JMS ABSORBABLE ANCHOR AND APPLICATOR

K041159 · Jms, Inc. · GDW · Jul 27, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041159
• Device Name: JMS ABSORBABLE ANCHOR AND APPLICATOR
• Applicant: Jms, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jul 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Absorbable Anchor™ and Applicator are indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Device Story

Absorbable Anchor™ and Applicator system designed for surgical fixation of prosthetic mesh to soft tissue. Used in minimally invasive and open general surgical procedures, specifically hernia repair. Device consists of an absorbable anchor and a dedicated applicator tool. Operated by surgeons in clinical/OR settings. Provides mechanical attachment of prosthetic material to tissue to facilitate repair. Benefits include secure mesh placement and use of absorbable materials to minimize long-term foreign body presence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Absorbable anchor material; mechanical fixation principle; applicator tool for deployment; intended for general surgical use.

Indications for Use

Indicated for fixation of prosthetic material to soft tissue during minimally invasive or open general surgical procedures, including hernia repair. No specific age or gender contraindications provided.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Public Health Service

JUL 2 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

John 1. Shipp, Ph.D., CTO JMS. Inc. 1221 1st Street, South, 7a Jacksonville Beach, Florida 32250

Re: K041159

Trade/Device Name: Absorbable Anchor™ and Applicator Regulation Number: 21 CFR 878.4650 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: June 17, 2004 Received: June 17, 2004

Dear Dr. Shipp:

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 docs 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 - John I. Shipp, Ph.D., CTO

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 vours,

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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## Indications for Use

510(K) Number (if known):

K041159

Not known

## Device Name:

Absorbable Anchor™ and Applicator

## Indication for Use:

The Absorbable Anchor™ and Applicator are indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-the Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** \$\frac{K04}{25} 1159\$