(177 days)
The CHASE Curved Left Heart Vent Catheter is indicated for use in venting the left heart during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.
The vent catheter consists of a preformed, flexible plastic tube, (20 French), with a perforated section. A small tapered tip of rigid plastic is attached to the perforated section to aid in the insertion of the catheter. A rigid plastic tube connector for 6.4mm (1/4") I.D. tubing is permanently attached to the other end of the catheter tube. Marking rings on the tube serve as an indication of insertion depth.
This document (K964194) is a 510(k) pre-market notification for a medical device (Chase Curved Left Heart Vent Catheter) and, as such, does not contain the kind of detailed clinical study data that you are requesting. It primarily focuses on demonstrating substantial equivalence to a predicate device (Sarns Curved Left Heart Vent Catheter K770430) and provides engineering and functional testing results.
Here's why much of the requested information is absent or not applicable in this context:
- Acceptance Criteria for a "device" vs. "algorithm": The acceptance criteria in your request (e.g., sensitivity, specificity, AUC) are typically for diagnostic algorithms or devices that interpret data (e.g., AI in medical imaging). This document is for a physical catheter, so the "acceptance criteria" are related to its physical performance, materials, and sterilization, not diagnostic accuracy.
- Study Design for "algorithm": Questions about sample sizes for test/training sets, data provenance, experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are all relevant to studies of AI or diagnostic algorithms. They are not applicable to the evaluation of a physical medical device like a catheter.
However, I can extract and restructure the available information that aligns with your request's format as best as possible, interpreting "acceptance criteria" through the lens of device performance for a physical product.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (for physical device properties) | Reported Device Performance (Chase Curved Left Heart Vent Catheter) |
|---|---|
| No leaks at 10 psi air | No leaks at 10 psi air on Chase device at 4ºC and 40°C |
| Tubing Bond Strength | Exceeds 10 lb. tensile strength @ 4°C and 40°C |
| Package Integrity | Tyvek/Polymylar passed burst test per ASTM F1140-88 |
| Shipping & Distribution | Passed National Safe Transit Ass. vibration and drop tests |
| Accelerated Aging (for 2-year shelf life) | (Implied to have met criteria for 2-year shelf life based on passing the tests listed.) |
| Sterilization Assurance Level (SAL) | Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL $10^{-6}$ |
| Functional Characteristics | Non-differentiable compared to the predicate device (exact same fit, form, and material composition). |
| Biocompatibility / Materials | All materials are identical to the predicate device. |
2. Sample sized used for the test set and the data provenance
This information is not provided. The testing described for functional characteristics, leak tests, bond strength, package integrity, and shipping/distribution are engineering tests on quantities of the device, not clinical trials with human subjects or retrospective/prospective data sets in the typical sense for an AI/diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a physical device's engineering performance is established through standardized test methods (e.g., ASTM F1140-88, National Safe Transit Ass. tests) and material specifications, not through expert clinical consensus.
4. Adjudication method for the test set
Not applicable, as this refers to clinical or diagnostic assessment.
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
Not applicable. This device is a physical catheter, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The "ground truth" for the physical device's performance aspects listed (leakage, bond strength, etc.) is based on established engineering standards, material specifications, and validated sterilization processes rather than expert consensus, pathology, or outcomes data typically associated with diagnostic algorithms.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device evaluation. The assessment relies on engineering tests and comparison to a predicate device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study:
The "study" described in the provided document is primarily a substantial equivalence demonstration combined with engineering and functional performance testing of a physical medical device.
- Substantial Equivalence: The primary "study" is the assertion and justification of substantial equivalence to the Sarns Curved Left Heart Vent Catheter (K770430) based on identical intended use, materials, fit, form, and primary functional characteristics.
- Functional Testing: "All functional characteristics of the Chase Medical Curved Left Heart Vent Catheter are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition." This implies a side-by-side comparison or reliance on the predicate's established performance.
- Bench Testing: Specific bench tests for physical properties were conducted to ensure basic safety and performance:
- Leak Test: Air pressure at specific temperatures.
- Tubing Bond Strength: Tensile strength at specific temperatures.
- Package Integrity: Burst test per ASTM F1140-88.
- Shipping & Distribution: Vibration and drop tests per National Safe Transit Ass. standards.
- Accelerated Aging: To support a two-year shelf life claim.
- Sterilization: Validation of an Ethylene Oxide cycle to SAL $10^{-6}$.
The document does not describe a clinical trial, a study involving human subjects for diagnostic accuracy, or an evaluation of an AI algorithm.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).