(373 days)
The HF-6000 Oxygenator provides the gas exchange and temperature regulating capacity required to support a patient undergoing a cardiopulmonary bypass procedure for a period of up to six (6) hours.
The Bard® William Harvey® HF-6000 Membrane Oxygenator is a single use gas exchange device with an integral venous side heat exchanger. Venous blood is pumped into the stainless steel heat exchanger, then is directed over the gas exchange hollow fibers. Oxygen and carbon dioxide transfer occur by diffusion as gas flows through the hollow fibers.
Here's a breakdown of the acceptance criteria and study information for the Bard® William Harvey® HF-6000 Membrane Oxygenator, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Performance | ISO/DIS 7199 (Performance Characteristics) | Substantially equivalent to predicate devices. |
| Integrity | ISO/DIS 7199 (Integrity Testing) | Met all criteria. |
| Ex Vivo Animal Study | Ability to provide gas exchange and temperature regulation for up to 6 hours on partial bypass, with no significant adverse clinical, physiological, hematological, serum chemistry, gross pathology, or histopathology observations. | Demonstrated ability to support an animal on partial bypass for up to six hours, with no meaningful adverse observations or concerns regarding safety. Concluded to be fully safe and effective. |
| Biocompatibility | ISO 10993 (Biological Evaluation of Medical Devices Part-1: Evaluation and Testing) | Passed all required tests. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set used in the ISO/DIS 7199 performance and integrity testing or the biocompatibility testing. For the ex vivo animal study, it mentions supporting "an animal," implying a single animal or an unspecified small number.
- Test Set Sample Size: Not explicitly stated for performance/integrity/biocompatibility. "An animal" for the ex vivo study.
- Data Provenance: The document does not specify the country of origin. The ex vivo animal study is prospective in nature (conducting a new experiment) but described retrospectively in the submission. The ISO/DIS 7199 testing and biocompatibility testing are also laboratory-based studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device and its testing. The "ground truth" for an oxygenator's performance is established by objective, quantitative measurements against international standards (like ISO/DIS 7199) and physiological markers in animal models, not by expert interpretation of images or patient outcomes in the same way as, for example, an AI diagnostic tool.
4. Adjudication Method for the Test Set
This is not applicable as the tests are objective measurements against standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. The device is an oxygenator, a medical device used in cardiopulmonary bypass, not an AI or imaging diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance and safety was established through:
- Objective measurements against international standards: ISO/DIS 7199 for performance and integrity.
- Physiological and histopathological data from an animal model: For the ex vivo animal study, assessing clinical outcomes, physiological responses, hematological and serum chemistry parameters, gross pathology, and histopathology.
- Biocompatibility testing against international standards: ISO 10993.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as #8.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”