(17 days)
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter measures a nominal 5.0 French in outside diameter. Catheter lengths of 80 and 135 cm are available. It is used percutaneously over a pre-positioned wire guide. The proximal end includes a Luer connector which provides access to the end hole lumen and a Luer connector which permits access to the balloon inflation lumen. The catheter incorporates radiopaque markers to assist fluoroscopic visualization of the balloon during use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter:
Executive Summary:
The provided 510(k) summary for the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter outlines a series of performance and safety tests conducted to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicitly met by the successful completion of these tests. However, the document does not explicitly state numerical acceptance criteria or provide specific reported performance values in a table format for each test. The studies performed are primarily bench and preclinical tests, not clinical efficacy or comparative effectiveness studies involving human subjects or AI.
Acceptance Criteria and Device Performance Study Analysis
1. Table of Acceptance Criteria and Reported Device Performance
It is important to note that the provided 510(k) summary lists the types of tests performed but does not explicitly state specific numerical acceptance criteria or quantifiable reported device performance values for each test. Instead, it concludes generally that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter."
To create a table, we must infer the acceptance criteria as the successful completion of each test without failure or deviation from expected safety and performance parameters for a PTA balloon catheter. The "Reported Device Performance" is broadly stated as "conformance to the requirements."
| Test Name | Acceptance Criteria (Inferred from documentation) | Reported Device Performance (as stated or inferred) |
|---|---|---|
| 1. Tensile Test | Device components (e.g., catheter shaft, balloon bond) must withstand specified tensile forces without breakage or unacceptable deformation. | Results provide reasonable assurance of conformance to requirements for use. |
| 2. Balloon Inflation/Deflation Test | Balloon must reliably inflate and deflate to specified pressures and durations without rupture, leakage, or permanent deformation. | Results provide reasonable assurance of conformance to requirements for use. |
| 3. Balloon Burst Test | Balloon must withstand a specified pressure beyond its nominal inflation pressure without catastrophic failure, or burst at a predictable pressure. | Results provide reasonable assurance of conformance to requirements for use. |
| 4. Balloon Compliance Test | Balloon diameter and length must conform to specified dimensions at various inflation pressures, exhibiting appropriate compliance characteristics. | Results provide reasonable assurance of conformance to requirements for use. |
| 5. Balloon Fatigue Test | Balloon must withstand repeated inflation/deflation cycles without structural degradation or loss of integrity. | Results provide reasonable assurance of conformance to requirements for use. |
| 6. Bond Strength Test | All bonded components (e.g., balloon to shaft) must maintain integrity under specified stress conditions. | Results provide reasonable assurance of conformance to requirements for use. |
| 7. Animal Test | Device must demonstrate safe and effective performance in an appropriate animal model, including biocompatibility and functional performance. | Results provide reasonable assurance of conformance to requirements for use. (No specific animal species or detailed outcomes are provided in the summary). |
| 8. Shelf Life Test | Device must maintain sterility, functionality, and integrity for its stated shelf life duration. | Results provide reasonable assurance of conformance to requirements for use. |
| 9. Sterility Test | Device must meet established sterility assurance level (SAL) requirements. | Results provide reasonable assurance of conformance to requirements for use. |
| 10. Biocompatibility Test | Device materials must demonstrate acceptable biological response (e.g., non-cytotoxic, non-sensitizing, non-irritating) as per ISO 10993 standards. | Results provide reasonable assurance of conformance to requirements for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (number of devices, number of animal subjects, etc.) for each of the listed tests.
The data provenance for the non-animal tests would be in-vitro (bench testing) performed by Cook Incorporated. The animal test provenance is preclinical. There is no indication of human clinical data or retrospective/prospective human studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the tests described are primarily engineering/bench tests and an animal study. They do not involve expert interpretation or ground truth establishment in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests is based on objective physical measurements, material properties, and biological responses.
4. Adjudication Method for the Test Set
This information is not applicable for the types of tests conducted. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving expert consensus for ground truth determination, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The provided text describes engineering tests and an animal study, not clinical studies involving human readers or assessment of AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical catheter, not an AI or software-as-a-medical-device (SaMD).
7. The Type of Ground Truth Used
The ground truth for the various tests is based on:
- Engineering specifications and standards: For tensile, inflation/deflation, burst, compliance, fatigue, and bond strength tests.
- Established biological testing standards (e.g., ISO 10993): For biocompatibility tests.
- Sterility assurance level (SAL) requirements: For sterility tests.
- Observed physiological and functional outcomes in an animal model: For the animal test.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this device is not an AI/ML algorithm. The "training" for the device's design comes from engineering principles, material science, and prior knowledge from predicate devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set in the context of AI/ML. The "ground truth" for the device's design and manufacturing processes would be established through industry standards, regulatory requirements, Cook Incorporated's internal quality systems, and experience with similar predicate devices.
§ 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).