MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

K993459 · Advanced Uroscience, Inc. · PAG · Nov 5, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993459
• Device Name: MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
• Applicant: Advanced Uroscience, Inc.
• Product Code: PAG · General, Plastic Surgery
• Decision Date: Nov 5, 1999
• 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

Surgical mesh matrix; sterile, processed, and treated porcine skin. Intended for soft tissue reconstruction; used in hernia repair or as a sling for female urinary incontinence. Implanted by surgeons in clinical settings to provide structural support to ruptured connective tissue or reposition the bladder neck. Device acts as a biological scaffold for tissue repair.

Clinical Evidence

Bench testing only; no clinical data provided.

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 a sling 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)

Submission Summary (Full Text)

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NOV - 5 1999

K993459

Advanced UroScience, Inc.

# Attachment 4

# 510(k) Summary

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

Karen E. Peterson Vice President of Regulatory, Clinical, & QA Advanced UroScience, Inc. 1290 Hammond Road St. Paul, MN 55110

Phone: [phone] Fax: [phone]

Submitted: October 12, 1999

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)

## 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 as or equivalent to the predicate device. Biocompatibility and bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest the shape of the bird's body and wings. The text is in a simple, sans-serif font and is evenly spaced around the circle.

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

Ms. Karen E. Peterson Vice President, Regulatory, Clinical, and Quality Affairs Advanced UroScience, Inc. 1290 Hammond Road SAINT PAUL MN 55110

SEP 2 8 2012

K993459 Re: Trade/Device Name: Surgical Mesh Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAG Dated: October 12, 1999 Received: October 13, 1999

Dear Ms. Peterson:

This letter corrects our substantially equivalent letter of November 5, 1999.

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/CDRH/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. 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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## Attachment 2

# Indications for Use Statement

X993459 510(k) Number (if known) Advanced UroScience {trade name} Device Name

Indications 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.

(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
Use ✓

OR

Over the Counter Use **__**
(Optimal Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K993459
510(k) Number