BIOELAST 5-0 SUTURE, MODEL 500100

K072470 · Entrigue Surgical, Inc. · NWJ · Nov 16, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072470
• Device Name: BIOELAST 5-0 SUTURE, MODEL 500100
• Applicant: Entrigue Surgical, Inc.
• Product Code: NWJ · General, Plastic Surgery
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4494
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioElast™ 5-0 absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Story

BioElast™ 5-0 Suture is a sterile, monofilament, absorbable surgical suture; composed of poly-4-hydroxybutyrate. Used by surgeons for soft tissue approximation and ligation. Device provides mechanical support to tissues during healing; material eventually absorbs. Clinical benefit includes secure tissue closure without permanent foreign body presence. Used in clinical settings; operated by physicians.

Clinical Evidence

Bench and in-vivo testing performed. No clinical trial data provided. Testing demonstrated biocompatibility and functional equivalence to predicate devices.

Technological Characteristics

Material: poly-4-hydroxybutyrate. Form: sterile, monofilament, absorbable suture. Size: 5-0. Class II device under 21 CFR 878.4494.

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Contraindicated for cardiovascular, neurological, microsurgical, or ophthalmic procedures.

Regulatory Classification

Identification

An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).

Predicate Devices

• Tepha, Inc., TephaFLEX® Absorbable Suture
• Ethicon, Inc., PDS*II

Submission Summary (Full Text)

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510(k) NumberKo72470

11.

## 510(k) SUMMARY

| Trade Name: | BioElast™ 5-0 Suture | NOV 16 2007 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | ENTrigue Surgical, Inc.<br>3463 Magic Drive, Suite 320<br>San Antonio, Texas 78229<br>Telephone: [phone]<br>Fax: [phone]<br>Contact Person: Gabriele G. Niederauer, Ph.D. | |
| Date of Summary: | August 31, 2007 | |
| Device Classification Name: | 21 CFR §878.4494<br>Absorbable Poly(hydroxybutyrate) Surgical Suture | |
| Classification: | According to Section 13 of the Federal Food, Drug<br>and Cosmetic Act, the device classification is Class II<br>Performance Standards. | |
| Predicate Devices: | Tepha, Inc., TephaFLEX® Absorbable Suture<br>Ethicon, Inc., PDS*II | |
| Device Description: | BioElast™ 5-0 Suture is a sterile, monofilament,<br>absorbable surgical suture composed of poly-4-<br>hydroxybutyrate. The BioElast™ 5-0 Sutures will be<br>provided undyed at a 5-0 size. | |
| Indications for Use: | BioElast™ 5-0 absorbable sutures are indicated for<br>use in general soft tissue approximation and/or<br>ligation, but not for use in cardiovascular or<br>neurological tissues, microsurgery or ophthalmic<br>surgery. | |
| Safety and Performance: | Results of bench and in-vivo testing demonstrate that<br>the BioElast™ 5-0 Suture is biocompatible and<br>substantially equivalent in function to the predicate<br>devices. | |

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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 two main elements: a symbol and surrounding text. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

NOV 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ENTrigue Surgical, Inc. % Gabriele G. Niederauer, PhD VP, Research & Development 3463 Magic Drive, Suite 320 San Antonio, Texas 78229

Re: K072470

Trade/Device Name: BioElast™ 5-0 Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Suture, recombinant technology Regulatory Class: II Product Code: NWJ Dated: August 13, 2007 Received: September 4, 2007

Dear Dr. Niederauer

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 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) 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 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 - Gabriele G. Niederauer, PhD

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), please contact the Office of Compliance 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

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

Device Name: BioElast™ 5-0 Suture

Indications for Use:

BioElast™ 5-0 absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Prescription Use 区

AND/OR

Over-The-Counter Use □

(Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number 10012470

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