(65 days)
The COOK CODA™ BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
The COOK CODA™ BALLOON CATHETER is a 2-lumen catheter. The distal lumen extends the length of the catheter for use over a ,035 wire quide. The other lumen communicates with the balloon and is used to expand and deflate it. Radiopaque bands are placed at both the distal and proximal aspects of the balloon to assist with positioning of the device under fluoroscopy. The balloon will be provided in diameters ranging from 30 to 40 mm, and in lengths ranging from 100 to 120 cm. The device is packaged in sterile, sealed double pouches.
The provided 510(k) summary for the COOK CODA™ BALLOON CATHETER does not contain detailed information regarding acceptance criteria, specific study designs, or performance metrics in a way that allows for the completion of all requested fields. This document focuses on demonstrating substantial equivalence to predicate devices based on general performance, biocompatibility, and mechanical property testing rather than a detailed clinical or comparative effectiveness study as would be seen for AI/ML-driven devices.
Here's the information that can be extracted from the provided text, and an explanation for the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not specified | Met test criteria |
| Mechanical Properties | Not specified | Met test criteria |
| Performance Characteristics | Not specified | Met test criteria |
| Safety | Not specified | Met test criteria |
Explanation for Missing Information:
The 510(k) summary only states that "The device met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." It does not provide the specific quantitative or qualitative acceptance criteria for these tests, nor does it present the detailed results of these tests.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "testing to assess biocompatibility, mechanical properties, performance characteristics, and safety," which implies laboratory-based testing rather than clinical data from a specific population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
Explanation for Missing Information:
This section is not applicable because the provided 510(k) summary describes a traditional medical device (balloon catheter) undergoing engineering and biocompatibility testing, not an AI/ML device requiring human expert ground truth for image or data interpretation.
4. Adjudication method for the test set
- Adjudication method: Not applicable.
Explanation for Missing Information:
As mentioned above, this type of adjudication is typically relevant for studies involving human interpretation or machine learning models, which is not the case for this device's reported testing.
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
- MRMC study: No.
- Effect size: Not applicable.
Explanation for Missing Information:
An MRMC comparative effectiveness study is not relevant for this type of traditional medical device. This is a common study type for AI-powered diagnostic devices, where the goal is to show the benefit of AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone study: No.
Explanation for Missing Information:
This concept is specific to AI/ML algorithms. The COOK CODA™ BALLOON CATHETER is a physical device, and its performance is evaluated in terms of its physical and material properties, not as a standalone algorithm.
7. The type of ground truth used
- Type of ground truth: Laboratory and engineering test results (e.g., measurements of mechanical properties, results of biocompatibility assays).
Explanation for Missing Information:
The term "ground truth" as typically used in AI/ML studies (expert consensus, pathology, outcome data) does not apply directly here. The "ground truth" for this device's testing would be established by validated test methodologies comparing the device's characteristics against predefined engineering specifications.
8. The sample size for the training set
- Training set sample size: Not applicable.
Explanation for Missing Information:
This device does not involve machine learning; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable.
Explanation for Missing Information:
Since there is no training set, there is no ground truth for a training set to be established.
§ 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).