(186 days)
K861152A
Not Found
No
The device description and intended use are for a standard blood collection needle, and there is no mention of AI or ML in the provided text.
No
The device is a blood collection needle used for diagnostic purposes (collecting blood for tests), not for treating a disease or condition.
No
Explanation: The device is a blood collection needle, which is used to collect blood for various tests. While the collected blood may be used for diagnostic purposes, the needle itself is a collection device, not a diagnostic one. It does not analyze, interpret, or provide any diagnostic information.
No
The device description clearly states it is a physical blood collection needle made of materials like stainless steel, synthetic rubber, and polypropylene, and does not mention any software component.
Based on the provided information, the Nipro Blood Collection Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "collect blood for various blood tests." This describes a tool used to obtain a sample, not a device that performs a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description clearly identifies it as a "hypodermic single lumen needle" and references the relevant FDA regulation (21 CFR 880.5570), which is for hypodermic single lumen needles, not IVD devices.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood or performing a diagnostic test. IVD devices typically involve reagents, analytical platforms, or software for interpreting results.
The Nipro Blood Collection Needle is a medical device used for specimen collection, which is a step prior to an in vitro diagnostic test, but it is not the IVD device itself.
N/A
Intended Use / Indications for Use
The blood collection needles are intended to be used to collect blood for various blood tests.
The Nipro Blood Collection Needle are intended to be used to collect blood for various blood tests.
Product codes
FMI
Device Description
The Nipro Blood collection needles that we intend to market include gauges 18, 20, 21, and 22. Each gauge is available in various lengths from 20 to 40 mm. Blood Collection Needles are described in hypodermic single lumen needle (21 CFR 880.5570). The materials used for the components include stainless steel SUS 304 (SS), synthetic rubber, and polypropylene (PP). Epoxy resin as an adhesive and silicone oil as a lubricant are also used.
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.
K861152A
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
K99^{2699}
FEB 1 4 2000
Image /page/0/Picture/2 description: The image shows the logo for Nipro. The logo consists of a stylized, intertwined double helix symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. The logo is black and white.
NIPRO MEDICAL CORPORATION 10877 N.W. 33rd Street Miami, Florida 33172 Tel.: (305) 599-7174 Fax: (305) 599-8454
SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® BLOOD COLLECTION NEEDLE
8807.92 (a)(1)
Contact Person:
Luis Candelario General Manager
August 2, 1999 Date of Summary Preparation:
$807.92 (a)(2)
Trade Name: Nipro® Blood Collection Needle
Blood Collection Needle Common Name:
Classification Name: Hypodermic Single Lumen Needle (21 CFR 880.5570) Establishment Registration Number: 9611446 Class: II Panel: 80 Procodes: FMI
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Exel International Blood collection needle (K861152A)
$807.92 (a)(4)
| Description of Device: | The Nipro Blood collection needles that we intend to
market include gauges 18, 20, 21, and 22. Each gauge is
available in various lengths from 20 to 40 mm. |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood Collection Needles are described in hypodermic
single lumen needle (21 CFR 880.5570). | |
| The materials used for the components include stainless
steel SUS 304 (SS), synthetic rubber, and polypropylene | |
1
(PP). Epoxy resin as an adhesive and silicone oil as a lubricant are also used.
8807.92 (a)(5)
The blood collection needles are intended to be used to collect Intended Use: blood for various blood tests.
§807.92 (a)(6)
Comparison of Technical Characteristics:
The Nipro and Exel devices are exactly the same devices, therefore, all technical characteristics are identical.
2
Image /page/2/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 perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above them that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2000
Nipro Medical Corporation c/o Ms. Kaelyn B. Hadley Nipro Medical Corporation Consultant C.L. McIntosh & Associates, Incorporated 1384 Copperfield Court Lexington, Kentucky 40514-1268
Re: K992699 Nipro® Blood Collection Needle Trade Name: Regulatory Class: II Product Code: FMI Dated: November 24, 1999 November 26, 1999 Received:
Dear Ms. Hadley:
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, qood 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
3
Paqe 2 - Ms. Hadley
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.
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) 594-4692. 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 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
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) Device Name: Nipro Blood Collection Needle
Indications for Use: The Nipro Blood Collection Needle are intended to be used to collect blood for various blood tests.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
Palica monite
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital, Devices
510(k) Number 4995499
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