(66 days)
The PIVO™ device attaches to a peripheral IV catheter system 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 needle- free 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.
The provided text describes a 510(k) premarket notification for the PIVO™ device, a blood specimen collection device. The submission is for a line extension to include a 24G compatible size device, along with some dimensional and material changes to existing 20G and 22G devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly provide a table of acceptance criteria with corresponding performance metrics. However, it lists several performance tests conducted and states that "All testing was performed on sterilized product." The overarching acceptance criterion for the subject device (PIVO™ 24G and modified 20G/22G) is that it "demonstrated that there are no new risks and the device is substantially equivalent" to the predicate devices. It also states that testing used "the same acceptance criteria as the predicate device."
Here's an inferred table based on the provided information:
| Performance Test | Implied Acceptance Criteria (based on "no new risks" and "same acceptance criteria as predicate") | Reported Device Performance |
|---|---|---|
| Leak testing | No leaks | Demonstrated no new risks, substantially equivalent to predicate. |
| Dimensional testing | Meets specified dimensions for compatibility | Differences do not create additional risk to safety and effectiveness. |
| Joint strength testing | Meets specified joint strength requirements | Demonstrated no new risks, substantially equivalent to predicate. |
| PIV compatibility testing | Compatible with PIV gauges (24G for subject device) | Compatible with smaller (24G) PIV systems; no additional risk. |
| Flow rate testing | Meets specified flow rate requirements (comparable to predicate) | Demonstrated no new risks, substantially equivalent to predicate. |
| Hemolysis testing | No significant hemolysis | Demonstrated no new risks, substantially equivalent to predicate. |
| Shelf life testing | Maintains performance over shelf life | Demonstrated no new risks, substantially equivalent to predicate. |
| Biocompatibility testing | Meets ISO 10993-1 requirements | Demonstrated no new risks, substantially equivalent to predicate. |
| Proximal Tube Material | (for material change) Performance (leak testing, joint strength, hemolysis) is not affected. | Material change does not affect the effectiveness of the subject device. |
| Inner Tubing Wall Thickness | (for wall thickness changes) Performance (hemolysis, flow rate, kink resistance) is not affected. | No additional risks to safety and effectiveness. |
The subsequent information is either not applicable (N/A), not explicitly stated (NSE), or can be inferred as follows:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: NSE. The document states that testing was performed, but does not specify the number of devices or samples used for each test.
- Data Provenance: NSE regarding country of origin or whether it was retrospective/prospective. The testing was conducted by the manufacturer, Velano Vascular (based in San Francisco, California, though this doesn't specify test location).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This device is a blood collection device, not an AI/diagnostic imaging device requiring expert interpretation of results for ground truth. Performance testing would rely on objective physical and chemical measurements rather than expert consensus on a 'ground truth' image or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for the performance testing described for this physical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This device is not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Physiological standards and engineering specifications. For a blood collection device, "ground truth" would be established by predefined engineering specifications (e.g., specific dimensions, flow rates), established biochemical limits (e.g., for hemolysis), and relevant international standards (e.g., ISO 10993-1 for biocompatibility). The claim of "no new risks" and "substantially equivalent" implies meeting these objective standards relevant to the device's function.
8. The sample size for the training set
- N/A. This device is a physical medical device, not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set for a physical device, this question is not applicable.
§ 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.