TUFFLEX POLYESTER SUTURE

K063194 · Axya Medical, Inc. · GAT · Dec 4, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063194
• Device Name: TUFFLEX POLYESTER SUTURE
• Applicant: Axya Medical, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Dec 4, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tufflex™ suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

Tufflex™ is a nonabsorbable, braided, sterile surgical suture composed of poly(ethylene terephthalate co-isophthalate). Designed for general soft tissue approximation and ligation; used by surgeons in cardiovascular, ophthalmic, and neurological procedures. Provides mechanical support for tissue closure. Manufactured from high molecular weight, long-chain, linear polyesters. Sterilized using processes equivalent to predicate devices.

Clinical Evidence

Bench testing only. Studies evaluated suture diameter and knot tensile strength per FDA Class II Special Controls Guidance Document for Surgical Sutures. Results confirmed compliance with USP requirements and equivalence to predicate materials.

Technological Characteristics

Nonabsorbable, braided, sterile surgical suture. Material: poly(ethylene terephthalate co-isophthalate). High molecular weight, long-chain, linear polyester. Sterilization: equivalent to predicate suture manufacturers. No software or electronic components.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring cardiovascular, ophthalmic, or neurological surgical procedures.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• AxyaFlex™ Polyester Suture (K060165)
• Smith & Nephew DuraBraid™ Polyester Suture (K040789)

Submission Summary (Full Text)

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K063194 1/2

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

# General Company Information

| Name: | Axya Medical, Inc. | DEC - 4 2006 |
|----------------------------|--------------------------------------------------------|--------------|
| Contact: | Howard Schrayer<br>Regulatory Affairs Consultant | |
| Address: | 100 Cummings Center<br>Suite 444C<br>Beverly, MA 01915 | |
| Telephone: | (978) 232 - 9997 | |
| Fax: | (978) 232 - 9998 | |
| Date Prepared | October 18, 2006 | |
| General Device Information | | |

- Product Name: Tufflex™ polyester suture
Classification: "Nonabsorbable poly(ethylene terephthalate) surgical suture" Product code: GAT - Class II 21 CFR 878.5000

## Predicate Devices

Axya Medical, Inc. AxyaFlex™ Polyester Suture [510(k) Number K060165]

Smith & Nephew DuraBraid™ Polyester Suture [510(k) Number K040789]

## Description

Tufflex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Tufflex™ sutures are braided for optimal handling properties.

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# Intended Use (Indications)

Tufflex™ suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

### Substantial Equivalence

This submission supports the position that the Tufflex™ polyester suture is substantially equivalent to a number of previously cleared devices, including the Axya Medical, Inc. AxyaFlex™ polyester suture and the Smith & Nephew DuraBraid™ Polyester Suture.

The 510(k) Notice contains summaries of studies that were conducted to evaluate the suture diameter and knot tensile strength as specified in the FDA Guidance Document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" (June 23, 2003).

The data presented demonstrate that the Tufflex™ polyester suture satisfied the USP requirements and was equivalent to the predicate materials.

The sutures are provided sterile. The suture material is sterilized using a process equivalent to the process used by the predicate suture manufacturers.

#### Conclusions

Axya Medical, Inc. believes that the information provided establishes that similar legally marketed sutures have been used for the same clinical applications for the Tufflex™ polyester suture. The material from which the Axya suture is fabricated and the suture coating have an established history of use in medical applications; and devices produced by Axya have been tested in accordance with applicable FDA guidelines.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Axya Medical, Inc. % Mr. Howard L. Schrayer 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

DEC - 4 2006

Re: K063194

Trade/Device Name: Tufflex™ Polyester Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulation Class: II Product Code: GAT Dated: November 6, 2006 Received: November 8, 2006

Dear Mr. Schrayer:

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 - Mr. Howard L. Schrayer

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,

for Phil

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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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Tufflex™ Polyester Suture

Indications For Use:

Tufflex™ Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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)

Pedro Muniz

(Division Sign-C Division of General, Restorative, and Neurological L

**510(k) Number** L 063194