(170 days)
The Chase Retrograde Cardioplegia Cannula is intended for use in perfusing blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery.
The Chase Retrograde Cardioplegia Cannula is a dual lumen 14 FR cannula. The cannula body contains a primary lumen for infusing blood or cardioplegia solutions and a secondary pressure monitoring lumen that begins at the cannula's tip and terminates in a stopcock with a female luer lock. During infusions, differential pressures occurring within the cannula automatically inflate a soft, low pressure balloon located near the cannula's distal tip. When flow ceases, the balloon spontaneously deflates. A stylet is also provided to aid transatrial cannula placement within the coronary sinus.
This document describes a medical device, the CHASE Retrograde Cardioplegia Cannula, and its safety and effectiveness based on equivalence to a predicate device. The information provided heavily relies on the concept of "substantial equivalence" rather than a standalone clinical study with detailed performance metrics against pre-defined acceptance criteria. Therefore, several of the requested sections below cannot be fully populated as they pertain to a different type of device evaluation.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on functional testing to demonstrate equivalence to a predicate device, rather than establishing clinical performance against specific acceptance criteria. The "acceptance criteria" presented are primarily engineering and material specifications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence | Nondifferentiable from predicate device in fit, form, and material composition |
| Leak Test Requirements (CHASE device) | 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 |
| Luer Connections | Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings |
| Package Integrity | Tyvek/Polymylar passed burst test per ASTM F1140-88 |
| Shipping & Distribution Testing | Per National Safe Transit Ass. vibration and drop tests |
| Accelerated Aging | Two year shelf life |
| Material Composition | All materials are identical to the predicate device |
| Sterilization | Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶ |
2. Sample Size Used for the Test Set and Data Provenance
The document describes functional testing and material comparisons, not a clinical test set with human subjects or a specified number of devices tested for performance. Therefore, typical sample size and data provenance information for a clinical study are not applicable in this context. The "test set" refers to the manufactured cannulas subjected to the engineering tests.
- Sample Size: Not explicitly stated for each test, but implied to be a sufficient number of devices to demonstrate compliance with engineering specifications. This would typically involve a statistically relevant sample from a production lot for each specific test (e.g., several cannulas for leak testing, several for bond strength, etc.).
- Data Provenance: The data originates from internal testing conducted by CHASE Medical Inc. in the US, as part of their pre-market notification process. This is retrospective in the sense that it's data collected on manufactured items to prove compliance, not data from a prospective clinical trial.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The evaluation of this device is based on engineering and material specifications, and comparison to a predicate device, not on expert clinical review of device performance in a patient population to establish a clinical ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. There was no "test set" in the context of clinical data requiring expert adjudication. The tests described are objective engineering measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a surgical tool, not an imaging or diagnostic device, and its evaluation is based on functional equivalence and material properties, not human interpretation improvement.
6. Standalone (Algorithm Only) Performance
This information is not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this product.
7. Type of Ground Truth Used
The "ground truth" for the device's acceptability is based on:
- Engineering Specifications and Standards: (e.g., ANSI/HIMA MD70.1-1983, ASTM F1140-88, National Safe Transit Ass. standards).
- Material Equivalence: Identity of materials to a previously cleared predicate device (Research Medical Retrograde Cardioplegia Cannula K880103).
- Functional Equivalence: Demonstrated "nondifferentiable" characteristics compared to the predicate device.
- Sterilization Validation: Validation of an Overkill Method for Ethylene Oxide sterilization.
There is no "expert consensus, pathology, or outcomes data" in the clinical sense being used to establish a ground truth for device performance in patients in this document.
8. Sample Size for the Training Set
This information is not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, this device does not utilize an AI or machine learning model with a training set.
§ 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).