(273 days)
The Angiography syringe is used to inject contrast media into the heart, great vessels, and coronary arteries during angiographic procedures.
The Angiography Syringe are plastic , single-use, disposable syringes to be offered in 6ml, 8ml, 10ml, 12ml size. As manual control syringe, each configuration includes bilateral, external finger rings located on the proximal barrel shaft. The proximal thumb rings located on the plunger, in tandem with the external finger rings on the barrel, allows for single handed movement to create aspiration and/or expulsion of fluids. The angiography syringe has two tip fitting: fixed adapter and rotating adapter
The provided text is a 510(k) summary for a medical device (Angiography Syringe) and does not describe the specific type of study, acceptance criteria, or expert involvement typically associated with AI/ML-based medical devices or diagnostic tools.
The document discusses "acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols," but these are for the mechanical and material properties of the syringe itself, not for diagnostic performance in the way a clinical study for AI would be evaluated.
Therefore, many of the requested details cannot be extracted from this document, as they are not applicable to the type of device and study presented.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists standards that the device complies with, which implicitly serve as acceptance criteria for those specific tests. However, it does not provide quantitative "reported device performance" against these criteria in a table format, other than stating compliance.
| Acceptance Criteria (Standards Complied With) | Reported Device Performance |
|---|---|
| ISO 594-1:1986 (Conical Fittings) | Complies |
| ISO 594-2:1998 (Lock Fittings) | Complies |
| ISO 7886-1:1993 (Sterile Hypodermic Syringes) | Complies |
| Biocompatibility (ISO 10993-x; In Vitro Hemolytic, Cytotoxicity, Skin Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogen) | Complies |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for non-clinical bench tests. The document states "Bench tests were conducted."
- Data Provenance: Not applicable. These are laboratory bench tests, not clinical data. The manufacturer is Shanghai Kindly Medical Instruments Co., Ltd., China.
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)
- Not applicable. This is a medical device (syringe), not an imaging or diagnostic AI/ML device requiring expert ground truth for its performance evaluation. The ground truth for its mechanical and biological safety is established by adherence to engineering and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no human interpretation or adjudication involved in the performance testing of a syringe against engineering or biocompatibility 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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of diagnostic performance. The "ground truth" for this device's performance is established by the specifications in the cited ISO standards for its physical and material properties (e.g., fit of luer connections, sterility, biocompatibility).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
Summary of the Study Proving the Device Meets Acceptance Criteria (as described in the document):
The study to prove the device meets acceptance criteria was primarily non-clinical bench testing. The manufacturer conducted various tests to verify that the Angiography Syringe met all device specifications and was substantially equivalent (SE) to a predicate device.
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Tests Performed:
- Compliance with ISO 594-1:1986 (Conical Fittings)
- Compliance with ISO 594-2:1998 (Lock Fittings)
- Compliance with ISO 7886-1:1993 (Sterile Hypodermic Syringes)
- Biocompatibility Testing (referencing ISO 10993 standards):
- In Vitro Hemolytic Properties
- In Vitro Cytotoxicity
- Skin Irritation
- Skin Sensitization
- Acute Systemic Toxicity
- Pyrogenicity
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Conclusion: The test results demonstrated that the proposed devices comply with the listed standards, indicating that they met the predetermined acceptance criteria for design verification and validation. The document explicitly states, "Clinical Test: It is not applicable."
§ 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.