(314 days)
The Quick Sampler Holder is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests
The Quick Sampler Holder is a non-contacting patient device. It is intended to be used in conjunction with a vacuum blood collecting vessel and bloodlines with y-ports, for blood banking. The Quick Sampler Holder consists of a double ended 18 gauge needle attached to a blood tube holder. The proximal needle tip, which is inserted into the yport, is blunt to prevent accidental needlesticks; the distal end, inside the holder, is sharp and is covered by a rubber sleeve to prevent blood loss during vial replacement/sample collection.
The provided text is a 510(k) summary for the Nipro Quick Sampler Holder, which is a medical device for blood specimen collection. This document does not describe a study using a device that meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
Instead, it's a regulatory submission demonstrating substantial equivalence to a predicate device (ITL Samplok Luer Kit, K021941) based on non-clinical performance testing. Therefore, most of the requested information regarding ground truth, expert consensus, MRMC studies, and sample sizes for test/training sets is not applicable to this type of submission.
Here's a breakdown of the available information based on your request, with an explanation of why certain categories are not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists "Performance characteristics" that were tested, but it does not provide specific numerical acceptance criteria or detailed reported performance values for each characteristic. It only states that the device was found to be "substantially equivalent" based on these tests.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Integrity test of tamper sealing | Not specified (implied to have met requirements for substantial equivalence) |
| Rubber sleeve functional tests | Not specified (implied to have met requirements for substantial equivalence) |
| Hub-needle functional tests | Not specified (implied to have met requirements for substantial equivalence) |
| Hub-Holder functional tests | Not specified (implied to have met requirements for substantial equivalence) |
| Chemical characteristics | Not specified (implied to have met requirements for substantial equivalence) |
| Microbiological characteristics | Not specified (implied to have met requirements for substantial equivalence) |
| Dimensional characteristics | Not specified (implied to have met requirements for substantial equivalence) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical tests" but does not detail the methodology, sample sizes, or provenance of materials used for these tests. The tests would likely be performed in a lab setting, not involving human subjects or data from a country of origin in the way a clinical study would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, expert consensus, and expert qualifications are relevant to studies involving diagnostic accuracy or classification tasks, typically for AI/ML devices or clinical trials. This submission focuses on the mechanical and functional performance of a blood collection device through non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in studies where human readers interpret data (e.g., medical images) and their agreement or disagreement needs to be resolved to establish ground truth. This is a non-clinical device performance submission.
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
No such study was done. This is a medical device for blood collection, not an AI/ML-powered diagnostic tool, and the submission explicitly states "No clinical testing required or submitted with this application."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The "truth" for these non-clinical tests would be defined by engineering specifications, material standards, and performance metrics (e.g., seal integrity, dimensions, functionality checks) rather than expert consensus on a clinical outcome or pathology.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" as this is not an AI/ML device.
Summary of Device and Acceptance:
The Nipro Quick Sampler Holder's acceptance by the FDA (as indicated by the 510(k) clearance) is based on demonstrating substantial equivalence to a predicate device (ITL Samplok Luer Kit, K021941) through non-clinical performance characteristics testing. The key difference between the Quick Sampler Holder and its predicate is a blunt proximal tip versus a luer tip. The submission asserts that "The Quick Sampler Holder is identical to the predicate in terms of indications for use and mode of operation" and "substantially equivalent ... in terms of functional, mechanical and material specifications." No clinical studies were required or submitted.
§ 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.