(183 days)
The product is a family of Angiographic Syringes for the injection of contrast media and saline. The syringe is for single use with US legally marketed angiographic injectors.
The Ecomed Disposable Angiographic Syringes are disposable syringes for use with contrast delivery systems that deliver contrast media or saline into the vascular system for the purpose of obtaining enhanced diagnostic images. The syringes are available in several sizes and configurations to ensure compatibility with US legally marketed contrast delivery systems.
The syringes are provided in kits that are configured from the following list of components:
- . Syringe(s)
- . Fill tube
- Vial Spike (small/large)
- . Transfer tubing set (length, y vs straight)
I will provide an answer assuming the request relates to the 'Ecomed Disposable Angiographic Syringes' as described in the provided text.
Based on the provided text, the device in question is the "Ecomed Disposable Angiographic Syringes," which are mechanical devices for injecting contrast media and saline. The text describes non-clinical performance (bench) tests to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets a specific clinical acceptance criterion with statistical performance metrics. Therefore, many of the requested fields related to diagnostic performance or human reader studies are not applicable.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerically reported "device performance" in the context of diagnostic accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicit in the compliance with various ISO and ASTM standards, which cover aspects like sterility, biocompatibility, packaging, and physical performance. The "reported device performance" is a general statement that the device fulfills these standards and is substantially equivalent.
| Acceptance Criterion (Implicitly based on standards) | Reported Device Performance |
|---|---|
| Sterility (ISO 11135-1, ISO 11607-1, ASTM F1980-07) | Compliance verified |
| Biocompatibility (ISO 10993-1, -5, -10, -11; ASTM F756-13, USP ) | Biocompatible, compliance verified |
| Physical Performance (Leak testing, dimensional compatibility) | Stable over T=1, T=2, T=3 test intervals; dimensional compatibility verified |
| Luer connectors (ISO 594-1) | ISO 594 compliant |
| Syringe standards (ISO 7886-1) | Compliance verified |
| Risk Management (ISO 14971) | Compliance verified |
| Shelf Life | 3 years (equivalent to primary predicate) |
| Fill size compatibility | 60mL, 150mL (verified with compatible injectors) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for each individual test mentioned (e.g., how many syringes were subjected to leak testing). It only states that "Non-clinical performance (bench) tests conducted on the subject devices to support substantial equivalence includes comparison testing and physical performance testing." The data provenance is laboratory bench testing, not patient data, so country of origin or retrospective/prospective status is not applicable in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a bench study for substantial equivalence of a medical device (angiographic syringes), not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication method for the test set
Not applicable, as it is a bench testing study, not a study requiring expert adjudication of results.
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 device is a disposable angiographic syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a disposable angiographic syringe, not an algorithm.
7. The type of ground truth used
For dimensional compatibility and physical performance tests, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate/reference devices, as well as the requirements set by the various ISO and ASTM standards. For biocompatibility and sterility tests, the "ground truth" would be the chemical, biological, and physical parameters defined by the relevant standards (e.g., absence of cytotoxicity, pyrogens, harmful reactions).
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI model.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.