The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

Device Description

Affinity Fusion Oxygenators contain both an integrated arterial filter and integrated heat exchanger. These are microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface or Cortiva BioActive Surface bonded to the blood contacting surfaces.
The Integrated Arterial Filter with Balance Biosurface or Cortiva BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery.
Additionally, some models are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.
Affinity Fusion Oxygenators are designed to be an integral part of the cardiopulmonary heart bypass circuit for use during cardiac surgery. Blood that comes from the patient is delivered through a pump to the oxygenator and other auxiliary devices, and back to the patient.
The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path. These connections are made with tubing connected to barbed or luer ports. The oxygenator is under constant fluid pressure. There is pressure exerted on the blood-side of the device from the blood pump and patient, the water-side of the device due to the flow of the heater-cooler for water, and the gas-side of the device due to the flow of gases through the device. The three compartments (blood-side, water-side and gas-side) must not leak into one another for the oxygenator to function properly.
The water-side of the oxygenator is connected to a heater/cooler device to enable temperature control of the blood. To prevent microbial growth within the heater/cooler, some manufacturers specify the addition of disinfectants to the heater/cooler water. During operation, the water path of the polyethylene terephthalate (PET) heat exchanger is exposed to these disinfectants.
The purpose of this 510(k) Notification is to notify the FDA of a change to allow for the use of hydrogen peroxide (330 ppm) in the water path of the oxygenator. There are no actual changes to the oxygenators.

AI/ML Overview

This document is a 510(k) premarket notification for Medtronic's Affinity Fusion Oxygenators, specifically seeking to allow the use of hydrogen peroxide (330 ppm) in the water path of the oxygenator. The submission focuses on demonstrating that this change does not affect the substantial equivalence of the device to its predicates. Therefore, the information provided primarily addresses the impact of hydrogen peroxide exposure rather than the general performance characteristics of the oxygenator itself.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the typical sense of a clinical or analytical study for device efficacy. Instead, it describes specific tests performed to ensure the device's compatibility with the proposed disinfectant.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Heat Exchanger Product Material Compatibility with Hydrogen Peroxide: The heat exchanger materials must remain compatible with hydrogen peroxide (330 ppm) without degradation or adverse effects.	Testing was conducted to verify that the chemical disinfectant has no adverse effects on the oxygenator water path.
Structural Integrity (pressure integrity, burst and port break tests): The device must maintain its structural integrity after exposure to hydrogen peroxide.	Structural Integrity Testing (pressure integrity, burst and port break tests) was performed. The conclusion states that the oxygenators remain substantially equivalent, implying these tests were passed.
Toxicological Risk Assessment for Hydrogen Peroxide: There should be no toxicological risk associated with the use of hydrogen peroxide at the specified concentration.	A Toxicological Risk Assessment for Hydrogen Peroxide was performed. The conclusion states that the oxygenators remain substantially equivalent, implying no unacceptable toxicological risk.
Heat Exchanger Permeability Testing: The heat exchanger should maintain its permeability characteristics after exposure to hydrogen peroxide, ensuring no leakage between compartments.	Heat Exchanger Permeability Testing was performed. The conclusion states that the oxygenators remain substantially equivalent, implying that permeability characteristics were maintained.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the "test set" for each of the compatibility and integrity tests. It generally refers to "testing and analysis was performed." There is no mention of data provenance in terms of country of origin or if it's retrospective/prospective since these are laboratory/engineering tests, not clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the type of testing described. The "ground truth" here is defined by engineering specifications and standards for material compatibility, structural integrity, and toxicology, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical or image-based studies where expert consensus is needed. The described tests are based on objective physical and chemical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. This type of study is relevant for evaluating diagnostic or therapeutic efficacy, typically involving human interpretation of data (e.g., medical images) with and without AI assistance. The current submission is for an oxygenator and its compatibility with a disinfectant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithm performance study was mentioned. This is not relevant for the type of device and change being described.

7. Type of Ground Truth Used

The "ground truth" for the tests performed (material compatibility, structural integrity, permeability, toxicological assessment) would be based on:

Engineering specifications and material properties.
Established toxicological thresholds and risk assessment methodologies.
Physical measurements and performance standards for medical devices.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product (oxygenator), not an AI algorithm that requires a training set. The tests performed are to confirm the physical and chemical properties of the device after a specific change in intended use.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

October 25, 2017

Medtronic, Inc. Lisa Stone Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K172626

Trade/Device Name: Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ, DTR, DTN, DTM, JOD Dated: August 31, 2017 Received: September 1, 2017

Dear Lisa Stone:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
-------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------

Indications for Use

510(k) Number (if known)	K172626
Device Name	Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Model BB811)
Indications for Use (Describe)	The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

510(k) Number (if known)

K172626

Device Name

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Model BB811)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740 EF
----------------------	-------------	-------------------------------------------

KXXXXXX Affinity Fusion Oxygenator Disinfectant Use

Medtronic Confidential

KXXXXXX
1-24

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017
	See PRA Statement below.

