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510(k) Data Aggregation
(29 days)
Coda LP Balloon Catheter
The Coda® LP Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.
The Coda LP Balloon Catheters are over-the-wire catheters that are available with an inflated balloon diameter of 32 millimeters and a balloon volume of 30 cc. The catheters are 9.0 French and are available in lengths of 100 or 120 centimeters. The Coda LP Balloon Catheter shaft contains two independent lumens within a single extrusion. 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 two inflation media exit ports within the balloon. The catheters are supplied sterile and are intended for one-time use.
The provided document is a 510(k) summary for the Coda® LP Balloon Catheter, which is a medical device. This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to predicate devices. It does not present information about a study involving an AI algorithm or human readers, but rather "Test Data" related to the physical performance of the balloon catheter.
Therefore, I will extract the available "acceptance criteria" and "device performance" for the physical device based on the provided "Test Data". I cannot provide information related to AI performance, multi-reader multi-case studies, or training/test set ground truth as these are not relevant to this type of device submission.
Here's the information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Burst Testing | Balloons burst above the maximum rated volume, with all failures non-fragmentary. | Testing showed that the balloons burst above the maximum rated volume, with all failures being non-fragmentary. The acceptance criteria were met. |
| Balloon Inflation/Deflation Testing | Balloons inflated to rated burst pressure within 30 seconds and fully deflated within 30 seconds. | Testing showed that the balloons inflated to rated burst pressure within 30 seconds and fully deflated within 30 seconds. The acceptance criteria were met. |
| Simulated Use Testing | Catheters capable of being inserted and retracted from an appropriately sized sheath without excessive resistance. Device able to expand an endovascular graft by inflating the balloon. | Testing showed that the catheters were capable of being inserted into and retracted from an appropriately sized sheath without experiencing excessive resistance. Testing showed that this device was able to expand an endovascular graft by inflating the balloon. The acceptance criteria were met. |
| Fatigue Testing | Balloons free from leakage and damage on inflation after withstanding 40 cycles of inflation/deflation. | Testing showed that the balloons were free from leakage and damage on inflation, withstanding 40 cycles of inflation/deflation. The acceptance criterion was met. |
| Occlusion and Migration Testing | Device able to occlude fluid flow without migrating. | Testing showed that this device was able to occlude fluid flow without migrating. The acceptance criteria were met. |
| Tensile Strength Testing | Peak load values in accordance with the acceptance criteria under proper clinical use. | Testing showed that under proper clinical use of the device, the peak load values were in accordance with the acceptance criteria. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of balloons for burst testing, number of catheters for simulated use). It also does not specify the provenance of the data (country of origin, retrospective/prospective), as it's a submission for a physical medical device. These tests are typically conducted in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for a physical device like a balloon catheter is determined by objective engineering and performance specifications and measurements (e.g., burst pressure, inflation time, tensile strength), not by expert consensus or interpretation of data.
4. Adjudication method for the test set:
Not applicable, as the tests involve objective physical measurements rather than subjective assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation is involved. The Coda® LP Balloon Catheter is an interventional device, and the testing focuses on its mechanical and functional performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, this concept is not applicable as the submission is for a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's testing is based on engineered performance specifications and objective measurements of its physical and functional properties, as described in the "Test Data" section. This includes measurements of burst pressure, inflation/deflation times, material strength, and performance during simulated use.
8. The sample size for the training set:
Not applicable. This device is not an AI algorithm; therefore, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this physical device.
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