DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE

K052551 · Devon Safety Products, Inc. · FMF · Sep 30, 2005 · General Hospital

Device Facts

• Record ID: K052551
• Device Name: DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
• Applicant: Devon Safety Products, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Sep 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The Devon Standard Syringe is intended for injection of fluids into, or withdrawing fluids from, parts of the body below the surface of the skin. Syringe with plunger for general medical uses. The Insulin syringes are intended for insulin injection.

Device Story

Devon Standard Syringe is a sterile, single-use, disposable device consisting of a barrel, plunger rod, piston, nozzle cap, and attachable hypodermic needle. Used for fluid injection or withdrawal; insulin-specific variants used for U100 insulin delivery. Operated by healthcare professionals or patients (for insulin) in clinical or home settings. Device functions via manual piston-driven displacement of fluids through the needle lumen. Provides a standard method for subcutaneous or intramuscular fluid administration/aspiration. Benefits include sterile, disposable delivery of medication or fluid sampling.

Clinical Evidence

Bench testing only. The device was shown to meet internationally recognized standards for syringe performance and labeling characteristics. No clinical data provided.

Technological Characteristics

Sterile, single-use, disposable piston syringe. Components: barrel, plunger rod, piston, nozzle cap, and single-lumen hypodermic needle. Manual operation. No electronic or software components.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from body tissues below the skin surface; general medical use; insulin syringes indicated for U100 insulin injection.

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

• Terumo, Disposable Hypodermic Syringe (K980181)
• Becton Dickinson, Insulin Syringes (K941657)
• Shandong Zibo Shanchuan Medical Instrument, Co., Ltd., Piston Syringe, Hypodermic Needle: Insulin Syringe (K021993)
• Nipro Medical Corp., Hypodermic Needle (K013293)

Submission Summary (Full Text)

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SEP 3 0 2005

K452551 (Pior2)

# 510(k) Summary

#### Submitted on behalf of:

Devon Safety Products DBA Devon Medical Supplies 1100 First Avenue, Suite 100 King Of Prussia, PA 19406

| Telephone: | 1-800-431-2273 |
|------------|----------------|
| Fax: | 610-768-4509 |

| By: | Barry Berler<br>Chief Operating Officer<br>1100 First Avenue, Suite 100<br>King of Prussia, PA 19406 |
|------------|------------------------------------------------------------------------------------------------------|
| Telephone: | 1-800-431-2273 x 4102 |
| Fax: | 610-768-4509 |

CONTACT PERSON: Barry Berler

DATE PREPARED: July 10, 2005

TRADE NAME: Devon Standard Syringe and as sold under various trade names COMMON NAME: Piston Syringe and Hypodermic Needle

### SUBSTANTIALLY EQUIVALENT TO:

The Devon Standard Syringe is substantially equivalent to:

K980181: Terumo, Disposable Hypodermic Syringe K941657: Becton Dickinson, Insulin Syringes. K021993: Shandong Zibo Shanchuan Medical Instrument, Co., Ltd., Piston Syringe, Hypodermic Needle: Insulin Syringe K013293: Nipro Medical Corp., Hypodermic Needle.

#### DESCRIPTION of the DEVICE:

The Devon Standard Syringe is a sterile, single use, disposable syringe with attachable hypodermic needle. The Devon Standard Syringe consists of a syringe barrel, a plunger rod, piston, nozzle cap and a single lumen hypodermic needle.

The Insulin syringes are used for the injection of U100 insulin only and have scale lines in insulin units.

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K452551 (P.2 of 2)

#### INDICATIONS FOR USE:

The Devon Standard Syringe is intended for injection of fluids into, or withdrawing fluids from, parts of the body below the surface of the skin.

Syringe with plunger for general medical uses.

The Insulin syringes are intended for insulin injection.

## SUMMARY of TESTING:

The Devon Standard Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

SEP 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Devon Safety products, Incorporated C/O Mr. Mark Job Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota, 55313

Re: K052551

Trade/Device Name: DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE Regulation Number: 21 CFR 880.5860 Regulation Name: PISTON SYRINGE Regulatory Class: II Product Code: FMF and FMI Dated: September 13, 2005 Received: September 16, 2005

Dear Mr. Job:

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.

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Page 2 - Mr. Job

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 yours,

Sujata y. Michie Oms.

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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# Indications for Use

K4222221 510(k) Number (if known):

Device Name: Devon Standard Syringe

Indications For Use:

This device is intended for injection of fluids into, or withdrawing fluids from, parts of the body below the surface of the skin.

Syringe with plunger for general medical uses.

The Insulin syringes are intended for insulin injection.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cim Un

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________