ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE

K970803 · Retractable Technologies, Inc. · MEG · May 29, 1997 · General Hospital

Device Facts

• Record ID: K970803
• Device Name: ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE
• Applicant: Retractable Technologies, Inc.
• Product Code: MEG · General Hospital
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The function of the VanishPoint™ Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

Device Story

VanishPoint™ Syringe functions as a standard hypodermic syringe for medication delivery or blood withdrawal. Device features a user-activated needle retraction mechanism; upon completion of injection, the contaminated needle is automatically withdrawn into the syringe barrel. Used in clinical settings by healthcare professionals. Primary benefit is the reduction of accidental needlestick injuries occurring between needle removal from the patient and disposal in a sharps container.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual hypodermic syringe with integrated needle retraction mechanism. Mechanical operation; no energy source or software components.

Indications for Use

Indicated for injection of medication or withdrawal of blood from patients. Intended for use by clinicians to reduce risk of accidental needlestick injuries during post-injection disposal.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 29 1997

Mr. Terance Grisso
Director of Regulatory Affairs and Quality
511 Lobo Lane
P.O. Box 9
Little Elm, Texas 75068-0009

Re: K970803
Trade Name: Vanish Point™ Syringe
Regulatory Class: II
Product Code: MEG
Dated: February 14, 1997
Received: March 4, 1997

Dear Mr. Grisso:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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

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Page 2 - Mr. Grisso

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 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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K970803

# Indications For Use

510(K) Number (if known): K970803

Device Name: VanishPoint™ Syringe

## Indications for use:

The function of the VanishPoint™ Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) *Rebecca Coccenti*
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number *K970803*

Prescription Use ☑
OR
Over-The-Counter Use ☐

(Optional Format 1-2-96)