DERMMATRIX SURGICAL MESH

K021160 · Carbon Medical Technologies, Inc. · FTM · Jun 12, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021160
• Device Name: DERMMATRIX SURGICAL MESH
• Applicant: Carbon Medical Technologies, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jun 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use in the treatment of hernias where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, and sacrocolposuspension.

Device Story

DermMatrix Surgical Mesh is a sterile, chemically treated, pyrogen-free, non-perforated porcine skin graft; epidermal and subdermal layers removed. Device serves as implantable scaffold for soft tissue reinforcement or hernia repair. Used by surgeons in clinical settings for procedures including urethral slings, prolapse repair, and pelvic floor reconstruction. Device provides mechanical support to weakened or ruptured connective tissue; facilitates tissue repair. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing, biocompatibility assessment, and established clinical experience with the predicate device.

Technological Characteristics

Sterile, chemically treated, non-perforated porcine skin graft; epidermal and subdermal layers removed. Pyrogen-free. Mechanical implant for soft tissue reinforcement.

Indications for Use

Indicated for patients requiring hernia repair or soft tissue reinforcement in urological, gynecological, or gastroenterological anatomy, including procedures for prolapse repair, pelvic floor reconstruction, and urethral 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.

Predicate Devices

• Carbon Medical Technologies DermMatrix Surgical Mesh (K993459)
• Tissue Science Laboratories Permacol (marketed by Bard as Pelvicol) (K992556)
• Cook Biotech, Inc. Surgisis Sling (K992159)

Submission Summary (Full Text)

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JUN 1 2 2002

K021160

Carbon Medical Technologies, Inc.

# EXHIBIT 5

## 510(k) Summary

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

Karen E. Peterson Vice President of Regulatory, Clinical, & QA Carbon Medical Technologies, Inc. 1290 Hammond Road St. Paul, MN 55110 651-762-2146 Phone: Phone: Fax: [phone]

Submitted: April 10, 2002

# Device Name

Trade Name: Classification Name: Common/Usual Name: DermMatrix Surgical Mesh Surgical Mesh, 21 CFR 878.3300 Surgical Mesh

# Predicate Devices

Carbon Medical Technologies DermMatrix Surgical Mesh [K993459] Tissue Science Laboratories Permacol (marketed by Bard as Pelvicol) [K992556] Cook Biotech, Inc. Surgisis Sling [K992159]

### Indication for Use

Intended for use in the treatment of hernias where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, and sacrocolposuspension.

### Device Description

DermMatrix is a sterile, chemically treated, pyrogen free, non-perforated porcine skin that has both the epidermal and subdermal sides removed.

### Technological Characteristics and Performance

The technological characteristics are identical to the predicate device (DermMatrix). Biocompatibility, 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.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

JUN 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen E. Peterson Vice President of Regulatory, Clinical and Quality Affairs Carbon Medical Technologies, Inc. 1290 Hammond Road St. Paul, MN 55110

Re: K021160

Trade/Device Name: DermMatrix Surgical Mesh Regulation Number: 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 10, 2002 Received: April 11, 2002

Dear Ms. Peterson:

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 – Ms. Karen E. Peterson

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" (21CFR 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 vours.

. Mark A. Millerson

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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#### EXHIBIT 3

# Indications for Use Statement

510(k) Number (if known)

510(k) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name

DermMatrix Surgical Mesh

Indications for Use

Intended for use in the treatment of hernias where the connective tissue has ruptured or

for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, and sacrocolposuspension.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over the Counter Use ______ |
|---------------------|--------------------------------------------|----|-----------------------------|
| (Per 21 CFR 801.109 | | | |

for Mark n Millberg

(Division Sign-Off) (Optimal Format 1-2-96)

Division of General, Restorative

and Neurological Devices

| 510(k) Number | K021160 |
|---------------|---------|
|---------------|---------|