(210 days)
Disposable Angiographic Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.
The applicant device of Disposable Angiographic Syringe are plastic, single-use, disposable syringes to be offered in 50/50ml, 50/200ml, 60/60 mL, 60/100mL, 90ml,, 120 ml., 130 mL, 150 mL and 200mL sizes. The syringes will be offered made of PP and PETG both materials, of which, are available in current legally marketed products. All series follow same design principle, same material, and same intended use. The only differences are volume and the connection (nozzle) to different angiography injector from different manufacturer. The connection differs to fit with US legally Market Angiographic Injectors. The connector difference is only to fit the injector and does not affect the performance of the syringes.
Here's a breakdown of the acceptance criteria and study information for the Disposable Angiographic Syringe (K082439) based on the provided text:
Important Note: The provided document is a 510(k) Summary and an FDA clearance letter. It typically does not contain detailed study protocols, raw data, or specific acceptance criteria with quantifiable metrics and reported performance values. The information provided will reflect what is typically found in such a summary, which is often high-level and attests to testing being completed successfully rather than providing a detailed report of the results.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, specific acceptance criteria values (e.g., "burst pressure > X psi") and corresponding reported performance metrics are not provided in this 510(k) summary. The summary states:
"Laboratory testing was conducted to validate and verify that Disposable Angiographic Syringe met all design specifications and was substantially equivalent to the predicate device."
This indicates that internal design specifications served as the acceptance criteria, and the device's performance met these unstated specifications. For a detailed table, one would need to access the full testing report submitted to the FDA, which is not publicly available in this summary.
General Inference of Acceptance Criteria: Based on the device type (angiographic syringe), acceptance criteria would likely relate to:
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Material Biocompatibility | Meets biocompatibility standards. |
| Sterility | Meets sterility assurance levels. |
| Functional Performance (e.g., plunger force, leakage) | Operates as intended without issues. |
| Pressure Resistance/Burst Strength | Withstands intended operating pressures. |
| Compatibility with Injectors | Fits and functions with listed injectors. |
| Durability/Integrity | Maintains integrity during use. |
| Dimensional Accuracy | Meets specified dimensions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: The studies were laboratory tests conducted by the manufacturer, Shandong Weigao Group Medical Polymer Co., Ltd., which is located in China. The data would be prospective in nature, as it was generated specifically for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. For a medical device like an angiographic syringe, ground truth is typically established through:
- Engineering specifications.
- Material testing standards.
- Performance test protocols.
- Compliance with recognized standards (e.g., ISO, ASTM).
It does not involve expert consensus in the same way an AI diagnostic algorithm for medical imaging would. The "ground truth" for this device's performance is objective physical and chemical measurements against pre-defined engineering and safety standards.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, particularly in clinical studies involving interpretation (e.g., by radiologists). For laboratory testing of a device's physical properties, the results are typically quantitative measurements, not subject to expert adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to assess the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. It is not relevant for the clearance of a basic medical device like a disposable syringe, whose function is mechanical and material-based.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
No, a standalone study in the context of an "algorithm only" performance was not done. This device is a physical medical instrument, not an AI algorithm. The performance evaluation involved laboratory testing of the syringe itself, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation was based on engineering specifications, material science standards, and performance testing against predetermined criteria. These would cover aspects like:
- Specified material properties (PP and PETG).
- Dimensional tolerances.
- Pressure resistance.
- Seal integrity.
- Biocompatibility (often tested against ISO 10993).
- Sterility (e.g., SAL of 10^-6).
- Leakage rates.
- Functional compatibility with specified injectors.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical product and does not involve a training set. The manufacturer's design and manufacturing processes are iteratively refined through quality control, but this isn't analogous to an ML training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. As explained in point 8, there is no "training set" in the context of this device.
§ 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.