AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE

K031394 · American Syringe Company · FMF · Jul 25, 2003 · General Hospital

Device Facts

• Record ID: K031394
• Device Name: AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE
• Applicant: American Syringe Company
• Product Code: FMF · General Hospital
• Decision Date: Jul 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The American Syringe Company 3cc Syringe is indicated for use in the injection of medication into a patient.

Device Story

The American Syringe Company 1cc and 3cc Syringe with Needle is a manual piston syringe used for the injection of medication into a patient. It consists of a syringe barrel and a single lumen hypodermic needle. The device is intended for use by healthcare professionals or patients in clinical or home settings. It functions as a standard manual delivery system for liquid medications. The device provides a simple, sterile, single-use mechanism for accurate medication administration, benefiting patients by facilitating controlled drug delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual piston syringe with single lumen hypodermic needle. Class II device. Materials and construction consistent with standard hypodermic syringe and needle specifications (21 CFR 880.5860, 880.5570).

Indications for Use

Indicated for injection of medication into patients. Suitable for both prescription and over-the-counter use.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2003

Mr. David M. Garvin President American Syringe Company 1200 Brickell Avenue, Suite 1480 Miami. Florida 33131

Re: K031394

Trade/Device Name: American Syringe Company 1cc and 3CC Syringe with Needle Regulation Number: 880.5860, 880. 5570 Regulation Name: Piston Syringe, Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF, FMF, FMI Dated: May 1, 2003 Received: May 2, 2003

Dear Mr. Garvin:

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 vour 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 - Mr. Garvin

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 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 [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,

fer

Susan Runner, DDDS, MA Interim 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

| 510(k) Number: | K031394 (To be assigned by FDA) |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Device Name: | American Syringe Company 3cc Syringe with Needle |
| Indications For Use: | The American Syringe Company 3cc Syringe is indicated for use in the injection of medication into a patient. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use <span style="text-decoration: underline;">✓</span> | OR Over - The - Counter Use <span style="text-decoration: underline;">✓</span> |
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(Per 21 CFR 801.109)

Patricia Cucenito

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

510(k) Number: K031394