(224 days)
The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be used to inject fluids into, or withdraw fluids from, the body.
The Merit Coronary Control Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip or seal. The barrel contains an ISO 594-2 compliant fixed male luer connector or male luer rotating adaptor, which are compatible with ISO 594-2 compliant female luer hubs.
This document is a 510(k) premarket notification for the Merit Coronary Control Syringe. It focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized consensus standards for medical devices. Therefore, the information provided does not specifically describe a study that proves the device meets acceptance criteria through clinical or AI-based performance metrics. Instead, it relies on bench testing as per established standards for mechanical and material properties.
However, I can extract the acceptance criteria and the "reported device performance" (which in this context refers to the demonstration of compliance with those criteria through testing) from the provided text.
Here's an interpretation of the request using the available information:
Acceptance Criteria and Device Performance (as demonstrated by compliance with standards):
The document states that the Merit Coronary Control Syringe complies with FDA recognized consensus standards ISO 7886-1 and ISO 594-2, and that "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use."
The acceptance criteria are implicitly defined by the requirements of these standards and other listed tests. The "reported device performance" is that the device met these criteria.
| Acceptance Criteria Category (from ISO Standards and Biocompatibility Tests) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7886-1 (Sterile hypodermic syringes for manual use) | Met all requirements |
| Cleanliness (Limits for acidity/alkalinity, extractable metals) | Compliant |
| Lubricant | Compliant |
| Tolerance on Graduated Capacity | Compliant |
| Graduated Scale | Compliant |
| Barrel | Compliant |
| Piston/Plunger Assembly | Compliant |
| Nozzle | Compliant |
| Performance - Freedom from air and liquid leakage past piston | Compliant |
| ISO 594-2 (Conical fittings with 6% (Luer) taper) | Met all requirements |
| Gauging | Compliant |
| Liquid leakage | Compliant |
| Air leakage | Compliant |
| Separation force | Compliant |
| Unscrewing torque | Compliant |
| Ease of assembly | Compliant |
| Resistance to overriding | Compliant |
| Stress cracking | Compliant |
| Biocompatibility Testing (ISO 10993 series) | Met all requirements |
| Cytotoxicity | Compliant |
| Sensitization | Compliant |
| Irritation | Compliant |
| Acute Systemic Toxicity | Compliant |
| Pyrogenicity | Compliant |
| Hemolysis | Compliant |
| USP Physicochemical | Compliant |
| Sterilization & Packaging Standards (Various listed ISO, ASTM, AAMI) | Met all requirements |
| Ethylene Oxide Sterilization | Compliant |
| Radiation Sterilization | Compliant |
| Packaging Integrity and Performance | Compliant |
Now, addressing the other specific points:
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each of the performance bench tests. It broadly states that "A battery of tests was performed."
- Data Provenance: The tests are "Performance Bench Testing" conducted on the physical device, indicating this is laboratory testing. The provenance is internal testing by Merit Medical Systems, Inc., to demonstrate compliance with international standards. There is no mention of country of origin for data in the sense of patient data, as this is a physical device rather than an AI/software device. The product is manufactured by Merit Medical Systems, Inc. (South Jordan, Utah, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a hardware product (coronary control syringe) that undergoes mechanical, chemical, and biological performance testing, not a diagnostic AI device requiring expert ground truth for interpretation of images or clinical outcomes.
- Therefore, there are no "experts" in the context of clinical interpretation establishing ground truth for a test set in this document. Ground truth for these tests is based on the quantifiable, measurable criteria defined by the ISO, ASTM, and AAMI standards themselves (e.g., specific thresholds for leakage, force, or biological reactivity). The "experts" would be the engineers and scientists conducting the tests and verifying compliance with the standard specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human readers or subjective assessments requiring adjudication. The tests are objective and based on measurable parameters defined by the consensus standards.
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 document pertains to a physical medical device (a syringe), not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to the device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance testing is based on predefined, measurable acceptance criteria specified by internationally recognized consensus standards (ISO, ASTM, AAMI). These standards set quantitative limits for performance attributes (e.g., "freedom from air and liquid leakage past piston," specific force for unscrewing torque, cytotoxicity levels). Compliance is determined by objective measurement against these established benchmarks.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI that would require a "training set." The focus is on manufacturing control and adherence to established engineering and material science standards.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
§ 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.