(317 days)
Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.
The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube and spike.
The provided text is a 510(k) Summary for a medical device (Sterile High-pressure Angiographic Syringes for Single-use). It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in a clinical setting.
Therefore, I cannot provide information regarding:
- Acceptance Criteria and Reported Device Performance for clinical outcomes: The document focuses on performance specifications (e.g., pressure, sterility, biocompatibility) of the device components, not clinical performance metrics or specific acceptance criteria for a clinical study.
- Sample size for the test set and data provenance: No clinical test set is described. The "test set" here refers to samples used for non-clinical engineering and biological tests.
- Number of experts and qualifications, and adjudication method: These pertain to clinical studies with a ground truth established by experts, which is not applicable here.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This is a type of clinical study not performed or referenced in this document.
- Effect size of human readers with/without AI assistance: This is irrelevant as the device is a syringe and connection tube, not an AI-assisted diagnostic tool.
- Standalone (algorithm only without human-in-the-loop performance): This is also irrelevant for this type of medical device.
- Type of ground truth used: Ground truth, typically defined by expert consensus or pathology in a clinical context, is not applicable here. The "ground truth" for these non-clinical tests is adherence to established engineering and biological standards.
- Sample size for the training set and how the ground truth for the training set was established: These concepts are related to machine learning and AI, which are not relevant to the described device.
What the document does provide in relation to "acceptance criteria" and "study that proves the device meets the acceptance criteria" (within the scope of a 510(k) for a physical medical device):
The document details a series of non-clinical tests performed to demonstrate that the proposed device meets established performance standards and is substantially equivalent to a predicate device. These standards effectively act as the "acceptance criteria" for the device's design and manufacturing.
Here's a summary of the non-clinical acceptance criteria (standards/tests) and the reported performance:
1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Complies (implied by "Non clinical tests were conducted to verify... met all design specifications") |
| ISO 10993-5:2009 (Tests for In Vitro cytotoxicity) | No Cytotoxicity |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | No Irritation, No Sensitization |
| ISO 10993-4:2017 (Selection of tests for interactions with blood) & ASTM F756:2017 (Hemolytic Properties) | No Hemolysis |
| **USP 41 NF 36 ** (Pyrogen Test) | No Pyrogen |
| Endotoxin Limit (USP 41-NF36 2018 ) | 20 EU per device |
| Functionality & Performance | |
| ISO 7886-1:2017 (Sterile hypodermic syringes for manual use) | Complies with test items (Overall length of scale, syringe dimension, nozzle lumen, dead space, liquid leakage, air leakage, flow characteristics) |
| ISO 7886-2:1996 (Sterile hypodermic syringes for use with power-driven syringe pumps) | Complies with test items (Lubricant weight, Graduated capacity tolerance, overall length of scale, syringe dimension, nozzle lumen, dead space, liquid leakage, air leakage and flow characteristics) |
| ISO 594-1:1986 (Conical fittings with a 6% (Luer) taper - General Requirements) | Complies with test items (Gauging test, liquid leakage, separation force and stress cracking) |
| ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper - Lock Fitting) | Complies with test items (Liquid leakage, air leakage, separation force, unscrew torque, ease of assembly, resistance to overriding and stress cracking) |
| Compatibility Test Report (Injectors, syringe, connection tube, spike/J shape tube) | Each device meets performance under maximum sustained pressure specification. Syringe, connection tube, and spike can withstand stated maximum pressure. |
| Sterilization & Packaging | |
| ASTM F88/F88M-15 (Seal strength of flexible barrier materials) | Complies |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package by Dye Penetration) | Complies |
| ISO 11134:2014 (Ethylene Oxide Sterilization) | Complies |
| **USP ** (Particular Matter in Injections) | Complies |
| Shelf Life Testing | 5-year shelf life demonstrated after accelerated aging. |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of units) used for each non-clinical test. It generally states that "Non clinical tests were conducted."
- The data provenance is from non-clinical laboratory testing performed by the manufacturer (Shenzhen Boon Medical Supply Co., Ltd) in China, as per the sponsor identification. These are not human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to established engineering and biological standards (e.g., ISO, ASTM, USP), not expert clinical adjudication. Compliance with these standards is determined by trained technicians/engineers through validated testing methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept relates to multi-expert clinical review, which is not relevant for non-clinical device testing verifying adherence to standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This is not relevant to a sterile syringe product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- For this device, the "ground truth" for proving it meets "acceptance criteria" is adherence to recognized international and national standards for medical device performance, biocompatibility, and sterility (e.g., ISO 7886, ISO 594, ISO 10993, ASTM F88, USP monographs).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- 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.