ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE

K973301 · Retractable Technologies, Inc. · MEG · Nov 7, 1997 · General Hospital

Device Facts

• Record ID: K973301
• Device Name: ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
• Applicant: Retractable Technologies, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Nov 7, 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 Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needle sticks. 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 conventional hypodermic syringe for medication injection or blood withdrawal. Device features an integrated, user-activated needle retraction mechanism. Following injection, user triggers retraction, pulling contaminated needle into syringe barrel. Mechanism prevents accidental needlesticks during post-procedure handling and disposal. Used in clinical or home settings by clinicians or patients. Output is the successful delivery of medication or collection of blood sample, with secondary benefit of sharps injury prevention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Piston-style hypodermic syringe with integrated needle retraction mechanism. Manual activation of retraction. No electronic components or software.

Indications for Use

Indicated for patients requiring medication injection or blood withdrawal. Suitable for use with insulin or allergy medications. Intended for use by healthcare professionals or patients (for insulin/allergy self-administration).

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

• 3cc VanishPoint® Syringe (Pop n' Lok Syringe)
• 5cc VanishPoint® Syringe
• 10cc VanishPoint® Syringe

Submission Summary (Full Text)

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K973301

NOV - 7 1997

October 13, 1997

## 510(k) SAFETY and EFFECTIVENESS SUMMARY page 1 of 2 Re:

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: | Anti-Stick Syringe with Integral Hypodermic Needle |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | VanishPoint™ Syringe |
| Common Name: | Safety Syringe |
| Classification Name: | Piston Syringe/Anti-Stick Syringe |
| Device Class: | Class II Medical Device |
| Classification Panel: | Panel 80 (General Hospital and Personal Use)<br>Procode: MEG - Anti-Stick Syringe |
| Performance Standard: | None established for hypodermic syringes. |
| Safety and Effectiveness: | No new issues of safety or effectiveness when prepared.<br>The 1cc VanishPoint® Syringe is a smaller version and is<br>substantially equivalent to the original 3cc VanishPoint® which<br>was introduced into the market in December 1995, and the 5cc and<br>10ccVanishPoint® Syringes which were introduced May 1997. |
| Facility Address: | Retractable Technologies, Inc.<br>511 Lobo Lane, P.O. Box 9<br>Little Elm, TX 75068-0009 |

Establishment Registration Number: 1647137

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 form accidental needle sticks. 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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## 510(k) SAFETY and EFFECTIVENESS SUMMARY ___page 2 of 2

:

| Substantial Equivalence | The 1 cc VanishPoint® is a smaller version of the original<br>3 cc VanishPoint® originally called a Pop n' Lok Syringe | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|--|
| Contact Information: | | |
| Name: | Terance Grisso<br>Director, Regulatory Affairs and Quality | |
| Address: | Retractable Technologies, Inc.<br>511 Lobo Lane, P.O. Box 9<br>Little Elm, TX 75068-0009 | |
| Telephone: | [phone] | |
| Facsimile: | [phone] | |

: 上一篇:

100 - 100 - 100

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Image /page/2/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 image of an eagle's head in profile, with three human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terance Grisso Director, Regulatory Affairs and Quality Retractable Technologies, Incorporated 511 Lobo Lane Little Elm, Texas 75068

NOV - 7 1997

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K973301 Re : VanishPoint® Syringe Trade Name: Requlatory Class: II Product Code: MEG Dated: August 28, 1997 Received: September 2, 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਬੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Grisso

through 542 of the Act for devices under the Electronic enroagn Badiation Control provisions, or other Federal laws or requlations.

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 markets premits 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 gener 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.fya.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timothy A Ulatows Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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K973301

## INDICATIONS FOR USE

510 (k) Number (if known):

VanishPoint ® Syringe Device Name:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Patricia Cucerite

(Division Sign Division of C and General H E i Oik) Numb

Prescription Use /

**Over-The-Counter Use** _/
_

For allergy syringes

The-Counter Use *_*_

for Insulin syringes

(Optional Format 1-2-96)