(85 days)
The Jostra Pediatric Arterial Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracoproeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less.
The Jostra Pediatric Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the aortic root or other large artery during extracorporeal circulation. The cannulaer are made from polyvinyl chloride (PVC) and range in size from 8fr. to 16fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for pediatric use.
Here's a breakdown of the acceptance criteria and study information for the Jostra Pediatric Arterial Cannulae, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | Performed, demonstrating substantial equivalency to predicate device. | No specific metrics provided, but comparison to a legally marketed predicate (Medtronic DLP Pediatric Arterial Cannulae) is the basis. |
| Flow-Pressure curves | Performed, demonstrating substantial equivalency to predicate device. | No specific metrics for curve shape, pressure limits, or flow rates are provided. |
| Kink Resistance | Performed, demonstrating substantial equivalency to predicate device. | No specific metrics for kink angle, force, or flow reduction are provided. |
| Bond Strength | Performed, demonstrating substantial equivalency to predicate device. | No specific metrics for bond strength (e.g., tensile strength, peel strength) are provided. |
| Leakage Test | Performed, demonstrating substantial equivalency to predicate device. | No specific metrics for leakage rate or pressure withstand are provided. |
| Effects on Cellular Components | In-vitro testing performed, demonstrating substantial equivalency to predicate device. | No specific metrics on cell lysis, activation, or count are provided. |
| Overall Safety and Effectiveness | Demonstrated through comparative testing that differences from the predicate (curved tip, vent plug) do not affect safety and effectiveness. | The statement directly addresses safety and effectiveness relative to the predicate, even with design variations. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Performance testing included" a list of tests, but does not provide details on the number of cannulae tested for a "test set."
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective. Given the nature of medical device testing for 510(k) (pre-market notification), it would typically involve prospective, controlled laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided as this submission is for a physical medical device (cannulae) and not an AI/software device that requires expert-established ground truth for image or data interpretation. The "ground truth" for this device's performance is established by direct physical measurements and laboratory tests against engineering specifications and comparison to an established predicate device.
4. Adjudication Method for the Test Set
This information is not applicable as the testing involved direct physical measurements and comparison to a predicate device, not subjective interpretation requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No.
- Effect size: Not applicable, as this is a physical medical device and not an AI system being evaluated for its impact on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Was it done?: Not applicable. This is not an AI/algorithm. The performance studies detailed are for the physical device itself.
7. Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily:
- Engineering Specifications / Performance Standards: Implied for tests like kink resistance, bond strength, leakage, and flow-pressure curves.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance of the legally marketed Medtronic DLP Pediatric Arterial Cannulae. The Jostra device performance is directly compared to it across various attributes ("operation, materials, design, and performance").
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
- How established?: Not applicable, as there is no training set for this type of device submission.
§ 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).