FORTAFLEX SURGICAL MESH

K021105 · Organogenesis, Inc. · FTM · May 10, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021105
• Device Name: FORTAFLEX SURGICAL MESH
• Applicant: Organogenesis, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

Device Story

FortaGen is a multi-laminate surgical mesh composed of Type I porcine collagen; supplied as a sterile, single-use sheet. Used by surgeons in clinical settings for soft tissue reinforcement and reconstructive procedures. Device provides a scaffold for tissue repair; physical properties support structural integrity during healing. No electronic, software, or algorithmic components.

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 of Type I porcine collagen. Supplied in sterile, double-layer peelable packaging. Non-electronic, mechanical implant.

Indications for Use

Indicated for patients requiring soft tissue reinforcement, including abdominal/thoracic wall defects, muscle flap reinforcement, rectal/vaginal prolapse, pelvic floor reconstruction, hernia repair, and suture-line reinforcement.

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 (K980431)

Submission Summary (Full Text)

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# MAY 1 0 2002

02 1105

### 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:

FortaGen™ Surgical Mesh, Tissue Repair Biomaterial Surgical Mesh (79FTM, 878.3300) Class II

## Predicate Device:

The device is similar to predicate collagen-based Surgical Mesh devices previously cleared for commercial distribution. The relevant predicate devices include GraftPatch (K970561) manufactured by Organogenesis Inc. and Surgisis (K980431) manufactured by Cook Biotech, Incorporated.

#### Statement of Substantial Equivalence:

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

### Intended Use:

FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suturc-line reinforcement and reconstructive procedures. The device is intended for one-time use.

#### Device Description:

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

#### Performance Data:

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

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 0 2002

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

Re: K021105

Trade/Device Name: FortaGen™ 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 & no review 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 associated in the 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. Michael L. Sabolinski, M.D.

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 yours,

Muriam 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.

#### 021105 510(k) Number (if known):

Device Name: FortaGen™

### Indications For Use:

FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures.

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)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Muriam C. Provost

(Optional Format 1-2-96)

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

K021105 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

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