YI XIN STERILE SYRINGE FOR SINGLE USE

K050999 · Jiangxi Sanxin (Eversincere) Medical Devices Group · FMF · Sep 2, 2005 · General Hospital

Device Facts

• Record ID: K050999
• Device Name: YI XIN STERILE SYRINGE FOR SINGLE USE
• Applicant: Jiangxi Sanxin (Eversincere) Medical Devices Group
• Product Code: FMF · General Hospital
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.

Device Story

YI XIN Sterile Syringe for Single Use is a manual, disposable, sterile device for fluid injection or withdrawal. Operated by clinicians or patients in clinical or home settings. Device consists of a barrel and plunger mechanism. No electronic components, software, or automated processing involved. Benefits include sterile, single-use delivery to prevent cross-contamination.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual piston syringe; single-use; sterile; non-reusable. Materials and dimensions consistent with standard syringe specifications.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body in patients requiring such procedures.

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

• YI XIN Safety syringe (K042102)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

SEP - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Yun Yuan Gao Manager Manager
Jiangxi Sanxin (Eversincere) Medical Devices Group Shanjiang Road Nanchang, Jiangxi Province, CHINA 330204

Re: K050999

K0509999
Trade/Device Name: YI XIN Sterile Syringe For Single Use Frade/Device Namber: 21 CFR 880.5860 and 21 CFR 880.5570 Regulation Name: Piston syringe and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF and FMI Dated: August 23, 2005 Received: August 30, 2005

Dear Mr. Gao:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in substantially equivalent (for the indications referenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the encrosule) to regary manetous provice Americal Device Ameralments, or to commerce prior to May 20, 1970, the chance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance whiles approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require suppro the general controls provisions of the Act. The You may, therefore, market the device, sabject to the gentration, listing of
general controls provisions of the Act include requirements for annual registranding and general controls provisions of the Act merator requires.
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 If your device is classified (sec above) nike exist one regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may may be subject to such additional controlis. Little 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Poderal Regarities in the Federal Register.

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Page 2 - Mr. Gao

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issumor of a backer complies with other requirements of the Act that FDA has made a decisimilation that Jour as 1991 as 1991 agencies. You must or any Federal statutes and regulations administers as your not limited to: registration and listing (21 comply with an the Act 3 requirements, mercessed cannot and includes as set CFR Part 807); nabeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if any 1000 1050 forin in the quality systems (QB) regardin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections our device as described in your Section 5 10(k) I his letter will anow you to begin manomig your antial equivalence of your device to a legally premarket notification. The PDA mixing of cassification 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 If you desire specific advice for Jour as 11 5. Also, please note the regulation entitled, Contact the Office of Comphance at (210) = 0.0 = 0.0 = 0.0 = 0.0 may obtain "Misoranding by relevelee to premainters in the Act from the Division of Small other general information on your responsion.com its toll-free number [phone] or Manufacturers, International and Consumit p://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suitte J. Michelin Cms

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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K042102 YI XIN Safety syringe

Attachment B5

## Indication for Use

510(K) Number (if known):

Device Name: Yi XIN Sterile Syringe for Single Use

Indication For Use:

YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.

Prescription Use (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

Anthony D. mss

General Hospital, of Anesthesio Infection Control. D

510(k) Number: