(28 days)
For percutaneous transluminal angioplasty of lesions in peripheral arteries including ilias, renal, popliteal, infrapopliteal, femoral and illio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The COOK PTA balloon catheter is an over-the-wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including ilias, renal, popliteal, infrapopliteal, femoral and illio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0(6.0) French vinyl tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.
The provided text describes a 510(k) premarket notification for a PTA Balloon Catheter. This type of submission is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies) is not typically included in a 510(k) submission and is absent from this document.
However, based on the information available, here's a breakdown of what can be inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it lists general types of tests conducted to assure "reliable design and testing parameters" and "conformance to the requirements for its use as a vascular PTA balloon."
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance |
|---|---|
| Tensile Strength: Adequate to withstand operational forces. | "The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon." |
| Flow Rate: Suitable for intended clinical use. | "The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon." |
| Repeated Balloon Inflation: Durability and performance over multiple inflations. | "The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon." |
| Balloon Burst Pressure: Withstands expected pressures without premature failure. | "The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon." |
| Biocompatibility: Safe for use in the human body. | "The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon." |
| In Vivo Performance: Functional and safe in a live biological system. | "The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "The balloon catheter was subjected to the following tests," but provides no numbers for samples tested for each type.
- Data provenance: The tests are described as being conducted on the device itself ("balloon catheter was sabled testing parameters"), suggesting laboratory testing and potentially animal testing. The focus is on the physical and biological characteristics of the device, not clinical data from a human population study. Therefore, specific country of origin or retrospective/prospective clinical data are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to a 510(k) submission of this nature. "Ground truth" in the context of device performance testing typically refers to objective measurements or established standards (e.g., a known tensile strength, a specified burst pressure, or a demonstrated biocompatibility according to ISO standards). It does not involve expert consensus in the way AI or diagnostic imaging studies would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. For engineering and biological testing of a medical device, adjudication methods as described are not used. The focus is on meeting predetermined test 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 device is a PTA Balloon Catheter, a physical medical device, not an AI-powered diagnostic tool or image analysis software. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests performed would be derived from:
- Engineering specifications and validated testing methods (e.g., tensile strength determined by a load cell, flow rate measured by a flow meter, burst pressure via a pressure transducer).
- Standardized biocompatibility tests (e.g., ISO 10993 series for biological evaluation of medical devices).
- Animal study observations for in vivo performance, likely assessed against pre-defined animal welfare and physiological endpoints.
8. The sample size for the training set:
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This document describes the testing of a physical medical device, not the development of an AI model.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of this device's testing.
§ 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).