(183 days)
The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.
The PIVO™ Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular catheter (IV) system. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing, and winged clip on the distal end. The winged clip attaches to the IV system. The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV.
The device is available in three sizes: 20GA, 22GA, and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPort™ IV Access.
The provided document is a 510(k) summary for the PIVOTM Pro Needle-free Blood Collection Device, which seeks to demonstrate substantial equivalence to a predicate device (PIVOTM Needle-free Blood Collection Device). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than proving absolute safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence, primarily through non-clinical performance testing and a comparison of technological characteristics.
Here’s a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists the performance tests conducted and states that the device "met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."
However, we can infer some "acceptance criteria" based on the tests performed:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Safety and Biocompatibility: | |
| Biocompatibility (ISO 10993-1) | Met all requirements |
| Packaging Integrity (ASTM D4169 & ISO 11607-1) | Met all requirements |
| Sterilization Validation (ISO 11137-1) | Met all requirements |
| Hemolysis | Met all requirements |
| Blood Leak | Met all requirements |
| Pressure Leak | Met all requirements |
| Vacuum Leak | Met all requirements |
| Device Functionality: | |
| Catheter Gauge Compatibility | Met all requirements |
| Extension Length | Met all requirements |
| Catheter Perforation | Met all requirements |
| Insertion | Met all requirements |
| Alignment | Met all requirements |
| Atraumatic Tip | Met all requirements |
| Flow Rate | Met all requirements |
| Pusher Pull Force | Met all requirements |
| Complete Retraction | Yes (inherent design feature, verified through testing) |
| Usability: | |
| Usability testing per FDA Guidance | Met all requirements |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes (N values) for each individual performance test (e.g., how many devices were tested for catheter perforation, how many for flow rate). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that these are bench and lab tests for device clearance, they are inherently prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable in the context of this 510(k) summary. The "ground truth" for this device is based on objective measurements and compliance with recognized standards and internal design requirements, not expert consensus on interpretations like with diagnostic imaging. Usability testing would involve users, but the number and qualifications of those users are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is not applicable here as these are performance and engineering tests, not studies requiring human interpretation and adjudication (e.g., clinical trials for diagnostic algorithms).
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
An MRMC study was not conducted. This type of study applies to AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices where human readers (e.g., radiologists) use AI assistance to improve their diagnostic performance. The PIVOTM Pro is a physical blood collection device, not an AI software. The submission explicitly states: "Clinical studies are not required to demonstrate substantial equivalence to the predicate device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical medical device, not an algorithm or AI system. Its performance is evaluated through physical and functional testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" relates to meeting engineering specifications, material properties, sterility, and functional performance benchmarks derived from industry standards (e.g., ISO, ASTM), internal design requirements, and prior knowledge from the predicate device. It is primarily based on:
- Physical measurements and criteria: e.g., acceptable flow rates, specified dimensions, absence of leaks, specified pull force.
- Compliance with recognized standards: e.g., ISO 10993-1 for biocompatibility, ISO 11137-1 for sterilization, ASTM D4169 and ISO 11607-1 for packaging.
- Functional tests: verifying proper insertion, alignment, and absence of catheter perforation.
8. The sample size for the training set
This is not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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.