(302 days)
The Sterile Disposable Syringes are intended for the injection of contrast media or saline, they shall be used with an U.S legally marketed angiographic injector.
The proposed devices are available in packs, which may include different configuration of syringes and accessories. The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S legally marketed angiography injector, compatibilities are shown in Table 1. The connecting tubes, which is used to connect the syringe and the catheter. The tubes are available in three configurations, which are straight tube, Type T tube and spiral tube. The different between these tubes is tube shape, which is available in straight shape for straight tube, spiral shape for spiral tube and T shape for T tube. The Type T tube is available in a various specifications to connect different model of syringe. J shape tube, which is used to draw contrast media/ saline into the syringe barrel. Spikes, which are used to draw contrast media/saline into the syringe barrel.
This document is a 510(k) Summary for Sterile Disposable Syringes, which is a regulatory submission to the FDA. It details the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device. It specifically states: "No clinical study is included in this submission."
Therefore, the following information about acceptance criteria and studies to meet them cannot be provided from the given text:
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A table of acceptance criteria and the reported device performance: While the document lists various non-clinical tests and standards (e.g., ISO 7886-2, ISO 594-1, ISO 594-2), it does not explicitly state numerical acceptance criteria for these tests or specific reported device performance results in a comparative table for a clinical study. It only states that the device "complies with the following standards" and that “non clinical tests were conducted to verify that the proposed device met all design specifications”. For biocompatibility, it states "No cytotoxicity," "No intracutaneous reactivity," etc., which can be considered performance relative to certain criteria.
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Sample sized used for the test set and the data provenance: No clinical test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set/study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no clinical test set/study.
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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 a medical device (syringes) and not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device (syringes) and not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as there is no clinical test set/study. The ground truth for the non-clinical tests would be the established specifications and standards (e.g., ISO for sterility, gauging, leakage).
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The sample size for the training set: Not applicable as there is no clinical study or algorithm that requires a training set. The device is a physical product (syringes).
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How the ground truth for the training set was established: Not applicable as there is no clinical study or algorithm that requires a training set.
Summary of available information regarding non-clinical acceptance and performance:
The non-clinical tests performed on the proposed device (Sterile Disposable Syringes) were conducted to verify that it met all design specifications and was Substantially Equivalent (SE) to the predicate device (ANT Angiographic Syringes K072696).
The tests and their compliance statements are:
| Test/Characteristic | Standard/Description | Reported Device Performance/Compliance Statement |
|---|---|---|
| Cleanliness | Clause 5 of ISO 7886-2:1996 | Complies with standard |
| Limits for acidity/alkalinity | Clause 6 of ISO 7886-2:1996 | Complies with standard |
| Limits for extractable metals | Clause 7 of ISO 7886-2:1996 | Complies with standard |
| Lubricant | Clause 8 of ISO 7886-2:1996 | Complies with standard |
| Tolerance on graduated capacity | Clause 9 of ISO 7886-2:1996 | Complies with standard |
| Graduated scale | Clause 10 of ISO 7886-2:1996 | Complies with standard |
| Barrel | Clause 11 of ISO 7886-2:1996 | Complies with standard |
| Piston/plunger assembly | Clause 12 of ISO 7886-2:1996 | Complies with standard |
| Nozzle | Clause 13 of ISO 7886-2:1996 | Complies with standard |
| Performance | Clause 14 of ISO 7886-2:1996 | Complies with standard |
| Gauging | Clause 4.1 of ISO 594-1:1986 | Complies with standard |
| Liquid leakage | Clause 4.2 of ISO 594-1:1986 | Complies with standard |
| Air leakage | Clause 4.3 of ISO 594-1:1986 | Complies with standard |
| Separation force | Clause 4.4 of ISO 594-1:1986 | Complies with standard |
| Stress cracking | Clause 4.5 of ISO 594-1:1986 | Complies with standard |
| Gauging | Clause 4.1 of ISO 594-2:1998 | Complies with standard |
| Leakage | Clause 4.2 of ISO 594-2:1998 | Complies with standard |
| Separation force | Clause 4.3 of ISO 594-2:1998 | Complies with standard |
| Unscrewing torque | Clause 4.4 of ISO 594-2:1998 | Complies with standard |
| Ease of assembly | Clause 4.5 of ISO 594-2:1998 | Complies with standard |
| Resistance to overriding | Clause 4.6 of ISO 594-2:1998 | Complies with standard |
| Stress cracking | Clause 4.7 of ISO 594-2:1998 | Complies with standard |
| Seal strength (Packaging) | ASTM F88/F88-09 | Complies with standard |
| Dye penetration (Packaging) | ASTM F1929-12 | Complies with standard |
| EO residue | ISO 10993-7:2008 | Complies with standard |
| ECH residue | ISO 10993-7:2008 | Complies with standard |
| Bacteria Endotoxin Limit | USP 38-NF 33 | Complies with standard |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Test | Performed on aging samples to verify the claimed shelf life of the device |
| Cytotoxicity | ISO 10993-5 | No cytotoxicity |
| Skin Sensitization | ISO 10993-10 | No skin sensitization |
| Intracutaneous Reactivity | ISO 10993-10 | No intracutaneous reactivity |
| Acute Systemic Toxicity | ISO 10993-11 | No systemic toxicity |
| Hemolytic Property | ASTM F756 | No hemolysis |
| Pyrogen | ISO 10993-11 | No pyrogen |
| Complement Activity | ISO 10993-4 | No complement |
§ 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.