(325 days)
The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.
The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely. The balloon in-deflation device mainly composes of four parts, injecting system (syringe), pressure gauge and extension tube, 3way stopcock, respectively. The syringe consists of a screw type plunger and a locking lever, by rotating palm grip to control the plunger; the pressure gauge is to measure pressure and the extension tube is to connect catheters. The angle of the pressure gauge can be re-adjusted during the procedure.
Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them:
The document does not detail specific acceptance criteria for each performance characteristic of the Mastro Plus Balloon In-deflation Device. Instead, it asserts substantial equivalence to predicate devices through a comparison of design specifications and non-clinical performance testing. The overarching "acceptance criteria" appear to be that the proposed device must meet all design specifications and perform as safely and effectively as the predicate devices.
1. A table of acceptance criteria and the reported device performance
While explicit acceptance criteria are not presented as numerical targets to be met, the table below infers the performance characteristics evaluated and the proposed device's performance as compared to its predicates. The "Acceptance Criteria" column reflects the general expectation for substantial equivalence (i.e., being comparable to or within acceptable ranges of the predicate's performance).
| Performance Characteristic | Inferred Acceptance Criteria (Comparable to Predicates) | Reported Device Performance (Mastro Plus Balloon In-deflation Device) |
|---|---|---|
| Volume | Comparable to predicate devices (20ml, 30ml) | 20ml, 30ml |
| Range of Positive Pressure | Zero to +35ATM (or similar) | Zero to +30ATM |
| Lock Mechanism | Thread lock mechanism | Thread lock mechanism |
| Plunger | Screw-type plunger | Screw-type plunger |
| Volume Dispensed | Comparable to predicate volume dispensed/rotation | Syringe with 20ml capacity: 0.43ml per 360° handle rotation; Syringe with 30ml capacity: 0.76ml per 360° handle rotation |
| Accuracy | ±2.5% full scale typical (or similar) | ±4.0% full scale typical (between ±0.8 and ±1 ATM/Bar) |
| Barrel Material | Polycarbonate | Polycarbonate |
| Handle/Plunger Material | ABS, Glass filled nylon 6/6 / Teflon (or similar) | PA66+30% Fiberglass |
| Extension Tubing | Polyurethane | Polyurethane |
| Gauge Material | EPDM; brass and stainless steel (or similar) | Brass and PC |
| Connector | Male, rotating | Male, rotating |
| Mechanism of quick release handle | Yes/No (depending on specific predicate feature) | No |
| Display Function | Yes/No (depending on specific predicate feature) | No |
| Biocompatibility | No Cytotoxicity; No Evidence of Dermal/Intracutaneous Reactivity | No Cytotoxicity; No Evidence of Dermal/Intracutaneous Reactivity |
| Sterilization | ETO | ETO |
| SAL | 10^-6 | 10^-6 |
| Sterilization Validation | Per ISO 11135-1:2006 | Per ISO 11135-1:2006 |
| Labeling | Complies with FDA Requirements | Implied compliance |
| Sterilization Package Performance | Complies with ISO 11607-1:2006 | Implied compliance |
| Package Material | Unknown (predicate) | PETG and Tyvek |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the non-clinical tests (biocompatibility or bench testing). It also does not provide details on the data provenance such as country of origin or whether the data was retrospective or prospective. The tests are described as general performance testing and biocompatibility testing.
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)
This section is not applicable. The device is a "Balloon In-deflation Device," which is a physical medical instrument used for inflation/deflation of balloons and stents. The "ground truth" here is established through engineering and biological testing against specifications and standards, not through expert clinical consensus on interpretations of medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As above, the "test set" refers to physical device testing, not clinical data requiring adjudication by experts.
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
This section is not applicable. The device is a physical medical instrument for catheter inflation/deflation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established through:
- Design specifications: The device is designed to perform according to a set of pre-defined engineering and functional specifications (e.g., pressure range, volume dispensed per rotation, material composition).
- Recognized industry standards: Compliance with standards like ISO 11135-1:2006 for sterilization validation and ISO 11607-1:2006 for sterilization package performance.
- Biocompatibility testing results: Tests like pyrogen, endotoxin, acute systemic toxicity, irritation, cytotoxicity, skin sensitization, haemolysis, complement activity, and thrombosis tests provide "ground truth" regarding the device's biological safety.
- Bench testing results: Tests for appearance, positive/negative pressure sealing, male luer lock, capacity scale, and gauge accuracy provide "ground truth" for the device's physical and functional performance.
8. The sample size for the training set
This section is not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable. As stated above, there is no "training set" for 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.