(373 days)
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No
The device description and performance studies focus on the physical components and gas exchange function of the oxygenator, with no mention of AI or ML technologies.
Yes
The device is described as providing gas exchange and temperature regulation for patients undergoing cardiopulmonary bypass, which are therapeutic interventions aimed at supporting physiological functions.
No
Explanation: The device is an oxygenator used for gas exchange and temperature regulation during cardiopulmonary bypass, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical gas exchange device with an integral heat exchanger, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to support a patient undergoing a cardiopulmonary bypass procedure. This is a procedure performed on a living patient, not on a sample of bodily fluid or tissue outside the body.
- Device Description: The description details how the device interacts with blood during a surgical procedure (cardiopulmonary bypass). It describes gas exchange and temperature regulation of blood flowing through the device, which is part of the patient's circulatory system during the bypass.
- IVD Definition: In Vitro Diagnostics are defined as medical devices and accessories used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform tests on samples; it directly interacts with the patient's blood during a procedure.
The HF-6000 Oxygenator is a device used in a surgical procedure to support a patient's physiological functions, not to diagnose or monitor a condition using samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Bard® William Harvey® HF-6000 Membrane Oxygenator, the Medtronic MAXIMA® Hollow Fiber Oxygenator (model 1380), and the Sarns™ Turbo Membrane Oxygenator (model 9443) were compared for performance characteristics using the ISO/DIS 7199 standard.
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.
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 above-referenced 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.”
0
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
1
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
2
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