SUPERGUARD SAFETY SYRINGE

K990831 · U.S. Safety Syringes Co., Inc. · MEG · Mar 8, 2000 · General Hospital

Device Facts

• Record ID: K990831
• Device Name: SUPERGUARD SAFETY SYRINGE
• Applicant: U.S. Safety Syringes Co., Inc.
• Product Code: MEG · General Hospital
• Decision Date: Mar 8, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SuperGuard™ Safety Syringe is intended as a sterile, single use, disposable syringe, employing an antistick device, for use in the administration of intramuscular and subcutaneous injections.

Device Story

SuperGuard™ Safety Syringe is a sterile, single-use, disposable piston syringe equipped with an integrated sharps injury prevention mechanism. The device functions by retracting the hypodermic needle into a protective sleeve following an injection, thereby shielding the needle from exposure and preventing reuse. It is intended for use by healthcare professionals in clinical settings for the administration of intramuscular and subcutaneous injections. The primary benefit is the reduction of accidental needlestick injuries to the operator.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Piston syringe with integrated needle retraction mechanism. Materials of construction are identical to predicate devices. Device is sterile and intended for single use.

Indications for Use

Indicated for use in the administration of intramuscular and subcutaneous injections in patients requiring such injections.

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

• Becton Dickinson Safety-Lok® Syringe (K920321 and K924072)
• Becton Dickinson Plastipak® (pre-amendment)

Submission Summary (Full Text)

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K990831/

## SUPERGUARD™ SAFETY SYRINGE PREMARKET NOTIFICATION [510(k)] Summary

| Submitter's Name: | US Safety Syringes Co., Inc. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1290 East Oakland Park Boulevard, Suite 200<br>Fort Lauderdale, FL 33334-4447 |
| Telephone: | 954-561-9500 |
| Fax: | 954-561-8835 |
| Contact Person: | James Ginesi, President |
| Date 510(k) Summary Prepared: | March 8, 1999 |
| 510(k) Number: | TBD |
| Trade or Proprietary Name(s): | SuperGuard™ Safety Syringe |
| Common Name: | Piston Syringe; Anti-stick Syringe |
| Classification Name: | Piston Syringe |
| Predicate Device(s): | Becton Dickinson Safety-Lok® Syringe (K920321<br>and K924072) |
| | Becton Dickinson Plastipak® (pre-amendment) |
| Device Description: | The SuperGuard ™ Safety Syringe is a piston<br>syringe combined with a sharps Injury Prevention<br>mechanism that shields the hypodermic needle<br>from exposure and reuse after an initial use. |
| Intended Use: | The SuperGuard™ Safety Syringe is intended as<br>a sterile, single use, disposable syringe for use in<br>the administration of intramuscular injection |

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Summary of Technological Characteristics to Predicate Device: The SuperGuard ™ Safety Syringe is an antistick device that retracts the needle into a protective sleeve after use and prevents reuse.

All component materials are identical to the named predicate devices and, therefore, the SuperGuard ™ Safety Syringe is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2000

Mr. James Ginesi President U.S. Safety Syringes Company, Inc. 1290 East Oakland Park Boulevard Suite 200 Fort Lauderdale, Florida 3334-4447

K990831 Re :

> SuperGuard™ Safety Syringe Trade Name: Requlatory Class: II Product Code: MEG Dated: December 12, 1999 Received: January 5, 2000

Dear Mr. Ginesi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಥ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Paqe 2 — Mr. Ginesi

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Revised Indications for Use 7.

510(k) Number (if known): K990831

Device Name:

SuperGuard™ Safety Syringe

Indications For Use:

The SuperGuard™ Safety Syringe is intended as a sterile, single use, disposable syringe, employing an antistick device, for use in the administration of intramuscular and subcutaneous injections.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _______

Pattuce Cucente

(Division Sign-Off) Division of Dental, Infor and General Hospital 510(k) Number

(Optional Format 1-2-96)

US Safety Syringes Co., Inc.

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