SECUREGUARD RETRACTABLE SAFETY SYRINGE

K012121 · Safegard Medical Products, Inc. · MEG · Oct 24, 2001 · General Hospital

Device Facts

• Record ID: K012121
• Device Name: SECUREGUARD RETRACTABLE SAFETY SYRINGE
• Applicant: Safegard Medical Products, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Oct 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.

Device Story

SECUREGARD® Retractable Safety Syringe; sterile, single-use, disposable hypodermic syringe. Features integrated sharps injury prevention mechanism and plunger-break feature to prevent reuse. Available in 0.5, 1, 2, 2.5, 3, 5, 10, and 20 mL volumes. Operated by clinicians for medication delivery; needle retracts or shields to protect user from accidental sticks. Prevents reuse via plunger breakage. Benefits include reduced risk of needle stick injuries and prevention of syringe reuse.

Clinical Evidence

Bench testing only. Sharps injury prevention feature demonstrated to be easily and safely activated; needle effectively shielded.

Technological Characteristics

Sterile, single-use, disposable hypodermic syringe. Sizes: 0.5, 1, 2, 2.5, 3, 5, 10, 20 mL. Mechanical sharps retraction/shielding mechanism. Plunger-break reuse prevention feature.

Indications for Use

Indicated for intramuscular and subcutaneous medication injection in patients. Contraindicated for blood collection.

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

• SOLOGARD® Locking Plus Syringe

Submission Summary (Full Text)

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K012/21

## OCT 2 4 2001

October 17, 2001

Page 1 of 1

## (510k) Summary of Safety and Effectiveness

Pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act, Safety and Effectiveness information is enclosed for the following device:

| Device Name: | SECUREGARD® Retractable Safety Syringe |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | SECUREGARD® Syringe |
| Common Name: | Safety Syringe |
| Classification name: | Piston Syringe / Anti-Stick Syringe |
| Device Class: | Class II |
| Classification Code: | MEG |
| Performance Standard: | None established. |
| Safety and Effectiveness: | No new issues safety and effectiveness as relating to hypodermic<br>syringes. The sharps injury prevention feature was demonstrated<br>to be easily and safely activated by the user, and the needle was<br>effectively shielded by the sharps protection feature. |
| Facility Address: | SafeGard Medical Systems (Hungary) KFT<br>Joszéréncsét tér 15, H-3608<br>Farkaslyuk, Hungary |

Establishment Registration Number: 9616482

Indications for Use: The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.

The SECUREGARD® Retractable Safety Syringe is Substantial Equivalence: substantially equivalent to the SOLOGARD® Locking Plus Syringe. The SECUREGARD is a sterile, single-use, disposable hypodermic syringe with sharps injury and reuse prevention features. It is manufactured in sizes of 0.5, 1, 2, 2.5, 3, 5, 10 and 20 mL volume.

Contact Information:

Pat Grant Jr. Director Regulatory Affairs SafeGard Medical Products, Inc 52 Dragon Court Woburn, MA 01801 Tel. [phone] Fax [phone]

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

OCT 2 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SafeGard Medical Products, Incorporated C/O Mr. Mike Dayton BioMed Research, Incorporated 14802 Hadleigh Way Tampa, Florida 33624

Re: K012121

Trade/Device Name: SECUREGARD® Retractable Safety Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 21, 2001 Received: October 1, 2001

Dear Mr. Dayton:

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 releved above and had in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Andelheinente, of to do roons one ic Act (Act) that do not require approval of a premarket the rederal I ood, Drag, Drag, therefore, market the device, subject to the general apper of a upprovisions 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 (1 NI ), It ina) of each of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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Page 2 - Mr. Dayton

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

[signature]

Tim y 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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Ko/2121

## Indications for Use Statement

510k Number (if known): ______________________________________________________________________________________________________________________________________________________ K012121

Device Name: SECUREGARD® Retractable Safety Syringe

Indications For Use:

The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.

(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

(Optional Format 1-2-96)

Patrice Crescent

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F 1 (k) Number _