BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

K982403 · Brennen Medical, Inc. · PAG · Sep 22, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982403
• Device Name: BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
• Applicant: Brennen Medical, Inc.
• Product Code: PAG · General, Plastic Surgery
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Brennen Biosynthetic Surgical Mesh is indicated 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 winary incontinence resulting from urethral hypermobility or sphincter deficiency.

Device Story

Brennen Biosynthetic Surgical Mesh Matrix is a surgical implant used for hernia repair and as a sling for female urinary incontinence. The device provides structural support to ruptured connective tissue or the bladder neck. It is intended for use by surgeons in an operating room setting. The mesh acts as a scaffold to facilitate tissue reinforcement or support, aiding in the correction of anatomical defects or functional incontinence. Benefits include stabilization of the bladder neck or reinforcement of abdominal wall defects.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Biosynthetic surgical mesh matrix; intended for surgical implantation. Specific material composition and ASTM standards are not detailed in the provided text.

Indications for Use

Indicated for patients requiring hernia repair where connective tissue has ruptured, or female patients with urinary incontinence due to urethral hypermobility or sphincter deficiency requiring bladder neck support.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with three heads.

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

Mr. Kenneth B. Herland Brennen Medical, Inc. Director, Regulatory Affairs/Quality Assurance 1290 Hammond Road ST PAUL MN 55110

SEP 2 8 2012

Re: K982403

Trade/Device Name: Brennan Biosynthetic Surgical Mesh Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAG Dated: July 8, 1998 Received: July 10, 1998

Dear Mr. Herland:

This letter corrects our substantially equivalent letter of September 22, 1998.

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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Perkins

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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## 510(k) Number (If Known): ├юр 82403

Device Name: Brennen Biosynthetic Surgical Mesh Matrix

## INDICATIONS FOR USE:

The Brennen Biosynthetic Surgical Mesh is indicated 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 winary incontinence resulting from urethral hypermobility or sphincter deficiency.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

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

tocoed

Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982403