TEPHAFLEX ABSORBABLE SUTURE

K082178 · Tepha, Inc. · NWJ · Oct 30, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082178
• Device Name: TEPHAFLEX ABSORBABLE SUTURE
• Applicant: Tepha, Inc.
• Product Code: NWJ · General, Plastic Surgery
• Decision Date: Oct 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4494
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TephaFLEX 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

TephaFLEX 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 during healing before being absorbed by the body. Performance verified through tensile strength, diameter, and needle attachment testing.

Clinical Evidence

Bench testing performed to USP 28 standards including suture diameter (<861>), needle attachment (<871>), and tensile strength (<881>). Biocompatibility and implant studies conducted per ISO 10993 to evaluate absorption rates, tensile strength retention, and mass loss.

Technological Characteristics

Monofilament absorbable suture; material: poly-4-hydroxybutyrate. Physical properties conform to USP 28 standards. Biocompatibility conforms to ISO 10993.

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Contraindicated for cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery.

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

• TephaFLEX Absorbable Suture (Tepha, Inc.)
• BioElast™ Absorbable suture (ENTrigue Surgical, Inc.)
• PDS II Absorbable Suture (Ethicon, Inc.)

Submission Summary (Full Text)

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K082178
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Image /page/0/Picture/1 description: The image shows the logo for TEPHA MEDICAL DEVICES. The word "TEPHA" is in large, bold, sans-serif font. Below it, "MEDICAL DEVICES" is in a smaller, sans-serif font. To the left of the word "TEPHA" is a black graphic element that appears to be an abstract shape.

OCT 3 � 2005

99 Hayden Avenue Suite 360 Lexington, MA 02421 tel: [phone]
fax: [phone]

## Section X Summary of Safety and Effectiveness

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Tepha, Inc. is submitting the following summary of information respecting safety and effectiveness:

| Trade Name: | TephaFLEX® Absorbable Suture |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Tepha, Inc.<br>99 Hayden Avenue, Suite 360<br>Lexington, MA 02421 |
| Device Classification Name: | CFR §878.4494<br>Absorbable Poly(hydroxybutyrate) Surgical Suture |
| Classification: | According to Section 13 of the Federal Food, Drug and<br>Cosmetic Act, the device classification is Class II.<br>Performance Standards. |
| Predicate Devices: | Tepha, Inc., TephaFLEX Absorbable Suture<br>ENTrigue Surgical, Inc., BioElast™ Absorbable suture<br>Ethicon, Inc., PDS II Absorbable Suture |
| Device Description: | TephaFLEX sutures are sterile, monofilament,<br>absorbable surgical sutures constructed of poly-4-<br>hydroxybutyrate. The TephaFLEX sutures are indicated<br>for use in general soft tissue approximation and/or<br>ligation, but not for use in cardiovascular or neurological<br>tissues, microsurgery, or ophthalmic surgery. |
| Safety and Performance: | Physical testing was performed on the TephaFLEX<br>sutures to USP 28, including <861> Suture Diameter,<br><871> Suture Needle Attachment, <881> Tensile<br>Strength. Animal testing was performed for<br>conformance to ISO 10993 for biocompatibility and<br>implant studies were conducted to demonstrate rates of<br>tensile strength and mass loss. |
| Conclusion: | Based on the indications for use, technological<br>characteristics, and safety and performance testing, the<br>TephaFLEX Absorbable Suture has been shown to be<br>substantially equivalent to predicate devices under the<br>Federal Food, Drug and Cosmetic Act. |

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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 a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, with its wings spread and stylized in a flowing, ribbon-like design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tepha Medical Devices, Inc. % Ms. Mary P. LeGraw V.P. Regulatory Affairs 99 Hayden Avenue, Suite 360 Lexington, Massachussetts 02421

OCT 3 0 2008

Re: K082178 Trade/Device Name: TephaFLEX® Absorbable Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Absorbable poly (hydroxybutyrate) surgical suture produced by recombinant DNA technology. Regulatory Class: II Product Code: NWJ Dated: July 31, 2008 Received: August 1. 2008

Dear Ms. LeGraw:

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

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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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Devicc Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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. Millikan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K082178

## Indications for Use

510(k) Number (if known):

Not Assigned

Device Name: TephaFLEX® Absorbable Suture

## Indications for Use:

TephaFLEX 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: X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter (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)

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Division S Division of General, Restorative, and Neurological Devices

**510(k) Num** or \$K_{0} 8^{2}17f\$