(276 days)
The High Pressure Tubing is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.
The High Pressure Tubing is a sterile, single use device which can withstand injection pressure to 1200psi. The High Pressure Tubing is composed of tubing with connector at each end. The connector is a female-male combination and rotating adapter. The High Pressure Tubing is supplied sterile by Ethylene Oxide and disposable device. The material of tube is PU with polvamides liner, and the appearance is braided.
The provided document describes the 510(k) premarket notification for a medical device called "High Pressure Tubing." The submission argues for the substantial equivalence of the proposed device to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the format typically associated with a clinical or analytical performance study of a diagnostic or AI device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing against established standards and a comparison of technological characteristics.
However, we can infer some criteria and reported performance from the "Non-clinical Test Conclusion" and the comparison table.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Integrity / Luer Compatibility: Conical fittings comply with ISO 594-1:1986 and ISO 594-2:1998 | Proposed device complies with ISO 594-1:1986, ISO 594-2:1998 |
| Pressure Withstand Capability: Withstand specified injection pressure | Proposed device "can withstand injection pressure to 1200psi" |
| Infusion Equipment Standards: Compliance with ISO 8536-4:2010 | Proposed device complies with ISO 8536-4:2010 |
| Sterility: Supplied sterile by Ethylene Oxide | Proposed device "is supplied sterile by Ethylene Oxide" |
| Single Use: Designed for single use | Proposed device "is a sterile, single use device" |
| Materials: Tubing material PU with polyamides liner for 1200psi | Tubing material is PU with polyamides liner for 1200psi |
The document states: "Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device. The test result demonstrates that the proposed devices comply with the following standards: ISO 594-1:1986, ISO 594-2:1998, ISO 8536-4:2010."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for the bench testing (e.g., number of tubing samples tested for pressure, luer compatibility, etc.). It only mentions that "Bench tests were conducted." The provenance of this test data (country of origin, retrospective/prospective) is also not specified beyond the fact that the manufacturer is "Shanghai Kindly Medical Instruments Co., Ltd."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The device is a piece of medical tubing, not a diagnostic or AI device requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its physical and functional specifications meeting industry standards, which is assessed through engineering and materials testing, not expert clinical review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As explained above, the assessment is based on objective measurements against engineering standards, not subjective expert judgment 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
This information is not applicable and not provided. The device is medical tubing, not an AI or diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is medical tubing, not an algorithm. Standalone algorithm performance studies are not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established engineering and medical device standards (ISO standards) and the device's own predetermined specifications (e.g., withstand 1200psi). It's essentially "compliance with specified physical and performance characteristics."
8. The sample size for the training set
This information is not applicable and not provided. The device is medical tubing; there is no "training set" in the context of machine learning or AI that would be relevant here.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set for this type of medical device, the establishment of ground truth for such a set is not relevant.
§ 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.