(262 days)
Not Found
Vacutainer® Brand Needle Holder #4893, Sage Products AutoDrop® Needle Holder #1510
No
The device description and intended use clearly describe a mechanical needle holder with no mention of AI or ML capabilities. The "Not Found" entries for AI/ML mentions and performance studies further support this conclusion.
No
The device is a needle holder used for venipuncture, which facilitates a medical procedure but does not directly provide therapy or treatment itself.
No
The device is a needle holder used for venipuncture and blood collection, not for diagnosing a medical condition.
No
The device description clearly states it is comprised of an assembly of 5 plastic injection molded parts, indicating it is a physical hardware device.
Based on the provided information, the Bio-Plexus DROP-IT® Needle Holder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for holding a needle during venipuncture (drawing blood from a vein). This is a procedure performed on the patient's body, not on a sample of the patient's body outside of the body.
- Device Description: The device is a mechanical holder for a needle. It does not perform any diagnostic testing on a sample.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The Bio-Plexus DROP-IT® Needle Holder is a tool used in the process of obtaining a sample, but it does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder which is recommended for use with standard blood collection needles including the PUNCTUR-GUARD® Blood Collection Needle as well as PUNCTUR-GUARD® Winged Sets for Blood Collection. It also mates with the Bio-Plexus Needle Disposal Container for easy needle disposal. This is a non-sterile reusable device recommended for a maximum of 100 uses.
Product codes
FMI
Device Description
The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder comprised of an assembly of 5 plastic injection molded parts. The device rigidly holds a blood collection needle during the venipuncture procedure and also allows the needle to be released by use of a pushbutton rather than by unwinding. This device is for use with standard blood collection needles including Punctur-Guard® blood collection needles and winged sets. Standard blood collection needles include the Becton Dickinson Vacutainer® Needle, the Sherwood Monoject® Needle and the Terumo Venoject® Needle. The DROP-IT® Needle Holder performs the same functions as other legally marketed needle holders, for example, the Vacutainer® Brand Needle Holder #4893 and the Sage Products AutoDrop® Needle Holder #1510. The DROP-IT® Needle Holder is to be used by healthcare workers who are familiar with the art of phlebotomy in healthcare facilities or in the home healthcare setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The DROP-IT® Needle Holder is to be used by healthcare workers who are familiar with the art of phlebotomy in healthcare facilities or in the home healthcare setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Vacutainer® Brand Needle Holder #4893, Sage Products AutoDrop® Needle Holder #1510
Reference Device(s)
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
510(k) SUMMARY JUN - 6 1997
Bio-Plexus Inc. 129 Resevoir Road Vernon, CT 06066 CONTACT: Carl R. Sahi (President) Date Submitted: 9/13/96
963748
Revised:
11/27/96
Proprietary Name: Classification Name: Regulation #: Class: Panel Code: Product Code: Reason for submission: Bio-Plexus Inc. Registration Number: Bio-Plexus DROP-IT® Needle Holder Needle Holder 880.5570 II 80 FMI New device 1224632
The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder comprised of an assembly of 5 plastic injection molded parts. The device rigidly holds a blood collection needle during the venipuncture procedure and also allows the needle to be released by use of a pushbutton rather than by unwinding. This device is for use with standard blood collection needles including Punctur-Guard® blood collection needles and winged sets. Standard blood collection needles include the Becton Dickinson Vacutainer® Needle, the Sherwood Monoject® Needle and the Terumo Venoject® Needle. The DROP-IT® Needle Holder performs the same functions as other legally marketed needle holders, for example, the Vacutainer® Brand Needle Holder #4893 and the Sage Products AutoDrop® Needle Holder #1510. The DROP-IT® Needle Holder is to be used by healthcare workers who are familiar with the art of phlebotomy in healthcare facilities or in the home healthcare setting.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Mr. Carl R. Sahi ·President Bio-Flexus, Incorported P.Ü. Box 560 Vernon, Connecticut 06066
K963748 Re : Bio-Plexus Drop-it Needle Holder Trade Name: Regulatory Class: II FMI Product Code: Dated: May 20, 1997 Received: May 23, 1997
Dear Mr. Sahi:
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 requlations 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 requlation may result in requlatory 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.
2
Page 2 - Mr. Sahi
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 requlation (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) 638-4041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
Timothy A. ulatowsk Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K963748
Device Name: BIO-PLEXUS DROP-IT® NEEDLE HOLDER
Indications For Use:
The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder which is recommended for use with standard blood collection needles including the PUNCTUR-GUARD® Blood Collection Needle as well as PUNCTUR-GUARD® Winged Sets for Blood Collection. It also mates with the Bio-Plexus Needle Disposal Container for easy needle disposal. This is a non-sterile reusable device recommended for a maximum of 100 uses.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Patricia Crucente
Division of Dental, Infection Control,
and General Hospital Devices 963748
510(k) Numb
Prescription Use (Per 21 CFR 801 109)
OR
Over -The-Counter Use
(Optional Format 1-2-96)