ORTHODEK

K033115 · Teleflex Medical · GAM · Nov 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033115
• Device Name: ORTHODEK
• Applicant: Teleflex Medical
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Nov 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Orthodek™ Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and /or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissue. Orthodek suture is particularly useful where extended wound support (up to 6 months) is desirable.

Device Story

Orthodek is a sterile, braided multifilament synthetic absorbable surgical suture composed of Poly(L-lactide). It is provided in various lengths, with or without needles, or on ligating reels. Used by surgeons in clinical settings for soft tissue approximation, ligation, and orthopedic repairs. The suture provides extended wound support for up to 6 months. It functions as a mechanical support device to hold tissue edges together during the healing process, eventually being absorbed by the body. It is a prescription-only device.

Clinical Evidence

Bench testing only. Evidence includes performance testing and conformance with voluntary standards, specifically USP Section XXVI - Absorbable Surgical Sutures and ANSI/AAMI/ISO 10993-1 for biological evaluation.

Technological Characteristics

Material: Poly(L-lactide). Form: Braided multifilament. Size: 2 (metric size 5). Sterilization: Sterile. Standards: Conforms to USP Section XXVI (except for oversized diameter) and ANSI/AAMI/ISO 10993-1.

Indications for Use

Indicated for general soft tissue approximation, ligation, and orthopedic procedures including tendon/ligament repair and bone reattachment. Contraindicated for ophthalmic, cardiovascular, or neurological tissue. Suitable for patients requiring extended wound support up to 6 months.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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

• Ethicon Panacryl Absorbable Surgical Suture (K974299)

Submission Summary (Full Text)

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K033/15
p/2

NOV 17 2003

# SECTION VI

### 510(k) Summary

#### Substantial Equivalence

In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule "... 510(k) Summaries and 510(k) Statements ... " and can be used to provide equivalence summary to anyone requesting it from the Agency.

| Manufacturer | Teleflex Medical<br>600 Airport Road<br>Fall River, MA 02720-4740 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Stephen Page<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | October 27, 2003 |
| Device Information | |
| Trade Name: | Orthodek™ Poly(L-lactide) Synthetic<br>Absorbable Surgical Suture. |
| Common Name: | Poly (L-lactide) Synthetic Absorbable Surgical<br>Sutures. |
| Classification Name: | Absorbable Poly (glycolide/L-lactide) Surgical<br>Suture. |

#### Indications for Use

Orthodek™ Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and /or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissue. Orthodek suture is particularly useful where extended wound support (up to 6 months) is desirable.

#### Device Description

Orthodek Poly (L-lactide) Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Orthodek is available in size 2 (metric size 5) undyed (white). The suture is a sterile, braided multifilament, is provided in a variety of lengths, with or without needles, and may be supplied in a variety of cut lengths or on ligating reels.

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K033/15 P2/2

## SECTION VI 510(k) Summary (Cont.)

#### Substantial Equivalence

The device is similar in intended use, materials, design, and performance characteristics to the cleared Ethicon Panacryl Absorbable Surgical Suture (K974299). Minor differences between the Teleflex Medical Suture and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function or intended use of this device.

The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.q. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXVI -Absorbable Surgical Sutures, Guidance Document "Guidance for Surgical Suture 510(k) s" issued on August 10, 2000 and the FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA", June 3, 2003.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

NOV 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen Page Director, Regulatory Affairs Teleflex Medical 600 Airport Road Fall River, Massachusetts 02720

Re: K033115 Trade/Device Name: Orthodeck™ Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: September 22, 2003 Received: September 30, 2003

Dear Mr. Page:

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. Iisting 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. Stephen Page

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/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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510(k) Number (if known) Device Name

Orthodek Poly(L-lactide) Absorbable Surgical Suture

Indications for Use

Orthodek™ Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and /or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissue. Orthodek suture is particularly useful where extended wound support (up to 6 months) is desirable.

· (Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR § 801.109) OR

Over-the-Counter Use __

(Optional Format 1-2-96)

Miriam C. Provost

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number: K033115