UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE

K993996 · Univec, Inc. · MEG · Jul 17, 2000 · General Hospital

Device Facts

• Record ID: K993996
• Device Name: UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
• Applicant: Univec, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Jul 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The UNIVEC Sliding Sheath Syringe (K993996) is an Active Safety Feature for a hypodermic syringe. The Sliding Sheath Mechanism is used with a traditional disposable syringe or the Univec Auto-Destruct syringe. The Univec Sliding Sheath Syringe is used to aid in the prevention of needle stick injuries. After an injection, the shield is easily moved from an unextended to an extended position with one hand so that the needle tip is covered by a 360 degree enclosure. The scale is printed on the barrel in a way that allows the Healthcare worker to read through the sheath or from the backside of the sheath.

Device Story

Device is a sliding sheath mechanism for hypodermic syringes; designed to prevent needle stick injuries. Mechanism attaches to traditional disposable syringes or Univec Auto-Destruct syringes. Post-injection, user manually slides shield over needle tip to provide 360-degree enclosure. Barrel features printed scale visible through or around sheath for dosage reading. Used in clinical settings by healthcare workers. Benefits include reduced risk of accidental needle sticks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical sliding sheath safety mechanism; compatible with traditional or auto-destruct hypodermic syringes; provides 360-degree needle enclosure; manual operation.

Indications for Use

Indicated for use by healthcare workers as an active safety feature for hypodermic syringes to aid in the prevention of needle stick injuries during or after 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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 7 2000

Mr. S. Levinson UNIVEC 22 Dubon Court Farminqdale, New York 11735

Re : K993996 UNIVEC Sliding Sheath Syringe with/without Trade Name: Auto-Destruct Feature Regulatory Class: II Product Code: MEG June 29, 2000 Dated: Received: July 3, 2000

## Dear Mr. Levinson

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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ 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 regulation 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 obligation you might have under sections 531 through 542 of

{1}------------------------------------------------

Page 2 - Mr. Levinson

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaracion Cherclose, "MBBB andary" (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

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

Enclosure

{2}------------------------------------------------

## UNIVEC SLIDING SHEATH INDICATIONS FOR USE

K993996

## HYPODERMIC SYRINGE WITH SHARPS PROTECTION

The UNIVEC Sliding Sheath Syringe (K993996) is an Active Safety Feature for a hypodermic syringe. The Sliding Sheath Mechanism is used with a traditional disposable syringe or the Univec Auto-Destruct syringe. The Univec Sliding Sheath Syringe is used to aid in the prevention of needle stick injuries. After an injection, the shield is easily moved from an unextended to an extended position with one hand so that the needle tip is covered by a 360 degree enclosure. The scale is printed on the barrel in a way that allows the Healthcare worker to read through the sheath or from the backside of the sheath.

Aven Neveau for PxC 1/7/00

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K 993996 510(k) Number_