VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH

K111424 · Medpro Safety Products, Inc. · FMI · Jul 29, 2011 · General Hospital

Device Facts

• Record ID: K111424
• Device Name: VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH
• Applicant: Medpro Safety Products, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jul 29, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The VACUETTE® PREMIUM Safety Needle System Tube-Touch is used in routine venipuncture procedures. The Needle System is designed with an integrated, multiple sample needle and safety shield. The safety shield is automatically activated and released upon insertion of the first blood collection tube and covers the needle immediately following blood collection from 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 Tube-Touch is a single-use, sterile, hypodermic needle system for routine venipuncture. Device features an integrated, multiple-sample needle and a safety shield. Operation: safety shield automatically activates and releases upon insertion of the first blood collection tube, covering the needle immediately after blood collection to prevent needlestick injuries. Used in clinical settings by trained healthcare professionals. Benefits include enhanced protection against accidental needlestick injury during blood collection procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, sterile, hypodermic needle system. Integrated multiple-sample needle and automatic safety shield mechanism. Materials are non-toxic and free of dry natural rubber. Mechanical activation of safety shield via blood collection tube insertion.

Indications for Use

Indicated for routine venipuncture procedures performed by trained healthcare professionals on patients requiring blood collection.

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

• VACUETTE® PREMIUM Safety Needle System (K072602)

Submission Summary (Full Text)

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KI11424

JUL 2 9 2011

## 510(k) SUMMARY

July 11, 2011

#### CONTACT:

Judi Smith Judi Smith, LLC P.O Box 103 Baldwin, MD 21013

#### NAME OF DEVICE:

Trade Name: VACUETTE® PREMIUM Safety Needle System Tube-Touch Common Names/Descriptions: Tube holder and safety needle Classification Name: Needle, Hypodermic, Single Lumen

PREDICATE DEVICE:

VACUETTE® PREMIUM Safety Needle System (K072602)

### DEVICE DESCRIPTION:

### INTENDED USE:

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

#### DESCRIPTION:

The VACUETTE® PREMIUM Safety Needle System Tube-Touch is a single-use, sterile needle system, non-toxic, designed with an integrated, multiple use drawing needle and safety shield to provide protection against needlestick injury during venipuncture. This device has no components made of dry natural rubber.

### SUBSTANTIAL EQUIVALENCE:

This Special 510(k) is intended to update the FDA's 510(k) file for non-significant changes made to the VACUETTE® PREMIUM Safety Needle System. The VACUETTE® PREMIUM Safety Needle System Tube-Touch which is the subject of this submission is substantially equivalent to the VACUETTE® PREMIUM Safety Needle System (K072602) in intended use and materials.

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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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MedPro Safety Products, Incorporated C/O Ms. Judi Smith Principal P.O. Box 103 Baldwin, Maryland 21013

2 9 2011 .100

Re: K111424

Trade/Device Name: Vacuette® Premium Safety Needle System Tube-Touch Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI, MEG Dated: July 11, 2011 Received: July 12, 2011

Dear Ms. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Smith

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AbouitFDA/CentersOffices/CDRH/ CDRHOffice s/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours
Susan Runner

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K111424

Device Name: VACUETTE® PREMIUM Safety Needle System Tube-Touch

Indications For Use:

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

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumore for R.C.

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

510(k) Number: K11424

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