(27 days)
The VascuTraK™ 2 PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the illiac, femoral, poplited, illio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The YMed VascuTraK™ 2 PTA Dilatation Catheter is a modification to the VascuTraK™ 2 PTA Dilatation Catheter cleared under K073025. The device is fabricated of the same materials as the unmodified device and has the same intended use. The distal balloon sizes for the modified device include diameters from 5.0 - 7.0 mm and lengths up to 300mm.
This appears to be a 510(k) summary for a medical device modification, specifically the VascuTraK™ 2 PTA Dilatation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data that would be associated with therapeutic software or AI devices. As such, several of the requested categories for AI/software studies will not be applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text, inferred) | Reported Device Performance (from text) |
|---|---|
| Tensile Strength | "All test results were satisfactory." |
| Balloon Fatigue | "All test results were satisfactory." |
| Compliance | "All test results were satisfactory." |
| Burst Pressure | "All test results were satisfactory." |
| Biocompatibility (of patient contact materials) | "The biological safety of the device was previously demonstrated through biocompatibility studies of patient contact materials in accordance with the requirements outlined in ISO 10993-1." |
| Sterility Assurance Level (SAL) of 10⁻⁶ | "The device conforms to a Sterility Assurance Level (SAL) of 10⁻⁶." |
| Indications for Use remain consistent | "The device is fabricated of the same materials as the unmodified device and has the same intended use." |
| Technological Characteristics Comparison (Design/Construction) | "The VascuTraK™ 2 PTA Dilatation Catheter is identical in design and construction to the currently marketed VascuTraK™ 2 PTA Dilatation Catheter. This version of the catheter features larger balloons for use in the larger peripheral arteries." |
| Labeling reflects applicable sheath size | "The revised labeling reflects the applicable sheath size for the larger balloon sizes." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the mechanical tests (tensile strength, fatigue, compliance, burst). It only states that "The modified device was tested using the same test procedures that were used for the unmodified device."
- Test Set Size: Not explicitly stated for each test; however, for medical devices undergoing mechanical testing, sample sizes are typically determined by statistical methods to achieve sufficient confidence in the results (e.g., n=3, n=5, n=10 per batch, etc., depending on the test and criticality).
- Data Provenance: Not specified, but generally, these types of tests are performed in a laboratory setting by the manufacturer (YMed, Inc.) or a contracted testing facility. This would be prospective testing of the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to the evaluation of a physical medical device like a dilatation catheter. "Ground truth" in this context would refer to objective measurements obtained from laboratory testing, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" concept is typically used in clinical studies or studies involving human interpretation (e.g., expert readers adjudicating discrepancies in image diagnosis). For physical device testing, results are typically objective measurements against predefined specifications.
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 physical medical device (catheter), not an AI/software device intended to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through objective engineering and laboratory testing based on predefined specifications and standards (e.g., ISO 10993-1 for biocompatibility). For example:
- Tensile strength is measured mechanically.
- Balloon fatigue is tested by repeatedly inflating and deflating the balloon.
- Compliance refers to the balloon's dimensional changes under pressure.
- Burst pressure is the pressure at which the balloon ruptures.
- Sterility is verified through bioburden testing and sterilization validation.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).