3D ANATOMICAL MESH

K990930 · Santerra Medical Technology, Inc. · FTL · Jun 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990930
• Device Name: 3D ANATOMICAL MESH
• Applicant: Santerra Medical Technology, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jun 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The singular intended use of 3D Anatomical™ Mesh is hernia repair.

Device Story

3D Anatomical™ Mesh is a polypropylene surgical mesh used for hernia repair. It is a passive implantable device intended for surgical use by physicians. The device is manufactured from monofilament, 100% polypropylene homopolymer. It functions as a prosthetic material to support tissue during hernia repair procedures. The device is provided for prescription use.

Clinical Evidence

Bench testing included weave density (0.91g/cm³), tensile strength (>40 daN), and burst strength (>500 kPa). Chemical characterization via infrared spectrometry and thermal analysis (fusion 160-175°C, crystallization >60%) confirmed material composition as polypropylene homopolymer. International clinical experience since 1994 involving thousands of implants is cited.

Technological Characteristics

Polypropylene surgical mesh; monofilament 100% polypropylene homopolymer. Manufactured in class 10,000 clean room per ISO 9001 and EN 46001. Weave density 0.91g/cm³; tensile strength >40 daN; burst strength >500 kPa. Fusion temperature 160-175°C; crystallization >60%.

Indications for Use

Indicated for inguinal hernia repair and ventral abdominal wall hernia repair.

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.

Submission Summary (Full Text)

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FAX NO. :

JUN 17 1999

Jun. 07 1999 10:56AM P2
K990730

## ATTACHMENT D: SUMMARY OF SAFETY AND EFFECTIVENESS 3D Anatomical™ Mesh

### 1. Standards and Intended Use:

At present, and to the best of our knowledge, there are no standards for polypropylene surgical mesh. The 3D Anatomical™ Mesh will conform to all future international standards for polypropylene mesh prostheses. The singular intended use of 3D Anatomical™ Mesh is hernia repair.

## 2. Manufacturing Procedures:

3D Anatomical™ Mesh is manufactured in a class 10,000 clean room environment in accordance with ISO 9001 and EN 46001 regulations. Full traceability will be maintained on all production lots.

# 3. Prior In-Vitro Tests and Clinical Experience:

3D Anatomical™ Mesh is CE marked (no. 0413)

In-vitro testing of the 3D Anatomical™ Mesh was conducted by Institut Textile de France, Ecully, France and produced the following results:

| a) weave density: | 0.91g/cm³ |
|----------------------|--------------------------------------------------------------------------------------------------------------------------|
| b) tensile strength: | 3D Anatomical™ Mesh must exceed 40 daN<br>(greater than 50% elongation prior to rupture) |
| c) burst strength: | 3D Anatomical™ Mesh must exceed 500 kPa |
| | Clinical experience of 3D Anatomical™ Mesh began internationally<br>in 1994 and now includes thousands of mesh implants. |

In-vitro chemical testing was performed by Laboratoire de Rheologie des Matieres Plastiques, St. Etienne, France and concluded:

- a) through comparative infrared spectrometry, a lot batch of 3D Anatomical polypropylene was positively compared to a reference polypropylene that was specified to be a monofilament, 100% polypropylene homopolymer.
- b) Through comparative thermal analysis, both the lot batch of 3D Anatomical polypropylene and the reference polypropylene sample exhibited fusion temperatures between 160°C and 175°C and both exhibited crystallization above 60%.

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4. Contact Information: Inquiries should be directed to: Santerra Medical Technology, Inc. 5451 Hilltop Avenue Lake Elmo, MN 55042-9539 Tel: [phone] Fax: [phone]

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and two curved lines representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 1999

Mr. David P. Lang Chief Executive Officer Santerra Medical Technology, Inc. 5451 Hilltop Avenue Lake Elmo, Minnesota 55042

Re: K990930 Trade Name: 3D Anatomical™ Mesh Regulatory Class: II Product Code: FTL Dated: March 16, 1999 Received: March 19, 1999

Dear Mr. Lang:

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.

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Page 2 - Mr. David P. Lang

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 vour 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,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

3D AnatomicaI™ Mesh Device Name:

Indications For Use:

The indications for use of 3D Anatomical™ Mesh are:

- l) inguinal hernia repair
- 2) ventral abdominal wall hernia repair

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-O)
Division of General Restorative Devices
510(k) Number C990430

**Prescription Use**
(21 CFR 801.109)

OR

Over-The-Counter Use

・

(Optional Format 1-2-96)