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510(k) Data Aggregation
(58 days)
NAMIC ClearaCIL Contrast Injection Lines are intended to be used in fluid management procedures.
The NAMIC ClearaCIL Contrast Injection Lines are used to establish a conduit for the passage of fluids from a vascular power injector to a catheter. The Luer fittings are used to establish a secure, leak-free connection to the injector and catheter.
This document is a 510(k) premarket notification for the NAMIC ClearaCIL Contrast Injection Lines. It does not describe a study involving AI or human readers, but rather a submission for a medical device that facilitates the passage of fluids. Therefore, I cannot provide information related to sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, as these concepts are not applicable to the context of this device and submission.
The document discusses performance data obtained through non-clinical testing. Here's a breakdown of the acceptance criteria and reported device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Name | Reported Device Performance |
|---|---|
| Luer Bond Flex Strength | Performance demonstrates substantial equivalence to predicate device |
| Luer Bond Tensile Strength | Performance demonstrates substantial equivalence to predicate device |
| Air Leak Resistance | Performance demonstrates substantial equivalence to predicate device |
| Tubing Transparency | Performance demonstrates substantial equivalence to predicate device |
| Hydrodynamic Fluid Leak Resistance | Performance demonstrates substantial equivalence to predicate device |
| Biocompatibility (per ISO 10993-1) | Performance demonstrates substantial equivalence to predicate device |
2. Study that Proves the Device Meets Acceptance Criteria
The document states that the device meets the acceptance criteria through non-clinical performance and material testing. The purpose of this 510(k) submission is to introduce a modified version of the NAMIC ClearaCIL Contrast Injection Lines with a material change, and the testing was conducted to demonstrate substantial equivalence to the legally marketed predicate device.
Specifically, the document states: "The proposed NAMIC ClearaCIL Contrast Injection Lines and the predicate NAMIC ClearaCIL Contrast Injection Lines are substantially equivalent to the specific predicate devices based on a comparison of technological characteristics and the results of non-clinical performance and material testing..."
Given the nature of the device (contrast injection lines) and the type of submission (510(k)), the "study" is a series of laboratory-based, non-clinical tests rather than a clinical trial involving human subjects or data analysis of medical images.
Additional Information Not Applicable to this Document:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components of the device, not a set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical tests would be established by engineering standards and measurement techniques, not expert consensus on medical images or diagnoses.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a medical device, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical medical device.
- The type of ground truth used: For the physical tests, the "ground truth" would be the established engineering specifications and measurement outcomes for parameters like bond strength, leak resistance, and biocompatibility, as referenced by standards like ISO 10993-1.
- The sample size for the training set: Not applicable. There is no algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
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