EXTRESAFE PHLEBOTOMY

K964042 · Specialized Health Products, Inc. · FMI · Jun 6, 1997 · General Hospital

Device Facts

• Record ID: K964042
• Device Name: EXTRESAFE PHLEBOTOMY
• Applicant: Specialized Health Products, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jun 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The ExtreSafe™ Phlebotomy device is intended to be used in phlebotomy procedures using vacuum blood collection tubes. A powered needle retraction feature provided a shield for the needle following use.

Device Story

ExtreSafe™ Phlebotomy device; used during blood collection procedures with vacuum tubes. Features powered needle retraction mechanism to shield needle post-use; reduces risk of accidental needlestick injuries. Operated by healthcare professionals in clinical settings. Device provides physical protection for user after blood draw; does not involve electronic processing or diagnostic analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical phlebotomy device with powered needle retraction mechanism. Designed for use with standard vacuum blood collection tubes. Non-electronic, non-software device.

Indications for Use

Indicated for use in phlebotomy procedures involving vacuum blood collection tubes. Intended for use by healthcare professionals.

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.

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

JUN - 6 1997

Mr. William E. McKay
Specialized Health Products, Incorporated
C/O RCMDI
9721 S. Altamont Drive
Sandy, Utah 06066

Re: K964042
Trade Name: Extresafe™ Phlebotomy
Regulatory Class: II
Product Code: FMI
Dated: April 21, 1997
Received: April 23, 1997

Dear Mr. McKay:

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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. McKay

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 at [phone].

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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510(k) Number (if known K 964042

Device Name: EXTRESAFE™ PHLEBOTOMY

Indications for Use:

* The ExtreSafe™ Phlebotomy device is intended to be used in phlebotomy procedures using vacuum blood collection tubes. A powered needle retraction feature provided a shield for the needle following use.

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

(Division Sign-Off) Tobacco Cooperative
Division of Dental, Infection Control
and General Hospital Devices
510(k) Number K 964042
Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The Counter Use ☐

(Optional Format 1-2-96)

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