(241 days)
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 necure f 11 following use.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding the Extresafe™ Phlebotomy device. This document does not describe any acceptance criteria or a study proving the device meets acceptance criteria. It primarily states that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.
Therefore, I cannot provide the requested information from the given document as it is not present.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other. The symbol is rendered in a dark color, contrasting with the white background.
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
K964042 Re : ﻪ ﮐ Trade Name: Extresafe™ Phlebotomy Requlatory 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 Requlations, 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 leqally 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 63842041 or at (301) 443-6597.
Sincerely yours,
K. Childress
Timothy K. 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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Page _ 1 _of _ 1 _
510(k) Number (if known K 964042
Device Name: _________________________________________________________________________________________________________________________________________________________________
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 necure
f 11 following use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Patricia Cossette
Division of Dental, Infection Control, Concurrence of CDRH, Office of Device Evaluation (ODE)
and General Hospital Devices
| 510(k) Number | K914042 |
|---|---|
| Prescription Use(Per 21 CFR 801.109) | ✓ OR Over-The Counter Use ______ |
(Optinal Format 1-2-96)
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).