(79 days)
The Ascendra Balloon Aortic Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
The Edwards Ascendra Balloon Aortic Valvuloplasty Catheter is used for balloon aortic valvuloplasty. The device consists of a coaxial polyamide catheter with a distal inflatable polyamide balloon intended to dilate (perform valvuloplasty on) the stenotic aortic valve prior to implantation of a bioprosthesis. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. At the proximal end of the catheter, there is a standard "Y" connector for balloon inflation and a guidewire lumen. An inflation device may be connected directly or indirectly (using the supplied extension tubing) to the balloon inflation luer port of the catheter. The balloon is inflated by injecting a diluted contrast medium solution through the luer port (marked "BALLOON") on the "Y" connector. The device is supplied sterile for single use only. The BAVC is provided in a 20 mm size and is compatible with a 0.035" guidewire and a 14F sheath.
This document is a 510(k) summary for the Ascendra Balloon Aortic Valvuloplasty Catheter. It does not describe an AI/ML device or algorithm. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided text, focusing on the device and its assessment, and stating "Not Applicable" for AI-specific questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General Categories) | Reported Device Performance and Assessment |
|---|---|
| Biocompatibility | Met per ISO 10993-1. |
| Sterilization Efficacy | Ethylene oxide sterilization validated. |
| Packaging Integrity | Package qualification performed. |
| Device Functional Performance (e.g., integrity, dimensions, inflation, strength) | Non-clinical testing included: |
- Surface/visual inspection
- Dimensional inspection
- Radiopacity
- Balloon diameter
- Insertion force into sheath
- Balloon inflation time
- Balloon compliance
- Catheter kink test
- Balloon catheter retrieval force
- Balloon fatigue and burst
- Leakage test
- Bond testing
(All concluded to demonstrate substantial equivalence) |
| Clinical Safety and Effectiveness | Literature review, comparison to currently marketed devices, and complaint analysis concluded that the use of Balloon Aortic Valvuloplasty (BAV) for predilation prior to TAVR or as a bridge to percutaneous/surgical aortic valve replacement is feasible and safe. This was supported by clinical trials reviewed as part of PMAs P110021 and P130009. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated for non-clinical or clinical assessment. For non-clinical tests, it would refer to the number of devices tested for each functional criterion. For the clinical assessment, it
refers to a "literature review, comparison to currently marketed devices and complaint analysis" and the results of clinical trials (P110021 and P130009), but specific sample sizes of patients/cases used in the literature review or complaint analysis are not provided in this summary. - Data Provenance: Not specified in this 510(k) summary (e.g., country of origin). The clinical assessment relies on literature and existing PMA clinical trials.
- Retrospective/Prospective: The literature review and complaint analysis would inherently involve retrospective data. The PMA clinical trials (P110021 and P130009) would have been prospective studies, but details are not provided here.
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. This is a medical device (catheter), not an AI/ML diagnostic or image analysis device that requires expert-established ground truth for a test set. The clinical assessment relies on scientific literature, comparison to predicate devices, and results from pre-market approval (PMA) clinical trials.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable, as this is not an AI/ML device relying on human expert adjudication for image interpretation or diagnosis.
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 medical device, not an AI/ML reading assistance tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device (catheter), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would be established engineering specifications, ISO standards, and predicate device performance. For the clinical assessment, the "ground truth" on safety and feasibility is derived from comprehensive clinical outcomes data from literature reviews, comparison with predicate devices, complaint analysis, and the results of clinical trials (P110021 and P130009) that likely involved patient outcomes, physiological measurements, and possibly pathology or imaging interpretation in the context of valuloplasty.
8. The sample size for the training set
Not Applicable. This device does not use a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not Applicable. This device does not use a training set.
§ 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.