi

Jim Bedi Lead Design Engineer

October 19, 2005
Date

October 19, 2004

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2004

Ms. Elizabeth Miller Regulatory Affairs Associate I Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K042897

Trade/Device Name: AUTOBAHN Tissue Closure Device and Disposable Cartridge Regulation Number: 21 CFR 878.4830 Regulation Name: Absorbable surgical gut suture Regulatory Class: II Product Code: GAL Dated: October 19, 2004 Received: October 20, 2004

Dear Ms. Miller:

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. Elizabeth Miller

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,

Miriam 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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### Indications for Use

510(k) Number (if known): Ko 42897

Device Name: AUTOBAHN Tissue Closure Device and Disposable Cartridge

Indications for Use: The AUTOBAHN Tissue Closure Device and Disposable Cartridge is intended for soft tissue approximation and/ or ligation in general surgical procedures.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Posted November 13, 2003)

Miriam C. Provost

Division of General, Restorative. and Neurological Devices

510(k) Number_ Ko42897