(12 days)
The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiple-sample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.
The BD Vacutainer™ Push Button Blood Collection Set is for venous blood collection. The wing set contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks. The retraction of the needle occurs when the user depresses the button.
The provided text describes the 510(k) summary for the BD Vacutainer™ Push Button Blood Collection Set. However, it does not include detailed information regarding specific acceptance criteria, a detailed study report demonstrating performance against those criteria, or the methodology (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) typically associated with such studies for AI/ML-based devices.
The submission is for a medical device (blood collection set) that is not an AI/ML-based device. Therefore, many of the requested categories (like "Number of experts used to establish the ground truth", "Adjudication method", "MRMC comparative effectiveness study", "Standalone performance", "Training set sample size", and "How the ground truth for the training set was established") are not applicable to this type of device and are not present in the provided document.
Here's an attempt to answer the questions based only on the provided text, flagging where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document states: "Extensive mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness." However, specific numerical acceptance criteria (e.g., "95% of needle retractions must be successful") and their corresponding reported performance values are not provided in this summary. The summary focuses on establishing substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | Extensive mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Extensive mechanical, simulated use and clinical testing were performed," but does not provide details on the sample sizes used for these tests, nor the data provenance (country of origin, retrospective/prospective nature).
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)
This question is not applicable as this is a physical medical device (blood collection set), not an AI/ML device requiring expert-established ground truth for algorithm evaluation. The document does not mention any expert review or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as this is a physical medical device, not an AI/ML device relying on human adjudication for performance evaluation. The document does not mention any adjudication method.
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
This question is not applicable as this is a physical medical device, not an AI-assisted diagnostic tool for human readers. The document does not mention an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this is a physical medical device, not an algorithm. The document does not describe standalone algorithm performance. The device itself operates "standalone" in mechanical function, but this refers to its physical operation, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This question is not applicable in the context of typical AI/ML device evaluation. For this physical device, "ground truth" would relate to successful mechanical function, sterility, and injury prevention, which would be assessed through standard engineering and clinical validation methodologies, not expert consensus on data interpretation. The document does not specify the "ground truth" methodology.
8. The sample size for the training set
This question is not applicable as this is a physical medical device, not an AI/ML device that requires a training set. The document does not mention a training set.
9. How the ground truth for the training set was established
This question is not applicable as this is a physical medical device, not an AI/ML device that requires a training set and its associated ground truth. The document does not mention how ground truth for a 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.