(262 days)
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio 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 iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French vinyl tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.
Here's an analysis of the provided text regarding the COOK PTA balloon catheter, focusing on the requested acceptance criteria and study information:
Acceptance Criteria and Device Performance Study for COOK PTA Balloon Catheter (K972800)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance (as described in the document) |
|---|---|---|
| Mechanical Performance | Tensile tests | "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 vascular PTA balloon." |
| Flow rate tests | "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 vascular PTA balloon." | |
| Repeated balloon inflation tests | "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 vascular PTA balloon." | |
| Balloon burst tests | "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 vascular PTA balloon." | |
| Biocompatibility | Biocompatibility tests | "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 vascular PTA balloon." |
| In Vivo Performance | Animal tests | "Animal tests to assess in vivo performance characteristics." (No specific results detailed, only that they were performed). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample sizes used for any of the tests (tensile, flow rate, inflation, burst, biocompatibility, or animal tests).
The data provenance is not explicitly stated beyond being part of a 510(k) submission from COOK INCORPORATED, a US-based company. It can be inferred that the testing was conducted by or for COOK INCORPORATED for regulatory submission. Whether the data is retrospective or prospective is not indicated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests described are largely objective engineering and biological assessments, not typically requiring human expert-established ground truth in the way a diagnostic imaging device would.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The described tests are objective measurements, not subjective assessments requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device submission. This type of study is typically relevant for diagnostic devices where human interpretation plays a significant role, not for a PTA balloon catheter which is a therapeutic device with objective performance metrics.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to a physical medical device like a PTA balloon catheter. There is no "algorithm" in the sense of AI or software that would have a standalone performance. The device's performance is inherently its standalone performance when used as intended.
7. Type of Ground Truth Used
The ground truth for the performance tests would be established by:
- Engineering specifications/standards: For tensile strength, burst pressure, flow rates, etc. (e.g., minimum burst pressure, maximum elongation).
- Biocompatibility standards: For biocompatibility tests (e.g., ISO 10993).
- Physiological/anatomical criteria: For animal tests (e.g., successful dilatation, absence of adverse events like vessel dissection or thrombosis).
The document states that the tests provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use," implying that predefined acceptance criteria (ground truth) were met.
8. Sample Size for the Training Set
This information is not applicable/provided. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data. The "training" for such devices typically involves materials science, engineering design, and manufacturing process optimization.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8.
§ 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).