UNIESTER C

K042286 · United Medical Industries Co. , Ltd. · GAT · Dec 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042286
• Device Name: UNIESTER C
• Applicant: United Medical Industries Co. , Ltd.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

UniEster C is a nonabsorbable polyamide surgical suture used for soft tissue approximation and ligation. Device functions as a mechanical fastener to hold tissue edges together during healing. Used by surgeons in clinical settings, including ophthalmic and neurological cardiovascular procedures. Provides physical closure of wounds or ligation of vessels; benefits patient by maintaining tissue integrity post-surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Nonabsorbable polyamide surgical suture. Class II device (21 CFR 878.5000). Product code GAT.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including ophthalmic and neurological cardiovascular 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 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: K042286

Trade/Device Name: UniEster C Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAT 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 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. Mohammed Azeez

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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## Indications for Use

510(k) Number (if known): k042286

Device Name:

UniEster C

Indications for Use:

UniEster C is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurological cardiovascular, 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

Division of General, Restorative, and Neurological Devices

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**510(k) Number** k042286