VIVOSORB SHEET, MODEL FS01

K042811 · Polyganics B.V., · FTL · Nov 8, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042811
• Device Name: VIVOSORB SHEET, MODEL FS01
• Applicant: Polyganics B.V.,
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VivoSorb Sheet is indicated for the use as a temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

Device Story

VivoSorb Sheet is a flexible, transparent, resorbable poly(DL-lactide-co-s-caprolactone) sheet; used as temporary wound support or for hernia/fascial defect repair. Device provides mechanical reinforcement to soft tissues; resorbable film minimizes tissue attachment to viscera upon contact. Provided sterile in various sizes for surgical use. Clinical benefit derived from temporary support and reduced adhesion risk. Safety and effectiveness established via bench testing, including suture retention, degradation, aging, and mechanical property analysis.

Clinical Evidence

Bench testing only. Evidence includes in vitro suture retention, degradation, aging, and mechanical testing. Biocompatibility and animal testing results, along with literature review, support safety for implantation.

Technological Characteristics

Resorbable poly(DL-lactide-co-s-caprolactone) sheet. Flexible, transparent form factor. Sterile, provided in Tyvek pouches. No specific ASTM standards cited. No electronic components or software.

Indications for Use

Indicated for temporary wound support, soft tissue reinforcement, or repair of hernia/fascial defects requiring reinforcing material. Applicable to patients requiring surgical intervention for tissue weakness or defects.

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

• Surgi Wrap (K031955)
• IMMIXTM Obi OsteoBiologics (K032673)

Submission Summary (Full Text)

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## NOV - 8 2004

510(k) Summary of Safety and Effectiveness

| Submitter: | Polyganics BV<br>L.J. Zielstraweg 1<br>9713 GX, Groningen<br>The Netherlands<br>www.polyganics.com |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Jan Nieuwenhuis<br>Managing Director<br>Tel : [phone]<br>Fax : [phone]<br>Mobile : [phone]<br>E-mail : [e-mail] |
| Date<br>Prepared: | Oct 7, 2004 |
| General<br>Provisions: | Trade Name: VivoSorb Sheet<br>Common Name: Absorbable Polymeric Surgical Mesh<br>Classification Name: Surgical Mesh, Polymeric, 21 CFR 878.3300<br>Device Classification: Class II |
| Predicate<br>Devices: | Surgi Wrap MAST MacroPore, Inc K031955 IMMIXTM Obi OsteoBiologics K032673 |
| Performance<br>Standards | For the VivoSorb Sheet performance, the FDA, under section 514 of the<br>Food, Drug and Cosmetic Act, has not established standards. |
| Indications<br>for Use | The VivoSorb Sheet is indicated for the use as a temporary wound support,<br>to reinforce soft tissues where weakness exists, or for the repair of hernia or<br>other fascial defects that require the addition of a reinforcing material to<br>obtain the desired surgical result. The resorbable protective film minimizes<br>tissue attachment to the device in case of direct contact with the viscera. |

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The VivoSorb Sheet is designed to be a flexible and transparent resorbable Device poly (DL-lactide-co-s-caprolactone) sheet to provide support to soft tissue Description where weakness exists.

> The VivoSorb Sheet is provided sterile in Tyvek pouch packages in a variety of sizes.

safety and effectiveness of the VivoSorb Sheet have been Performance The demonstrated via data collected from design verification tests and analyses. Data: The design verification testing consisted of the following:

- In vitro suture retention testing -
- In vitro degradation testing ।
- Aging testing -
- Mechanical testing -

of The design, fundamental technology and intended use (safety and efficacy) Summary featured with the VivoSorb Sheet are substantially equivalent to those Substantial featured with the competitor devices Surgi Wrap (ref. 510(k) 031995; Equivalence MarcoPore, Inc) and the Immix™ (ref. 510(k) 032673, Obi OsteoBiologics, Inc).

> Biocompatibility, mechanical and physical property testing and in vitro degradation testing provide reasonable scientific evidence that VivoSorb Sheet is substantially equivalent to the predicate devices. Evaluation of the Polyganics VivoSorb Sheet based on biocompatibility testing, animal tests, results from literature and the comparison of the VivoSorb Sheet with its predicate devices, shows that the VisoSorb Sheet is safe for implantation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2004

Ms. Jan Nieuwenhuis Managing Director Polyganics BV L.J. Zielstraweg 1 9713 GX Groningen The Netherlands

Re: K042811

Trade/Device Name: VivoSorb® Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: October 8, 2004 Received: October 14, 2004

Dear Ms. Nieuwenhuis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave determined the article predicate devices marketed in interstate for use stated in the encreate) to regists the Medical Device Amendments, or to connine.co prior to May 20, 1978, are example with the provisions of the Federal Food, Drug, devices that nave been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of use ice, 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 If your device is classified (600 a00 royals. Existing major regulations affecting your device can may be subject to back additions, 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 r lease be advised that i Dr o lesames as our device complies with other requirements of the Act that I DA has made a acterimalations administered by other Federal agencies. You must or any I cacal statutes and regarations and limited to: registration and listing (21

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Page 2 - Ms. Jan Nieuwenhuis

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the sections in the quality by books of the provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you to ought timaing of substantial equivalence of your device to a legally prematics notification: "The Pro 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 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 mionnation of Journer 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

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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VivoSorb® Sheet K042811

bioresorbable soft tissue fixation
**POLYGANICS**

## Indications for Use Form

K042811 510(k) Number:

Device Name: VivoSorb® Sheet

Indications for Use:

The VivoSorb Sheet is indicated for the use as a temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

x Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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 Division of General, Restorative, and Neurological Devices

**510(k) Number** K042811

25-Oct-04