PORCINE SURGICAL MESH; DERMAL MATRIX

K081272 · Brennen Medical, LLC · FTM · Jul 31, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081272
• Device Name: PORCINE SURGICAL MESH; DERMAL MATRIX
• Applicant: Brennen Medical, LLC
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jul 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including but not limited to: Plastic and reconstructive surgery: Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Device Story

Porcine Dermal Matrix is a sterile, pyrogen-free, single-use porcine skin graft with epidermal and subdermal layers removed. Used by surgeons for soft tissue reinforcement and repair in clinical settings. Implanted to support weakened tissue or repair damaged membranes; does not replace normal body structure or provide full mechanical strength for tendon repairs. Relies on sutures or bone anchors for biomechanical strength in tendon applications. Benefits patients by providing a scaffold for tissue reinforcement in hernia and reconstructive procedures.

Clinical Evidence

No clinical trial data presented. Evidence based on biocompatibility testing per ISO 10993-1, bench testing, and historical clinical experience with predicate devices.

Technological Characteristics

Porcine-derived dermal matrix; sterile, pyrogen-free, single-use. Biocompatibility tested per ISO 10993-1. Identical technological characteristics to predicate devices (Porcine Surgical Mesh and DermMatrix).

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair, including plastic/reconstructive surgery, muscle flap reinforcement, hernia repair (abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, incisional), suture-line reinforcement, and tendon reinforcement (rotator cuff, patellar, Achilles, biceps, quadriceps). Not intended to provide full mechanical strength for tendon repair.

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

• Porcine Surgical Mesh (K993459)
• Porcine Surgical Mesh (K030460)
• DermMatrix (K021160)
• Permacol/Pelvicol (K013625)
• SurgiMend (K071807)

Submission Summary (Full Text)

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K081272
pg 1 of 2

2008

# SUMMARY OF SAFETY AND EFFECTIVEN SECTION 16:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

## SUBMITTER INFORMATION 16.1

| a. | Company Name: | Brennen Medical, LLC |
|----|--------------------------------------|--------------------------------------------------|
| b. | Company Address: | 1290 Hammond Road<br>St. Paul, MN 55110 |
| c. | Company Phone:<br>Company Facsimile: | [phone]<br>[phone] |
| d. | Contact Person: | Kenneth B. Herland<br>V.P. Regulatory Affairs/QA |
| e. | Date Summary Prepared: | July 28, 2008 |

## DEVICE IDENTIFICATION 16.2.

| a. Trade/Proprietary Name: | Porcine Dermal Matrix (TBD) |
|----------------------------|-----------------------------|
| b. Regulation Number : | 21 CFR 878.3300 |
| c. Regulation Name : | Surgical Mesh |
| d. Device Class : | II |
| e. Product Code : | FTM |

#### IDENTIFICATION OF PREDICATE DEVICES 16.3

| Company | Device | 510(k) No. | Date Cleared |
|----------------------|-----------------------|------------|--------------|
| Advanced Uroscience | Porcine Surgical Mesh | K993459 | 11/05/1999 |
| Brennen Medical | Porcine Surgical Mesh | K030460 | 03/07/2003 |
| Brennen Medical | DermMatrix | K021160 | 06/12/2002 |
| Tissue Sciences Labs | Permacol/Pelvicol | K013625 | 01/17/2002 |
| TEI Biosciences | SurgiMend | K071807 | 08/06/2007 |

# DEVICE DESCRIPTION 16.4

Porcine Dermal Matrix is a prescription, sterile, pyrogen free, single use, porcine skin

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K081272
pg 202

that has both the epidermal and subdermal sides removed. The product is available in several sizes.

#### SUBSTANTIAL EQUIVALENCE 16.5

Porcine Dermal Matrix is substantially equivalent to DermMatrix, Permacol/Pelvicol, and SurgiMend surgical meshes. Porcine Dermal Matrix is equivalent in intended use, mode of action, and design to the predicate devices. The introduction of this product does not raise any new issues of safety or effectiveness.

#### 16.6 INTENDED USE

Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. Specifically indicated for: Plastic and reconstructive surgery; Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons.

#### TECHNOLOGICAL CHARACTERISTICS 16.7

The technological characteristics are identical to the predicate devices (Porcine Surgical Mesh and DermMatrix). Biocompatability testing conducted per ISO 10993-1, bench testing and numerous clinical experiences have demonstrated that the device is safe and effective for its intended use, and that its performance is substantially equivalent to the predicate devices.

# 16.8 CONCLUSIONS

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. Test evaluations of Porcine Dermal Matrix show that the device performs as intended and substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three curved lines. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Brennen Medical, LLC % Mr. Kenneth B. Herland VP Regulatory Affairs/QA 1290 Hammond Road Saint Paul, Minnesota 55110

JUL 3 1 2008

Re: K081272

Trade/Device Name: Porcine Dermal Matrix Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 1, 2008 Received: May 5, 2008

Dear Mr. Herland:

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 - Mr. Kenneth B. Herland

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 Center for Devices and Radiological Health's (CDRH) s) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely vours.

Mark M. Mullison

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K081272

# Indications for Use

510(k) Number (if known): K081272

Device Name: Porcine Dermal Matrix Surgical Mesh

Indications for Use:

Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including but not limited to: Plastic and reconstructive surgery: Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Mark X Melkerson

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

**510(k) Number** K08172

Prescription Use Over-The-Counter Use (X) AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of (Posted November 13, 2003)