UNIPLAIN & UNICHROM

K042287 · United Medical Industries Co. , Ltd. · GAL · Sep 7, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K042287
• Device Name: UNIPLAIN & UNICHROM
• Applicant: United Medical Industries Co. , Ltd.
• Product Code: GAL · General, Plastic Surgery
• Decision Date: Sep 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

UniPlain & UniChrom are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.

Device Story

UniPlain & UniChrom are absorbable surgical gut sutures used for soft tissue approximation and ligation. Intended for use by surgeons in clinical settings, including ophthalmic procedures. Device functions as a mechanical closure tool to hold tissue edges together during healing. Benefits include temporary support of tissue followed by absorption. Not for use in cardiovascular or neurological surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Absorbable surgical gut suture. Class II device. Material is processed animal gut tissue. Form factor is a sterile, flexible strand for tissue ligation/approximation. No software or electronic components.

Indications for Use

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

Regulatory Classification

Identification

An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Public Health Service

SEP - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042287

Trade/Device Name: UniPlain & UniChrom Regulation Number: 21 CFR 878.4830 Regulation Name: Absorbable surgical gut suture Regulatory Class: II Product Code: GAL Dated: June 8, 2005 Received: June 10, 2005

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 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 vours.

Barbara Buellur
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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042287 pg.lof/

## Indications for Use

510(k) Number (if known):

KO42287

Device Name:

UniPlain & UniChrom

Indications for Use: UniPlain & UniChrom are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Suppari C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Baubare Bneulds Br MixM

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K04 2287