(145 days)
The CHASE Phrenic Nerve Pad is indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body.
The CHASE Phrenic Nerve Pad consists of a heart shaped, 1/8 inch, closed cell piece of foam with an 18 inch silicone tail.
The provided documentation describes a 510(k) premarket notification for the CHASE Phrenic Nerve Pad. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to establish de novo safety and effectiveness. Therefore, the information requested regarding acceptance criteria based on a study of the device's performance is not directly applicable in the way it would be for a novel device undergoing a formal effectiveness study.
However, I can extract the relevant information from the document to address your points in the context of a 510(k) submission, focusing on the comparisons made to the predicate device.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) device, "acceptance criteria" primarily relate to demonstrating that the new device is as safe and effective as the predicate. In this case, the criteria are based on equivalence to the predicate device, not on specific performance metrics established through clinical trials.
| Acceptance Criterion (Basis for Equivalence) | Reported Device Performance (vs. Predicate) |
|---|---|
| Materials | All material are identical to the predicate device. |
| Sterilization | Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶ |
| Functional Characteristics | Non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition. |
| Package Integrity (Burst Test) | Tyvek/Polymylar passed burst test per ASTM F 140-88 |
| Shipping & Distribution Testing | Per National Safe Transit Ass. vibration and drop tests |
| Accelerated Aging (Shelf Life) | Two year shelf life |
| Indications for Use | "Indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body." (Identical to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical "test sets" for effectiveness in a 510(k) for this type of device. The "testing" involved material comparisons, sterilization validation, and package/shipping tests.
- Data Provenance: The document does not specify the country of origin for the data related to material testing, sterilization, or package integrity. Given it's a US submission, it's presumed to be in compliance with US standards. The data is retrospective in the sense that it relies on established standards and comparisons to an already marketed device (Medtronic/DLP Phrenic Nerve Pad, K890707).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For a 510(k) cleared based on substantial equivalence to the design and materials of a predicate device, there is no "test set" in the sense of clinical data requiring expert human review or ground truth establishment.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a Class I medical device (though later reclassified to Class II by FDA in the letter), and its 510(k) submission focused on demonstrating substantial equivalence based on material composition, fit, form, and function to a predicate device, not on human interpretive performance with or without AI assistance.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No, this device is a physical medical product, not an algorithm or AI system. Therefore, standalone algorithm performance testing is not applicable.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this 510(k) submission is primarily the established safety and effectiveness of the predicate device (Medtronic/DLP Phrenic Nerve Pad, K890707) as demonstrated by its prior market clearance. For the specific tests conducted (materials, sterilization, packaging), the "ground truth" would be adherence to recognized standards (e.g., ASTM F 140-88 for burst test, SAL 10⁻⁶ for sterilization validation).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable as there is no training set for this type of medical 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).