(31 days)
The Presto™ Inflation Device is indicated for use with angioplasty balloon dilatation catheters to create and monitor the pressure in the angioplasty balloon dilatation catheter and to deflate the angioplasty balloon dilatation catheter.
The Presto™ Inflation Device is an ultra high pressure, large volume inflation device used to inflate, monitor pressure, and deflate angioplasty balloon dilatation catheters. It is a onepiece, 30 mL disposable inflation device rated for 40 atm with a lever-lock design that controls the piston, a manometer, and a high-pressure connecting tube with a male Luer rotating adapter. Also enclosed is a high-pressure 3-way stopcock to aid in preparation and use of the device. The manometer measures pressures ranging from 0 atm up to 40 atm in 1 atm increments. The accuracy of the manometer has been determined to be within ±1.6 ATM. These products are not made with natural rubber latex.
The provided text describes a 510(k) summary for the Presto Inflation Device, focusing on its substantial equivalence to a predicate device. The information details the device's function, its similarities and differences to the predicate, and various performance tests conducted.
However, the document does not contain the kind of detailed information typically found in a clinical study report that would allow me to fully answer your request regarding acceptance criteria, specific test results, and experimental design (like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies).
The provided text focuses on non-clinical in vitro tests to demonstrate substantial equivalence, rather than clinical efficacy or diagnostic accuracy studies. Therefore, it lacks the specific data points you're asking for in a clinical context.
Here's an attempt to answer based on the available information, noting where data is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Syringe Volume | (Volume of device specified/met) | "a one-piece, 30 mL disposable inflation device" |
| Rated Inflation Pressure | (Device rated for 40 atm) | "rated for 40 atm" | |
| Fatigue Testing | (Withstand specified cycles/pressure without failure) | "met all the predetermined acceptance criteria of design verification and validation" | |
| ISO Luer and Stop Cock Hub Testing | (Conform to ISO standards for luer and stopcock connections) | "met all the predetermined acceptance criteria of design verification and validation" | |
| Pressure Reading Accuracy (Manometer) | Within ±1.6 ATM | "accuracy of the manometer has been determined to be within ±1.6 ATM" | |
| Tubing Tensile Strength | (Withstand specified tensile forces) | "met all the predetermined acceptance criteria of design verification and validation" | |
| Syringe Barrel Graduation Markings | (Accurate and clearly readable markings) | "met all the predetermined acceptance criteria of design verification and validation" | |
| Usability/Functionality | User Validation (Bubble Visualization) | (Ability to visualize bubbles during priming/use) | "met all the predetermined acceptance criteria of design verification and validation" |
| Packaging & Sterilization | Packaging (Visual Inspection, Dye Penetration, Tray Seal Tensile) | (Maintain sterility barrier, integrity, and specified seal strength) | "met all the predetermined acceptance criteria of design verification and validation" |
| Shelf Life | (Viable shelf life based on accelerated aging and stability program) | "Product will have a viable shelf life based upon successful completion of testing" | |
| Sterilization | (Achieved and maintained sterility) | "Same method of sterilization" (as predicate, implying effective sterilization) | |
| Biocompatibility | Cytotoxicity | (Non-cytotoxic) | "Successful testing for Cytotoxicity" |
| Sensitization | (Non-sensitizing) | "Successful testing for... Sensitization" | |
| Intracutaneous Reactivity | (Non-reactive intracutaneously) | "Successful testing for... Intracutaneous Reactivity" | |
| Pyrogenicity | (Non-pyrogenic) | "pyrogenicity testing is conducted to support labeling claims" |
Study Proving Acceptance Criteria:
The device meets its acceptance criteria through a series of in vitro non-clinical tests as detailed in the "Performance Data" section of the 510(k) summary. These tests were conducted using FDA Guidance Documents, recognized standards (e.g., ASTM F1980-07, ISO 10993-1:2009), and internal Risk Assessment procedures. The document states: "The results from these tests demonstrate that the technological characteristics and performance criteria of the Presto™ Inflation Device is comparable to the predicate devices and that it can perform in a manner equivalent to balloon inflation devices currently on the market with the same intended use."
Information Not Available in the Provided Text:
The following points are primarily relevant for studies involving diagnostic algorithms, AI, or clinical efficacy/safety trials with human subjects. The Presto Inflation Device is a mechanical medical device (angiographic injector), and the provided 510(k) summary focuses on demonstrating substantial equivalence through engineering and physical performance tests, rather than clinical outcomes or diagnostic accuracy. Therefore, the information for points 2-9 is not present in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The described tests are in vitro engineering and materials tests, not data-driven test sets in the context of AI or diagnostic algorithms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. Ground truth, in this context, would be defined by engineering specifications, recognized standards, and objective measurements, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication relates to resolving disagreements in human interpretation, which is not part of these mechanical device tests.
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 / Not provided. This is relevant for AI-assisted diagnostic tools, not for a mechanical inflation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Specifications and Recognized Standards: The "ground truth" for this device's performance would be derived from its design specifications (e.g., 30ml volume, 40 atm rating), adherence to international standards (e.g., ISO, ASTM), and the results of validated physical and chemical tests (e.g., biocompatibility testing).
8. The sample size for the training set
- Not applicable / Not provided. This device does not involve a training set as it is not an AI or machine learning model.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this question is not relevant.
§ 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.