(54 days)
The Affinity Pixie hollow fiber oxygenator with Balance biosurface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Balance biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie cardiotomy/ venous reservoir 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 Pixie hollow fiber oxygenator with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie cardiotomy/ venous reservoir 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 Pixie Oxygenators are microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded blood contacting surface. The oxygenator is used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool and warm the blood during routine cardiopulmonary bypass procedures up to six (6) hours in duration. The oxygenator has a low prime volume which is appropriate for use in neonate, infant and small pediatric patients.
The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Cortiva BioActive Surface or Balance Biosurface is a single use device designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Pixie 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. The CVR allows a lower operating volume which is appropriate for use in neonate, infant and small pediatric patients.
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.
The provided FDA 510(k) summary (K172984) is for Medtronic's Affinity Pixie Oxygenator devices and addresses a specific modification related to the use of hydrogen peroxide in the water path, rather than a clinical study evaluating the primary performance of the oxygenator itself or an AI-based device. Therefore, much of the requested information regarding acceptance criteria and performance as it relates to AI or human interpretation is not applicable here.
However, based on the document, I can extract information related to the device modification study:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for "device performance" in terms of clinical outcomes or diagnostic accuracy. Instead, the study focuses on the material compatibility and structural integrity of the existing oxygenator when exposed to hydrogen peroxide. The "reported device performance" is that the device meets the requirements for continued function and safety under the new condition.
| Acceptance Criteria Category | Reported Device Performance (for the modified use) |
|---|---|
| Material Compatibility | Device materials (specifically the heat exchanger) demonstrated compatibility with hydrogen peroxide (330 ppm) without adverse effects. |
| Structural Integrity (Pressure) | The device maintained pressure integrity, burst strength, and port break strength after exposure to hydrogen peroxide. (Implied to meet pre-defined thresholds) |
| Toxicological Risk | Assessment concluded no toxicological risk associated with hydrogen peroxide exposure. (Implied to be below acceptable safety limits) |
| Heat Exchanger Permeability | Maintained required permeability characteristics after hydrogen peroxide exposure. (Implied to be within functional specifications) |
| Premarket Special Controls | Most special controls were deemed not applicable for this change, and applicable ones were addressed (e.g., material compatibility, structural integrity). |
| Substantial Equivalence | Demonstrated substantial equivalence to predicate devices under the new condition, confirming no change in intended use, operating principle, or fundamental characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (e.g., number of devices tested) for the material compatibility, structural integrity, toxicological risk assessment, or permeability testing. It refers to these as "testing and analysis performed." The provenance of the data is implied to be from Medtronic's own testing as part of their 510(k) submission (manufacturer-generated data), and it would be prospective in the sense that the tests were conducted specifically to evaluate this proposed change. There is no information regarding country of origin for the data within this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The study is a bench and laboratory-based engineering and materials assessment, not an AI or clinical study requiring expert ground truth for interpretation of diagnostic images or clinical outcomes. The "ground truth" here is the physical and chemical properties of the materials and device performance under specified test conditions, measured by instruments and analyzed by engineers and toxicologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as it's a bench testing study, not a clinical or AI performance study involving human interpretation or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a cardiopulmonary bypass oxygenator, not a diagnostic AI system requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or AI device. The study described is bench testing of a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the tests conducted:
- Material Compatibility, Structural Integrity, Heat Exchanger Permeability: The "ground truth" is established by direct physical and chemical measurements using standardized testing methods and engineering principles. For example, burst pressure is a direct measurement, and material degradation is assessed through chemical analysis or visual inspection.
- Toxicological Risk Assessment: The "ground truth" is established through scientific literature, established toxicology principles, and potential migration studies to determine patient exposure and compare it against toxicological thresholds.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2017
Medtronic, Inc. Lisa Stone Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K172984
Trade/Device Name: Affinity Pixie Oxvgenator with Balance Biosurface (Model BBP211). Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241). Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass (CPB) Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR, DTN, JOD Dated: September 25, 2017 Received: September 27, 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
{1}------------------------------------------------
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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 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 | |
| Indications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
| 510(k) Number (if known) | K172984 |
| Device Name | Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211) |
| Indications for Use (Describe) | The Affinity Pixie hollow fiber oxygenator with Balance biosurface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L\min.The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration. |
| 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
:
{3}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
| 510(k) Number (if known) | K172984 |
| Device Name | Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241) |
| Indications for Use (Describe) | |
| The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Balance biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin. | |
| The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration. | |
| The Affinity Pixie cardiotomy/ venous reservoir 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. | |
| 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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@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 |
{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) | K172984 |
|---|---|
| Device Name | Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211) |
| Indications for Use (Describe) | The Affinity Pixie hollow fiber oxygenator with Cortiva bioactive surface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin.The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration. |
| 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 |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
{5}------------------------------------------------
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K172984 |
|---|---|
| Device Name | Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) |
| Indications for Use (Describe) | The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin. The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration. The Affinity Pixie cardiotomy/ venous reservoir 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. |
| 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
,第
{6}------------------------------------------------
510(K) SUMMARY 5
| Date Prepared: | September 25, 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 Pixie™ Oxygenator with Balance™Biosurface (Model BBP211)Affinity Pixie™ Oxygenator andCardiotomy/Venous Reservoir with Balance™Biosurface (Model BBP241)Affinity Pixie™ Oxygenator with Cortiva™BioActive Surface (Model CBP211)Affinity Pixie™ Oxygenator andCardiotomy/Venous Reservoir with Cortiva™мBioActive Surface (Model CBP241) |
| Common Name: | Oxygenator |
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Classification: | Classification: Class IIPanel: CardiovascularRegulation: 21 CFR 870.4350Product Code: DTZ |
| Predicate Device: | Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211) – K100645 |
| Affinity Pixie™ Oxygenator andCardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241) – K100645 and K141233 | |
| Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211) – K100645 | |
| Affinity Pixie™ Oxygenator andCardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241) – K100645 and K141233 |
{7}------------------------------------------------
Device Description
The Affinity Pixie Oxygenators are microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded blood contacting surface. The oxygenator is used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool and warm the blood during routine cardiopulmonary bypass procedures up to six (6) hours in duration. The oxygenator has a low prime volume which is appropriate for use in neonate, infant and small pediatric patients.
The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Cortiva BioActive Surface or Balance Biosurface is a single use device designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Pixie 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. The CVR allows a lower operating volume which is appropriate for use in neonate, infant and small pediatric patients.
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
{8}------------------------------------------------
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 Pixie Oxygenator with Balance Biosurface (Model BBP211)
The Affinity Pixie hollow fiber oxygenator with Balance biosurface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241)
The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Balance biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
{9}------------------------------------------------
The Affinity Pixie cardiotomy/ venous reservoir 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.
Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211)
The Affinity Pixie hollow fiber oxygenator with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)
The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie cardiotomy/ venous reservoir 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.
Comparison to Predicate Devices
When compared to the predicate devices, the Affinity Pixie 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 ●
{10}------------------------------------------------
- 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 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 .
Conclusion
In conclusion, the information provided within this submission demonstrates the Affinity Pixie Oxygenators with/without Cardiotomy/Venous Reservoir and Balance Biosurface or Cortiva BioActive Surface are substantially equivalent to the marketed predicate devices.
§ 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.”