(73 days)
No
The device description and intended use are for a standard hypodermic needle, and there is no mention of AI or ML in the provided text.
No
Explanation: A hypodermic needle is a device used to inject or withdraw fluids, which is an instrumental function. It is not considered a therapeutic device because it does not treat or cure a disease or condition itself.
No
Explanation: The device, a hypodermic needle, is intended for injecting or withdrawing fluids, which is a therapeutic or procedural function, not a diagnostic one. There is no mention of it being used to identify or analyze a disease or condition.
No
The device description explicitly states it is a hypodermic needle, which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into or withdraw fluids from parts of the body below the surface of the skin." This describes a direct interaction with the body for therapeutic or diagnostic purposes in vivo (within a living organism).
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening. This process happens in vitro (outside of a living organism).
- Device Description: The description of the device as a "hypodermic needle" further supports its use for in vivo procedures, not for testing specimens in vitro.
The information provided clearly indicates a device used for direct interaction with the body, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The Nipro® Hypodermic Needle is intended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
Product codes
FMI
Device Description
The devices that we intend to market are hypodermic needles as described in 21 CFR §880.5570. Two types of hypodermic needles will be available: types L (long) and S (short). Type L hypodermic needles are 11/2 to 11/2 inches long and Type S needles 74 to 1 inch long.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin
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)
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
KOI 3293
Image /page/0/Picture/1 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized graphic to the left of the word "NIPRO" in bold, sans-serif font. Below this is the text "NIPRO MEDICAL CORPORATION" and the address "3150 N.W. 107 Avenue".
Miami, Florida 33172 Tel: (305) 599-7174 Fax: (305) 599-8454 DEC 1 4 2001
SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO HYPODERMIC NEEDLE
$807.92 (a)(1)
Contact Person: Eiji Shinozaki
Hypodermic Single Lumen Needle
21 CFR 880.5570
Date of Summary Preparation: December 4, 2001
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: K944355 Nipro Hypodermic Needle
$807.92 (a)(4)
·
Description of the Device:
The devices that we intend to m rket are hypodermic needles as described in 21 CFR $880.5570. Two types of hypodernic needles will be available: types L (long) and S (short). Type L hypodermic needles are 11/2 to 11/2 inches long and Type S necdles 74 to 1 inch long.
$807.92 (a)(5)
Intended Use:
The Nipro Hypodernic Needle is : tended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
8807.92 (a)(6)
Comparison of Technical Characte ristics:
Nipro Hypodermic Needles are smilar in design, technical, performance, and biological characteristics to those marketed inder K944355.
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 stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2001
Ms. Kaelyn B. Hadley Consultant Nipro Medical Corporation 1384 Copperfield Court Lexington, Kentucky 40514
Re: K013293
Trade/Device Name: Nipro® Hypodermic Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Needle Regulatory Class: II Product Code: FMI Dated: September 27, 2001 Received: October 2, 2001
Dear Ms. Hadley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket the Pouchal P 600g, 100g, 1herefore, market the device, subject to the general appear as approvisions of the Act. The general controls provisions of the Act include controls providers 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr.), it inch obe of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
2
Page 2 - Ms. Hadley
You must comply with all the Act's requirements, including, but not limited to: registration 1 od inust compry with and 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF R Pat 807), adolity systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section This letter will and w you to began mainly of substantial equivalence of your device to 3 rott) promanced nowledge 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and Office of Compliance vice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under noutheation (21 OF ICP at 1077). In the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runne
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) number (if known): KOL3293
Device name: Nipro® Hypodermic Needli _
Indications for use: The Nipro® Hypode: mic Needle is intended to be used to inject fluids into or withdraw fluids from parts of the body be נוש the surface of the skin
Atuar Cucurita
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 293 5 . 0(k) Number .
(Do not write below this line- continue ( 1 another page if needed.)
Concurrence of CDRH, )ffice of Device Evaluation (ODE)
Prescription Use J (Per 21 CFR 801.109)
0]·.
Over-The- Counter-Use (optional Format 1-2-9 )