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510(k) Data Aggregation
(189 days)
125mL CT Syringe
For use with the Liebel-Flarsheim Optivantage and Liebel-Flarsheim CT 9000 ADV Injectors for the injection of contrast media or saline.
The 125mL CT Syringe will be sold as a single syringe. The following configurations may also be offered:
i. 125mL Syringe and Fill Tube
ii. 125mL Syringe with Coiled Line and Spike
iii. 2 125mL Syringes with 2 Spikes
iv. 125mL Syringe and Coiled Extension Line
v. 2 125mL Syringes with Extension Y-Line and 2 Spikes
The provided text is a 510(k) summary for the Coeur 125mL CT Syringe, which aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission focuses on engineering and performance characteristics of a medical device, rather than the performance of an AI algorithm or a diagnostic tool. Therefore, the information requested about AI performance, multi-reader multi-case studies, ground truth establishment for AI, and similar metrics are not applicable to this document.
However, I can extract the relevant acceptance criteria and study information provided for the device itself.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance/Verification Approach |
|---|---|
| Visual Conformance | Inspection of the product for conformance to visual requirements. (Passed) |
| Dimensional Accuracy (ISO 594-2:1998) | Syringe evaluation to dimensional requirements of ISO 594-2 using go/no go gage. (Passed) |
| Injector Fit (Optivantage DH Injector) | Evaluation of product for fit and function with the Optivantage DH Injector. (Passed) |
| Injector Fit (CT 9000ADV Injector) | Evaluation of product for fit and function with the CT 9000ADV Injector. (Passed) |
| Volume Accuracy | Evaluation for volume accuracy when used with injectors. (Passed) |
| Dynamic Pressure (min. 330 psi) | Syringe tested at a minimum of 330psi in simulated injections. (Passed) |
| Failure Pressure | Failure testing following dynamic testing, where syringes are pressurized under increasing pressures until failure is observed. (Performed, no specific pass/fail defined, but likely within acceptable engineering limits) |
| ISO 594-2:1998 (Overall Syringe Requirements) | Syringe evaluation to requirements of the ISO 594-2 standard. (Passed) |
| ISO 7886-2:1996 (Syringe Requirements) | Syringe evaluation to applicable requirements of the ISO 7886 standard. (Passed) |
| Shelf Life (2 years) | Age Verification: Based on packaging and testing of accelerated aged samples. (Supported an initial 2-year expiration) |
| Biocompatibility | Biocompatibility testing conducted on the device (though materials were noted as identical to cleared predicate). (Passed) |
Note: The document only indicates that these tests were performed and the conclusions drawn were that the device is "substantially equivalent." Specific quantitative performance values are not typically included in these summary documents, but rather reported in full test reports submitted to the FDA.
The following information is not applicable to this 510(k) submission as it pertains to a physical medical device (syringe) and not an AI or diagnostic algorithm:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
This document outlines the engineering and material equivalence of a syringe to a previously approved device, not the performance of a diagnostic or AI-powered system.
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