(130 days)
Not Found
No
The document describes a mechanical device for mixing and delivering fluids during cardiopulmonary bypass and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the delivery of oxygenated blood/cardioplegia solution to the patient during cardiopulmonary bypass procedures, which is a therapeutic intervention.
No
Explanation: The device is intended for mixing, warming/cooling, and delivery of blood/cardioplegia solution during cardiopulmonary bypass procedures, which is a therapeutic function, not diagnostic.
No
The device description explicitly details physical components made of polycarbonate, polyvinyl chloride, and plastisol materials, including housing, tubing, and connectors. It also mentions a bioactive surface coating. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution" during cardiopulmonary bypass procedures. This is a direct intervention on the patient's blood outside the body for therapeutic purposes, not for diagnostic testing of a sample in vitro.
- Device Description: The description focuses on the physical components and materials used for handling and delivering blood and solutions. It doesn't mention any components or functions related to analyzing biological samples for diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays for testing
- Measuring analytes or biomarkers
The device is designed to support a surgical procedure (cardiopulmonary bypass) by preparing and delivering solutions to the patient's circulatory system. This falls under the category of a medical device used for treatment or support, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The MYOtherm XP with Cortiva bioactive surface 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.
Product codes
DTR
Device Description
The MYOtherm XP cardioplegia delivery system with Cortiva bioactive surface is comprised of polycarbonate housing and comes preconnected to tubing and connector components comprised of polycarbonate, polyvinyl chloride and plastisol materials and provided in Y-type, straight, reducer and tubing configurations. The MYOtherm XP cardioplegia delivery system with Cortiva bioactive surface is available with or without an additional optional bridge, which is a preconnected 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 Cortiva bioactive surface and associated tubing and connector components are coated with a heparin-based non-leaching thromboresistant surface.
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
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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
Testing: Pressure Integrity; Description: Water path must withstand 45 PSI pressure for 6 hours without leaking; Result: Pass
Testing: Burst; Description: Water path burst testing should be comparable to that of the control devices; Result: Pass
Testing: Port Break; Description: Water path break force shall be comparable to that of the control device; Result: Pass
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2017
Medtronic, Inc. Harsh Dharamshi Regulatory Operations Specialist 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K162774
Trade/Device Name: MYOtherm XPTM Cardioplegia Delivery System with Cortiva™ BioActive Surface 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. Isting 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
1
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" (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. Willemsen
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) K162774
Device Name
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface
Indications for Use (Describe)
The MYOtherm XP with Cortiva bioactive surface 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.
| 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 XP™ Cardioplegia Delivery System with Cortiva™ BioActive Surface
- Classification: Class II
- Panel: Cardiovascular
- Regulation: 21 CFR 870.4240
- Product Code: DTR
Predicate Device:
K003724 MYOtherm XP Cardioplegia Delivery System with Carmeda BioActive Surface
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Device Description
The MYOtherm XP cardioplegia delivery system with Cortiva bioactive surface is comprised of polycarbonate housing and comes preconnected to tubing and connector components comprised of polycarbonate, polyvinyl chloride and plastisol materials and provided in Y-type, straight, reducer and tubing configurations. The MYOtherm XP cardioplegia delivery system with Cortiva bioactive surface is available with or without an additional optional bridge, which is a preconnected 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 Cortiva bioactive surface 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 Cortiva bioactive surface 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) add 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", in order to be consistent with Uncoated and Trillium biosurface MYOtherm XP cardioplegia delivery systems. (b) add the 6 hour duration of use specification to the indications for use statement in order to be consistent with the testing and all other cardiopulmonary bypass (CBP) devices in the CPB circuit.
Indications for Use
The MYOtherm XP with Cortiva bioactive surface 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.
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Contraindications
Use the device only as indicated.
Comparison to Predicate Devices
When compared to predicate device K003724, the Medtronic MYOtherm XP cardioplegia delivery system with Cortiva bioactive surface 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 .
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 | |
| 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 |
Conclusion
The data included in this submission is sufficient to demonstrate substantial equivalence of the subject device with proposed labeling change to the marketed predicate devices.