(89 days)
Not Found
No
The summary describes a physical device for gas exchange and filtration during cardiopulmonary bypass, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
It is used to oxygenate and remove carbon dioxide from the blood, and to cool or warm the blood, which directly treats the patient's physiological functions during cardiopulmonary bypass procedures.
No
The device is an oxygenator used to oxygenate and remove carbon dioxide from blood, and to cool or warm blood during cardiopulmonary bypass procedures, and to filter microemboli. It performs a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, single-use, hollow-fiber gas-exchange device with integrated components, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in an extracorporeal perfusion circuit to oxygenate, remove carbon dioxide, and cool/warm blood during cardiopulmonary bypass procedures. This is a direct interaction with the patient's blood outside the body for therapeutic purposes, not for diagnostic testing in vitro (in a test tube or lab setting).
- Device Description: The description details a device for gas exchange and filtration of blood, consistent with its intended use in a bypass circuit.
- Performance Studies: The performance studies focus on the functional and physical/mechanical aspects of the device's operation in a bypass circuit (oxygen and CO2 transfer, heat exchange, filtration efficiency, integrity, etc.). These are not studies related to diagnostic accuracy or the detection of substances in a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda 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 procedures up to 6 hours in duration.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
Product codes
DTZ
Device Description
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma-resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The device is sterilized by ethylene oxide.
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
In vitro testing was carried out in accordance with the relevant requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff issued on November 13, 2000, "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions: Final Guidance for Industry and FDA" issued on November 29, 2000, ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)"; and ISO 15675 "Cardiovascular implants and artificial organs -Cardiopulmonary bypass systems - Arterial blood line filters".
In vitro testing was carried out to demonstrate both the substantial equivalence with the predicate device and also to comply with safety and effectiveness requirements. Testing supplied in the 510(k) premarket notification includes performance tests, physical and mechanical integrity tests that demonstrate compliance with performance specifications.
The tests that were performed are listed in the following summary table. The Affinity Fusion Oxygenator passed each test mentioned in the table below.
| Test | Test Classification | Test Title |
|---|
- | Functional/Performance | Oxygen and Carbon Dioxide Transfer
- | Functional/Performance | Time Dependent Performance Changes
- | Functional/Performance | Heat Exchanger Performance
- | Functional/Performance | High Flow Blood Trauma
- | Functional/Performance | Min Flow Blood Trauma
- | Functional/Performance | Plasma Breakthrough
- | Functional/Performance | Time to Prime
- | Functional/Performance | Gross Air Handling
- | Functional/Performance | Filtration Efficiency
- | Physical/Mechanical | Cap Pulls
- | Physical/Mechanical | Integrity
- | Physical/Mechanical | Blood Volumes
- | Physical/Mechanical | Port Break and Tube Pull
- | Physical/Mechanical | Luer port design - sampling port
- | Physical/Mechanical | Luer port design - air purge line
- | Functional/Performance | Carmeda Coverage/Leaching
- | Functional/Performance | Carmeda Bioactivity
- | Functional/Performance | Particulate Shedding
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K1283314
510(k) Summary of Safety and Effectiveness
October 15, 2012 Date Prepared: Medtronic. Inc. Applicant: Medtronic Perfusion Systems 7611 Northland Drive Brooklyn Park, MN 55428 Establishment Registration No. 2184009 Mary Donlin Contact Person: Senior Regulatory Affairs Specialist Phone: (763) 526-9172 Fax: (763) 367-8147 E-mail:marv.e.donlin@medtronic.com Affinity Fusion® Oxygenator with Integrated Arterial Filter and Trade Name: Carmeda® BioActive Surface Oxygenator Common Name: Classification Name: Cardiopulmonary bypass oxygenator Classification: Class II, 21 CFR 870.4350 Product Code: DTZ Name of Predicate Device: Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda BioActive Surface Model CB511 (K000430)
Device Description:
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma-resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The device is sterilized by ethylene oxide.
Intended Use:
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda 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 procedures up to 6 hours in duration.
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The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
Contraindications:
Do not use this device for any purpose other than indicated.
Comparison to the Predicate Device:
The Affinity Fusion Oxygenator Model CB811 has the same intended use and principles of operation and technology when compared to the predicate device. The design also incorporated an integrated heat exchanger and an integrated arterial filter. The material used to manufacture the housing of the oxygenator is a copolyester material that is Bisphenol A-free (BPA free).
