(251 days)
The HOLDEX® Single-Use Holder PP is for use in venous blood collection procedures in combination with blood collection devices with a female luer port.
The Greiner HOLDEX Single-Use Holder PP is a disposable plastic holder, which consists of a cylinder made from polypropylene plastic with an off-center molded male luer at the top. The off-center location of the male luer is to facilitate venipuncture when using luer needles. A stainless steel needle with a sleeve is bonded to the inside of the holder to facilitate blood draw by puncturing the cap of an attached blood collection device. The sleeve is made from Synthetic Polyisoprene Compound.
The Greiner HOLDEX® Single-Use Holder PP is a disposable plastic holder used for venous blood collection procedures with blood collection devices featuring a female luer port. The submission aims to extend its indication for use.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No failure during use | Performed "without failure" during simulated venous blood draw testing. |
| No leakage during use | Performed "without leakage" during simulated venous blood draw testing. |
| Conformity to ISO 594-1 | The luer part is made and verified by testing in conformity to ISO 594-1. |
2. Sample Size Used for the Test Set and Data Provenance
The test set used 180 blood collection devices with female luer ports. The devices were of common brands legally marketed in the US market. The study appears to be retrospective in the sense that it tested the device with existing, commercially available blood collection devices. The document does not specify if the testing was performed on actual human subjects or simulated laboratory conditions (though "simulated venous blood draw testing" suggests a laboratory setting).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not mention the use of experts to establish ground truth for the test set. The performance data is based on engineering and simulated testing rather than expert clinical assessment of outcomes.
4. Adjudication Method for the Test Set
No adjudication method is mentioned in the document as it does not rely on human assessment of findings. The testing involves observing for failure and leakage.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is a key component. The Greiner HOLDEX is a medical device for blood collection, and its performance is assessed through physical and functional testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable to the Greiner HOLDEX® Single-Use Holder PP. This device is a physical medical device, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that its mechanical function is evaluated, but it doesn't involve "human-in-the-loop" performance in the context of an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing was based on objective criteria of mechanical integrity and functionality: absence of failure and absence of leakage during simulated use, and conformity to an international standard (ISO 594-1).
8. The Sample Size for the Training Set
This product is a physical medical device; therefore, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve engineering specifications and quality control, but not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for an algorithm, this question is not applicable.
§ 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).