VACUETTE PREMIUM SAFETY NEEDLE SYSTEM

K072602 · Medpro Safety Products, Inc. · FMI · Jun 18, 2008 · General Hospital

Device Facts

• Record ID: K072602
• Device Name: VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
• Applicant: Medpro Safety Products, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jun 18, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

Device Story

VACUETTE® PREMIUM Safety Needle System is a single-use, sterile blood collection device. It integrates a needle and safety shield within a holder. During venipuncture, insertion of the first blood collection tube automatically releases the safety shield. Upon withdrawal, the shield covers the needle to prevent needlestick injuries. Used by trained healthcare professionals in clinical settings. The device provides physical protection for the clinician post-venipuncture, reducing the risk of accidental exposure to bloodborne pathogens.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Single-use, sterile, integrated needle and safety shield holder. Passive shielding mechanism triggered by blood collection tube insertion. Materials and dimensions are consistent with standard hypodermic single lumen needles (21 CFR 880.5570).

Indications for Use

Indicated for routine venipuncture procedures in patients requiring blood collection. For use by trained healthcare professionals only.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• The Guarded Needle 2000 (K003406)
• BD Vacutainer Passive Shielding Blood Collection Needle (K003461)

Submission Summary (Full Text)

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## SECTION V

JUN 1 8 2008

## 510(k) SUMMARY

## Contact:

510(k) Owner's Name - MedPro Safety Products, Inc. Address - 817 Winchester Road, Suite 200, Lexington, KY 40505 Phone - [phone] Facsimile - [phone] Contact Person - Mr. Walter Weller Date of Summary - September 12, 2007

## Name of Device:

Trade or Proprietary Name - VACUETTE® PREMIUM Safety Needle System Common Name - Safety device for blood collection Classification Name - Hypodermic single lumen needle with antistick syringe (21 CFR 880.5570, Product Code FMI and 21 CFR 880.5860, Product Code MEG)

| Predicate Device: | The Guarded Needle 2000 |
|----------------------|-------------------------|
| 510(k) Number: | K003406 |
| Date of Concurrence: | January 21, 2001 |

BD Vacutainer Passive Shielding Blood Collection Needle Predicate Device: 510(k) Number: K003461 Date of Concurrence: February 1, 2001

## Substantial Equivalence Declaration:

The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR §807, Subpart E, under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

## Device Description:

#### Product Description

The VACUETTE® PREMIUM Safety Needle System is a single use, sterile holder designed with an integrated, multiple sample needle and safety shield to provide protection against needlestick injury during venipuncture.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 8 2008

Medpro Safety Products, Incorporated C/O Mr. Greg E. Mitchell Frost Brown Todd, LLC 250 West Main Street, Suite 2700 Lexington, Kentucky 40507-1749

Re: K072602

Trade/Device Name: VACUETTE® PREMIUM Safety Needle System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI, MEG Dated: June 11, 2008 Received: June 12, 2008

Dear Mr. Mitchell:

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 indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Mitchell

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. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Suite y. Michael md.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

## 510(k) Number (if known): New submission

Device Name: VACUETTE® PREMIUM Safety Needle System

### Indications for Use:

The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Anthony Dean

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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