(29 days)
The PIVO™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.
The PIVO™ device is a sterile, single use device. It is a needlefree blood collection device that attaches to a peripheral IV (PIV) catheter system. The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The inner tube is then advanced to collect a blood sample. Once complete, the inner tube is retracted, and the device is removed from the PIV. The device is available in three sizes, 20, 22, and 24 gauge.
This looks like a 510(k) summary for a medical device called PIVO™. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than a study proving performance against acceptance criteria in the context of AI/ML.
Here's why it's not applicable to the requested information and what information it does contain:
-
No AI/ML Component: The PIVO™ device is a "blood specimen collection device" (a needle-free blood collection device that attaches to a peripheral IV catheter). There is no mention of any AI or machine learning component in its functionality or development. Therefore, questions related to AI performance, such as sample size for test sets, ground truth establishment, MRMC studies, or standalone algorithm performance, are not relevant.
-
Substantial Equivalence, Not De Novo Performance: The document's primary purpose is to justify that the modified PIVO™ device is "substantially equivalent" to an already legally marketed predicate device (K190604). This means the focus is on showing that the changes (alternate colorant material, second contract manufacturer, alternate packaging material) do not raise new questions of safety or effectiveness. It's not about proving inherent performance against new, specific acceptance criteria for a novel device.
-
Performance Testing for Equivalence: The "Performance Testing" section lists tests conducted to demonstrate that the modifications do not negatively impact the device's performance compared to the predicate. These are:
- Leak testing
- Dimensional testing
- Joint strength testing
- Flow rate testing
- Packaging testing (per ASTM D4169-16, ASTM F1980-16, ISO 11607-1:2019)
- Biocompatibility testing (per ISO 10993-1)
The document states: "All testing was performed on sterilized product." And, "The changes made were tested using the same acceptance criteria as the predicate device and demonstrated that there are no new risks and the device is substantially equivalent."
Since it's not an AI/ML device and the submission is for substantial equivalence rather than original performance evaluation, I cannot fill in the requested table and study details related to an AI/ML device. The document does not provide information on:
- Acceptance Criteria and Reported Device Performance (as typically defined for AI): It states "same acceptance criteria as the predicate device" for the performance tests listed, but doesn't quantify them.
- Sample sizes for test set and data provenance.
- Number of experts used to establish ground truth and qualifications.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.