YIXIN SAFETY SYRINGE

K042102 · Jiangxi Sanxin (Eversincere) Medical Devices Group · MEG · Mar 8, 2005 · General Hospital

Device Facts

• Record ID: K042102
• Device Name: YIXIN SAFETY SYRINGE
• Applicant: Jiangxi Sanxin (Eversincere) Medical Devices Group
• Product Code: MEG · General Hospital
• Decision Date: Mar 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

YI XIN Safety Syringe is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into or withdraw fluids from the body, while reducing the risk of sharps injuries and the potential for syringe reuse. The safety syringes are for IV and IM use.

Device Story

Manual retractable safety syringe; sterile, single-use, disposable. Used for IV/IM fluid injection or withdrawal. Features manual retraction mechanism to shield needle after use, reducing sharps injury risk and preventing reuse. Operated by healthcare professionals in clinical settings. Output is delivery or aspiration of fluids; safety mechanism provides physical barrier against needle sticks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual retractable safety syringe; sterile, single-use, disposable. Materials and dimensions standard for medical syringes. No electronic components or software.

Indications for Use

Indicated for patients requiring IV or IM injection or withdrawal of fluids. Intended for single-use by healthcare professionals to reduce sharps injuries and prevent syringe reuse.

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)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

MAR 8 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Liu Kun Sheng Manager Jiangxi Sanxin (Eversincere) Medical Devices Group Limited Shan Jiang Zhen Road Nan Chang, Jiangxi CHINA 330204

Re: K042102

Trade/Device Name: YI XIN Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe with Safety Feature Regulatory Class: II Product Code: MEG Dated: November 29, 2004 Received: January 6, 2005

Dear Mr. Sheng:

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 offecting 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 Eederal Register.

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

Page 2 - Mr. Sheng

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 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/industry/support/index.html.

Sincercly yours,

Chiu 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

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

K042102 YI XIN Safety syringe

## Indication for Use

510(K) Number (if known): K042102

Device Name: YI XIN Safety Syringe

Indication For Use

YI XIN Safety Syringe is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into or withdraw fluids from the body, while reducing the risk of sharps injuries and the potential for syringe reuse. The safety syringes are for IV and IM use.

Prescription Use V (Part 21CFR 801 Subpart D)

... ...

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Antons Rur

അം നിരീ clogy, General Hospitali tron Dental Devices

Number K443142