(100 days)
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.
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.
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.
This document describes a 510(k) premarket notification for the "MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and Uncoated MYOtherm XP Cardioplegia Delivery System." The submission seeks to allow the use of disinfectants (specifically hydrogen peroxide) in the device's water path and updates the indications for use statement.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Water path must withstand 45 PSI pressure for 6 hours without leaking | Pass |
| Water path burst testing should be comparable to that of the control devices | Pass |
| Water path break force shall be comparable to that of the control device | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes used for each test. It also does not provide information on the data provenance such as country of origin or whether the studies were retrospective or prospective. The studies appear to be bench testing performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The device validation tests (Pressure Integrity, Burst, Port Break) are objective engineering tests that do not require expert interpretation or establishment of ground truth in the same way as, for example, a diagnostic imaging study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for these types of engineering performance tests. The results are objective measurements (e.g., pass/fail for pressure integrity, comparison to control for burst and break force) rather than subjective assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical devices involving human interpretation of data, typically AI-powered diagnostic tools. The MYOtherm XP Cardioplegia Delivery System is a Class II medical device for cardiopulmonary bypass procedures, and its safety and effectiveness are evaluated through engineering performance testing, not human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone performance evaluation was done in the sense that the device's physical performance characteristics (pressure integrity, burst strength, port break force) were tested directly without human intervention or interpretation as part of the test (beyond setting up and operating the testing equipment). There is no "algorithm" in the context of AI being tested here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these tests are the objective engineering measurements related to material strength and integrity. For Pressure Integrity, the ground truth is whether the device withstands 45 PSI for 6 hours without leaking. For Burst and Port Break, the ground truth is the comparative performance against control devices, indicating that the device performs equivalently or acceptably.
8. The sample size for the training set:
This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The tests performed are engineering validation tests for a physical device.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
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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 (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
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (763) 505-8646 Fax: (763) 514-9521 Email: harsh.dharamshi@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
- 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 ofthe control devices | Pass |
|---|---|---|
| Port Break | Water path break force shall be comparable to that of thecontrol 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.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
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.(b)
Classification. Class II (performance standards).