MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

K030460 · Brennen Medical, Inc. · PAG · Mar 7, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030460
• Device Name: MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
• Applicant: Brennen Medical, Inc.
• Product Code: PAG · General, Plastic Surgery
• Decision Date: Mar 7, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

Device Story

Brennen Medical Biosynthetic Surgical Mesh Matrix is a sterile, processed, and treated porcine skin device. It is intended for the reconstruction of soft tissue deficiencies. The device is used by surgeons in clinical settings for hernia repair or as a sling for female urinary incontinence. It provides structural support to ruptured connective tissue or the bladder neck. The device is a biological implant; it functions as a scaffold for tissue repair.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and literature review.

Technological Characteristics

Sterile, processed, and treated porcine skin. Surgical mesh form factor. Class II device (21 CFR 878.3300).

Indications for Use

Indicated for treatment of hernias with ruptured connective tissue or as sling material for bladder neck support in females with urinary incontinence due to urethral hypermobility or sphincter deficiency.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Brennen Biosynthetic Surgical Mesh Matrix (K982403)
• Advanced UroScience Surgical Mesh (K993459)

Submission Summary (Full Text)

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K030460

# Attachment 4

## 510(k) Summary

MAR 0 7 2003

#### Submitter's Name, Address, and Date of Submission

Kenneth B. Herland Vice President Regulatory Affairs Brennen Medical, Inc. 1290 Hammond Road St. Paul, MN. 55110

Phone: [phone] Fax:

Submitted: February 10, 2003

Device Name

Trade Name: Classification Name: Common/Usual Name: (trade name) Surgical Mesh, 21 CFR 878.3300 Surgical Mesh

Predicate Device

Brennen Biosynthetic Surgical Mesh Matrix (K982403) and Advanced UroScience Surgical Mesh (K993459).

#### Indication for Use

For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

### Device Description

(Trade name) is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.

## Technological Characteristics and Performance

The technological characteristics are the same or equivalent to the predicate device. Testing and review of the literature has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.

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CONFIDENTIAL

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Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Kenneth B. Herland Vice President Regulatory Affairs Brennen Medical, Inc. 1290 Hainmond Road ST PAUL MN 55110

SEP 2 8 2012

K030460 Re: Trade/Device Name: Brennen Medical Biosynthetic Surgical Mesh Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAG Dated: February 10, 2003 Received: February 13, 2003

Dear Mr. Herland:

This letter corrects our substantially equivalent letter of March 7, 2003.

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 (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 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Benjamin R. Krebs

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment 2

## Indications for Use Statement

KD30460 510(k) Number (if known)

Device Name Brennen Medical Biosynthetic Surgical Mesh Matrix

Indications for Use

For use in the treatment of hernias where the connective tissue has ruptured or as a sling material r or use in the readinon. org and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

-Muriam C. Provost
Division Sign Off

Division of Gener | Restorative and Neurologi ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Number K030460

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over the Counter Use

(Optimal Format 1-2-96)

Brennen Medical, Inc. Surgical Mesh Special 510(k) Page 11 of 14