(28 days)
Not Found
No
The description focuses on the physical components and function of the oxygenator and filter, with no mention of AI or ML. The purpose of the submission is a material change to luer caps.
Yes
The device is described as an oxygenator that oxygenates and removes carbon dioxide from the blood, and cools or warms the blood during cardiopulmonary bypass procedures, which directly treats the patient's blood by performing functions of the lungs and regulating temperature.
No
Explanation: This device is an oxygenator used in cardiopulmonary bypass procedures, which is a therapeutic device, not a diagnostic one. Its function is to oxygenate blood, remove carbon dioxide, and filter microemboli, all of which are interventions rather than diagnostic assessments.
No
The device description clearly indicates it is a physical, single-use, microporous, hollow-fiber, gas exchange device with integrated components like a heat exchanger and arterial filter, used in an extracorporeal perfusion circuit. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as part of an extracorporeal perfusion circuit to oxygenate, remove carbon dioxide, and cool/warm blood during cardiopulmonary bypass. It also filters microemboli. These are all functions performed on the blood as it circulates outside the body, not on a sample of blood or other biological material to provide diagnostic information.
- Device Description: The description reinforces the device's role in the extracorporeal circuit for gas exchange, heat exchange, and filtration.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze a sample, detect a condition, or provide any information for diagnosis.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is therapeutic and supportive during a medical procedure, not diagnostic.
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 procedures up to six 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 Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active 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 six hours in duration.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active 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 (comma separated list FDA assigned to the subject device)
DTZ
Device Description
Affinity Fusion Oxygenators with Integrated Arterial Filter and with Balance Biosurface or Carmeda BioActive Surface are single-use, microporous, hollow-fiber, gas exchange device with plasma-resistant fiber and integrated heat exchanger and arterial filter. The oxygenators are bonded on their primary blood contacting surfaces with either Balance Biosurface or Carmeda BioActive Surface.
The device is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood. The device is also used to cool or warm the blood during routine cardiopulmonary bypass procedures up to six hours in duration. The integrated filter is designed to filter from the extracorporeal circuit microemboli larger than the specified micron size (25u). The filtration functionality is achieved through the progressively tighter fiber spacing within the fiber bundle assembly (FBA) inside the oxygenator.
The purpose of this Special 510(k) Notification was to notify the FDA of an alternate material formulation for the luer caps used on the recirculation, cardioplegia and sampling ports of the Affinity Fusion Oxygenator with Integrated Filter and with either Balance Biosurface or Carmeda BioActive Surface.
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
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required to establish substantial equivalence.
The following performance tests were conducted:
- Biocompatibility
- Positive pressure integrity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic, Inc. Lisa Stone Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K142784
Trade/Device Name: Affinity Fusion® Oxygenator with Integrated Arterial Filter and with Balance TM Biosurface or Carmeda® BioActive Surface Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: September 26, 2014 Received: September 26, 2014
Dear Ms. Stone:
This letter corrects our substantially equivalent letter of October 24, 2014.
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours.
M.A. Hillebrand
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
510(k) Number (if known) K142784
Device Name
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface
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 procedures up to six 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.
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
Affinity Fusion Oxygenators Medtronic Confidential
KXXXXXXX 1-26
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142784
Device Name
Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active Surface
Indications for Use (Describe)
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carneda Bio-Active 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 six hours in duration.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active 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.
| 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)
PSC Publishing Services (301) 443-6740
Affinity Fusion Oxygenators Medtronic Confidential
Image /page/3/Picture/21 description: The image contains two lines of text. The first line reads "KXXXXXXX", with the letter K followed by a series of X's. The second line reads "1-27", which appears to be a numerical range or identifier. The text is presented in a clear, legible font.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
510(k) Summary of Safety and Effectiveness
| Date Prepared: | September 23, 2014 |
|---|---|
| Applicant: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Brooklyn Park, MN 55428 | |
| Establishment Registration No. 2184009 | |
| Contact Person: | Lisa Stone |
| Principal Regulatory Affairs Specialist | |
| Medtronic, Inc. | |
| Coronary and Structural Heart Disease Management | |
| 8200 Coral Sea Street NE, MVS 83 | |
| Mounds View, MN 55112 | |
| Phone: (763) 514-9866 | |
| Fax: (763) 367-8147 | |
| Email: lisa.j.stone@medtronic.com | |
| Trade Name: | Affinity Fusion® Oxygenator with Integrated Arterial Filter |
| and with Balance™ Biosurface or Carmeda® BioActive | |
| Surface | |
| Common Name: | Oxygenator |
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Classification: | Class II, 21 CFR 870.4350 |
| Product Code: | DTZ |
| Name of Predicate Device: | Affinity Fusion® Oxygenator with Integrated Arterial Filter |
| and with Balance™ Biosurface, Model BB811 (K122827) | |
| Affinity Fusion® Oxygenator with Integrated Arterial Filter | |
| and with Carmeda® BioActive Surface, Model CB811 | |
| (K123314) |
5
Device Description
Affinity Fusion Oxygenators with Integrated Arterial Filter and with Balance Biosurface or Carmeda BioActive Surface are single-use, microporous, hollow-fiber, gas exchange device with plasma-resistant fiber and integrated heat exchanger and arterial filter. The oxygenators are bonded on their primary blood contacting surfaces with either Balance Biosurface or Carmeda BioActive Surface.
The device is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood. The device is also used to cool or warm the blood during routine cardiopulmonary bypass procedures up to six hours in duration. The integrated filter is designed to filter from the extracorporeal circuit microemboli larger than the specified micron size (25u). The filtration functionality is achieved through the progressively tighter fiber spacing within the fiber bundle assembly (FBA) inside the oxygenator.
The purpose of this Special 510(k) Notification was to notify the FDA of an alternate material formulation for the luer caps used on the recirculation, cardioplegia and sampling ports of the Affinity Fusion Oxygenator with Integrated Filter and with either Balance Biosurface or Carmeda BioActive Surface.
Intended Use
There were no changes to the intended use of the devices as related to the change purposed in this Special 510(k) Notification. The current Indications for Use statement is 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 procedures up to six 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 Carmeda BioActive Surface (Model CB811)
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 six hours in duration.
6
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.
Comparison to the Predicate Device
The Affinity Fusion Oxygenators with Integrated Filter and with Balance Biosurface or Carmeda BioActive Surface are substantially equivalent to the previous versions (predicate) of these devices.
The modified oxygenators have the following similarities to the predicate devices which received 510(k) clearance:
- Same intended use/indications ●
- Same operating principle ●
- Same fundamental technological characteristics
- Same overall design, dimensions and performance ●
- Substantially equivalent materials All materials are the same except for the protective o luer caps used on the recirculation, cardioplegia and sampling ports. These caps have undergone a minor formulation change.
- Same packaging materials and design ●
- Same sterilization requirements ●
Summary of Performance Data
Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required to establish substantial equivalence.
The following performance tests were conducted:
- Biocompatibility
- Positive pressure integrity
Conclusion
In summary, the information included in this submission demonstrates that with changes made to the Affinity Fusion Oxygenators with Integrated Filter and with Balance Biosurface or Carmeda BioActive Surface are substantially equivalent to the legally marketed predicate versions.