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510(k) Data Aggregation
(23 days)
PROTECTIV ACUVANCE IV CATHETER SYSTEM
A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.
Intravascular catheters are single use devices which provide access to veins or arteries.
The provided text describes a 510(k) submission for the PROTECTIV ACUVANCE IV Catheter System. This document focuses on the device's capability for use with power injectors up to 300 psi, rather than a diagnostic AI device requiring the kind of extensive performance evaluation breakdown requested in the prompt.
Therefore, many of the requested categories are not applicable to this submission. However, I can extract the relevant information regarding acceptance criteria and the study that demonstrates the device meets these criteria.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Appropriate for use with power injectors | Bench testing demonstrates that the 14 to 22 gauge ACUVANCE catheters are appropriate for use with power injectors up to 300 psi. |
| Withstands pressure up to 300 psi | (Implied by the above statement through "appropriate for use with power injectors up to 300 psi") |
| Maintains functional integrity during infusion | (Implied by the above statement) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of patient data or clinical trials. The "performance data" refers to bench testing. Therefore, details like sample size for a test set, country of origin, or retrospective/prospective nature are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance evaluation was bench testing, not an assessment requiring expert interpretation of diagnostic data.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring adjudication.
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
Not applicable. This is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used
For the specific claim of "use with power injectors up to 300 psi," the ground truth was established through bench testing results. This means physical measurements and observations during simulated use conditions.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would involve a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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