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To be used in routine venipuncture procedures

non-sterile reusable plastic device to be used in routine venipuncture procedures.

This device is a Greiner VACUETTE Multi-use Holder, which is a non-sterile reusable plastic device used in routine venipuncture procedures. In this 510(k) summary, the manufacturer is claiming substantial equivalence to Becton Dickinson's preamendment VACUTAINER® Brand holder. The summary does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria.

Here's why and what information is missing:

• Type of Device: This is a physical, reusable plastic medical device for venipuncture, not a software-driven or AI-based diagnostic tool. The detailed questions about acceptance criteria, performance studies, sample sizes, ground truth (pathology, outcomes data), expert consensus, MRMC studies, and training sets are primarily relevant to diagnostic algorithms, AI, or imaging devices.
• Submission Type: This is a 510(k) premarket notification claiming "substantial equivalence" to a predicate device. For devices like this, substantial equivalence is typically demonstrated through comparisons of material, manufacturing process, intended use, and general performance characteristics that do not involve complex clinical or algorithmic efficacy trials.
• Content of the Document: The provided text is a 510(k) summary and the FDA's response letter. These documents describe the device, its intended use, and the FDA's finding of substantial equivalence. They do not typically include detailed study designs, acceptance criteria tables, or performance metrics in the way your questions are structured for AI/diagnostic devices. The regulatory pathway for this type of device does not usually require such studies for 510(k) clearance, especially given the predicate device was preamendment.

Therefore, the requested information cannot be extracted from the provided text for the following points:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

For this type of device, a "study"proving acceptance criteria would likely involve:

• Material compatibility testing: Ensuring the plastic does not react adversely with blood or commonly used cleaning agents.
• Manufacturing quality control: Demonstrating consistent production to specifications.
• Dimensional compatibility: Ensuring it fits standard collection tubes and needles.
• Functional tests: E.g., ensuring it can hold a tube securely during venipuncture without accidental dislodgement, or that the needle connection is secure.

However, none of these specific details are included in the provided 510(k) summary. The summary focuses on comparing the new device to the predicate device in terms of material (polypropylene plastic) and intended use (routine venipuncture procedures) to demonstrate substantial equivalence, rather than providing detailed performance metrics from a formal study.

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