MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

K162958 · Medtronic, Inc. · DTR · Feb 1, 2017 · Cardiovascular

Device Facts

• Record ID: K162958
• Device Name: MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
• Applicant: Medtronic, Inc.
• Product Code: DTR · Cardiovascular
• Decision Date: Feb 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4240
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MYOtherm XP Cardioplegia Delivery System Models XP41 and XP41B (uncoated) - The MYOtherm XP cardioplegia delivery system is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump. MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface Models XP41T and XP41BT - The MYOtherm XP system with Trillium biosurface is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

Device Story

The MYOtherm XP Cardioplegia Delivery System is a heat exchanger used during cardiopulmonary bypass (CPB) procedures. It facilitates the mixing, warming, or cooling of oxygenated blood and cardioplegia solution in a predetermined ratio. The system is operated by a single occlusive roller pump, which delivers the mixture to the patient via a cannula. It is used in clinical settings (e.g., OR) by perfusionists or surgical staff. The device includes an optional bridge line for independent arterial blood delivery. The Trillium biosurface version features a heparin-based, non-leaching thromboresistant coating. The device is intended for procedures lasting up to 6 hours. The current submission updates the Instructions for Use to permit the use of hydrogen peroxide (330 ppm) as a disinfectant in the water path, ensuring the integrity of the heat exchanger during clinical use.

Clinical Evidence

Bench testing only. No clinical data was required to establish substantial equivalence. Performance testing included pressure integrity (45 PSI for 6 hours), burst testing, and port break force testing, all of which met acceptance criteria.

Technological Characteristics

Device consists of a polycarbonate housing with PVC and plastisol tubing/connectors. Operates as a heat exchanger for blood/cardioplegia mixing. Trillium biosurface models utilize a heparin-based, non-leaching thromboresistant coating. The system is designed for use with a single occlusive roller pump. The water path is verified for compatibility with hydrogen peroxide (330 ppm) disinfectant.

Indications for Use

Indicated for patients undergoing routine cardiopulmonary bypass (CPB) procedures requiring mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution for up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

Predicate Devices

• Trillium MYOtherm XP Cardioplegia Delivery System (K011864)
• MYOtherm XP Cardioplegia Delivery System (K971105)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic, Inc. Harsh Dharamshi Regulatory Operations Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K162958

Trade/Device Name: MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and MYOtherm XP Cardioplegia Delivery System Uncoated Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary Bypass Heat Exchanger Regulatory Class: Class II Product Code: DTR Dated: January 25, 2017 Received: January 26, 2017

Dear Mr. Dharamshi:

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

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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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hilleman

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) K162958

Device Name

MYOtherm XP Cardioplegia Delivery System MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface

Indications for Use (Describe)

MY Otherm XP Cardioplegia Delivery System Models XP41 and XP41B (uncoated) -

The MYOtherm XP cardioplegia delivery system is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

MY Otherm XP Cardioplegia Delivery System with Trillium Biosurface Models XP41BT -The MYOtherm XP system with Trillium biosurface is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 5. 510(k) Summary of Safety and Effectiveness

Date Prepared: January 25, 2017

Submitter: Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009

- Contact Person: Harsh H. Dharamshi Regulatory Operations Specialist Medtronic Perfusion Systems Phone: [phone] Fax: [phone] Email: [e-mail]
#### Alternate Contact: Susan C. Fidler

Sr. Regulatory Affairs Manager Medtronic Perfusion Systems Phone: [phone] Fax: [phone] Email: [e-mail]

- Common Name: Heat-Exchanger, Cardiopulmonary Bypass. Cardiopulmonary bypass heat exchanger.
Trade Name: MYOtherm XPTM Cardioplegia Delivery System with Trillium™ Biosurface and Uncoated MYOtherm XP™ Cardioplegia Delivery System

Classification: Class II

- Panel: Cardiovascular
- Regulation: 21 CFR 870.4240
- Product Code: DTR

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### Predicate Devices: K011864 – Trillium MYOtherm XP Cardioplegia Delivery System (with or without Bridge); K971105 - MYOtherm XP Cardioplegia Delivery System (with or without Bridge)

## Device Description

The MYOtherm XP cardioplegia delivery system with Trillium biosurface and Uncoated MYOtherm XP cardioplegia delivery system are comprised of polycarbonate housing and come pre-connected to tubing and connector components comprised of polycarbonate, polyvinyl chloride and plastisol materials which are provided in Y-type, straight, reducer and tubing configurations. Both the MYOtherm XP cardioplegia delivery system with Trillium biosurface and Uncoated MYOtherm XP cardioplegia delivery system are available with or without an additional optional bridge, a pre-connected independent tubing line for the delivery of additional arterial blood without the mixing with cardioplegia solution. The blood contacting surfaces of the MYOtherm XP cardioplegia delivery system with Trillium biosurface and associated tubing and connector components are coated with a heparin-based non-leaching thromboresistant surface.

### Description of Change

The proposed change is to allow the use of disinfectants in the water path. The Instructions for Use (IFU) for MYOtherm XP cardioplegia delivery system with Trillium biosurface and Uncoated MYOtherm XP cardioplegia delivery system will be updated to allow disinfectant use (hydrogen peroxide) in the water path. The IFU warning will change as noted below:

Current Warning: Disinfectants must not be used in the heater/cooler system when the heat exchanger is in use. If disinfectants are used in the heater/cooler system prior to use, the system must be thoroughly flushed.

New Warning: Follow institution CPB protocol when using disinfectants in the heater/cooler during bypass. The integrity of the water path has been verified with hydrogen peroxide (330 ppm). Contact Medtronic for information regarding the use of additional disinfectants.

Along with the proposed IFU warning change, the "Indications for Use" statement is also being updated as noted in the section below to (a) reinstate the last sentence in the indications for use statement, i.e. "Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump" for Uncoated MYOtherm XP cardioplegia delivery system. This sentence was removed in error and is being added back in order to be consistent with MYOtherm XP cardioplegia delivery system with Trillium biosurface. (b) add the 6 hour duration of use specification to the indications for use statements for Uncoated and Trillium biosurface MYOtherm XP cardioplegia delivery systems. This statement regarding 6 hour duration of use specification is being added in order to be consistent with the testing and all other cardiopulmonary bypass (CBP) devices in the CPB circuit.

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# Indications for Use

MYOtherm XP Cardioplegia Delivery System Models XP41 and XP41B (uncoated) -The MYOtherm XP cardioplegia delivery system is a device intended for the mixing. warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface Models XP41T and XP41BT -

The MYOtherm XP system with Trillium biosurface is a device intended for the mixing. warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

# Contraindications

Use the device only as indicated.

# Comparison to Predicate Devices

When compared to predicate devices (K971105 and K011864), the Medtronic MYOtherm XP cardioplegia delivery systems presented in this submission have the same:

- Same Intended Use ●
- Same Technological characteristics and Operating principle ●
- Same Design Features
- Same Performance
- Same Base Materials ●
- Same Shelf Life
- Same Trillium Coating, if applicable ●

## Summary of Testing

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 |

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| Burst | Water path burst testing should be comparable to that of<br>the control devices | Pass |
|------------|---------------------------------------------------------------------------------|------|
| Port Break | Water path break force shall be comparable to that of the<br>control device | Pass |

# Conclusion

The data included in this submission is sufficient to demonstrate substantial equivalence of the subject devices with proposed labeling change to the marketed predicate devices.