(149 days)
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No
The document describes a physical medical device (oxygenator) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as an oxygenator used in extracorporeal perfusion to oxygenate, remove carbon dioxide, and cool/warm blood during cardiopulmonary bypass procedures, which are temporary life support functions rather than therapeutic interventions that treat a disease or condition.
No
The device is an oxygenator used in extracorporeal perfusion circuits to facilitate gas exchange and temperature regulation, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical, single-use gas exchange device with an integral heat exchanger and various surface coatings, not a software-only product.
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 intervention on the patient's blood flow, not a test performed in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a "gas exchange device" that interacts directly with blood flowing through it. This aligns with a therapeutic or life-support device, not a diagnostic one.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze blood samples, detect biomarkers, or provide information for diagnosis. Its function is purely to modify the blood's composition and temperature during a medical procedure.
IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device's function is entirely different.
N/A
Intended Use / Indications for Use
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (with Carmeda BioActive surface or 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 procedures up to 6 hours in duration.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
The Medtronic Affinity NT Hollow Fiber Oxygenator is a single use gas exchange device with plasma resistant fiber. It is designed to have the blood flow outside the fiber and includes an integral heat exchanger. The oxygenator is available uncoated or bonded on its blood contacting surfaces with either Carmeda BioActive Surface or Trillium Biosurface. The device is single-use, nontoxic, nonpyrogenic, and supplied sterile for clinical use.
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber 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 back to the patient.
The purpose of this 510(k) Notification was to notify the FDA of an alternate material formulation for the luer caps used on the access port and the sample port as well as report previous changes on the Affinity NT Oxygenator models identified in the table below.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was used to verify the performance characteristics of this device. In addition, real-time aging testing for devices incorporating the previously implemented changes was completed and supports substantial equivalence. Clinical testing was not required to establish substantial equivalence.
The following performance tests were conducted with results being "Pass" for all:
- Subject of 510(k): Biocompatibility (Ensures alternate material for the luer cap is biocompatible according to ISO 10993-1, externally communicating, circulating blood contact, limited duration)
- Subject of 510(k): Positive Pressure Integrity Testing (Ensures luer caps made with the alternate material maintains appropriate seal on the device ensure the device does not leak)
- Previously Implemented Changes (real time aging): Gas Transfer (oxygen and carbon dioxide) (Demonstrates the devices transfer gas to specification)
- Previously Implemented Changes (real time aging): Pressure Drop (Blood and Gas) (Demonstrates the devices meet pressure drop requirements)
- Previously Implemented Changes (real time aging): Plasma Breakthrough (Demonstrates the devices meet Plasma Breakthrough requirements)
- Previously Implemented Changes (real time aging): Blood Trauma (hemolysis, Platelets, White Blood Cells) (Demonstrates the devices meet Blood Trauma requirements)
- Previously Implemented Changes (real time aging): Pressure Integrity (Demonstrates the devices meet Pressure Integrity requirements)
- Previously Implemented Changes (real time aging): Heat Exchanger Performance (Demonstrates the devices meet the heat exchanger efficiency requirements)
- Previously Implemented Changes (real time aging): Coating Testing (Coating testing demonstrates that the coated devices meet the coating requirements)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Medtronic Affinity Oxygenator (K932252), Medtronic Affinity Oxygenator with Trillium Biosurface (K973760), Medtronic Affinity Oxygenator with Carmeda BioActive Surface (K000430)
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.
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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).
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§ 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.”
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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or fabric.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Medtronic, Inc. Jessica Sixberry Principal Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428
Re: K143073
Trade/Device Name: Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: February 13, 2015 Received: February 18, 2015
Dear Ms. Sixberry,
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
1
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 devicerelated 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" (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.
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,
MA-Kille
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143073
Device Name Affinity NT Hollow Fiber Oxygenator
Indications for Use (Describe)
Model 511:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber 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.
Model CB511:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with 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.
Model 511T:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Trillium Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass 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) |
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Image /page/3/Picture/0 description: The image shows the Medtronic logo. On the left side of the logo is a gray circle with a human figure inside. The human figure is in three different positions, as if they are rotating. To the right of the circle is the word "Medtronic" in blue, bold letters.
