(105 days)
Not Found
Not Found
No
The description focuses on a mechanical needle retraction mechanism for safety, with no mention of AI, ML, or data processing for decision-making.
No
The device is described as a tube holder facilitating blood withdrawal and protecting the phlebotomist from needle stick injuries, not as a device for treating a medical condition.
No
Explanation: The device is designed for blood withdrawal and needle retraction safety, not for diagnosing medical conditions. It facilitates the collection of samples for later diagnostic testing, but it does not perform the diagnosis itself.
No
The device description clearly describes a physical tube holder and adapter designed for blood collection, with a mechanical needle retraction mechanism. There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary function described is facilitating blood withdrawal from a patient and preventing needlestick injuries to the phlebotomist. This is a device used for specimen collection, not for performing a diagnostic test on the specimen itself.
- No Diagnostic Function: The description does not mention any analysis, testing, or interpretation of the blood sample for diagnostic purposes. The device's role ends with the collection of the blood into the tube.
- Focus on Safety and Collection: The emphasis is on the safety mechanism (needle retraction) and the ability to hold different sizes of blood collection tubes.
IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device is used in vivo (on the patient) for the collection of the specimen.
N/A
Intended Use / Indications for Use
The function of the VanishPoint® Tube Holder is to provide a safe and reliable method for facilitating blood withdrawal from a patient into evacuated blood collection tubes without exposing the phlebotomist to an accidental needlestick injury. The VanishPoint® Tube Holder works like a conventional tube holder except for its ability to retract the contaminated needle inside of the tube holder immediately after blood collection. Regular size collection tubes are inserted into the tube holder blood through the blood collection needle. Regular size collection tubes are 13mm and 16mm diameter. After the last evacuated tube is removed and the tube holder endcap is pressed onto the back-end of the needle retraction mechanism is automatically activated and the contaminated needle is withdrawn from the patient's vein and carried into the tube holder. This automatic needle retraction protects the phlebotomist from an accidental needlestick. The tube holder cannot be reused. Accidental needlesticks typically occur between removing the needle from the patient, removing the needle from a reusable tube holder and disposing of the needle into a sharps disposal container.
The function of the VanishPoint®Small Tube Adapter is to permit the phlebotomist to use the VanishPoint® Tube Holder with small volume blood collection tubes. Small volume collection tubes are 10.25mm in diameter. The tube adapter is inserted into the tube holder and the small collection tube is inserted into the tube adapter. After the evacuated tube is filled with blood, the tube adapter is removed from the tube is removed from the tube adapter. The tube adapter can be reused.
Product codes
FMI
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
patient's vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
phlebotomist
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 stylized eagle with three heads, representing service to individuals and families. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terance Grisso Director, Regulatory Affairs & Quality Retractable technologies, Incorporated 511 Lobo Lane P.O. Box 9 75068 Little Elm, Texas
AUG 26 1997
K971763 Re : Blood Collection Tube Holder Vanishpoint™ Trade Name: Tube Holder and Vanishpoint™ Small Tube Adapter II Requlatory Class: Product Code: FMI Dated: August 4, 1997 August 5, 1997 Received:
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. ﮐﮯ ﻧ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:
1
Page 2 - Mr. Grisso
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 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 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
K97/763
Indications For Use
510(K) Number (if known): K971763
VanishPoint® Tube Holder and VanishPoint®Small Tube Adapter Device Name:
Indications for Use:
The function of the VanishPoint® Tube Holder is to provide a safe and reliable method for facilitating blood withdrawal from a patient into evacuated blood collection tubes without exposing the phlebotomist to an accidental needlestick injury. The VanishPoint® Tube Holder works like a conventional tube holder except for its ability to retract the contaminated needle inside of the tube holder immediately after blood collection. Regular size collection tubes are inserted into the tube holder blood through the blood collection needle. Regular size collection tubes are 13mm and 16mm diameter. After the last evacuated tube is removed and the tube holder endcap is pressed onto the back-end of the needle retraction mechanism is automatically activated and the contaminated needle is withdrawn from the patient's vein and carried into the tube holder. The tube holder This automatic needle retraction protects the phlebotomist from an accidental needlestick. cannot be reused. Accidental needlesticks typically occur between removing the needle from the patient, removing the needle from a reusable tube holder and disposing of the needle into a sharps disposal container.
The function of the VanishPoint®Small Tube Adapter is to permit the phlebotomist to use the VanishPoint® Tube Holder with small volume blood collection tubes. Small volume collection tubes are 10.25mm in diameter. The tube adapter is inserted into the tube holder and the small collection tube is inserted into the tube adapter. After the evacuated tube is filled with blood, the tube adapter is removed from the tube is removed from the tube adapter. The tube adapter can be reused.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Palacia Cucenti
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K971763
Prescription Use √ OR Over-The-Counter Use __
(Optional Format 1-2-96)