(85 days)
Not Found
No
The device description is purely mechanical and there is no mention of AI, ML, or any related concepts in the summary.
No.
This device is for "venous blood collection," which is a diagnostic procedure, not a therapeutic one. It is used to obtain a sample for analysis, not to treat a condition.
No
Explanation: The device is described as a tubular stainless steel device for venous blood collection, which is a blood collection tool and not a device used to diagnose a medical condition.
No
The device description clearly describes a physical, tubular stainless steel device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in venous blood collection." This describes a device used to collect a biological sample, not to test or analyze it.
- Device Description: The description details a needle used for withdrawing blood and connecting to a blood collection tube. This is a tool for sample acquisition.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, measurement, or testing of the blood sample itself. IVDs are designed to provide information about a patient's health status through the examination of in vitro samples.
This device is a blood collection needle, which is a medical device used in the process of obtaining a sample for potential in vitro diagnostic testing, but it is not the diagnostic device itself.
N/A
Intended Use / Indications for Use
For use in venous blood collection
Product codes
FMI
Device Description
The Vacuette® Multi- sample needle is a tubular stainless steel device sharpened at both ends, one end to withdraw blood, and the other end to be threaded into a needle holder which is used to guide the needle into an evacuated blood collection tube..
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 17 1997
==
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for it's Greiner Vacuette® Multi- sample needle. The Vacuette® Multi- sample needle is a tubular stainless steel device sharpened at both ends, one end to withdraw blood, and the other end to be threaded into a needle holder which is used to guide the needle into an evacuated blood collection tube..
Greiner is claiming substantial equivalence to Gainor Medical's Suresharp® needles (K950159). Both multi-sample needles have the same intended use and contain the same material. The material of the Greiner needle is stainless steel and is the same material used for the Gainor needle. The material of the hub for both needles is made from polypropylene. The sleeve covering the short end of the needle is made from rubber. The needle shield is made from polypropylene. The equivalency of the needles is certified by a statement that the needles are the same and purchased from the same supplier in Japan.
Greiner's 510(k) has been submitted on Monday, September 22, 1997, by Douglas L. Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, Maryland, 21014 (410-836-8228).
1
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Douq Harris Manaqinq Director Greiner Meditech, Incorporated 260 Gateway Drive, Suite 17A Bel Air, Maryland 21014
DEC 17 1997
Re : K973620 Vacuette Multi-Sample Needle Trade Name: II Requlatory Class: Product Code: FMI Dated: September 18, 1997 September 23, 1997 Received:
Dear Mr. Harris:
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, Druq, 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 aqainst 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Harris
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 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 ons regaration theation" (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
Timo Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known) _ K 9 7 34 20
Device Name: VACUETTE® Multi-sample Needle
Indications for Use: For use in venous blood collection
Labaux Cucinol
(Division Sign-Off) Division of Dental, Info and General Hospi 510(k) Number
Prescription Use X
18:00
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________