(116 days)
The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapoplal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Advance® 35LP PTA Balloon Dilatation Catheters are over-the-wire catheters that will be available with inflated balloon diameters of 3, 4. 5, 6, 7, 8, 9, 10, and 12 millimeters and balloon lengths of 1.5. 2. 2.5. 3. 4. 6. 8. 10. 12. 14. 17. and 20 centimeters. The catheters are 5.2 French or 5.7 French, dependent upon device specification, and will be available in lengths of 80 and 135 centimeters. The catheters are compatible with a 0.035 inch (0.89 millimeter) diameter wire guide. The catheters will be supplied sterile and are intended for one-time use.
The provided text describes the acceptance criteria and a study demonstrating that the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter meets these criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Compliance Testing | Under simulated body temperature conditions, each balloon met its labeled diameter at the nominal pressure. | "Testing showed that, under simulated body temperature conditions, each balloon met its labeled diameter at the nominal pressure. The predetermined acceptance criteria were met." |
| Balloon Profile Testing | Diameters for each catheter were less than the maximum outside diameter appropriate for the intended sheath size. | "Testing showed that diameters for each catheter were less than the maximum outside diameter appropriate for the intended sheath size. The predetermined acceptance criteria were met." |
| Balloon Fatigue Testing | Balloons were free from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation, in conformance with ISO 10555-4. | "Testing showed that the balloons were from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation. In conformance with the applicable sections of ISO 10555-4, the predetermined acceptance criteria were met." |
| Balloon Burst Testing | Balloons would burst at or above the minimum rated burst pressure, with all failure modes being linear tears. | "Testing showed that the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met." |
| Balloon Inflation/Deflation Testing | Balloons inflated to rated burst pressure within 60 seconds and fully deflated within 60 seconds. | "Testing showed that the balloons inflated to rated burst pressure within 60 seconds and fully deflated within 60 seconds. The predetermined acceptance criteria were met." |
| Sheath Compatibility Testing | Catheters were capable of being inserted and retracted from an appropriately sized sheath without experiencing excessive resistance. | "Testing showed that the catheters were capable of being inserted and retracted from an appropriately sized sheath without experiencing excessive resistance. The predetermined acceptance criteria were met." |
| Tensile Strength Testing | Under proper clinical use of the device, the peak load values were in accordance with the applicable values of ISO 10555-1. | "Testing showed that under proper clinical use of the device, the peak load values shall be in accordance with the applicable values of ISO 10555-1. The predetermined acceptance criteria were met." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state a specific numerical sample size for each test. Instead, it uses phrases like "each balloon," "diameters for each catheter," and "the balloons," implying that multiple devices were tested to ensure consistency across their product line.
- Data Provenance: The data appears to be retrospective and internal to Cook Medical, generated from laboratory testing conducted on manufactured devices ("under simulated body temperature conditions"). There is no mention of data from external sources or clinical trials. The country of origin for the company is the U.S. (Bloomington, IN).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are engineering and performance-based (e.g., measuring diameter, resistance, burst pressure, fatigue cycles), which typically do not involve human expert consensus for 'ground truth' in the same way clinical diagnoses would. The "ground truth" for these tests is defined by pre-established engineering specifications and international standards (e.g., ISO 10555-4, ISO 10555-1).
4. Adjudication method for the test set:
This information is not applicable as the tests are objective, performance-based measurements against predefined engineering criteria, rather than subjective assessments requiring adjudication by multiple experts.
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:
This is not applicable. The device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm. The "standalone performance" is demonstrated by the physical and mechanical tests outlined (e.g., compliance, burst, fatigue).
7. The type of ground truth used:
The ground truth used for these tests is based on engineering specifications, predetermined acceptance criteria, and compliance with international standards (ISO 10555-1, ISO 10555-4). For example, the "labeled diameter at the nominal pressure" and "minimum rated burst pressure" serve as the ground truth against which device performance is measured.
8. The sample size for the training set:
This is not applicable. The device undergoes physical and mechanical testing, not machine learning or AI model training. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above; there is no training set mentioned or implied as this is not an AI/ML 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).