SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH

K040868 · Genzyme Corp. · FTM · Jun 4, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040868
• Device Name: SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
• Applicant: Genzyme Corp.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jun 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sepramesh™ IP Bioresorbable Coating- Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Device Story

Sepramesh™ IP is a sterile, dual-component surgical mesh for soft tissue reconstruction/hernia repair. Device consists of co-knitted polypropylene and polyglycolic acid (PGA) fibers. Visceral side features a bioresorbable coating of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC), and polyethylene glycol (PEG) hydrogel. During surgery, the fascial side is placed to encourage fibroblastic tissue ingrowth through the polypropylene mesh interstices. The visceral side's hydrophilic coating acts as a temporary barrier to minimize tissue attachment and visceral adhesions during the wound-healing period. The coating resorbs in <30 days; PGA fibers absorb in 50-80 days; polypropylene remains as a permanent scaffold. Used by surgeons in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Dual-component surgical mesh; materials: polypropylene (permanent), polyglycolic acid (PGA, absorbable), and bioresorbable coating (sodium hyaluronate, carboxymethylcellulose, polyethylene glycol hydrogel). Form factor: co-knitted mesh. Mechanism: mechanical scaffold for tissue ingrowth with temporary anti-adhesion barrier. Sterilization: sterile.

Indications for Use

Indicated for reconstruction of soft tissue deficiencies, including hernia repair, in patients requiring surgical mesh.

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

• Sepramesh™ (K994328)
• Bard® Mesh (Pre-amendment)
• Bard® Composix® E/X Mesh (KK002684)
• Vicryl™ Knitted Mesh (K810428)
• Dexon® PGA Mesh (K830889)

Submission Summary (Full Text)

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K040868

#### 510(K) SUMMARY (as required by 21 CFR 807.92) 10.0

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for Sepramesh™ IP Bioresorbable Coating - Permanent Mesh (Sepramesh™ IP), as well as the substantial equivalence decision making process used for Sepramesh™.

#### 10.1 Sponsor/Applicant Name and Address:

Genzyme Corporation 500 Kendall Street Cambridge, MA 02142

#### 10.2 Sponsor Contact Information:

Michael G. Halpin Director, Regulatory Affairs Phone: [phone] FAX: [phone] email: [e-mail]

#### 10.3 Date of Preparation of 510(k) Summary:

May 25, 2004

#### 10.4 Device Trade or Proprietary Name:

Sepramesh™ IP Bioresorbable Coating -- Permanent Mesh

#### 10.5 Device Common/Usual or Classification Name:

Surgical Mesh

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| Name of Predicate Device | Name of Manufacturer<br>(Town, State) | 510(k) Number |
|-----------------------------|---------------------------------------|---------------|
| Sepramesh™ | Genzyme Corporation,<br>Cambridge, MA | K994328 |
| Bard® Mesh | Davol Inc., Cranston, RI | Pre-amendment |
| Bard® Composix® E/X<br>Mesh | Davol Inc., Cranston, RI | KK002684 |
| Vicryl™ Knitted Mesh | Ethicon Inc., Somerville, NJ | K810428 |
| Dexon® PGA Mesh | Davis & Geck Inc., Norwalk, CT | K830889 |

#### Identification of the Legally Marketed Devices to which Equivalence is Being Claimed: 10.6

#### 10.7 Device Description:

Sepramesh™ IP Bioresorbable Coating - Permanent Mosh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.

The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.

#### 10.8 Intended Use:

Sepramesh™ IP Bioresorbable Coating- Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.

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K040864

### 10.9 Comparison of Technological Characteristics of Sepramesh™ IP with Legally Marketed Devices:

Table 15 is the Table of Similarities and Differences between Genzyme's Sepramesh™ IP Bioresorbable Coating - Permanent Mesh and the legally marketed devices identified in Section 10.6.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2004

Mr. Michael G. Halpin Director, Regulatory Affairs Genzyme Corporation 500 Kendall Street Cambridge, Massachusetts 02142

Re: K040868

Trade/Device Name: Sepramesh™ IP Bioresorbable Coating - Permanent mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 1, 2004 Received: April 5, 2004

Dear Mr. Halpin:

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 use surfally in the encreated of 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, do hoosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and coometre fore, 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 G. Halpin

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse FDA finding of substantial equivalence of your device to a legally premaired predicated 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 if you desire specific acrepliance 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 other general michhaal 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,

Sincerely yours,

Mark A. Milhousen

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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# 16040868

## Indications for Use Form

510(k) Number (if known): K040868

Device Name: Sepramesh™ IP Bioresorbable Coating -- Permanent Mesh

Indications for Use:

Sepramesh™ IP Bioresorbable Coating - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millhurn

Division Sign=Off Division of General, Restorative, and Neurological Devices

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1040868 510(k) Number_