510(k) Summary
| Date Prepared: | March 18, 2015 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Jessica Sixberry |
| Principal Regulatory Affairs Specialist | |
| Phone: (763) 514-9849 | |
| Fax: | |
| Email: jessica.m.sixberry@medtronic.com |
Device Name and Classification:
| Trade Name: | Affinity NT Oxygenator Uncoated or with Carmeda® BioActive |
|---|---|
| Surface or with Trillium® Biosurface | |
| Common Name: | Oxygenator |
| Classification Name: | Cardiopulmonary bypass Oxygenator |
| Classification Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.4350 |
| Product Code: | DTZ |
| Classification: | Class II |
Predicate Devices
Medtronic Affinity Oxygenator (K932252) Medtronic Affinity Oxygenator with Trillium Biosurface (K973760) Medtronic Affinity Oxygenator with Carmeda BioActive Surface (K000430)
Device Description
The Medtronic Affinity NT Hollow Fiber Oxygenator is a single use gas exchange device with plasma resistant fiber. It is designed to have the blood flow outside the fiber and includes an integral heat exchanger. The oxygenator is available uncoated or bonded on its blood contacting surfaces with either Carmeda BioActive Surface or Trillium Biosurface. The device is single-use, nontoxic, nonpyrogenic, and supplied sterile for clinical use.
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber 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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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 back to the patient.
The purpose of this 510(k) Notification was to notify the FDA of an alternate material formulation for the luer caps used on the access port and the sample port as well as report previous changes on the Affinity NT Oxygenator models identified in the table below.
| Models | Description |
|---|---|
| 511 | Affinity NT Oxygenator |
| CB511 | Affinity NT Oxygenator with Carmeda BioActive Surface |
| 511T | Affinity NT Oxygenator with Trillium Biosurface |
Indications for Use
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (with Carmeda BioActive surface or 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 procedures up to 6 hours in duration.
Comparison to Predicate Devices
The Affinity NT Oxygenators have the same intended use, design and materials, and principles of operation and technology when compared to the predicate Affinity Oxygenators (including previously implemented changes).
- Intended Use: The intended use is the same as the predicate devices.
- Design: The design is the same as the predicate devices.
- Materials: The materials of the Affinity NT Oxygenator are the same or equivalent to . the materials used in the predicate devices.
- Principles of Operation and Technology: The principles of operation are the same as ● the predicate devices.
- Performance: The performance of the device is the same as the predicate device. ●
Summary of Performance Data
Bench testing was used to verify the performance characteristics of this device. In addition, real-time aging testing for devices incorporating the previously implemented changes was completed and supports substantial equivalence. Clinical testing was not required to establish substantial equivalence.
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The following performance tests were conducted:
| Testing | Description | Result | |
|---|---|---|---|
| Subject of 510(k) | Biocompatibility | Ensures alternate material for the luer cap is | |
| biocompatible according to ISO 10993-1, | |||
| externally communicating, circulating blood | |||
| contact, limited duration | Pass | ||
| Positive Pressure | |||
| Integrity Testing | Ensures luer caps made with the alternate | ||
| material maintains appropriate seal on the | |||
| device ensure the device does not leak | Pass | ||
| Previously Implemented Changes (real time aging) | Gas Transfer | ||
| (oxygen and carbon | |||
| dioxide) | Demonstrates the devices transfer gas to | ||
| specification | Pass | ||
| Pressure Drop | |||
| (Blood and Gas) | Demonstrates the devices meet pressure drop | ||
| requirements | Pass | ||
| Plasma | |||
| Breakthrough | Demonstrates the devices meet Plasma | ||
| Breakthrough requirements | Pass | ||
| Blood Trauma | |||
| (hemolysis, | |||
| Platelets, White | |||
| Blood Cells) | Demonstrates the devices meet Blood | ||
| Trauma requirements | Pass | ||
| Pressure Integrity | Demonstrates the devices meet Pressure | ||
| Integrity requirements | Pass | ||
| Heat Exchanger | |||
| Performance | Demonstrates the devices meet the heat | ||
| exchanger efficiency requirements | Pass | ||
| Coating Testing | Coating testing demonstrates that the coated | ||
| devices meet the coating requirements | Pass |
Conclusion
Medtronic has demonstrated that the Affinity NT Oxygenators are substantially equivalent to the predicate devices based upon design, test results, and indications for use.