Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface

K143073 · Medtronic, Inc. · DTZ · Mar 25, 2015 · Cardiovascular

Device Facts

• Record ID: K143073
• Device Name: Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
• Applicant: Medtronic, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Mar 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 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. 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.

Device Story

Single-use gas exchange device; integral heat exchanger; plasma-resistant hollow fibers. Blood flows outside fibers; oxygen/CO2 exchange occurs across fiber membrane. Used in extracorporeal heart-lung bypass circuits during cardiac surgery. Operated by perfusionists/clinicians. Provides oxygenation, CO2 removal, and thermal control. Benefits patient by maintaining physiological gas exchange and temperature during bypass. Device available uncoated or with Carmeda BioActive or Trillium Biosurface coatings to improve biocompatibility.

Clinical Evidence

Bench testing only. No clinical data required. Testing included biocompatibility (ISO 10993-1), positive pressure integrity, gas transfer, pressure drop, plasma breakthrough, blood trauma (hemolysis, platelets, WBCs), heat exchanger performance, and coating integrity. All tests passed.

Technological Characteristics

Hollow fiber oxygenator with integral heat exchanger. Materials: plasma-resistant fiber, optional Carmeda BioActive or Trillium Biosurface coatings. Single-use, sterile, non-pyrogenic. Connectivity: None (mechanical).

Indications for Use

Indicated for patients undergoing routine cardiopulmonary bypass procedures requiring extracorporeal blood oxygenation, carbon dioxide removal, and temperature regulation (cooling/warming) for up to 6 hours.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Medtronic Affinity Oxygenator (K932252)
• Medtronic Affinity Oxygenator with Trillium Biosurface (K973760)
• Medtronic Affinity Oxygenator with Carmeda BioActive Surface (K000430)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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: [phone] |
| | Fax: |
| | Email: [e-mail] |

### 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<br>biocompatible according to ISO 10993-1,<br>externally communicating, circulating blood<br>contact, limited duration | Pass |
| | Positive Pressure<br>Integrity Testing | Ensures luer caps made with the alternate<br>material maintains appropriate seal on the<br>device ensure the device does not leak | Pass |
| Previously Implemented Changes (real time aging) | Gas Transfer<br>(oxygen and carbon<br>dioxide) | Demonstrates the devices transfer gas to<br>specification | Pass |
| | Pressure Drop<br>(Blood and Gas) | Demonstrates the devices meet pressure drop<br>requirements | Pass |
| | Plasma<br>Breakthrough | Demonstrates the devices meet Plasma<br>Breakthrough requirements | Pass |
| | Blood Trauma<br>(hemolysis,<br>Platelets, White<br>Blood Cells) | Demonstrates the devices meet Blood<br>Trauma requirements | Pass |
| | Pressure Integrity | Demonstrates the devices meet Pressure<br>Integrity requirements | Pass |
| | Heat Exchanger<br>Performance | Demonstrates the devices meet the heat<br>exchanger efficiency requirements | Pass |
| | Coating Testing | Coating testing demonstrates that the coated<br>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.