(31 days)
The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.
The Occlusion Balloon Catheter is a triple lumen balloon catheter designed to temporarily occlude large vessels. The "Infusion" lumen is used to infuse contrast material through the catheter. The "Distal .035" lumen extends the length of the catheter and is used for placement over wire guides. The "Balloon" lumen is used to inflate and deflate the balloon. The Occlusion Balloon Catheter is available in one configuration. The catheter has two radiopaque marker bands on the shaft, enclosed within the balloon bonds, to help identify the location of the balloon under fluoroscopy. The balloon has a variable diameter up to a maximum of 40 mm when inflated and a catheter length of 75 cm.
Acceptance Criteria and Device Performance for Occlusion Balloon Catheter (K101877)
This document describes the acceptance criteria and the study that proves the Occlusion Balloon Catheter meets these criteria, based on the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) submission for the Occlusion Balloon Catheter (K101877) focuses on establishing substantial equivalence to a predicate device (CODA Balloon Catheter, K032869) through design and performance testing. The document lists several tests conducted but does not explicitly state numerical acceptance criteria or specific quantitative performance values for each test within the document. Instead, it concludes that the "results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use."
However, based on the nature of the tests listed and general device safety and effectiveness principles, we can infer the common acceptance criteria for such a device and assume the reported performance met these underlying standards.
| Test Category | Implicit Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Burst Pressure Testing | The balloon catheter must withstand specified maximum internal pressures without bursting, maintaining integrity during clinical use. | "The proposed Occlusion Balloon Catheter was subjected to... Burst Pressure Testing." (Implied: device met predefined non-bursting pressure limits) |
| Bond Strength Testing | All catheter bonds (e.g., balloon to shaft) must withstand specified forces without delamination or failure. | "The proposed Occlusion Balloon Catheter was subjected to... Bond Strength Testing." (Implied: bonds met predefined strength requirements) |
| Tensile Testing | The catheter shaft and its components must withstand specified tensile forces without breaking or permanent deformation. | "The proposed Occlusion Balloon Catheter was subjected to... Tensile Testing." (Implied: device met predefined tensile strength requirements) |
| Fatigue Testing | The device must withstand repeated inflation/deflation cycles or other relevant mechanical stresses without failure, demonstrating durability. | "The proposed Occlusion Balloon Catheter was subjected to... Fatigue Testing." (Implied: device demonstrated durability over specified cycles) |
| Sheath Compatibility Testing | The catheter must be able to be introduced and withdrawn smoothly through compatible introducer sheaths without damage to the catheter or sheath. | "The proposed Occlusion Balloon Catheter was subjected to... Sheath Compatibility Testing." (Implied: demonstrated compatibility and smooth passage) |
| Inflation/Deflation Time | The balloon must inflate and deflate within clinically acceptable timeframes for efficient temporary occlusion. | "The proposed Occlusion Balloon Catheter was subjected to... Inflation/Deflation Time." (Implied: met predefined time limits for inflation/deflation) |
| Occlusion Testing | The inflated balloon must effectively occlude the intended vessel lumen, preventing flow past the balloon. | "The proposed Occlusion Balloon Catheter was subjected to... Occlusion Testing." (Implied: successfully demonstrated effective vessel occlusion) |
| Accelerated Aged Testing | The device must maintain its functional and mechanical properties after simulating a specified shelf-life period. | "The proposed Occlusion Balloon Catheter was subjected to... Accelerated Aged Testing." (Implied: demonstrated stability over simulated shelf-life) |
| Biocompatibility Testing | The device materials must be biocompatible, not eliciting adverse biological responses (e.g., cytotoxicity, sensitization, irritation). | "The proposed Occlusion Balloon Catheter was subjected to... Biocompatibility Testing." (Implied: materials met ISO 10993 standards for biocompatibility) |
Overall Reported Performance: The document states: "The results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use." This indicates that all acceptance criteria were met.
2. Sample Size for Test Set and Data Provenance
The provided 510(k) submission does not explicitly state the sample sizes used for each of the performance tests (Burst Pressure, Bond Strength, Tensile, Fatigue, Sheath Compatibility, Inflation/Deflation Time, Occlusion, Accelerated Aged, and Biocompatibility Testing).
The data provenance is from Cook Incorporated, USA, as the submitter is located in Bloomington, IN, USA. The studies are described as prospective device performance tests conducted on the manufactured device.
3. Number of Experts and Qualifications for Ground Truth
This type of device submission (mechanical medical device) does not typically involve human expert adjudication for establishing "ground truth" in the same way an AI/ML-based diagnostic device would.
For mechanical performance testing, the "ground truth" is based on engineering specifications and scientific principles, verified through objective measurements and validated test methods. The "experts" involved would be the design engineers, quality control personnel, and test laboratory technicians conducting and interpreting the results according to established international and internal standards (e.g., ISO, ASTM, internal Cook specifications). Their qualifications would include engineering degrees, relevant certifications, and experience in medical device testing.
4. Adjudication Method for Test Set
As explained in point 3, no human adjudication method (like 2+1 or 3+1) was used or is applicable for this type of mechanical device performance testing. The "adjudication" is inherent in the objective measurement and comparison of test results against predefined engineering specifications and criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices (especially imaging-based AI) where human readers interpret data, and the AI's impact on their performance is evaluated. The Occlusion Balloon Catheter is a mechanical therapeutic device, not a diagnostic one.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Occlusion Balloon Catheter is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.
7. Type of Ground Truth Used
The ground truth used for the device's performance testing is based on:
- Engineering Specifications: Predefined performance metrics (e.g., minimum burst pressure, maximum inflation time, required tensile strength) derived from design requirements, risk analysis, and relevant standards.
- Physical Measurements: Objective data obtained from laboratory testing using calibrated equipment.
- Biocompatibility Standards: Compliance with recognized international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
8. Sample Size for the Training Set
Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" in the context of device development refers to iterative design, prototyping, and testing phases to refine the device, but not in the sense of a machine learning algorithm's training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated in point 8, there is no training set for this type of device submission.
§ 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).