UNIMIDE

K042284 · United Medical Industries Co. , Ltd. · GAR · Dec 3, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042284
• Device Name: UNIMIDE
• Applicant: United Medical Industries Co. , Ltd.
• Product Code: GAR · General, Plastic Surgery
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

UniMide is a nonabsorbable polyamide surgical suture used for soft tissue approximation and ligation. It is intended for use by surgeons in cardiovascular, ophthalmic, and neurological procedures. The device functions as a mechanical fastener to hold tissue edges together during healing. It is provided as a sterile, ready-to-use surgical instrument.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nonabsorbable polyamide surgical suture. Class II device. Product code GAR. Regulation 21 CFR 878.5020.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in cardiovascular, ophthalmic, and neurological procedures. No specific age or gender restrictions noted.

Regulatory Classification

Identification

Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2004

Mr. Mohammed Azeez M.Sc., Quality Assurance Manager United Medical Industries Co. Ltd. (Unimed) P.O. Box-51871, Riyadh - 11553 Kingdom of Saudi Arabia

Re: K042284

Trade/Device Name: UniMide Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: November 7, 2004 Received: November 9, 2004

Dear Mr. Azeez:

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 sct 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.

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

## Page 2 - Mr. Mohammed Azeez M.Sc.,

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

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

## Indications for Use

510(k) Number (if known):

K042284

UniMide ______________________________________________________________________________________________________________________________________________________________________ Device Name:

UniMide is indicated for use in general soft tissue Indications for Use: 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 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Page of

Division of General, Restorative, and Neurological Devices

**510(k) Number** K042284