(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.
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Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832 508-373-1000
OCT 30 1996 K954850
Image /page/0/Picture/2 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined in black. The letter "A" is stylized with a triangle shape in the middle.
510(k) SUMMARY FOR THE BARD® WILLIAM HARVEY® HF-6000 MEMBRANE OXYGENATOR
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
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.
This product will have the following indications:
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 predicate devices for this 510(k) Notification are:
Based on a review of FOI-released copies of 510(k) #K920889 and the 510(k) summary for 510(k) #K941653 (which makes reference to 510(k) #K903436), the Medtronic MAXIMA® Hollow Fiber Oxygenator and the Sarns™ Turbo Membrane Oxygenator appear to be covered by the 510(k)'s listed above.
The "510(k) Substantial Equivalence Decision-Making Process (Detailed)" decision tree (FDA 92-415. Premarket Notification 510(k): Regulatory Requirements for Medical Devices. Page 51) was utilized to make a determination of substantial equivalence as follows:
1. Does New Device Have Same Indication Statements?
Yes. The Bard® William Harvey® HF-6000 Membrane Oxygenator has the same indications as both the Medtronic MAXIMA® Hollow Fiber Oxygenator and the
Bard® William Harvey® HF-6000 Membrane Oxygenator 510(k) Submission
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Sams™ Turbo Membrane Oxygenator. Àll of these devices provide 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.
2. Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?
No. Although the Bard® William Harvey® HF-6000 Membrane Oxygenator, the Medtronic MAXIMA® Hollow Fiber Oxygenator and the Sarns™ Turbo Membrane Oxygenator have the same technological characteristics and many of the same materials, the Bard® William Harvey® HF-6000 Membrane Oxygenator does include some other materials and components which are different.
3. Could the New Characteristics Affect Safety or Effectiveness?
Yes. These different materials could result in changes in biocompatibility, safety, or performance.
4. Do the New Characteristics Raise New Types of Safety or Effectiveness Questions?
No. The materials used in the Bard® William Harvey® HF-6000 Membrane Oxygenator will raise the same questions concerning biocompatibility, safety and performance as those used in the predicate devices, including questions of cell damage, toxicity, etc.
5. Do Accepted Scientific Methods Exist for Assessing Effects of the New Characteristics?
Yes. Tests of performance and integrity for oxygenators are delineated in the ISO Draft International Standard 7199 (ISO/DIS 7199), "Cardiovascular implants and artificial organs - Blood-gas exchangers." In addition, an ex vivo animal test protocol was developed. Finally, the biocompatibility tests performed on the Bard® William Harvey® HF-6000 Membrane Oxygenator address the requirements of the International Standard ISO 10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA-modified testing matrix included in the ODE May 1, 1995 General Program Memorandum #G95-1.
6. Are Performance Data Available to Assess Effects of New Characteristics?
Yes. The Bard® William Harvey® HF-6000 Membrane Oxygenator, the Medtronic MAXIMA® Hollow Fiber Oxygenator (model 1380), and the Sarns™ Turbo
Bard® William Harvey® HF-6000 Membrane Oxygenator 510(k) Submission
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Membrane Oxygenator (model 9443) were compared for performance characteristics using the above-referenced ISO/DIS 7199.
In addition, the Bard® William Harvey® HF-6000 Membrane Oxygenator was subjected to integrity testing per the ISO/DIS 7199, ex vivo animal testing to assess its ability to sustain an animal on partial bypass, and biocompatibility testing to assess its safety.
7. Performance Data Demonstrate Equivalence?
The performance of the Bard® William Harvey® HF-6000 Membrane Yes. Oxygenator was equivalent to those of the predicate devices.
When tested in accordance with ISO/DIS 7199, the Bard® William Harvey® HF-6000 Membrane Oxygenator was substantially equivalent with respect to performance to the predicate devices. In addition, the Bard® William Harvey® HF-6000 Membrane Oxygenator met all criteria with respect to integrity when tested per the abovereferenced ISO standard.
In animal testing, the Bard® William Harvey® HF-6000 Membrane Oxygenator demonstrated the ability to provide the gas exchange and body temperature regulating capacity required to support an animal undergoing a partial cardiopulmonary bypass procedure for a period of up to six hours. In this study, there were no meaningful observations with regard to clinical outcomes, physiological responses, hematological and serum chemistry parameters, gross pathology and histopathology that raise any concerns about the safety of the Bard HF-6000 oxygenator. It was concluded that the Bard device is fully safe and effective for use.
The Bard® William Harvey® HF-6000 Membrane Oxygenator passed all tests of biocompatibility required by the International Standard ISO 10993.
SUBSTANTIALLY EQUIVALENT DETERMINATION:
The Bard® William Harvey® HF-6000 Membrane Oxygenator is substantially equivalent to the predicate devices, the Medtronic MAXIMA® Hollow Fiber Oxygenator and the Sams™ Turbo Membrane Oxygenator.
Douglas E. Ferguson
Douglas E. Ferguson Regulatory Affairs Specia
10/20/95
Date
Bard® William Harvey® HF-6000 Membrane Oxygenator 510(k) Submission
§ 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.”