(70 days)
The Monarch™ COMPAK Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices, and to measure the pressure within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid.
The subject Monarch™ COMPAK Inflation Syringe is a single use, balloon inflation and fluid dispensing device with an integrated pressure transducer, microprocessor, LED display, threaded plunger assembly with lock/release handle, a flexible high pressure extension tubing and a three-way stopcock. The Monarch™ COMPAK has a shorter barrel than the standard Monarch™ device. It is designed to generate and monitor pressures over a range of -0.4 to +30 ATM.
The provided text does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets detailed performance metrics for the Monarch™ COMPAK Inflation Syringe.
Instead, it relies on a statement of substantial equivalence to predicate devices and general claims about design verification testing. Here's a breakdown of what can be extracted and what information is missing based on your request:
Acceptance Criteria and Reported Device Performance
The provided text does not list specific, quantifiable acceptance criteria or detailed performance results in a table format as requested. The closest available information is a general statement from the "Safety & Performance Tests" section:
"Verification testing, determined to be applicable to the safety and efficacy of the device, was shown to meet predetermined acceptance criteria."
This statement confirms that acceptance criteria exist and were met, but it does not provide the criteria themselves or the reported performance data.
Missing Information:
- Detailed Acceptance Criteria: Specific numerical thresholds (e.g., pressure accuracy within X mmHg, inflation/deflation time within Y seconds).
- Reported Device Performance: Actual measured values from the verification tests to compare against the acceptance criteria.
Therefore, the following points from your request cannot be answered based on the provided text:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This kind of detailed performance data is typically found in design verification and validation reports, which are usually proprietary and not included in a 510(k) summary. The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing exhaustive performance data.
§ 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.