(268 days)
INOUE BALLOON™ A is intended for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.
INOUE BALLOON™ A is intended for the treatment of patients with aortic valvuloplasty (BAV). The device is transported over a guidewire as it is inserted through a percutaneous entry site and expanded with a predetermined amount of the diluted contrast medium by use of specified syringe with extension tube connected to the balloon inflation luer-lock hub. This results in the staged inflation of the balloon from hour-glass to barrel shape. The balloon is stretched and made thinner by pushing the inner tube in during passing thorough the introducer sheath. A radiopaque marker is provided for fluoroscopic positioning of the device across the valve.
This document is a 510(k) summary for the INOUE BALLOON™ A, a balloon aortic valvuloplasty catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance directly. Therefore, it does not contain the detailed clinical study information typically provided for AI/ML-driven devices.
Here's an analysis based on the provided text, addressing your questions where possible and noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in a formal table with quantitative targets for each performance metric, as might be found for a new clinical efficacy study. Instead, it lists various physical performance tests and states that the device "meets specifications." The performance is implicitly deemed acceptable if it is "similar to that described by the predicate device" and indicates the device is "as safe and effective as the predicate device."
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Radio-detectability | Similar to predicate | Meets specifications |
| Surface | Similar to predicate | Meets specifications |
| Corrosion resistance | Similar to predicate | Meets specifications |
| Peak tensile force | Similar to predicate | Meets specifications |
| Freedom from leakage | Similar to predicate | Meets specifications |
| Hubs | Similar to predicate | Meets specifications |
| Designation of nominal size | Similar to predicate | Meets specifications |
| Diameter of largest guidewire | Similar to predicate | Meets specifications |
| Sheath compatibility | Similar to predicate | Meets specifications |
| Balloon minimum burst strength | Similar to predicate | Meets specifications |
| Balloon fatigue (leakage/damage) | Similar to predicate | Meets specifications |
| Balloon inflation/deflation times | Similar to predicate | Meets specifications |
| Torquing | Similar to predicate | Meets specifications |
| Balloon preparation | Similar to predicate | Meets specifications |
| Bending | Similar to predicate | Meets specifications |
| Balloon over inflation | Similar to predicate | Meets specifications |
| Catheter removal | Similar to predicate | Meets specifications |
| Usability evaluation | Similar to predicate | Meets specifications |
| Biocompatibility | ISO 10993-1 for short duration blood contact | Meets ISO 10993-1 |
| Sterilization | SAL 10^-6 level | Achieved via ethylene oxide |
2. Sample Size Used for the Test Set and Data Provenance
This document describes pre-clinical performance data, primarily engineering and material tests, not tests on human clinical data. Therefore, the concept of a "test set" and "data provenance" related to patient data (country, retrospective/prospective) is not applicable here. The "sample size" would refer to the number of devices tested for each performance characteristic, which is not specified in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth from medical experts is relevant for diagnostic claims, often involving image interpretation. This device is a medical instrument (balloon catheter), and its performance data focuses on physical and material properties. Usability evaluations would typically involve feedback from clinicians, but the number and qualifications are not specified in this summary.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to establish a robust ground truth from multiple expert interpretations, typically in diagnostic or screening studies. This document does not describe such studies.
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 device is an interventional medical device, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
For the pre-clinical performance tests, the "ground truth" would be established by the defined test methodologies and expected outcomes (e.g., a burst strength test has a quantitative "ground truth" for the maximum pressure it can withstand). For biocompatibility, the ground truth is adherence to ISO 10993-1 standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" presented here is a collection of pre-clinical performance data (i.e., laboratory and bench testing) designed to demonstrate that the INOUE BALLOON™ A functions as intended and is as safe and effective as its predicate device. This includes:
- Mechanical and Material Property Tests: Radio-detectability, surface integrity, corrosion resistance, peak tensile force, freedom from leakage, hub integrity, nominal size designation, guidewire compatibility, sheath compatibility, balloon minimum burst strength, balloon fatigue, inflation/deflation times, torquing, balloon preparation, bending, balloon over-inflation, and catheter removal.
- Biocompatibility Testing: According to ISO 10993-1 for short-duration contact with blood (
§ 870.1255 Balloon aortic valvuloplasty catheter.
(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.