SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX

K994328 · Genzyme Corp. · FTL · Mar 2, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994328
• Device Name: SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
• Applicant: Genzyme Corp.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sepramesh™ Biosurgical Composite is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Device Story

Sepramesh™ Biosurgical Composite is a sterile, dual-component surgical mesh for soft tissue reconstruction. It consists of a polypropylene mesh base coated on one side with a bioresorbable barrier of sodium hyaluronate (HA) and carboxymethylcellulose (CMC), bonded with PLA/PGA. The uncoated polypropylene side facilitates fibroblastic response and tissue ingrowth for structural support. The HA/CMC side acts as a hydrophilic barrier to minimize visceral tissue attachment during the wound-healing period; the coating hydrates into a gel, resorbing within 5-7 days and clearing the body within 30 days. Used by surgeons in clinical settings for hernia repair. The device provides mechanical support similar to traditional meshes while reducing post-surgical adhesions. Benefits include effective tissue reinforcement and decreased risk of visceral attachment to the implant.

Clinical Evidence

No human clinical data provided. Evidence based on in vivo rabbit hernia repair model comparing Sepramesh™ to Bard® Mesh and Bard® Composix™ Mesh. Results showed comparable cellular response and tissue ingrowth. Adhesion reduction was superior or equivalent to predicate devices. Bench testing confirmed mechanical properties (mesh thickness, pore size, mass/area, suture retention, burst strength) are comparable to predicates. Biocompatibility testing conducted per ISO 10993.

Technological Characteristics

Dual-component sterile prosthesis. Base: single bar knit 6 mil monofilament polypropylene fiber. Coating: sodium hyaluronate (HA) and carboxymethylcellulose (CMC) bonded with PLA/PGA. Sterilization: Gamma radiation. Dimensions: 3"x6" to 8"x12". Mechanical properties: comparable to standard polypropylene meshes.

Indications for Use

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

• Bard® Mesh (Pre-amendment)
• Bard® Composix™ Mesh (K971745)
• Mersilene™ Mesh (Pre-amendment)

Submission Summary (Full Text)

{0}------------------------------------------------

---------------------------------------------------------------------------

510(k) Notification tion 10: 510(k) Summary ember 21, 1999

#### 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™ Biosurgical Composite (Sepramesh™), as well as the substantial equivalence decision making process used for Sepramesh™.

## Sponsor/Applicant Name and Address: 10.1

Genzyme Corporation One Kendall Square Cambridge, MA 02139

- 10.2 Sponsor Contact Information:
John A. DeLucia Director, Regulatory Affairs Phone: [phone] FAX: [phone] email: [e-mail]

- Date of Preparation of 510(k) Summary: 10.3
December 21, 1999

- 10.4 Device Trade or Proprietary Name:
Sepramesh™ Biosurgical Composite

- 10.5 Device Common/Usual or Classification Name:
Surgical Mesh

{1}------------------------------------------------

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

| Name of Predicate Device | Name of Manufacturer<br>(Town, State) | 510(k) Number |
|--------------------------|---------------------------------------|---------------|
| Bard® Mesh | Davol Inc., Cranston, RI | Pre-amendment |
| Bard® Composix™ Mesh | Davol Inc., Cranston, RI | K971745 |
| Mersilene™ Mesh | Ethicon, Inc., Somerville, NJ | Pre-amendment |

## 10.7 Device Description:

Sepramesh™ Biosurgical Composite (Sepramesh™) is a dual-component (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ is constructed of a polypropylene mesh that is coated on one side with a bioresorbable coating composed of sodium hyaluronate (HA) and carboxymethylcellulose (CMC).

The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth similar to polypropylene mesh alone and providing support for soft tissue repair. The HA/CMC side of the mesh provides a hydrophilic bioresorbable coating separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period to minimize tissue attachment to the mesh. Shortly after placement, the HA/CMC coating becomes a hydrated gel that is slowly resorbed from the site of placement within 5-7 days and excreted from the body within 30 days.

# 10.8 Intended Use:

Sepramesh™ Biosurgical Composite is indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.

{2}------------------------------------------------

- Comparison of Technological Characteristics of Sepramesh™ with Legally Marketed 10.9 Devices:
Table 12 is the Table of Similarities and Differences between Genzyme's Sepramesh™ Biosurgical Composite and the legally marketed devices identified in Section 10.6.

