(164 days)
This device is intended for use in venous blood collection.
This device is intended for use in venous blood collection.
IMC blood collection needles are manufactured from stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is shorter end and is fitted with a protective rubber sleeve. And a needle cap. The opposite end of the needle is 1" or 1 ½" for withdrawing blood. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity.
IMC blood collection needles are a sterile single use disposable product. The needles are nontoxic and non-pyrogenic and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1 ½').
The document describes the acceptance criteria and performance of the IMC Blood Collection Needle, comparing it to the predicate device, VACUETTE VISIO PLUS blood collection needle (K061483).
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristics | Acceptance Criteria | IMC Blood Collection Needle Performance |
|---|---|---|
| Hub/needle bond strength | 20G: >54N | Meets Standard Criteria |
| 21G: >44N | Meets Standard Criteria | |
| 22G: >40N | Meets Standard Criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size used for the hub/needle bond strength test. It states "Meets Standard Criteria," implying that an adequate number of samples were tested to demonstrate compliance with the ISO 7894:1993 standard for each gauge. The data provenance is not specified, but given the submission for FDA approval, it is presumably from testing conducted by or for the manufacturer, International Medsurg Connection. The study is a prospective performance test designed to meet pre-defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of device and test described. The "ground truth" for hub/needle bond strength is established by objective physical measurement against a specified international standard (ISO 7894:1993), not by expert opinion or interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The test involves direct physical measurement and comparison to quantitative criteria, not subjective assessment requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The IMC Blood Collection Needle is a physical medical device, and its performance is evaluated through engineering and mechanical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device does not involve algorithms or human-in-the-loop performance in the context of diagnostic interpretation. The performance reported is that of the device itself.
7. The Type of Ground Truth Used:
The ground truth used is based on objective measurement against an international standard (ISO 7894:1993). The hub/needle bond strength is a quantifiable physical property, and the acceptance criteria are numerical thresholds defined by this standard.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of this device. The testing described is a performance validation test, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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).