(140 days)
The Merit analog inflation syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
The Merit analog inflation syringe is a single use disposable device capable of generating and monitoring pressure in angioplasty or other similar interventional devices. It is fitted with a threaded plunger assembly with lock/release bar, flexible high pressure extension tube. It is provided with a 510(k)-cleared three way medium pressure stopcock.
The provided text describes a 510(k) premarket notification for the Merit Medical Systems, Inc. Analog Inflation Syringe (BasixCOMPAK). This device is intended to inflate and deflate angioplasty balloons and measure pressure. The submission asserts substantial equivalence to a predicate device, the Merit Monarch COMPAK Inflation Syringe & Universal Fluid Dispensing Device (K083523). The primary difference noted is the display type: analog for the subject device versus digital for the predicate.
The document lists various tests performed to demonstrate safety and efficacy, drawing upon industry standards and guidance. However, it does not provide detailed acceptance criteria values or specific performance data for each test. Instead, it broadly states that "the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device."
Here's an attempt to extract and structure the information based on your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (General Description) | Reported Device Performance (General Description) | Specific Numeric Values/Details from Document |
|---|---|---|---|
| Functional Tests | Ensure proper inflation/deflation and pressure measurement. | Successfully completed. | Not specified. |
| - Fluid | Ability to function with fluid. | Successfully completed. | Not specified. |
| - Air | Ability to function with air. | Successfully completed. | Not specified. |
| Mechanical/Strength Tests | Withstand operational forces, maintain integrity. | Successfully completed. | Not specified. |
| - Torqueability | Ability for components to withstand rotational forces. | Successfully completed. | Not specified. |
| - Tensile | Ability for components to withstand pulling forces. | Successfully completed. | Not specified. |
| Leak/Integrity Tests | Maintain fluid/air containment. | Successfully completed. | Not specified. |
| - Thermal Shock – Leak Test | Maintain integrity after thermal stress. | Successfully completed. | Not specified. |
| - Vacuum Capability | Ability to maintain vacuum pressure. | Successfully completed. | Not specified. |
| Durability/Environmental Tests | Withstand typical handling and transportation. | Successfully completed. | Not specified. |
| - Transportation Simulation | Maintain integrity and function after simulated shipping. | Successfully completed. | Not specified. |
| Performance Accuracy/Precision | Accurate and consistent pressure measurement. | Successfully completed. | Not specified. |
| - Gauge Responsiveness | Speed and accuracy of gauge response to pressure changes. | Successfully completed. | Not specified. |
| - Volumetric Comparison | Comparison of inflated volume to expected volume. | Successfully completed. | Not specified. |
| - Greening Effect | (Likely refers to material compatibility or degradation over time) | Successfully completed. | Not specified. |
| - Gauge Accuracy and Precision | Accuracy and consistency of pressure readings. | Successfully completed. | Not specified. |
| Biocompatibility | Ensure material safety in contact with biological systems. | Based on ISO 10993-1 and FDA Modified ISO 10993 Test Profile. | Details of specific tests or results not provided. |
| Sterilization | Ensure effective sterilization and acceptable residuals. | Based on ISO 11135-1 and ISO 10993-7. | Details of specific tests or results not provided. |
| Aging | Ensure sterile barrier integrity over time. | Based on ASTM F1980-07. | Details of specific tests or results not provided. |
| Fittings | Ensure proper and secure connections. | Based on ISO 594-1 and ISO 594-2. | Details of specific tests or results not provided. |
Important Note: The provided document states generally that the device "met the acceptance criteria necessary to demonstrate the safety and efficacy of the device" for all listed tests. However, it does not provide the specific quantitative acceptance criteria values (e.g., "pressure must be accurate within +/- X mmHg") nor the specific reported performance values (e.g., "the device demonstrated accuracy of +/- Y mmHg"). The document lists the types of tests performed and the standards they were based on, implying that the specific criteria and results are in the full test reports, which are not included here.
Regarding the other requested information, the document unfortunately does not contain details for points 2 through 9:
- 2. Sample size used for the test set and the data provenance: Not mentioned. The document lists tests but not the number of units tested.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a mechanical instrument, and its performance is evaluated against engineering specifications and industry standards, not subjective expert assessment of data like in an AI diagnostic device.
- 4. Adjudication method for the test set: Not applicable. Performance is measured objectively.
- 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 a standalone medical device, not an AI-assisted diagnostic tool involving human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, by definition, the safety and performance tests described were for the standalone device. However, the term "algorithm only" is more typically associated with software-based devices, which this is not.
- 7. The type of ground truth used: For this device, the "ground truth" would be established engineering specifications, calibrated measurement standards, and requirements outlined in the referenced ISO and ASTM standards. For example, a "gauge accuracy" test would compare the device's reading to a known, highly accurate reference pressure gauge.
- 8. The sample size for the training set: Not applicable. This is a physical device, not an AI model 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.