(54 days)
No
The document describes a mechanical device for extracorporeal circulation and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The change being notified is related to the use of hydrogen peroxide in the water path, not a software or algorithmic change.
Yes
Explanation: The device is used in extracorporeal perfusion circuits to oxygenate, remove carbon dioxide, and cool or warm blood, which are therapeutic interventions for patients undergoing cardiopulmonary bypass procedures.
No
The device is an oxygenator and reservoir system used in extracorporeal perfusion circuits during cardiopulmonary bypass procedures, designed to oxygenate, remove carbon dioxide, and filter blood, rather than to diagnose conditions.
No
The device description clearly outlines physical components like hollow fibers, filters, heat exchangers, and reservoirs, indicating it is a hardware device used in extracorporeal perfusion circuits. The 510(k) is for a change related to material compatibility with a disinfectant in the water path, not a software modification.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in an extracorporeal perfusion circuit to oxygenate, remove carbon dioxide, and cool/warm blood during cardiopulmonary bypass procedures. It also mentions filtering microemboli and collecting venous/cardiotomy blood. These are all functions performed directly on blood outside the body as part of a life support system, not for the purpose of examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the components and their functions within the extracorporeal circuit, such as gas exchange, heat exchange, and blood collection. Again, these are all related to processing blood outside the body during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing blood or other specimens for diagnostic purposes, detecting analytes, or providing information for medical decisions based on laboratory testing.
Therefore, the Affinity Fusion oxygenator and related components are considered medical devices used in a surgical setting, not IVDs.
N/A
Intended Use / Indications for Use
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 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.
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.
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.
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.
Product codes
DTZ, DTR, DTN, DTM, JOD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
- Structural Integrity Testing (pressure integrity, burst and port break tests)
- Toxicological Risk Assessment for Hydrogen Peroxide
- Heat Exchanger Permeability Testing
Key Metrics
Not Found
Predicate Device(s)
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Model BB811) – K142784, Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BB841) – K142784, Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva BioActive Surface (Model CB811) – K142784, Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva BioActive Surface and Cardiotomy/Venous Reservoir with Balance Biosurface (Model CB841) – K142784
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
1
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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. |
| 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
"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
3
| 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.
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
"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
4
| 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 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 and Cardiotomy/Venous Reservoir with |
| Balance Biosurface (Model CB841) | |
| 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. | |
| 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.
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 1PSC Publishing Services (301) 443-6740EF
อรป และเวอร์นทร์เป็น เดิมเกอร์ชุรกิ
XXXXXXXXXXX
6
SUMMARY OF SAFETY AND EFFECTIVENESS 5
| Date Prepared: | August 31, 2017 |
|---|---|
| Submitter's Name and Address: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Lisa J. Stone, RAC |
| Principal Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: (763) 514-9866 | |
| Email: lisa.j.stone@medtronic.com | |
| Alternate Contact: | Jake Roeller |
| Senior Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: (763) 526-0404 | |
| Email: jake.w.roeller@medtronic.com | |
| Proprietary Name: | Affinity Fusion™ Oxygenator with Integrated |
| Arterial Filter and Balance™ Biosurface | |
| (Model BB811) | |
| Affinity Fusion™ Oxygenator with Integrated | |
| Arterial Filter and Cardiotomy/Venous | |
| Reservoir with Balance™ Biosurface (Model | |
| BB841) | |
| Affinity Fusion™ Oxygenator with Integrated | |
| Arterial Filter and Cortiva™ BioActive | |
| Surface (Model CB811) | |
| Affinity Fusion™ Oxygenator with Integrated | |
| Arterial Filter and Cortiva™ BioActive | |
| Surface and Cardiotomy/Venous Reservoir | |
| with Balance™ Biosurface (Model CB841) |
7
| Common Name: | Oxygenator |
|---|---|
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Classification: | Classification: Class II |
| Panel: Cardiovascular | |
| Regulation: 21 CFR 870.4350 | |
| Product Code: DTZ | |
| Predicate Device: | Affinity Fusion™ Oxygenator with Integrated |
| Arterial Filter and Balance™ Biosurface | |
| (Model BB811) – K142784 | |
| Affinity Fusion™ Oxygenator with Integrated | |
| Arterial Filter and Cardiotomy/Venous | |
| Reservoir with Balance™ Biosurface (Model | |
| BB841) – K142784 and K132972 | |
| Affinity Fusion™ Oxygenator with Integrated | |
| Arterial Filter and Cortiva™ BioActive | |
| Surface (Model CB811) – K142784 | |
| Affinity Fusion™ Oxygenator with Integrated | |
| Arterial Filter and Cortiva™ BioActive | |
| Surface and Cardiotomy/Venous Reservoir | |
| with Balance™ Biosurface (Model CB841) – | |
| K142784 and K132972 |
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
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)
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.
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 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.
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.
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.
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.