{3}------------------------------------------------

: ' .

| Table 12: Table of Similarities and Differences/Substantial Equivalence to Predicate Devices | | | | | |
|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Feature | Sepramesh™ Biosurgical<br>Composite | Bard®<br>Mesh | Mersilene™<br>Mesh | Bard® Composix™ Mesh | Comments on<br>Differences |
| 510(k) No. | To be determined | Pre-amendment | Pre-amendment | K971745 | Not Applicable |
| Classification | Class II: Polymeric<br>Surgical Mesh | Class II: Polymeric<br>Surgical Mesh | Class II: Polymeric<br>Surgical Mesh | Class II: Polymeric<br>Surgical Mesh | Substantially Equivalent |
| Indication | Reconstruction of soft<br>tissue deficiencies, such<br>as for the repair of hernias | Reinforce soft tissue<br>where weakness<br>exists, i.e., repair of<br>hernias and chest wall<br>defects | Repair of hernia and<br>other fascial<br>deficiencies that<br>require the addition of<br>a reinforcing or<br>bridging material | Reconstruction of soft<br>tissue deficiencies, such as<br>for the repair of hernias and<br>chest wall defects | Substantially Equivalent |
| Labeling Claims | HA/CMC surface<br>minimizes tissue and<br>visceral adhesions to<br>device | None | None | ePTFE minimizes<br>adhesions to device | Substantially Equivalent |
| Product Design | Polypropylene mesh with<br>HA/CMC coating on one<br>surface | Polypropylene mesh | Polyester mesh | Two layers of<br>polypropylene mesh with<br>PTFE coating on one<br>surface | HA/CMC and ePTFE surface<br>placed facing viscera. |
| Materials<br>● | Polypropylene, HA/CMC,<br>PLA/PGA | Polypropylene | Polyethylene<br>terephthalate (PET) | Polypropylene, ePTFE | PLA/PGA bonds HA/CMC<br>coating to polypropylene. |
| Coating | Yes (HA/CMC) | No | No | Yes (ePTFE) | Substantially Equivalent |

# Table 12・ Table of Similarities and Differences/Substential Equivalones to Prodicato Doviega

{4}------------------------------------------------

| Feature | Sepramesh™ Biosurgical<br>Composite | Bard®<br>Mesh | Mersilene™<br>Mesh | Bard® Composix™ Mesh | Comments on<br>Differences |
|--------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------|-----------------------------------------------|----------------------------|
| Mesh Design | Single bar knit from 6 mil<br>monofilament<br>polypropylene fiber | Single bar knit from 6<br>mil monofilament<br>polypropylene fiber | Two bar knit from<br>multifilament PET fiber | Indeterminate | Substantially Equivalent |
| Mesh Pore<br>Size | Substantially Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent | Substantially Equivalent |
| Performance<br>Results | | | | | |
| • Burst<br>Strength | Substantially Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent | Not tested | Substantially Equivalent |
| • Suture<br>Retention | Substantially Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent | Not tested | Substantially Equivalent |
| • Tissue<br>Ingrowth | Complete tissue<br>incorporation of implant | Complete tissue<br>incorporation of<br>implant | Not tested | Complete tissue<br>incorporation of implant | Substantially Equivalent |
| • Tissue<br>Attachment<br>(Adhesions)<br>to Mesh | Decreased compared to<br>Bard® Mesh and<br>Composix™ | Extensive adhesions | Not tested | Decreased adhesions<br>compared to Bard® Mesh | Substantially Equivalent |
| Sterilization | Gamma | EtO | Gamma, EtO, or<br>Steam | EtO | Substantially Equivalent |
| Sizes | 3"x6" to 8"x12" | 1"x4" to 10"x14" | 2.5"x4.5" and 12"x12" | 2"x4" to 8"x10" | Substantially Equivalent |

{5}------------------------------------------------

## Summarv of Nonclinical Data: 10.10

The biocompatibility and safety tests conducted for Sepramesh™ were selected in accordance with the Blue Book Memorandum G95-1. "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." All studies were conducted pursuant to 21 CFR. Part 58. Good Laboratory Practices. Based on the results from these studies. Sepramesh™ is considered to be non-toxic, non-mutagenic, nonsensitizing, biocompatible and safe.

The effectiveness of Sepramesh™ was compared in vivo in a rabbit hernia repair model to Bard® Mesh and Bard® Composix™ Mesh. The overall performance of Sepramesh™. including adhesion formation and tissue ingrowth. was substantially equivalent to these hernia repair products. Cellular response and tissue ingrowth for all three groups was comparable. Sepramesh™ performed substantially equivalent or better than Bard® Mesh and Bard® Composix™ Mesh in all of the evaluated adhesion reduction categories.

