(284 days)
The OutFlo Aortic Valve Dilatation Balloon Catheter is indicated for balloon aortic valvuloplasty.
The OutFlo Aortic Valve Dilatation Balloon Catheter (marketing name: OutFlo) is a sterile, single use, Over-the-Wire (OTW) dual-lumen catheter with a hub at the proximal end and a balloon cluster at the distal end. The proposed device consists of a series of parallel balloons on a catheter which, when deployed, provides an outward radial force while also creating an inter balloon space or passage for blood flow. Thus, buildup of pressure in the ventricle is avoided. The dilation catheter is intended to be used in conjunction with a 14F or larger guiding catheter and a 0.035" or smaller guidewire, and Y-connectors, none of which are supplied by the manufacturer. The OutFlo Aortic Valve Dilatation Balloon Catheter is provided in five models. The only difference between the models are the balloon diameter.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text. It's important to note that the document is a 510(k) summary, which often provides high-level information rather than detailed study protocols. Therefore, some information might be missing or stated generally.
Device Name: OutFlo Aortic Valve Dilatation Balloon Catheter
Indications for Use: The OutFlo Aortic Valve Dilatation Balloon Catheter is indicated for balloon aortic valvuloplasty.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" for the clinical study in a quantifiable manner (e.g., "X% success rate"). Instead, it describes the objectives and results. The primary clinical "acceptance criteria" can be inferred from the study's evaluation points.
| Acceptance Criteria (Inferred from Study Objectives) | Reported Device Performance |
|---|---|
| Primary Clinical Objective: | |
| Ability to be deployed within the aortic valve while allowing blood flow through the inter-balloon space, thus eliminating the need for pacing during the procedure. | Demonstrated. |
| Evaluated by investigators, and the study results support this, with a high procedural success rate and no related adverse events. | |
| Safety Objective: | |
| Freedom from major adverse events (MAE) and death related to the device or procedure. | High Safety Profile. |
| No reported deaths. | |
| No reported MAEs related to the device or valvuloplasty procedure. | |
| Effectiveness Objective: | |
| Procedural success rate. | 98% Procedural Success Rate. |
| Compliance with Special Controls (21 CFR 870.1255 (b)(4)) | Complies. The clinical testing supports substantial equivalence and compliance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 40 subjects.
- Data Provenance: The study was a "prospective, multi-center, observational study." The country of origin is not explicitly stated for the test data, but the submitter (DISA Medinotec) is based in Johannesburg, South Africa, which might be where some or all of the centers were located. However, this is an inference, not a stated fact.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document states, "Performance of the device was evaluated by the investigators." It does not specify the number of individual experts per case or their specific qualifications (e.g., "radiologist with 10 years of experience"). "Investigators" typically refers to the physicians (e.g., interventional cardiologists) performing the procedures and assessing outcomes in a clinical trial. Given the nature of a valvuloplasty device, these would likely be highly experienced interventional cardiologists.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It only mentions that "[p]erformance of the device was evaluated by the investigators." In a multi-center observational study, the primary investigators at each site would typically assess the outcomes for their patients. Central adjudication by an independent committee is common for clinical trials but is not mentioned here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study was a clinical observational study of the device's performance, not a comparison of human readers' performance with and without AI assistance. The device in question is a medical device (balloon catheter), not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This question is not applicable as the device is a physical medical instrument (a balloon catheter) used by a human operator, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth was established by clinical observation and assessment by investigators. This includes:
- Procedural Success: Determined by the medical professionals performing and observing the valvuloplasty procedure.
- Major Adverse Events (MAE) and Death: Clinically observed and reported.
- Ability to Allow Blood Flow / Eliminate Pacing: Assessed during the procedure by the clinical team.
8. The Sample Size for the Training Set
N/A. The provided information pertains to the clinical performance study of a physical medical device. There is no mention of a "training set" in the context of an AI/machine learning model, as this device itself is not an AI algorithm. The training for the device itself would come from its engineering and design processes, and validation from bench and clinical testing.
9. How the Ground Truth for the Training Set was Established
N/A. As there is no AI/ML component or "training set" in the context of this device, this question is not applicable.
§ 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.