TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)

K022278 · Taiject Medical Device Co., Ltd. · MEG · Sep 12, 2002 · General Hospital

Device Facts

• Record ID: K022278
• Device Name: TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
• Applicant: Taiject Medical Device Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Sep 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

The TMD™ Safety Syringe (FA12 Series 3ML/FA13 Series 5ML) is a manual hypodermic syringe designed to deliver fluids or withdraw body fluids. It incorporates safety features to prevent accidental needle sticks. Used in clinical settings by healthcare professionals, the device functions as a standard syringe with an integrated mechanism to protect the user from the needle after use. It aids in infection control by reducing the risk of sharps injuries during and after medical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual hypodermic syringe with integrated safety mechanism. Class II device. Product codes MEG (Anti-Stick Syringe) and FMI (Single Lumen Hypodermic Needle).

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2002

Taiject Medical Device Company Limited C/O Mr. Jim-Son Chou Acheve Technology, Incorporated P.O. Box 8853 Newport Beach, California 92658

Re: K022278

Trade/Device Name: TMD™ Safety Syringe (FA12 Series 3ML/FA13 Series 5ML) Regulation Number: 880.5860 and 880.5570 Regulation Name: Anti-Stick Syringe/Single Lumen Hypodermic Needle Regulatory Class: II Product Code: MEG and FMI Dated: July 12, 2002 Received: July 15, 2002

Dear Mr. Chou:

This letter corrects our substantially equivalent letter of September 12, 2002 regarding the address.

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). 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 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.

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## Page 2 - Mr. Chou

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.

This letter will allow you to continue 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 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Clus Ls/or
Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure