FORTAFLEX SURGICAL MESH

K020049 · Organogenesis, Inc. · FTM · Mar 18, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020049
• Device Name: FORTAFLEX SURGICAL MESH
• Applicant: Organogenesis, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Mar 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FortaFlex™ Surgical Mesh 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 also intended for reinforcement of the soft tissues which are repaired by suture or sutere anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one-time use.

Device Story

FortaFlex Surgical Mesh is a multi-laminate sheet composed primarily of Type I porcine collagen; used as a surgical implant for soft tissue reinforcement. Device is supplied in sterile, peelable packaging in various sizes. Intended for use by surgeons during procedures including hernia repair, pelvic floor reconstruction, and rotator cuff repair (supraspinatus). Provides mechanical reinforcement to tissues repaired via sutures or suture anchors. Device is for one-time use.

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. Dimensions range from 5 x 5 cm to 12 x 36 cm. Non-electronic, mechanical implant.

Indications for Use

Indicated for patients requiring soft tissue reinforcement in abdominal/thoracic wall defects, muscle flaps, rectal/vaginal prolapse, pelvic floor reconstruction, hernias, suture-line reinforcement, and rotator cuff repair (specifically supraspinatus 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

• Material cleared in K011025
• Restore® Orthobiologic Soft Tissue Implant (K001738)

Submission Summary (Full Text)

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K020049

# 510(K) SUMMARY

## Submitted by:

MAR 1 8 2002

Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021

# Contact

Patrick R. Bilbo [phone] Telephone: [phone] Facsimile:

Date: January 4, 2002

## Device:

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

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

# Predicate Device:

The FortaFlex Surgical Mesh is equivalent to the material cleared in K011025 for use in surgical procedures for reinforcement of soft tissue. The relevant predicate device for the expanded indications for use is the Restore® Orthobiologic Soft Tissue Implant (K001738) manufactured by DePuy, Inc.

## Statement of Substantial Equivalence:

The FortaFlex Surgical Mesh is substantially equivalent to the predicate device, having similar intended use, technological characteristics, materials, physical construction and performance.

#### Intended Use:

FortaFlex™ Surgical Mesh 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 also intended for reinforcement of the soft tissues which are repaired by suture or sutere anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one-time use.

## Device Description:

FortaFlex Surgical Mesh 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:

FortaFlex Surgical Mesh 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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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 a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2002

Mr. Patrick R. Bilbo Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021

Re: K020049

Trade/Device Name: FortaFlex™Surgical Mesh Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: January 4, 2002 Received: January 7, 2002

Dear Mr. Bilbo:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave as nowed your weeks mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surve in the encreations of the enactment date of the Medical Device Amendments, or to conniner of prior to ria) 2011-11-11 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 I ou may , ateres, and second 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. Patrick R. Bilbo

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,

Miriam C. Provost

For 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 STATEMENT

Applicant: Organogenesis Inc.

510(k) Number (if known): k020049

Device Name: FortaFlex™ Surgical Mesh

Indications For Use:

FortaFlex™ Surgical Mesh 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 morement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures.

The device is also intended for reinforcement of the soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.

The device is intended for one-time use.

Muriam C. Provost

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

510(k) Number K020049

(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 _

(Optional Format 1-2-96)

01/04/02