PERFECT SAFETY SYRINGE

K030604 · Perfect Medical Industry Co., Ltd. · MEG · Apr 30, 2004 · General Hospital

Device Facts

• Record ID: K030604
• Device Name: PERFECT SAFETY SYRINGE
• Applicant: Perfect Medical Industry Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Apr 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The primary intended use for the Perfect Safety Syringe is for IM/SC use only. The secondary intended use for the Perfect Safety Syringe is for needlestick protection, the device may aid in the reduction of needlestick injuries. In addition, when the syringe user breaks off the plunger, reuse of the syringe is prevented.

Device Story

Perfect Safety Syringe is a manual medical device designed for IM/SC injections; incorporates a safety mechanism to reduce needlestick injuries; features a breakable plunger to prevent device reuse. Operated by clinicians or healthcare providers; used in clinical settings. Device functions as a standard syringe with integrated safety features; provides physical protection against accidental needle exposure; ensures single-use compliance through mechanical destruction of the plunger.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual syringe with integrated safety mechanism for needlestick protection and a breakable plunger for anti-reuse. Class II device, product code MEG.

Indications for Use

Indicated for intramuscular (IM) or subcutaneous (SC) injections. Intended to reduce risk of needlestick injuries and prevent syringe reuse via a breakable plunger mechanism.

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

APR 3 0 2004

Perfect Medical Industry Company Limited C/O Dr. Eric Luo Lodestar Products, Incorporated 6833 Saint Lawrence Street Plano, Texas 75024

Re: K030604

Trade/Device Name: Perfect Safety Syringe Regulation Number: 880.5860 Regulation Name: AntiStick Syringe Regulatory Class: II Product Code: MEG Dated: March 17, 2004 Received: March 19, 2004

Dear Dr. Luo:

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.

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Page 2 - Dr. Luo

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 mean that I Dr mas may Federal statutes and regulations administered by other Federal agencies. or the Free of any I vith all the Act's requirements, including, but not limited to: registration r ou into comply with 807); labeling (21 CFR Part 801); good manufacturing practice and insting (x as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) rine letet notification. The FDA finding of substantial equivalence of your device to a premaired predicated. - 11 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), 11 you deather 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.

Ching-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): __ K030604

Device Name: Perfect Safety Syringe

Indications for Use:

The primary intended use for the Perfect Safety Syringe is for IM/SC use only. The secondary intended use for the Perfect Safety Syringe is for needlestick protection, the device may aid in the reduction of needlestick injuries. In addition, when the syringe user breaks off the plunger, reuse of the syringe is prevented.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-Thc-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)

Therese Nadeau for ADW 4/29/04

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

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