(127 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 lumens: one 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 luerlock 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 quidewire size are indicated on the package label.
The provided text describes a 510(k) premarket notification for a medical device, the True™ Flow Valvuloplasty Perfusion Catheter. It details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.
However, the document does not describe an AI/machine learning device or a study involving human readers or expert consensus on medical images. The "performance data" section (page 6) lists in vitro tests conducted on the physical catheter and its components (e.g., balloon diameter, catheter shaft length, burst pressure, biocompatibility tests). These are engineering performance criteria for a physical medical device, not AI model performance.
Therefore, many of the requested elements for an AI device's acceptance criteria and study proving its performance (e.g., sample size for test set, adjudication method, MRMC study, training set details) cannot be extracted from this document because it is not about an AI device.
Here's an attempt to address the parts that are applicable to this document, with a strong disclaimer that it is not an AI device:
Device: True™ Flow Valvuloplasty Perfusion Catheter
Type of Device: Physical medical device (catheter for balloon aortic valvuloplasty), NOT an AI/machine learning device.
Study Purpose (as described): To demonstrate substantial equivalence of the subject device to a predicate device by evaluating its technological characteristics and performance criteria through in vitro testing.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests but does not provide a quantitative table of acceptance criteria and reported numerical performance values. It broadly states that the device "met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
Below is a list of the types of performance criteria and tests mentioned, but no specific numerical values or pass/fail thresholds are provided in this document.
| Acceptance Criteria (Test Category / Parameter) | Reported Device Performance (Qualitative Summary) |
|---|---|
| Physical Dimensions | |
| Catheter Shaft Length | Met criteria |
| Catheter Shaft Inner Diameter | Met criteria |
| Catheter Shaft Outer Diameter | Met criteria |
| Balloon Outer Diameter | Met criteria |
| Balloon Length | Met criteria |
| Marker Band Alignment | Met criteria |
| Functional Performance | |
| Trackability | Met criteria |
| Sheath Compatibility | Met criteria |
| Luer Interface | Met criteria |
| Hub Stress (and 48 Hours) | Met criteria |
| Inflation | Met criteria |
| Deflation to Restore Valve Function | Met criteria |
| Complete Deflation | Met criteria |
| Rated Burst Pressure | Met criteria |
| Catheter Leak | Met criteria |
| Shaft Burst | Met criteria |
| Catheter Elongation | Met criteria |
| Perfusion Test | Met criteria |
| Radial Force Test | Met criteria |
| Radiopacity—Prior to Inflation | Met criteria |
| Radiopacity—Inflated | Met criteria |
| Balloon Distensibility | Met criteria |
| Biocompatibility / Safety | |
| Dye Penetration | Met criteria |
| Media Interaction | Met criteria |
| MEM Elution Test | Met criteria |
| Kligman Maximization Test | Met criteria |
| Intracutaneous Injection Test | Met criteria |
| Systemic Injection Test | Met criteria |
| Rabbit Pyrogen Test | Met criteria |
| Hemolysis - Rabbit Blood Contact | Met criteria |
| Complement Activation Test | Met criteria |
| In Vitro Thrombogenicity | Met criteria |
| In Vivo Thrombogenicity | Met criteria |
| Integrity / Durability | |
| Visual Inspection of Product | Met criteria |
| Visual Inspection of Sterile Barrier Packaging Heat Seals | Met criteria |
| Tip Morphology | Met criteria |
| Fatigue | Met criteria |
| Tip to Balloon Tensile | Met criteria |
| Failure Mode | Met criteria |
| Hub to Shaft Tensile | Met criteria |
| Balloon to Shaft Tensile | Met criteria |
| Pouch Tensile (leveraged from previous testing) | Met criteria |
Regarding AI-specific criteria (not applicable to this document):
- Sample sizes for test set and data provenance: Not applicable. The document describes in vitro engineering tests, not a dataset for an AI model.
- Number of experts and qualifications for ground truth: Not applicable. Ground truth for an AI model (e.g., image annotations) is not relevant for a physical medical device.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This study focuses on the physical performance of a catheter, not on the impact of AI assistance on human readers.
- Standalone (algorithm-only) performance: Not applicable. There is no algorithm.
- Type of ground truth used: For this device, the "ground truth" for performance is established through physical measurements, engineering specifications, and established biocompatibility testing standards. It's not based on expert consensus, pathology, or outcomes data in the context of diagnostic AI.
- Sample size for training set: Not applicable. There is no AI model that requires a training set.
- How ground truth for training set was established: 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.