ACELL UBM SURGICAL MESH ML AND MLPLUS

K041140 · Acell, Inc. · FTM · Jul 7, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041140
• Device Name: ACELL UBM SURGICAL MESH ML AND MLPLUS
• Applicant: Acell, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jul 7, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACell UBM Surgical Mesh ML and MLPlus are intended for implantation to reinforce soft tissue where weakness exists in urological, gynecological, and gastroenterological anatomy including, but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacrocolposuspension, hernia and body wall repair, and esophageal repair. By providing pubourethrai support, the ACell surgical mesh may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. The device is intended for one-time use.

Device Story

ACell UBM Surgical Mesh ML and MLPlus are porcine collagen-based surgical meshes; supplied sterile in sizes 16 cm² to 14x20 cm. Intended for implantation by surgeons to reinforce soft tissue in urological, gynecological, and gastroenterological anatomy; used in procedures including pelvic floor reconstruction, hernia repair, and treatment of urinary incontinence. Device provides mechanical support to weakened tissue; facilitates tissue repair. Single-use device.

Clinical Evidence

Bench testing only. Biocompatibility and performance testing conducted to assess material properties; results confirmed device safety and effectiveness.

Technological Characteristics

Porcine collagen-based surgical mesh; supplied sterile. Dimensions range from 16 cm² to 14x20 cm. Single-use, implantable device.

Indications for Use

Indicated for patients requiring soft tissue reinforcement in urological, gynecological, and gastroenterological procedures, including prolapse repair, pelvic floor reconstruction, hernia/body wall repair, and esophageal repair. Also indicated for urinary incontinence treatment due to urethral hypermobility or intrinsic 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

• ACell UBM Surgical Mesh (K040621)
• Surgisis™ Sling (K992159)

Submission Summary (Full Text)

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R41140

ACell UBM Surgical Mesh ML and MLPLus Abbreviated 510(k) Premarket Notification

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## Submitter: ACell, Inc.

| JUL - 7 2004 | Section 9.0<br>510(k) SUMMARY |
|------------------------|-----------------------------------------------------------------------------------------------|
| | ACell UBM Surgical Mesh ML and MLPlus |
| 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: | 410-715-1700 |
| Fax Number: | 410-715-4511 |
| Date Prepared: | April 30, 2004 |
| Device Trade Name: | ACell UBM Surgical Mesh ML and MLPlus |
| Device Common<br>Name: | Surgical mesh |
| Classification Name: | Mesh, Surgical (FTM; 21 CFR 878.3300) |
| Predicate Devices: | K040621; ACell, Inc., ACell UBM Surgical Mesh<br>K992159; Cook Biotech, Inc., Surgisis™ Sling |
| Device Description: | The ACell UBM Surgical Mesh ML and MLPlus are composed of |

f porcine collagen and are supplied sterile in sizes ranging from 16 cm² to 14x20 cm.

The ACell UBM Surgical Mesh ML & MLPLus are intended for Intended Use: implantation to reinforce soft tissue where weakness exists in urological, gynecological, and gastroenterological anatomy including, but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacrocolposuspension, hernia and body wall repair, and esophageal repair. By providing pubourethrai support, the ACell surgical mesh may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. The device is intended for one-time use.

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Submitter:

ACell, Inc.

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| Discussion of tests<br>and test results: | The ACell Surgical Mesh ML and MLPlus were subjected to a number of<br>tests to assess the biocompatibility and the performance of the<br>materials. They passed the requirements of all tests and were shown to<br>be safe and effective as surgical mesh devices as indicated. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | These devices, with respect to material composition, device<br>characteristics and intended use, are substantially equivalent to the<br>predicate devices. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three abstract shapes, possibly representing human figures or wings, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2004

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

Re: K041140

Trade/Device Name: ACell UBM Surgical Mesh ML and MLPlus Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 30, 2004 Received: April 30, 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 for answer or 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) I mis letter will anow you to begin mailing of substantial equivalence of your device to a legally premarket notification: "The PDF intrallegsification 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 If you desire specific at novier Joss [phone]. Also, please note the regulation entitled, Contact the Office of Commarket notification" (21CFR Part 807.97). You may obtain Misoranding of reference to prenessonsibilities under the Act from the Division of Small other general information 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,

iriam C. Provost

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):

Device Name: _________________________________________________________________________________________________________________________________________________________________

KO41140

Indications for Use:

The ACell UBM Surgical Mesh ML and MLPlus are intended for implantation to reinforce soft tissue where weakness exists in urological, gynecological, and gastroenterological anatomy including, but not limited to the following gastronomical and support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacrocolposuspension, hemia and body wall repair, and esophageal repair, Sacroonpourethral support, the ACell surgical mesh may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. The device is intended for one-time use.

Over-The-Counter Use × Prescription Use AND/OR (21 CFR 807 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)

Muriam C. Provost

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

(Posted November 13, 2003)

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510(k) Number_K 64 // 40

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