(78 days)
The True® Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.
The True® Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables continuous hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque markers are located on the guidewire lumen. These bands are positioned at the proximal and distal balloon shoulders. These markers are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum guidewire size are indicated on the package label.
The provided text describes a 510(k) premarket notification for the True® Flow Valvuloplasty Perfusion Catheter, which claims substantial equivalence to a previously cleared predicate device (K152613). The core of the information regarding device performance and acceptance criteria comes from a post-market clinical study conducted on the predicate device, the TRUE-FLOW study.
Here's an analysis of the acceptance criteria and study data based on the provided text:
Acceptance Criteria and Reported Device Performance
The text describes two primary endpoints for the TRUE-FLOW study, which effectively serve as performance and safety acceptance criteria for the device's functionality during balloon aortic valvuloplasty.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Endpoint) | Reported Device Performance |
|---|---|
| Primary Performance Endpoint: Successful dilatation of the aortic valve using the True® Flow Valvuloplasty Perfusion Catheter. | In 21 (87.5%) cases, the True® Flow catheter successfully dilated the aortic annulus without clinically significant movement. (Note: Data for one subject was not recorded, implying the 87.5% is out of 24 subjects, with 3 unsuccessful or unrecorded cases). The study indicated that the design allowed adequate blood flow to perform complete dilation of a stenotic aortic valve prior to TAVI without the need for rapid pacing. |
| Primary Safety Endpoint: Freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure. | No device-related serious adverse events were reported during the study. |
Study Details:
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Sample Size and Data Provenance:
- Test Set Sample Size: 24 subjects were included in the analysis population. 25 subjects were initially enrolled, but one withdrew consent post-discharge.
- Data Provenance: The study (TRUE-FLOW) was a post-market clinical study conducted on the predicate device. The text does not specify the country of origin, but given the FDA submission, it implicitly aligns with US regulatory requirements and likely US-based data, though this is not explicitly stated. It was a prospective, observational study.
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Number of Experts and Qualifications for Ground Truth:
- The text does not provide information on the number or qualifications of experts used to establish ground truth for the test set. It describes clinical outcomes observed by the study, presumably by the treating physicians and study investigators, but there's no mention of independent expert review for ground truth establishment per se.
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Adjudication Method for the Test Set:
- The text does not specify any explicit adjudication method (e.g., 2+1, 3+1). Decisions regarding "successful dilatation" and "freedom from adverse events" would have been part of the study's pre-defined endpoints and data collection protocols, likely adjudicated by the study investigators or a clinical events committee, but the method is not detailed.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This study was a clinical performance and safety study of the device itself, not an evaluation of human readers' performance with or without AI assistance. The device is a physical catheter, not an AI diagnostic tool.
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Standalone (Algorithm Only) Performance:
- Not applicable. The device is a physical medical device (catheter) used in a medical procedure, not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.
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Type of Ground Truth Used:
- The ground truth for the performance and safety endpoints was based on clinical outcomes data from the patients undergoing the procedure. This includes observed success of aortic valve dilatation and the absence of pre-defined device-related or procedure-related adverse events.
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Training Set Sample Size:
- Not applicable. This study is not a machine learning model, so there is no concept of a "training set" in the context of this device. The data mentioned is for clinical validation of the device's performance and safety.
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How Ground Truth for Training Set Was Established:
- Not applicable, as there is no training set for a physical medical device.
In summary, the provided document focuses on the clinical performance and safety evaluation of a physical medical device. It outlines the specific performance and safety criteria (endpoints) that the device needed to meet and presents the observed outcomes from a prospective clinical study of the predicate device. The concepts of AI-related ground truth establishment, expert adjudication, MRMC studies, or training sets are not relevant to this type of device submission.
§ 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.