YUE PFONG SAFETY SYRINGE (3ML)

K040105 · Yue Pfong International Industrial Co., Ltd. · MEG · Apr 7, 2004 · General Hospital

Device Facts

• Record ID: K040105
• Device Name: YUE PFONG SAFETY SYRINGE (3ML)
• Applicant: Yue Pfong International Industrial Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The YUE PFONG® Safety Syringe (3ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into the body.

Device Story

YUE PFONG® Safety Syringe (3ml) is a sterile, single-use, manual retractable syringe; includes plunger, barrel, piston, adaptor, O-ring, needle, needle hub, and needle sheath. Used by clinicians for injection of medical fluids into the body. Retractable mechanism reduces risk of sharps injuries and prevents syringe reuse. Device is manual; no electronic or automated components.

Clinical Evidence

Bench testing and simulated use study only; no clinical data.

Technological Characteristics

Manual retractable piston syringe (3ml). Materials conform to ISO 10993 series. Standards: ISO 7864 (needle), ISO 7886-1 (syringe), ISO 11607-1 (packaging), ISO 11135 (sterilization), and USP pyrogenic standards. Sterilized, single-use, disposable.

Indications for Use

Indicated for the injection of medical fluids into the body. Designed to reduce the risk of sharps injuries and syringe reuse in patients requiring injections.

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.

Predicate Devices

• TMD™ Safety Syringe (FA12 Series 3ml) (K022278)

Submission Summary (Full Text)

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

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being s the requirements of SMDA and 21 CFR §807.92

- 1. Submitter's Name: YUE PFONG International Industrial Co., Ltd. No.18, 23 Road, Taichung Ind. Zone, Taiwan [phone] Address: Phone: [phone] Fax: Mr. Chang Yao-Chamr Contact:
-

APR = 7 2004

- 2. Device Name : YUE PFONG® Safety Syringe (3ml) Trade Name: Common Name: Safety Syringe (provided with needle) Classification name Anti-Stick Syringe
- 3. Classification: Class II Regulatory Number: 880.5860 Product Code: MEG
- ♦ TMD™ Safety Syringe (FA12 Series 3ml )with 510K number K022278 Predicate Device: 4. Marketed by Taiject Medical Device Co., Ltd.
- Device Description: The YUE PFONG® Safety Syringe (3ml) is sterile, single-use, disposable , 5. Non-reusable, Manual , Retractable, 3ml Piston Syringe, provided with needle attached in place., which is used for injection of fluids into the body. (Needle Spec. including 1'/2" or shorter, 18-28 gauge). The YUE PFONG® Safety Syringe (3ml) consist of the following major components. 1 Plunger , 2 Barrel , 3 Piston, @ adaptor , \$ O- Ring , 6 Needle & Needle Hub, 7 Needle Sheath.
- The YUE PFONG® Safety Syringe (3ml) is designed as an anti-stick 6. Intended Use: syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into the body.

FDA 510(K) SUMMARY

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

In terms of Physical specification, Chemical specification 7. Performance specification & Sterilization Specification, the device conforms to Summary: applicable standards included ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards---etc.

## 8. Conclusions:

The YUE PFONG® Safety Syringe (3ml) has the same intended use and similar technological characteristics as the TMD™ Safety Syringe --FA12 Series 3ml market by Taiject Medical Device Co., Ltd. Moreover, bench testing & simulated use study contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the YUE PFONG International Industrial Co., Ltd. is substantially equivalent to the predicate devices.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that form the shape of the bird's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 7 2004

Yue Pfong International Industrial Company Limited C/O Ms. Jennifer Reich 3892 South America West Trail Flaggstaff,Arizona 86001

Re: K040105

Trade/Device Name: YUE PFONG® Safety Syringe (3mL) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 4, 2004 Received: March 15, 2004

Dear Ms. Reich:

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.

{3}------------------------------------------------

Page 2 - Ms. Reich

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 (OS) 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 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 vour 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 (301) 594-56. 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.

f. Hader

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

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known):__K#040105

YUE PFONG® Safety Syringe (3ml) Device Name: YUE PFONG International Industrial Co., Ltd.

Indications For Use:

The YUE PFONG® Safety Syringe (3ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into the body.

Prescription Use_ X (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)

SAWitcher

Page 1 of 1

510(k) Number