(57 days)
The VACUTAINER® Brand Luer Adapter is a sterile, non-invasive device used to connect venous access devices such as needles, blood collection sets, and infusion sets to blood collection tubes. They are also used in connection with non-needle devices for collection of blood from catheters. The VACUTAINER® Brand Luer Adapter is sold by itself and as a component of other VACUTAINER Brand devices.
The VACUTAINER® Brand Multiple Sample Luer Adapter consists of a male luer-slip fitting which mates with the female connector of other medical devices, and a non-patient (NP) cannula which punctures the stopper of an evacuated tube. The luer hub is injection molded polystyrene to which the stainless steel NP cannula is assembled with epoxy. The hub is threaded at the NP end to allow assembly to a VACUTAINER Brand Needle Holder.
The NP cannula of the multi-sample luer adapter is covered by a sleeve that recovers over the cannula to stop blood flow during collection of multiple tubes. In the principal device, this sleeve is manufactured of latex-free synthetic isoprene rubber.
The provided text is a 510(k) summary for a medical device (VACUTAINER® Brand Multiple Sample Luer Adapter), which details its description, intended use, and a comparison to predicate devices for substantial equivalence. It does not contain information about acceptance criteria, detailed study designs, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI devices. The document predates common AI/ML regulations and evaluation methods.
Therefore, I cannot extract the requested information about acceptance criteria or a study that proves the device meets those criteria from the provided text in the format you've requested for AI/ML devices. The text describes a traditional medical device's regulatory submission based on substantial equivalence to existing predicate devices, not an AI-powered diagnostic or treatment device with performance metrics like sensitivity, specificity, or AUC against a defined ground truth.
Here's a breakdown of why each requested point cannot be answered:
- 1. Table of acceptance criteria and reported device performance: Not present. The document states "Functional and Mechanical testing was done to compare the performance..." and "Results of the testing demonstrated that the modified... performed as well or better than both the currently manufactured... and the TERUMO® Brand VENOJECT™ Lucr Adapter." However, specific numerical acceptance criteria (e.g., "tensile strength > X N") and corresponding quantitative performance metrics values are not provided.
- 2. Sample size for test set and data provenance: No sample size is mentioned for the functional and mechanical testing. Data provenance is not applicable as this is a physical device, not an AI model trained on data.
- 3. Number of experts and qualifications: Not applicable. This is not an AI/ML study involving expert ground truth labeling.
- 4. Adjudication method: Not applicable. This is not an AI/ML study involving expert ground truth labeling.
- 5. MRMC comparative effectiveness study: No. This is a physical device, not an AI system.
- 6. Standalone performance: "Functional and Mechanical testing" was performed on the device itself, but specific performance metrics are not detailed in this summary.
- 7. Type of ground truth: Not applicable in the context of AI/ML. For a physical device, performance is typically assessed against engineering specifications and functional requirements.
- 8. Sample size for the training set: Not applicable. This is not an AI/ML model.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML model.
§ 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.