(50 days)
Not Found
No
The document describes a mechanical device for oxygenating blood during bypass surgery and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is intended to treat a condition by oxygenating and removing carbon dioxide from blood, and cooling or warming it during cardiopulmonary bypass procedures, which is a therapeutic function.
No
The device is an oxygenator used in cardiopulmonary bypass procedures, performing functions like oxygenation, carbon dioxide removal, and temperature regulation of blood; it does not diagnose medical conditions.
No
The device description clearly indicates it is a physical medical device (oxygenator) used in extracorporeal perfusion circuits, not a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states 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 of samples.
- Device Description: The description reinforces its role in a heart-lung bypass circuit, processing blood that comes from and returns to the patient.
- Lack of Diagnostic Language: There is no mention of analyzing blood samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical integrity and function of the device (pressure, burst, port break), not on the accuracy or reliability of diagnostic measurements.
IVD devices are designed to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on supporting the patient's physiological processes during surgery.
N/A
Intended Use / Indications for Use
Model 511:
The Affinity NT 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 cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
Model 511T:
The Affinity NT Oxygenator with Trillium Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
Product codes (comma separated list FDA assigned to the subject device)
DTZ, DTR
Device Description
The device listed in this 510(k) Notification is single use, non-toxic, non-pyrogenic, and is supplied sterile in packaging.
The Medtronic Affinity NT Oxygenator is a single use device designed to oxygenate and remove carbon dioxide from the blood and with the heat exchanger and arterial filter cools or warms the blood during extracorporeal circulation. The oxygenator has either a blood contacting Trillium Biosurface or is uncoated.
The Affinity NT 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 cardiopulmonary bypass procedures up to 6 hours in duration.
Affinity NT Oxygenator is designed to be an integral part of the cardiopulmonary heart lung bypass circuit for use during cardiac surgery. Blood that comes from the patient is delivered through a blood pump to the oxygenator and other auxiliary devices, and then back to the patient.
The purpose of this 510(k) Notification is to notify the FDA of a labeling change to the disinfectant warning on the Instructions for Use to allow for disinfectant use in the water path of the oxygenator as well as report previous changes for the Affinity NT Oxygenator models included in this submission.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:
Pressure Integrity: Water path must withstand 45 PSI pressure for 6 hours without leaking - Pass
Burst: Water path burst testing should be comparable to that of the control devices - Pass
Port Break: Water path break force shall be comparable to that of the control device - Pass
An analysis was also completed to characterize the physical properties of the materials used to construct the water side of the heat exchanger.
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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 06, 2016
Medtronic Cardiac and Vascular Group Renee Cveykus Principal Regulatory Affairs Specialist 8200 Coral Sea St. NE Mounds View, MN 55112
Re: K162896
Trade/Device Name: Affinity NT Oxygenator (Model 511), Affinity NT Oxygenator with Trillium Biosurface (Model 511T) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR Dated: October 14, 2016 Received: October 17, 2016
Dear Ms. Cveykus:
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
1
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/Resourcesfor You/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.
M.A. Hilleman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K162896
Device Name Affinity NT Oxygenator
Indications for Use (Describe)
Model 511:
The Affinity NT 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 cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
Model 511T:
The Affinity NT Oxygenator with Trillium Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5.1 510(k) Summary
| Date Prepared: | October 14, 2016 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Renee L. Cveykus |
| Principal Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: (763) 505-3059 | |
| Fax: (763) 367-0401 | |
| Email: renee.l.cveykus@medtronic.com | |
| Alternate Contact: | Susan C. Fidler |
| Sr. Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: (763) 514-9839 | |
| Fax: (763) 367-8360 | |
| Email: susan.c.fidler@medtronic.com |
Proprietary Name:
| Proprietary Name: | |
|---|---|
| Models | Description |
| 511 | Affinity NTTM Oxygenator |
| 511T | Affinity NTTM Oxygenator with TrilliumTM Biosurface |
Device Name and Classification:
| Trade Name: | Affinity NTTM Oxygenator with TrilliumTM Biosurface |
|---|---|
| Common Name: | Oxygenator |
| Classification Name: | Cardiopulmonary bypass Oxygenator |
| Classification Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.4350 |
| Product Code: | DTZ |
| Classification: | Class II |
4
Predicate Device:
Medtronic Affinity NT Oxygenators (K143073). The scope of this predicate submission is below and included both uncoated and Trillium coated models.
| Product Family | Model | Description |
|---|---|---|
| Affinity NT Oxygenator | 511 | Affinity NT Oxygenator |
| 511T | Affinity NT Oxygenator with Trillium Biosurface |
Device Description
The device listed in this 510(k) Notification is single use, non-toxic, non-pyrogenic, and is supplied sterile in packaging.
The Medtronic Affinity NT Oxygenator is a single use device designed to oxygenate and remove carbon dioxide from the blood and with the heat exchanger and arterial filter cools or warms the blood during extracorporeal circulation. The oxygenator has either a blood contacting Trillium™ Biosurface or is uncoated.
The Affinity NT 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 cardiopulmonary bypass procedures up to 6 hours in duration.
Affinity NT Oxygenator is designed to be an integral part of the cardiopulmonary heart lung bypass circuit for use during cardiac surgery. Blood that comes from the patient is delivered through a blood pump to the oxygenator and other auxiliary devices, and then back to the patient.
The purpose of this 510(k) Notification is to notify the FDA of a labeling change to the disinfectant warning on the Instructions for Use to allow for disinfectant use in the water path of the oxygenator as well as report previous changes for the Affinity NT Oxygenator models included in this submission.
5
Indications for Use
There is no change to the intended use of the devices within the scope of the proposed change in this Traditional 510(k) Notification. The current Indications for Use statements for these devices are listed below:
The Affinity NT Oxygenator (Model 511) is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity NT Oxygenator with Trillium Biosurface (model 511T) is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
Comparison to Predicate Devices
The Affinity NT Oxygenator has the same intended use, design and materials, and principles of operation and technology when compared to the predicate Affinity NT Oxygenator.
- Intended Use: The intended use is the same as the predicate device. ●
- Design: The design is the same as the predicate device.
- Materials: The materials of the Affinity NT Oxygenator are the same as the predicate device.
- Principles of Operation and Technology: The principles of operation are the same as the predicate device.
- Performance: The performance of the device is the same as the predicate device. ●
Summary of Performance Data
Testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:
| Testing | Description | Result |
|---|---|---|
| Pressure Integrity | Water path must withstand 45 PSI pressure for 6 hours without leaking | Pass |
| Burst | Water path burst testing should be comparable to that of the control devices | Pass |
| Port Break | Water path break force shall be comparable to that of the control device | Pass |
6
An analysis was also completed to characterize the physical properties of the materials used to construct the water side of the heat exchanger.
7
Conclusion
In summary, the information provided within the submission demonstrates that the Affinity NT Oxygenator Uncoated or with Trillium Biosurface is substantially equivalent to the marketed predicate devices.