510(k) Number (if known)	K172626
Device Name	Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BB841)
Indications for Use (Describe)
The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1
	PSC Publishing Services (301) 443-6740 EF

อรป และเวอร์นทร์เป็น เดิมเกอร์ชุรกิ

ХХХХХХХХХ

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
510(k) Number (if known)	K172626
Device Name	Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva BioActive Surface (Model CB811)
Indications for Use (Describe)
The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)	Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
KXXXXXX Affinity Fusion Oxygenator Disinfectant Use
Medtronic Confidential
KXXXXXX
1-26

{5}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K172626
Device Name	Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva BioActive Surface and Cardiotomy/Venous Reservoir withBalance Biosurface (Model CB841)
Indications for Use (Describe)
	The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to beused in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the bloodand to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours induration.
	The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed tofilter from the circuit microemboli larger than the specified micron size for periods up to 6 hours duringCPB surgery.
	The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is intended to be used in an extracorporealperfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6hours in duration. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures.
	The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is also intended for use after open heart surgeryto collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)Page 1 of 1PSC Publishing Services (301) 443-6740EF

อรป และเวอร์นทร์เป็น เดิมเกอร์ชุรกิ

XXXXXXXXXXX

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SUMMARY OF SAFETY AND EFFECTIVENESS 5

Date Prepared:	August 31, 2017
Submitter's Name and Address:	Medtronic, Inc.Medtronic Perfusion Systems8200 Coral Sea Street NEMounds View, MN 55112Establishment Registration Number: 2184009
Contact Person:	Lisa J. Stone, RACPrincipal Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: (763) 514-9866Email: lisa.j.stone@medtronic.com
Alternate Contact:	Jake RoellerSenior Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: (763) 526-0404Email: jake.w.roeller@medtronic.com
Proprietary Name:	Affinity Fusion™ Oxygenator with IntegratedArterial Filter and Balance™ Biosurface(Model BB811)
	Affinity Fusion™ Oxygenator with IntegratedArterial Filter and Cardiotomy/VenousReservoir with Balance™ Biosurface (ModelBB841)
	Affinity Fusion™ Oxygenator with IntegratedArterial Filter and Cortiva™ BioActiveSurface (Model CB811)
	Affinity Fusion™ Oxygenator with IntegratedArterial Filter and Cortiva™ BioActiveSurface and Cardiotomy/Venous Reservoirwith Balance™ Biosurface (Model CB841)

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Common Name:	Oxygenator
Classification Name:	Cardiopulmonary Bypass Oxygenator
Classification:	Classification: Class IIPanel: CardiovascularRegulation: 21 CFR 870.4350Product Code: DTZ
Predicate Device:	Affinity Fusion™ Oxygenator with IntegratedArterial Filter and Balance™ Biosurface(Model BB811) – K142784
	Affinity Fusion™ Oxygenator with IntegratedArterial Filter and Cardiotomy/VenousReservoir with Balance™ Biosurface (ModelBB841) – K142784 and K132972
	Affinity Fusion™ Oxygenator with IntegratedArterial Filter and Cortiva™ BioActiveSurface (Model CB811) – K142784
	Affinity Fusion™ Oxygenator with IntegratedArterial Filter and Cortiva™ BioActiveSurface and Cardiotomy/Venous Reservoirwith Balance™ Biosurface (Model CB841) –K142784 and K132972

Device Description

The Integrated Arterial Filter with Balance Biosurface or Cortiva BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery.

Additionally, some models are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect

{8}------------------------------------------------

venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

Affinity Fusion Oxygenators are designed to be an integral part of the cardiopulmonary heart bypass circuit for use during cardiac surgery. Blood that comes from the patient is delivered through a pump to the oxygenator and other auxiliary devices, and back to the patient.

The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path. These connections are made with tubing connected to barbed or luer ports. The oxygenator is under constant fluid pressure. There is pressure exerted on the blood-side of the device from the blood pump and patient, the water-side of the device due to the flow of the heater-cooler for water, and the gas-side of the device due to the flow of gases through the device. The three compartments (blood-side, water-side and gas-side) must not leak into one another for the oxygenator to function properly.

The water-side of the oxygenator is connected to a heater/cooler device to enable temperature control of the blood. To prevent microbial growth within the heater/cooler, some manufacturers specify the addition of disinfectants to the heater/cooler water. During operation, the water path of the polyethylene terephthalate (PET) heat exchanger is exposed to these disinfectants.

The purpose of this 510(k) Notification is to notify the FDA of a change to allow for the use of hydrogen peroxide (330 ppm) in the water path of the oxygenator. There are no actual changes to the oxygenators.

Indications for Use

There is no change to the intended use of the devices within the scope of the proposed change in this 510(k) Notification. The current Indications for Use statement for each device model are noted below:

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Model BB811)

{9}------------------------------------------------

The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BB841)

The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva BioActive Surface (CB811)

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during cardiopulmonary bypass (CPB) surgery.

Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva BioActive Surface and Cardiotomy/Venous Reservoir with Balance Biosurface (Model CB841)

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon

{10}------------------------------------------------

dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

The Affinity Fusion oxygenator with Integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

Comparison to Predicate Devices

When compared to the predicate devices, the Affinity Fusion Oxygenators are substantially equivalent. The oxygenators within scope of this 510(k) Notification have the following similarities:

Same intended use
Same operating principle
Same fundamental technological characteristics ●
Same design, dimensions and performance
Same device materials ●
Same packaging materials and design ●
Same sterilization requirements ●

Summary of Performance Data

While these devices are subject to special controls, most of the special control requirements are not applicable for this proposed change. During use, the water path of the heat exchanger is the only part of the oxygenator that is exposed to a disinfectant. Because of this, it is not necessary to repeat all recommended testing by the specified special control guidance documents. It is however necessary to conduct testing to verify the chemical disinfectant has no adverse effects on the oxygenator water path. The following testing and analysis was performed:

Heat Exchanger Product Material Compatibility with Hydrogen Peroxide ●

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Structural Integrity Testing (pressure integrity, burst and port break tests) ●
Toxicological Risk Assessment for Hydrogen Peroxide ●
Heat Exchanger Permeability Testing

Conclusion

In conclusion, the information provided within this submission demonstrates the Affinity Fusion Oxygenators with Integrated Filter and Cortiva BioActive Surface or Balance Biosurface, with or without Cardiotomy/Venous Reservoir with Balance Biosurface are substantially equivalent to the marketed predicate devices.

Regulation Number and Section

§ 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.”