AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE

K061039 · Amsino International, Inc. · FMF · Jun 29, 2006 · General Hospital

Device Facts

• Record ID: K061039
• Device Name: AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
• Applicant: Amsino International, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AMSure® Disposable Syringe with/without Needle is intended for the injection of fluids into, or the withdrawal of fluids from parts of the body below the skin. AMSure® Needles are intended to mate with male nozzles of piston syringes or administration sets.

Device Story

AMSure® Disposable Syringe is a sterile, single-use hypodermic device; consists of barrel, plunger rod, piston, nozzle cap, and optional single lumen hypodermic needle. Needle features metal tube sharpened at one end with female hub connector. Used by healthcare professionals for fluid injection or withdrawal below skin. Operates via manual piston action to create pressure/vacuum. Benefits patient by providing sterile, disposable means for fluid delivery or aspiration.

Clinical Evidence

Bench testing and biocompatibility testing only; no clinical data provided.

Technological Characteristics

Sterile, single-use, manual piston syringe. Components include barrel, plunger rod, piston, nozzle cap, and stainless steel needle. Connectivity: None. Energy source: Manual. Sterilization: Not specified.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from parts of the body below the skin. Intended for use with piston syringes or administration sets.

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

• Monoject® Piston Syringes (K945715)
• Nipro® Disposable Hypodermic Syringes with or without Needle (K051574)

Submission Summary (Full Text)

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KC6'039

AMSINO

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Disposable syringe w/wo Needle 510(k) Submission

20 112

## 510(K) Summary of Safety and Effectiveness
AMSure® Disposable Syringe with/without Needle

JUN 2 9 2006

| Company: | Amsino International, Inc.<br>855 Towne Center Drive<br>Pomona, CA 91767<br>[phone] |
|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ching Ching Seah, Ph.D.<br>Director of Regulatory Affairs |
| Date Prepared: | January 20, 2006 |
| Classification Name: | Syringe, Piston (880.5860)<br>Hypodermic Single Lumen Needle (880.5570) |
| Common/Usual Name:<br>Proprietary Name:<br>Product Code:<br>Medical Specialty:<br>Device Class: | Disposable hypodermic syringe<br>AMSure® Disposable Syringe with/without Needle<br>FMF and FMI<br>General Hospital<br>Class II |
| Predicate Devices: | Monoject® Piston Syringes (K945715)<br>Nipro® Disposable Hypodermic Syringes with or without Needle (K051574) |
| Device Description: | The AMSure® Disposable Syringe is a sterile, single-use hypodermic syringe<br>with or without an attachable hypodermic needle. It consists of a syringe<br>barrel, a plunger rod, a piston, a nozzle cap and/or a single lumen hypodermic<br>needle. The AMSure® Needle is comprised of a metal tube sharpened at one<br>end and joined to a female connector (hub) at the other end. |
| Intended Use: | The AMSure® Disposable Syringe with/without Needle is intended for the<br>injection of fluids into, or the withdrawal of fluids from parts of the body<br>below the skin. AMSure® Needles are intended to mate with male nozzles of<br>piston syringes or administration sets. |
| Comparison to Predicate: | The AMSure® Disposable Syringe with/without Needle is similar to the<br>predicate devices in operational principle, materials, design, technical<br>characteristics and intended use. Any existing differences do not<br>affect safety and effectiveness of the device. |
| Non-Clinical Testing: | Performance and biocompatibility testing has demonstrated that the<br>AMSure® Disposable Syringe with/without Needle is safe and effective<br>for its intended use. |

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## JUN 2 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Ching Ching Seah Director of Research & Development and Regulatory Affairs Amsino International, Incorporated 855 Towne Center Drive Pomona, California 91767

Re: K061039

Trade/Device Name: AMSURE® Disposable Syringe with/without Needle Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: April 14. 2006 Received: April 14, 2006

Dear Dr. Seah:

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 H (PMA), it may be subject to such additional controls. Existing major regulations affècting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 tinfo98. In addition. FDA may publish further announcements concerning your device in the Federal Register.

.. ...

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## Page 2 -Dr. Seah

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.

Sincerely vours.

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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K061039

## Indications For Use

510(k) Number (if known): K061039

Device Name: AMSURE® Disposable Syringe with/without Needle

Indications For Use:

The AMSURE® Disposable Syringe with/without Needle is intended for the injection of fluids into, or the withdrawal of fluids from parts of the body below the skin. Needles are intended to mote with mace nozzles of piston syringes or administration sets.

Prescription Use × (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)

Chinta (S)

"estology, General Hospital. Mul Dental Devices

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