(153 days)
K861152A
Not Found
No
The device description and intended use clearly describe a physical luer adaptor for blood collection, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is described as an attachment for blood collection equipment used for various blood tests. It does not treat, cure, or prevent any disease or condition.
No
The Nipro Luer Adaptor is used for blood collection, which is a step in obtaining samples for diagnostic tests, but the device itself does not perform any diagnostic function. It is an accessory for the blood collection process.
No
The device description clearly states it is a physical product made of materials like stainless steel, synthetic rubber, and polypropylene, and is intended as an attachment for a needle. It is a hardware device.
Based on the provided information, the Nipro Luer Adaptor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for blood collection, which is a step prior to in vitro diagnostic testing. The device is used to obtain the sample, not to perform a test on the sample itself.
- Device Description: The description focuses on the physical components and function of the adaptor for connecting to a needle and vacuum blood collection equipment. It does not describe any components or processes related to analyzing or testing the blood sample.
- Lack of Diagnostic Function: An IVD device is designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This luer adaptor does not perform any such examination or analysis.
The device is a medical device used in the process of obtaining a sample for IVD testing, but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required for various blood tests.
Product codes
FOZ, FMI
Device Description
The Nipro Luer Adaptor that we intend to market is a multi-type with a cannula that has an outer diameter of 0.90 mm and a back end length of 20 mm to 24 mm. The Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required for various blood tests. The luer adaptor is used to connect to a blood collection needle that has a female luer taper for use. As such, this product has a hub with a male luer taper. The product is a sterilized single-use product. 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K861152A
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
JAN 1 3 2000
Image /page/0/Picture/2 description: The image shows the word "NIPRO" in bold, sans-serif font, next to a stylized logo. The logo is composed of two interlocking shapes that resemble the infinity symbol or a figure eight. The logo and the word "NIPRO" are both in black, contrasting with the white background.
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® LUER ADAPTOR
8807.92 (a)(1)
Contact Person:
Luis Candelario General Manager
August 2, 1999 Date of Summary Preparation:
$807.92 (a)(2)
Nipro® Luer Adaptor Trade Name: Common Name: Luer adaptor Classification Name: Intravascular Administration Set (21 CFR 880.5440) Establishment Registration Number: 9611446 Class: II Panel: 80 Procodes: FOZ
8807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Exel International Luer Adaptor (K861152A)
8807.92 (a)(4)
Description of Device: The Nipro Luer Adaptor that we intend to market is a multi-type with a cannula that has an outer diameter of 0.90 mm and a back end length of 20 mm to 24 mm.
The Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required for various blood tests. The luer adaptor is used to connect to a blood collection needle that has a female luer taper for use. As such, this product has a hub with a male luer taper. The product is a sterilized single-use product.
1
| | Luer Adaptors are described in Intravascular Administration
Set (21 CFR 880.5440). |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. |
| §807.92 (a)(5) | |
| Intended Use: | The luer adaptor is intended to be used as an attachment for a
needle with a luer taper hub for blood collection. The luer adaptor
is used as part of the vacuum blood collection equipment for blood
collection required for various blood tests intended to be used to
collect blood for various types of 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 is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person's profile. The symbol is positioned in the center of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2000
Nipro Medical Corporation c/o Ms. Kaelyn B. Hadley Consultant for Nipro Medical Corporation C.L. McIntosh & Associates, Incorporated Medical & Requlatory Affairs Services 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
K992729 Re :
Trade Name: Nipro® Luer Adaptor Requlatory Class: II Product Code: FMI November 24, 1999 Dated: 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, 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, 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 Manufacturinq Practice for Medical Devices: General (GMP) requlation (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
3
Page 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 requlations.
This letter will allow you to beqin marketinq 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 diaqnostic 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 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
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
K 992729 510(k) Number (if known) _ Device Name: Nipro Luer Adaptor
Indications for Use: The Nipro Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required 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)
-4-
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Patrice Cusmite
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Dev 6 - Number --