Intended Use:
The Affinity Fusion Oxygenator has the same intended use as the predicate Affinity NT oxygenator (K000430) with the addition of the filtering capability due to the integration of arterial filter within the fiber bundle assembly.
. Design and Materials:
The design and the materials of the Affinity Fusion Oxygenator and the predicate device are essentially the same. The design of the oxygenator device is similar in that they each contain a heat exchanger for temperature control, and a fiber bundle assembly for gas transfer. The device is manufactured with various adhesives and urethanes. The housing of the Affinity Fusion oxygenator is made of a Bisphenol A-free (BPA-free) Eastman Tritan 114 Copolyester, MX731, which differs from the polycarbonate material used in the predicate device. The Affinity Fusion oxygenator Model CB811 is provided with Carmeda BioActive Surface coating. Carmeda is a biocompatible surface coating made with non-leaching heparin that increases the thromboresistance of the blood contact surfaces. The coating reduces platelet activation and adhesion and provides improved platelet preservation and maintenance of platelet function when compared to an uncoated surface. Carmeda coating is also available on the predicate Affinity NT Hollow Fiber Oxygenator.
• Principles of Operation and Technology:
The principles of operation of the subject device and the predicate devices are essentially identical. Blood is pumped into the heat exchanger portion of the device whereby blood temperature is controlled with the use of essentially a water bath. After the blood exits the heat exchanger, it enters the oxygenator portion of the device through the fiber bundle assembly through which the gas transfer occurs (i.e., introduction of oxygen; removal of carbon dioxide). The gas transfer and filtration process occurs via diffusion across the walls of the hollow fiber membranes contained within the oxygenator.
2
• Performance:
In vitro testing was carried out in accordance with the relevant requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff issued on November 13, 2000, "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions: Final Guidance for Industry and FDA" issued on November 29, 2000, ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)"; and ISO 15675 "Cardiovascular implants and artificial organs -Cardiopulmonary bypass systems - Arterial blood line filters".
In vitro testing was carried out to demonstrate both the substantial equivalence with the predicate device and also to comply with safety and effectiveness requirements. Testing supplied in the 510(k) premarket notification includes performance tests, physical and mechanical integrity tests that demonstrate compliance with performance specifications.
The tests that were performed are listed in the following summary table. The Affinity Fusion Oxygenator passed each test mentioned in the table below.
| Test | Test Classification | Test Title |
|---|---|---|
| 1. | Functional/Performance | Oxygen and Carbon Dioxide Transfer |
| 2. | Functional/Performance | Time Dependent Performance Changes |
| 3. | Functional/Performance | Heat Exchanger Performance |
| 4. | Functional/Performance | High Flow Blood Trauma |
| 5. | Functional/Performance | Min Flow Blood Trauma |
| 6. | Functional/Performance | Plasma Breakthrough |
| 7. | Functional/Performance | Time to Prime |
| 8. | Functional/Performance | Gross Air Handling |
| 9. | Functional/Performance | Filtration Efficiency |
| 10. | Physical/Mechanical | Cap Pulls |
| 11. | Physical/Mechanical | Integrity |
| 12. | Physical/Mechanical | Blood Volumes |
| 13. | Physical/Mechanical | Port Break and Tube Pull |
| 14. | Physical/Mechanical | Luer port design - sampling port |
| 15. | Physical/Mechanical | Luer port design - air purge line |
| 16. | Functional/Performance | Carmeda Coverage/Leaching |
| 17. | Functional/Performance | Carmeda Bioactivity |
| 18. | Functional/Performance | Particulate Shedding |
3
Conclusion:
Pursuant to the statutory requirements under Section 513(i)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act), this new device; the Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface is substantially equivalent in principle and performance to the predicate (K000430) device legally marketed in the US and is labeled with the following intended use:
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda 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 procedures up to 6 hours in duration.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
JAN 2 2 2013
Medtronic Cardiovascular Mary E. Donlin, Senior Regulatory Affairs Specialist 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 55112
Re: K123314
Trade/Device Name: Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: October 25, 2012 Received: October 25, 2012
Dear Ms. Donlin:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Mary E. Donlin
forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number. (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
M.A. Hillen
from the first of the first of the first of the first of Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
6
Indications for Use Statement
510(k) Number (if known): K123314
Device Name:
Affinity Fusion® Oxygenator with Integrated Arterial Filter and Carmeda® BioActive Surface.
Indications for Use:
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda 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 procedures up to 6 hours in duration.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K123314 |
|---|---|
| --------------- | --------- |