Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

Q: Who is the manufacturer of Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)?

Medtronic Perfusion Systems filed the 510(k) submission for Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) (K240666).

Q: What is the FDA product code for Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)?

DTZ. It is classified under 21 CFR 870.4350 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K240666 · Medtronic Perfusion Systems · DTZ · Jul 10, 2024 · Cardiovascular

Device Facts

Record ID	K240666
Device Name	Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
Applicant	Medtronic Perfusion Systems
Product Code	DTZ · Cardiovascular
Decision Date	Jul 10, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4350
Device Class	Class 2
Attributes	Therapeutic

Intended 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 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 six hours during cardiopulmonary bypass 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 Story

Affinity Fusion Oxygenator is a microporous, hollow-fiber gas-exchange device integrated with an arterial filter and heat exchanger; used in extracorporeal perfusion circuits during cardiopulmonary bypass (up to 6 hours). Input: venous blood from patient via pump; Output: oxygenated, CO2-depleted, temperature-regulated blood returned to patient. Operated by perfusionists in clinical cardiac surgery settings. Device utilizes hollow-fiber membrane bundle for gas exchange; blood flows over fiber exterior while gas flows through interior. Integrated reservoir collects venous/cardiotomy blood and supports VAVD. Output allows clinicians to maintain patient physiological stability during bypass. Benefits include effective gas exchange, microemboli removal, and blood volume management.

Clinical Evidence

Bench testing only. No clinical data. Testing included O2/CO2 transfer, pressure integrity, burst, filtration efficiency, hemolysis, and platelet/leukocyte retention. Biocompatibility testing performed per ISO 10993-1:2018, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility (complement activation, PTT, platelet/leukocyte counts). All tests passed.

Technological Characteristics

Microporous hollow-fiber oxygenator with integrated arterial filter and heat exchanger. Blood-contacting surfaces feature Balance Biosurface. Materials evaluated per ISO 10993-1. Connectivity: interfaces with heater/cooler, recirculation, and cardioplegia circuits. Standalone device. Sterilization: not specified (includes non-sterile model).

Indications for Use

Indicated for patients undergoing routine cardiopulmonary bypass surgery (up to 6 hours) requiring blood oxygenation, CO2 removal, temperature control, and microemboli filtration. Reservoir indicated for venous/cardiotomy blood collection, VAVD procedures, and post-operative autologous blood salvage.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (K230640)

Reference Devices

Medtronic Affinity NT Oxygenator (K191077)

Related Devices

K031223 — SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR · Dideco S.P.A. · May 2, 2003
K973760 — AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE · Avecor Cardiovascular, Inc. · Feb 18, 1998
K123314 — AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE · Medtronic, Inc. · Jan 22, 2013
K022115 — CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR · Terumo Corp. · Sep 27, 2002
K093522 — QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C · Maquet Cardiopulmonary, AG · Dec 7, 2009

Submission Summary (Full Text)

