FORTAFLEX SURGICAL SLING

K021107 · Organogenesis, Inc. · FTM · May 15, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021107
• Device Name: FORTAFLEX SURGICAL SLING
• Applicant: Organogenesis, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FortaPerm™ is intended for implantation to reinforce and support soft tissues where weakness exists, including but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolposuspension, reconstructive procedures and tissue repair. By providing pubourethral support, the FortaPerm™ may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is intended for one-time use.

Device Story

FortaPerm is a multi-laminate surgical mesh composed primarily of Type I porcine collagen; supplied as sterile sheets ranging from 2x5 cm to 12x36 cm. Intended for surgical implantation to reinforce soft tissue in procedures including pelvic floor reconstruction, prolapse repair, and pubourethral support for urinary incontinence. Device provides mechanical support to weakened tissues; intended for one-time use. Used by surgeons in clinical/OR settings.

Clinical Evidence

Bench testing only. Device subjected to a panel of tests assessing biocompatibility, integrity, and performance; passed all requirements.

Technological Characteristics

Multi-laminate sheet composed predominantly of Type I porcine collagen. Supplied in sterile double-layer packaging. Dimensions range from 2x5 cm to 12x36 cm.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or support, including pelvic floor reconstruction, prolapse repair, and treatment of urinary incontinence 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

• GraftPatch (K970561)
• Surgisis Sling (K992159)

Submission Summary (Full Text)

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# K021107

# MAY 1 5 2002

### 510(K) SUMMARY

#### Submitted by:

Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021

#### Contact

Michael L. Sabolinski Telephone: [phone] Facsimile: [phone]

April 25, 2002 Date:

#### Device:

Trade Name: Common/Usual Name: Classification Name: Regulatory Class:

FortaPerm™ Surgical Mesh, Sling, Tissue Support Biomaterial Surgical Mesh (79FTM, 878.3300) Class II

#### Predicate Device:

The device is similar to predicate collagen-based surgical mesh and sling devices previously cleared for commercial distribution. The relevant predicate devices include GraftPatch (K970561) manufactured by Organogenesis Inc. and Surgisis Sling (K992159) manufactured by Cook Biotech, Incorporated.

#### Statement of Substantial Equivalence:

FortaPerm is substantially equivalent to the predicate devices, having similar intended use, technological characteristics, materials, physical construction and performance.

#### Intended Use:

FortaPerm is intended for implantation to reinforce and support soft tissue where weakness exists including, but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolposuspension, reconstructive procedures and tissue repair. By providing pubourethral support, FortaPerm may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is intended for one-time use.

#### Device Description:

Forta Perm consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 2 x 5 cm to 12 x 36 cm in sterile double laye packaging.

#### Performance Data:

FortaPerm was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests.

Organogenesis Inc., Amendment to \$10(k) Premarket Notification April 25, 2002

Page 15

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2002

Mr. Michael L. Sabolinski, M.D. Executive Vice President Medical and Regulatory Affairs Organogenesis, Inc. 150 Dan Road Canton, MA 02021

Re: K021107

Trade/Device Name: FortaPerm™ Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: April 4, 2002 Received: April 5, 2002

Dear Dr. Sabolinski:

We have reviewed your Section 510(k) premarket notification of intent to market the device w t nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreases of the enactment date of the Medical Device Amendments, or to conimeres prior to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Oosmeter For (110) and the device, subject to the general controls provisions of the Act. The I ou may) attests 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. Michael L. Sabolinski, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) r market notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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 O wier general missimal 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,

Miriam C. Provost

for Celia 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 STATEMENT

Applicant: Organogenesis Inc.

or 1107 510(k) Number (if known):

Device Name: FortaPerm™

Indications For Use:

FortaPerm™ is intended for implantation to reinforce and support soft tissues where weakness exists, including but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolnosuspension, reconstructive procedures and tissue repair. By providing pubourethral support, the FortaPerm™ may be used for the treatment of Dy providing pacourounce resulting from urethral hypermobility or intrinsic sphincter deficiency.

The device is intended for one-time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

Prescription Use (Per 21 CFR 801.109)

K021107 510(k) Number. Over The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Organogenesis Inc., Amendment to 510(k) Premarket Notification April 25, 2002

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