ACELL UBM SURGICAL MESH

K040621 · Acell, Inc. · FTM · Apr 14, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040621
• Device Name: ACELL UBM SURGICAL MESH
• Applicant: Acell, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Apr 14, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACell UBM Surgical Mesh is intended for implantation to reinforce soft tissue. The device is intended for one-time use.

Device Story

ACell UBM Surgical Mesh is a sterile, single-use implantable device composed of porcine collagen. It is supplied as sheets ranging from 16 cm² to 360 cm². Used by surgeons in clinical settings to reinforce soft tissue. The device functions as a scaffold for tissue repair. It is implanted during surgical procedures to provide structural support to weakened or damaged soft tissue. Benefits include biocompatible material support for surgical reconstruction.

Clinical Evidence

Bench testing only. The device underwent biocompatibility and performance testing to assess material safety and effectiveness for soft tissue reinforcement. No clinical trial data provided.

Technological Characteristics

Material: Porcine collagen. Form factor: Sterile single sheets (16 cm² to 360 cm²). Principle: Implantable scaffold for soft tissue reinforcement. No energy source or software components.

Indications for Use

Indicated for patients requiring soft tissue reinforcement via surgical implantation. No specific age or gender restrictions provided. Contraindications not specified.

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

• ACell UBM Lyophilized Wound Dressing (K021637)
• Cook Biotech, Inc., SurgiS/S® (K980431)

Submission Summary (Full Text)

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APR 1 4 2004

Submitter: ACell, Inc.

ACell UBM Surgical Mesh Abbreviated 510(k) Premarket Notification

KO4062

## Section 9.0 510(k) SUMMARY—ACell UBM Surgical Mesh

| Submitter Name: | ACell, Incorporated |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 10555 Guilford Road<br>Suite 113<br>Jessup, Maryland 20790 |
| Contact Person: | James R. DeFrancesco<br>Chief Executive Officer |
| Phone Number:<br>Fax Number: | 410-715-1700<br>410-715-4511 |
| Date Prepared: | March 9, 2004 |
| Device Trade Name: | ACell UBM Surgical Mesh |
| Device Common<br>Name: | Surgical mesh |
| Classification Name: | Mesh, Surgical (FTM, 21 CFR 878.3300) |
| Predicate Devices: | K021637, ACell, Inc., ACell UBM Lyophilized Wound Dressing<br>K980431, Cook Biotech, Inc., SurgiS/S® |
| Device Description: | The ACell UBM Surgical Mesh is composed of porcine collagen and is<br>supplied sterile in single sheet sizes ranging from $16 cm^2$ to $360 cm^2$ . |
| Intended Use: | The ACell UBM Surgical Mesh is intended for implantation to reinforce<br>soft tissue. The device is intended for one-time use. |
| Discussion of tests<br>and test results: | The ACell UBM Surgical Mesh was subjected to a number of tests to<br>assess the biocompatibility and the performance of the material. It<br>passed the requirements of all tests and was shown to be safe and<br>effective as a surgical mesh for soft tissue reinforcement. |
| Conclusion: | This device, with respect to material composition, device characteristics<br>and intended use, is substantially equivalent to the predicate devices. |

:

...

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2004

ACell, Inc. c/o Ms. Patsy J. Trisler, J.D., RAC 5610 Wisconsin Avenue, #304 Chevy Chase, Maryland 20815

Re: K040621

Trade/Device Name: ACell UBM Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: March 9, 2004 Received: March 9, 2004

Dear Ms. Trisler:

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. Patsy J. Trisler, J.D., RAC

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark Milliken

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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## Indications for Use

510(k) Number (if known): \$04062(

ACell UBM Surgical Mesh Device Name:

Indications for Use:

The ACell UBM Surgical Mesh is intended for implantation to reinforce soft tissues. The device is intended for one-time use.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

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

(Posted November 13, 2003) 510(k) Number K040621 Page 1 of 1