(89 days)
The COBE® Vacuum Relief Check Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excessive vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent flow of air into the heart.
The COBE® Vacuum Relief Check Valve is a sterile device with a non-pyrogenic fluid pathway. It is for single use only and is not to be resterilized by the user. The device consists of a housing with a 1/4" inlet port and a combination 1/4" and 3/8" outlet port (to accommodate either 1/4" or 3/8" ID tubing on the outlet side). It contains a unidirectional valve which prevents retrograde flow and an umbrella valve that opens under excessive vacuum, allowing air in to relieve the excessive vacuum pressure in the line. In addition, the device contains an over-pressure relief band which opens under excess positive pressure, allowing blood to escape. Arrows molded into the housing indicate the direction of flow through the device.
The COBE® Vacuum Relief Check Valve is intended for use during cardiopulmonary bypass surgery to prevent excessive vacuum pressure during suctioning from the heart or surgical field and to prevent accidental air flow into the heart.
Here's an analysis of the provided information regarding the acceptance criteria and study for the COBE® Vacuum Relief Check Valve:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a general statement that "Performance testing was conducted to demonstrate substantial equivalence of the COBE® Vacuum Relief Check Valve to the predicate devices." It then lists the types of performance testing, but does not explicitly state specific numerical acceptance criteria (e.g., "vacuum pressure relief must occur within X mmHg") nor the precise quantitative results ("device relieved vacuum at Y mmHg") for the COBE device or the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Vacuum Pressure Relief | Substantially equivalent to predicates |
| Positive Pressure Relief | Substantially equivalent to predicates |
| Retrograde Flow Prevention | Substantially equivalent to predicates |
| Hemolysis (minimal/comparable) | Substantially equivalent to predicates |
| Leak Testing | Substantially equivalent to predicates |
| Connection Bond Strength (adequate) | Substantially equivalent to predicates |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Performance testing was conducted," but does not specify the sample size used for the test set for any of the listed tests. Furthermore, there is no information provided about the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) submission for a device, it's highly probable these were prospective laboratory tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The testing described involves objective physical and mechanical measurements (e.g., pressure, flow, leaks, material integrity), not subjective interpretation requiring expert consensus on a "ground truth" like in imaging studies.
4. Adjudication Method for the Test Set
This is not applicable as the tests are objective physical measurements and not subject to expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and an AI's impact on their performance is being evaluated. The COBE® Vacuum Relief Check Valve is a mechanical device, and its performance is evaluated through engineering and biological testing, not human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a mechanical component and does not involve an algorithm or AI. The performance discussed is inherent to the device's physical function.
7. The Type of Ground Truth Used
For the performance tests conducted, the "ground truth" would be established by objective physical measurements and engineering standards. For example:
- Vacuum Pressure Relief: Measured pressure at which the valve opens.
- Positive Pressure Relief: Measured pressure at which the relief band opens.
- Retrograde Flow Prevention: Observation and measurement of any backward flow.
- Hemolysis: Laboratory analysis of blood samples for signs of red blood cell damage.
- Leak Testing: Observation or measurement of any fluid leakage.
- Connection Bond Strength: Measurement of the force required to dislodge connections.
This is a form of objective measurement against defined physical parameters or established ASTM/ISO standards often used in medical device testing.
8. The Sample Size for the Training Set
This is not applicable. As a mechanical device, there is no "training set" in the context of machine learning or AI development. The device's design is based on engineering principles and prototypes are tested.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. Since there is no training set, there is no ground truth establishment process for it.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.