BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX

K021835 · Brennen Medical, Inc. · FTL · Oct 17, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021835
• Device Name: BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
• Applicant: Brennen Medical, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Glucamesh™/Glucatex™ Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.

Device Story

GlucaMesh/Glucatex surgical mesh; constructed of polypropylene or polyester; intended for implantation by qualified surgeons in general surgery settings. Device serves as a permanent, non-biodegradable prosthesis for abdominal wall reinforcement, hernia repair, eventrations, and prolapse correction. Provides mechanical support, strength, and durability; porosity facilitates tissue ingrowth. Implanted during surgical procedures to reinforce weakened or damaged tissue structures.

Clinical Evidence

Bench testing only; conducted in accordance with FDA guidance document 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh.' No clinical data provided.

Technological Characteristics

Materials: Polypropylene or polyester. Form factor: Surgical mesh. Properties: Biocompatible, non-biodegradable, porous for tissue ingrowth. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring surgical repair of abdominal wall reinforcements, hernia repairs, eventrations, and rectal or genitourinary prolapses.

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

• Prolene Soft (Polypropylene)
• Mersilene (Polyester)
• Biomesh (polypropylene)

Submission Summary (Full Text)

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K021835

OCT 1 7 2002

#### Summary of Safety and Effectiveness (As required by 21 CFR 807.92)

Device Name: GlucaMesh and or Glucatex (Polypropylone/Polyester) Mesh.

Predicate Device Name: Prolene Soft (Polypropylene), Mersilene (Polyester ) and Biomesh (polypropylene) mesh.

Device Description Glucatex mesh is constructed of polypropylene or polyester which is identical in composition to that used in Prolene Soft Mesh, Mersitence or Biomesh. The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth.

Intended Use This mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse.

Indications Statement This mesh is used for the repair of abdominal wall reinforcements, hernia repairs, eventrations, rectal or genitourinary prolapses.

Technological Characteristics For technical characteristics, the values established for GlucaMesh and Glucatex are similar to those established by Prolene, Mersilenc and Biomesh which were constructed of polypropylenc and polyester.

Performance Data Sufficient bench testing was conducted in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."

Conclusions Based on the 510(k) summaries and 510(k) statements (21 ClFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device(s) under the Federal Food, Drug and Cosmetic Act.

| Contact | Philip B. Lawin, Ph.D.<br>President<br>Brennen Medical<br>1290 Hammond Road<br>St. Paul, MN 55110<br>Contact Telephone Number 651-429-7413 |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Date | October 8, 2002 |

Phillip B. Lawin, Ph. D.
President

Date: 10/9/02

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles overlapping each other, creating a sense of depth and unity. The profiles are arranged in a way that suggests movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2002

Brennen Medical, Inc. Phillip B. Lawin, Ph.D. President 1290 Hammond Road St. Paul, Minnesota 55110

Re: K021835

Trade/Device Name: Brennen Medical Surgical Mesh. GlucaMesh/Glucatex Regulation Number: 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: August 8, 2002 Received: August 12, 2002

Dear Dr. Lawin:

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 – Dr. Phillip B. Lawin

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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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K 021835

Page 1 of 1

# 510(k) Number (If Known):

Device Name: Brennen Medical GlucaMesh Surgical Mesh

# INDICATIONS FOR USE:

Glucamesh™/Glucatex™ Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.

### (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)

Atpt Rurle

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________