(276 days)
Intended for temporary occlusion of large vessels, or to expand vascular prostheses.
The Coda Balloon Catheter is a 10.0 French device measuring 120 or 140 cm in usable length. The Coda Balloon Catheter shaft contains two independent lumens. The distal lumen extends the length of the catheter and is used for placement over a 0.035 inch diameter wire guide. The balloon (inflation and deflation) lumen extends from the proximal hub to the inflation ports within the balloon. The maximum inflation diameter is 46 mm, with a corresponding maximum balloon inflation volume of 60 mL. The device will be supplied sterile, intended for one-time use.
Here's an analysis of the provided text regarding the Coda Balloon Catheter, organized according to your requested information:
Coda Balloon Catheter Acceptance Criteria and Study Details
The provided document describes a Special 510(k) Premarket Notification, which typically focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel clinical effectiveness. Therefore, the "study" described is a series of engineering and performance tests, not a clinical trial involving human subjects or AI algorithms.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Minimum Burst Strength & Compliance | Minimum rated burst volume, calculated for 99% coverage and 95% confidence, is greater than the 60 mL inflation volume corresponding to a 46 mm balloon diameter. | The predetermined acceptance criteria were met (specifically, the minimum rated burst volume was greater than 60 mL at 46 mm diameter). |
| Occlusion and Migration | At the 95% confidence level and with 90% minimum coverage, ability to occlude a mock vessel when pressurized without any evidence of liquid leakage or migration. | The predetermined acceptance criteria were met (demonstrated ability to occlude a mock vessel without leakage or migration). |
| Balloon Fatigue | Balloons are free from leakage and damage on inflation, withstanding 40 cycles of inflation/deflation (20 unconstrained/20 constrained). | The predetermined acceptance criteria were met (balloons were free from leakage and damage after 40 cycles). |
| Inflation/Deflation Time | 90% of the overall population from which test articles were sampled have an inflation and deflation time (independently evaluated) below 30 seconds with a 95% confidence level. | The predetermined acceptance criteria were met (90% of the population had inflation/deflation times below 30 seconds with 95% confidence). |
| Simulated Use | Device compatibility with recommended sheath and wire guide, and performance according to the instructions for use in a vascular prosthesis and anatomical model. | The predetermined acceptance criteria were met (devices showed compatibility with sheath/wire guide and performed according to IFU in simulated use). |
| Catheter Usable Length | Usable catheter length verifies to the specified length ± 2 cm. | The predetermined acceptance criterion was met (usable catheter length verified to the specified length ± 2 cm). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for each test in terms of the number of individual catheters or components tested. However, it mentions statistical confidence levels and coverage, implying that a statistically significant number of samples were used for tests like "Balloon Minimum Burst Strength and Compliance," "Occlusion and Migration," and "Inflation/Deflation Time."
- Sample Size: Not explicitly stated as a specific number for each test. Phrases like "99% coverage and 95% confidence," "95% confidence level and with 90% minimum coverage," and "90% of the overall population from which test articles were sampled... with a 95% confidence level" indicate a statistically sound approach was taken to determine the number of samples needed.
- Data Provenance: The tests are described as pre-clinical bench testing and simulated use testing. This is not human clinical data. The location of the testing is not specified, but it can be inferred to be from the manufacturer (Cook Incorporated) or its contracted testing facilities. This is prospective testing conducted to evaluate the modified device before seeking market clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of testing does not involve "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images). The ground truth is defined by the objective physical and mechanical properties and performance standards of the device itself. The "experts" involved would be the engineering and quality assurance personnel who designed, executed, and analyzed these tests, following established engineering standards and protocols. Their qualifications would be in engineering, materials science, and quality assurance, not clinical practice.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where there is subjective assessment (e.g., by human readers). Since these are objective engineering and performance tests, there is no need for such adjudication. The results are quantitative measurements or observations against predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This document pertains to the clearance of a medical device (a balloon catheter) based on its physical characteristics and engineering performance, not the interpretative accuracy of an AI algorithm or human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this is not applicable. This document describes a physical medical device, not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The ground truth used for these tests is objective, measurable engineering and performance specifications. For example:
- Burst Strength: The maximum pressure the balloon can withstand before rupturing.
- Occlusion: The ability to form a complete seal in a mock vessel without leakage.
- Fatigue: The ability to withstand inflation/deflation cycles without structural damage.
- Inflation/Deflation Time: The time taken to reach full inflation/deflation.
- Usable Length: A precise measurement of the catheter's length.
These are not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on physical science and engineering principles.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device clearance. This is not an AI/machine learning device. The design and manufacturing processes are established based on engineering principles and regulatory standards, not on "training data."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it. The performance standards and acceptance criteria for the physical device are based on established engineering principles, industry standards, and the performance of the predicate device (K032869).
§ 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).