(32 days)
The Vision Blood Cardioplegia System with GBS™ coating is indicated for use in applications that require control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit. The device may be used for normothermic or hypothermic applications. It is designed to operate at flow rates of one hundred (100) to six hundred (600) milliliters per minute for periods up to six (6.0) hours.
The Gish Vision Blood Cardioplegia System with GBS™ coating consists of an extracorporeal heat exchanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows, configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible.
The device allows for the monitoring of pressure and allows for trapping and removal of air. I he us not allow to the cludes an integral bubble trap, gross particulate filter (105 u) and Aaalonarely and evere designed to open in the event of excessive fluid pressure (600 mmHg) during use. Solutions are delivered to the patient through the extension line and appropriate cannula. Blood flow is driven by a roller pump connected through an extension line.
The components of this system which have contact with the fluid path are sterile and nonpyrogenic.
All blood contact materials of the Vision Blood Cardioplegia System with GBS™ coating are All Blood comatible and coated with a proprietary coating.
The provided text describes a medical device, the "Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with GBS™ Coating," and its FDA 510(k) submission. However, it does not contain specific acceptance criteria, reported device performance data, or details about a study designed to prove the device meets such criteria.
The document makes general statements about testing, but lacks the detailed information requested in your prompt.
Here's a breakdown of why I cannot fulfill your request for acceptance criteria and study details based on the provided text:
- No specific acceptance criteria: The document states, "Final testing for the systems... photographed that the device meets all of its functional requirements and performance specifications." It also refers to compliance with "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) This submission complics with "Guidanto for Caracepain" and other Guidance and Standards." However, it does not list or specify what those functional requirements, performance specifications, or acceptance criteria are (e.g., minimum heat exchange efficiency, pressure drop limits, etc.).
- No reported device performance: While it claims the device "meets all of its functional requirements and performance specifications," it does not provide any numerical results or data points from performance testing (e.g., "Heat exchange efficiency was X%", "Pressure drop was Y mmHg").
- No details about a study: The text mentions "extensive safety, performance, and validations prior to release" and "Final testing for the systems..." but provides no information about:
- Sample size for any test set.
- Data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Conclusion:
Based on the provided 510(k) summary, I cannot generate the table of acceptance criteria and reported device performance, nor can I describe the study details as requested. The document focuses on regulatory compliance, device description, and equivalence to a predicate device, rather than detailed performance study results.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).