{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 and the words "U.S. Food & Drug Administration". July 10, 2024 Medtronic Perfusion Systems Megan Schlichting Regulatory Affairs Manager 7611 Northland Drive Minneapolis, Minnesota 55428 ### Re: K240666 Trade/Device Name: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ Dated: June 7, 2024 Received: June 7, 2024 Dear Megan Schlichting: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Nicole M. Gillette -S Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Submission Number (if known) Device Name Affinity FusionTM Oxygenator with Integrated Arterial Filter and BalanceTM Biosurface (BB811); Affinity FusionTM Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with BalanceTM Biosurface (BB841); Affinity FusionTM Oxygenator with Integrated Arterial Filter and BalanceTM Biosurface NON STERILE (BB811-NS) Indications for Use (Describe) ### Model BB811 and Model BB811-NS 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 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 six hours during cardiopulmonary bypass surgery. ### Model BB841 Oxygenator with Integrated Arterial Filter 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 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 six hours during cardiopulmonary bypass surgery. Cardiotomy/Venous Reservoir 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 affer 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ #### 12.0 510(k) Summary Date Prepared: June 3, 2024 | Submitter: | Medtronic, Inc. | |------------|--------------------------------------------| | | Medtronic Perfusion Systems | | | 7611 Northland Drive | | | Minneapolis, MN 55428 | | | Establishment Registration Number: 2184009 | Contact Person: Megan Schlichting Regulatory Affairs Manager Medtronic Perfusion Systems Phone: (763) 526-3087 Fax: (763) 514-9521 Email: megan.schlichting@medtronic.com Alternate Contact: Kimberly Peterson Regulatory Affairs Director Medtronic Perfusion Systems Phone: (763) 526-6751 Email: kimberly.m.peterson@medtronic.com {5}------------------------------------------------ #### 12.1 Device Name and Class | Model | Trade name | Common Name | Classification Name | Class | Class Classification Panel | Regulation (21 CFR) | Product Code | |----------|---------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------|-------------|----------------------------------|----------------------------------|-------------------| | BB811 | AffinityTM Fusion Oxygenator with Integrated Arterial Filter and BalanceTM Biosurface | Oxygenator | Cardiopulmonary bypass oxygenator | Class II | Cardiovascular | 870.4350 | DTZ | | BB841 | AffinityTM Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with BalanceTM Biosurface | Oxygenator | Cardiopulmonary bypass oxygenator and Cardiopulmonary bypass blood reservoir | Class II | Cardiovascular | 870.4350 870.4260 870.4400 | DTZ DTM DTN | | BB811-NS | Affinity FusionTM Oxygenator with Integrated Arterial Filter and BalanceTM Biosurface (Non-Sterile) | Oxygenator | Cardiopulmonary bypass oxygenator | Class II | Cardiovascular | 870.4350 | DTZ | {6}------------------------------------------------ #### 12.2 Predicate Device Information | | Trade Name | Affinity FusionTM Oxygenator with Integrated Arterial Filter and BalanceTM Biosurface (BB811) | |--|------------------|-----------------------------------------------------------------------------------------------------------------------------------| | | | Affinity FusionTM Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with BalanceTM Biosurface (BB841) | | | | Affinity FusionTM Oxygenator with Integrated Arterial Filter and BalanceTM Biosurface (Non-Sterile) (B811-NS) | | | 510(k) | K230640 | | | Concurrence Date | April 6, 2023 | #### 12.3 Device Description The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811), Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841), and Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Non-Sterile) (B811-NS) are collectively referred to as the Affinity Fusion Oxygenator in the summary. The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter 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. Some models of the Affinity Fusion Oxygenator 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. #### Principles of Operation 12.4 Affinity Oxygenators are designed to be an integral part of the cardiopulmonary heart bypass circuit for use during cardiac surgery. The Affinity Oxygenators are 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 procedures up to 6 hours in duration. {7}------------------------------------------------ The oxygenator is composed of the "fiber bundle" which is the gas exchange portion of an oxygenator. The "fiber bundle" is comprised of tiny hollow tubes, or "hollow fibers" that consist of a microporous membrane that allows for gas exchange. Blood flows over the outside surfaces of the hollow fibers while fresh gas is delivered to the inside of the fibers allowing for gas exchange. 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. 