The physical and mechanical characteristics of Sepramesh™, such as mesh thickness, mesh knit characteristics, pore size, mesh mass/area, suture retention and burst strength, are comparable to the currently marketed predicate devices.

#### 10.11 Substantial Equivalence Decision Making Process:

The quidance document titled. "Premarket Notification 510/k): Requirements for Medical Devices," Appendix A3. "Substantial Equivalence" Decision-Making Process (Detailed)" revised August 1992 by Center for Devices and Radiological Health, was used to determine the substantial equivalence for Genzyme's Sepramesh™. Please refer to Appendix 1 for a diagram of the 510(k) Decision Tree. The answers to the questions listed below lead to a determination of substantial equivalence to the predicate devices.

# a. Does the new device have the same indication statement?

Yes. Sepramesh™ has the same intended use as Bard® Mesh (pre-amendment device), Bard® Composix™ Mesh (K971745) and Mersilene™ Mesh (pre-amendment device) which are legally marketed hernia repair devices. Sepramesh™ Biosurgical Composite is indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. Therefore, Sepramesh™ has the same intended use as the predicate devices and is considered to be "substantially equivalent."

{6}------------------------------------------------

#### Does the new device have the same technological characteristics, e.q. design, materials etc? b.

No. Sepramesh™ has different technological characteristics. However, the technological differences meet or exceed the functional requirements of surgical meshes compared to the predicate devices. Please refer to Table 12 for the Table of Similarities and Differences/Substantial Equivalence to predicate devices.

## Could the new technological characteristics affect safety and effectiveness? C.

Yes, the new technological characteristics could affect safety and effectiveness. However, the differences in safety and effectiveness meet or exceed the requirements of surgical meshes compared to the predicate devices.

#### ರ. Do the new characteristics raise new types of safety or effectiveness guestions?

No. The safety and effectiveness questions are not new and include issues such as materials, pore size, mesh strength, suture retention, biocompatibility and tissue ingrowth. Sufficient data has been provided in this premarket notification to address any new safety and efficacy questions. Additionally, there are a variety of other meshes currently on the market with different characteristics compared to Sepramesh™ or the predicate devices.

# Do accepted scientific methods exist for assessing the new characteristics? e.

Yes. The effects of the new characteristics of Sepramesh™ can be assessed by common methods utilized for surgical meshes. These include mechanical testing, scanning electron microscopy, biocompatibility testing and in vivo safety and effectiveness testing.

# 1. Are performance data available to assess the effects of the new characteristics?

Yes. Extensive testing has been performed to assess the effects of the new characteristics of Sepramesh™. These tests compared the effects of Sepramesh™ against the predicate devices as applicable, and included mechanical testing, scanning electron microscopy, biocompatibility testing and in vivo safety and effectiveness testing.

{7}------------------------------------------------

#### Do performance data demonstrate equivalence? g.

Yes. Based on the results of the tests summarized in Section 8 of this application, the physical and mechanical characteristics of Sepramesh™ are comparable to the currently marketed predicate devices. The results of the in vivo testing indicate that tissue ingrowth is comparable to that of the predicate devices and that the tissue attachment at the visceral surfaces in contact with Sepramesh™ is minimized compared to the predicate devices. Results from all the safety tests conducted demonstrate that Sepramesh™ is nonmutagenic and biocompatible.

Based on this information, Sepramesh™ is determined to be substantially equivalent to the predicate devices.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three heads.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2000

Mr. John A. DeLucia Director, Regulatory Affairs Genzyme Corporation One Kendall Square Cambridge, Massachusetts 02139-1562

K994328 Re: Trade Name: Sepramesh™ Biosurgical Composite Regulatory Class: II Product Code: FTL Dated: December 21, 1999 Received: December 22, 1999

Dear Mr. DeLucia:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{9}------------------------------------------------

Page 2 – Mr. John A. DeLucia

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

.
Wilf. R.P. Ogden

James E. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{10}------------------------------------------------

# INDICATIONS FOR USE FORM

(per Attachment #1 of CDRH's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh™ March 2, 1999)

Page 536 of 544

510(k) Number (if known): To be determined

Device Name: Sepramesh™ Biosurgical Composite

Indications for Use:

Sepramesh™ Biosurgical Composite is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

> (Dim. r Sigr. 94) ai manata! Restorative Demoks نت 5 . - - Nember _______________________________________________________________________________________________________________________________________________________________

(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)