PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.

K022664 · Arc Medical Supplies (Beijing) Co, Ltd. · GAM · Sep 10, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022664
• Device Name: PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
• Applicant: Arc Medical Supplies (Beijing) Co, Ltd.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Sep 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PGA (polyglycolic) Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation; including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

Device Story

PGA (Polyglycolic) Synthetic Absorbable Suture is a sterile, braided or monofilament surgical suture. It is coated with polycaprolate and calcium stearate and available in undyed or D&C Violet No. 2 dyed forms. The device is used by surgeons for soft tissue approximation. It functions by providing temporary wound support during the healing process before being absorbed by the body. The device is intended for use in clinical settings, specifically for general soft tissue and ophthalmic procedures.

Clinical Evidence

Bench testing only. Testing performed according to U.S.P. XXIII methods for suture diameter, length, knot pull tensile strength, needle attachment strength, and absorption rate. Results demonstrate the device meets or exceeds U.S.P. specifications and is equivalent to the predicate device.

Technological Characteristics

Material: Polyglycolic acid (PGA) synthetic absorbable polymer. Coating: Polycaprolate and calcium stearate. Form: Braided or monofilament. Standards: U.S.P. XXIII. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for general soft tissue approximation, including ophthalmic surgery. Contraindicated for cardiovascular and neurological tissue.

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

• SURGISORB absorbable surgical sutures (Samyang Corporation)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 1 0 2002

KOZZ 664

p.21

# ARC Medical Supplies(Beijing) Co., Ltd.

#66 Qian Ban Bi Jie, Xizhimen Nei, Beijing CHINA 100035 Tel: [phone] Fax: [phone] Email: aremedie a public.bta.net.en

Page 1 of 2

### 510(k) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: ---------------------------------------------------------------------------------

| Applicant | ARC Medical Supplies (Beijing) Co., Ltd.<br>#66 Quian Ban Bi Jie, Xizhimen Nei<br>Beijing, China 100035<br>Telephone: [phone]<br>Fax: [phone] |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mr. Charles F. Andrews<br>C.F. Andrews & Associates<br>1591 S. Moorland Road, Suite 104<br>New Berlin, WI 53151<br>Telephone: [phone]<br>Fax: [phone] |
| Date | August 7, 2002 |
| Name of Device | |
| Proprietary Name: | PGA (Polyglycolic)<br>Synthetic Absorbable Suture U.S.P. |
| Common or Usual Name: | Absorbable suture, synthetic absorbable suture,<br>PGA suture |
| Classification Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |

{1}------------------------------------------------

KC22664
p.22

## ARC Medical Supplies(Beijing) Co., Ltd.

#66 Qian Ban Bi Jie, Xizhimen Nei, Beijing CHINA 100035 Tel: [phone] Fax: [phone] Email: arcmedie a public.bta.net.cn

Page 2 of 2

#### 510(k) SUMMARY - continued

PGA (Polyglycolic) Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical Supplies (Beijing) Co., Ltd. are equivalent to SURGISORB absorbable surgical sutures manufactured by SAMYANG Corporation.

The PGA (Polyglycolic) Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and SAMYANG Corporation are braided and monofilament types and coated with polycaprolate and calcium stearate and are un-dyed with D&C Violet No. 2.

PGA (Polyglycolic) Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation; including use in ophthalmic surgery but not for use in cardiovascular and neurological tissue.

Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength and absorption rate according to methods outlined in U.S.P. XXIII demonstrates that ARC Medical PGA (Polyglycolic) Synthetic Absorbable sutures meet or exceed U.S.P. specifications and are equivalent in terms of the above parameters to synthetic absorbable polyglycolic surgical sutures manufactured by SAMYANG Corporation.

K

8-6-02

Richard Kuo, Chairman

Date

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2002

ARC Medical Supplies (Beijing) Company, LTD. c/o C.F. Andrews & Associates Charles F. Andrews 1591 S. Moorland Road, Suite 104 New Berlin, Wisconsin 53151

Re: K022664

Trade/Device Name: PGA (Polyglycolic) Synthetic Absorable Suture U.S.P. Regulation Number: 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: August 7, 2002 Received: August 9, 2002

Dear Mr. Andrews:

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 nean 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.

{3}------------------------------------------------

Page 2 -- Mr. Charles F. Andrews .

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Sincerery yours,

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

{4}------------------------------------------------

K022664

#### IX. INDICATIONS FOR USE

PGA (polyglycolic) Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation; including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

Hyde Runde

(Division Sigh-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________