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 water-side of the oxygenator is connected to a heater/cooler device to enable temperature control of the blood. #### 12.5 Indications for Use ## Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance™ Biosurface (Model BB811 and BB811-NS) 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 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 six hours during cardiopulmonary bypass surgery. # Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BB841) # Oxygenator with Integrated Arterial Filter 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 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 six hours during cardiopulmonary bypass surgery. # Cardiotomy/Venous Reservoir 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. {8}------------------------------------------------ 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. #### 12.6 Comparison to Predicate Device A comparison of the modified product to the currently marketed predicate product Affinity Fusion Oxygenator (K230640) indicates the following similarities: - Intended Use / Indications for use ● - Contraindications - Operating Principle - Mechanism of action - Performance ● - . Shelf Life - Packaging configuration and materials - . Sterilization process and requirements When compared to the predicate device. the Affinity Fusion Oxygenator devices presented in this submission have the following differences: - addition of an alternate supplier of the hollow fiber for use in the oxygenator fiber ● bundle The alternate hollow fiber was previously cleared for use in Medtronic Affinity NT Oxygenator (K191077). Design verification and biocompatibility testing were completed, and they have led to the conclusion that no newly emerging hazards or risks were identified. #### 12.6.1 Design Verification testing The proposed Affinity Fusion Oxygenator has been evaluated through testing to demonstrate that it meets the pressure integrity, burst, and other Special Controls requirements. Test results are presented in Table 12-1. Testing demonstrated results within specification, and therefore the Affinity Fusion Oxygenator manufactured with the hollow fiber supplied by the new supplier is deemed to be substantially equivalent to the predicate Affinity Fusion Oxygenator manufactured with the current hollow fiber supplier. Testing results demonstrate that the performance is comparable to the predicate Affinity Fusion Oxygenator devices (BB811, BB841, and BB811-NS) currently in market. | Test Item | T=0 | T=2yrAA | T=20 months RTA | |--------------------------|------|---------|-----------------| | O2 Transfer | PASS | PASS | NA | | CO2 Transfer | PASS | PASS | NA | | Blood Side Pressure Drop | PASS | PASS | NA | | 6 Hour O2 Transfer | PASS | PASS | NA | Table 12-1: Summary of Device Testing {9}------------------------------------------------ | 6 Hour CO2 Transfer | PASS | PASS | NA | |----------------------------------|-------|-------|------| | Pressure Integrity | PASS* | PASS* | NA | | Burst | PASS | PASS | NA | | Gas Pathway Integrity | NA | NA | PASS | | Plasma Breakthrough | PASS | PASS | NA | | Filtration Efficiency | PASS | PASS | NA | | Hemolysis (Max Flow) | PASS | PASS | NA | | White Blood Cell Retention | PASS | PASS | NA | | Platelet (PLT) retention | PASS | PASS | NA | | Functional platelet retention | PASS | PASS | NA | | Platelet PLT Function (min flow) | PASS | PASS | NA | | Prime Volume | PASS | PASS | NA | | Coverage | PASS | PASS | NA | | Leaching | PASS | PASS | NA | *Devices conditioned only to factors significant for leaks (per Two Proportion statistical test) #### 12.6.2 Biocompatibility Biocompatibility testing was performed in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The Affinity Fusion Oxygenator is categorized as an external communicating device in contact with circulating blood for less than twenty-four (24) hours per ISO 10993-1:2018 and appropriate tests were selected. Test results are presented in Table 12-2. The results of the biological endpoint testing concluded that the Affinity Fusion Oxygenator with the alternate hollow fiber is non-cytotoxic, a non-sensitizer, a non-irritant, non-pyrogenic, non-hemolytic, non-genotoxic, and hemocompatible in regard to complement activation, partial thromboplastin time and platelet & leukocyte count. {10}------------------------------------------------ | Biocompatibility Test Method | Testing Category | Results | |---------------------------------------------------------------------------------------|-----------------------------------------------------------|---------| | ISO MEM Elution Cytotoxicity, L929 Mouse Fibroblast Cells | Cytotoxicity | PASS | | ISO Maximization Sensitization Study, 0.9%Sodium Chloride & Sesame Oil, NF extract | Sensitization | PASS | | ISO Intracutaneous Study – 0.9% Sodium Chloride & Sesame Oil, NF extract | Intracutaneous Reactivity | PASS | | ISO Systemic Toxicity Study - 0.9% Sodium Chloride & Sesame Oil, NF extract | Acute Systemic Toxicity | PASS | | Pyrogen Study – Material Mediated -0.9%Sodium Chloride | Material Mediated Pyrogen Study – 0.9% Sodium Chloride | PASS | | ASTM In-vitro Hemolysis, Rabbit Blood | Hemocompatibility | PASS | | Complement Activation, SC5b-9, Human Serum | Hemocompatibility | PASS | | ASTM Partial Thromboplastin Time, Direct Contact, Human Plasma | Hemocompatibility | PASS | | Genotoxicity, Bacterial Reverse Mutation Study | Genotoxicity | PASS | | Genotoxicity: Mouse Lymphoma Assay | Genotoxicity | PASS | | Platelet and Leukocyte Count- with comparison article | Hemocompatibility | PASS | Table 12-2: Summary of Biocompatibility Testing #### 12.7 Conclusion Medtronic has demonstrated through testing completed that the addition of a second hollow fiber supplier for the Affinity Fusion Oxygenator described in this summary results in a substantially equivalent device because fundamental scientific principle, operating principle, design features and intended use are unchanged.