(100 days)
Not Found
No
The description focuses on the mechanical and material aspects of a cardioplegia delivery system, with no mention of AI or ML capabilities for control, analysis, or decision-making.
No
The device is used to mix, warm/cool, and deliver cardioplegia solution during CPB procedures, which supports a medical procedure but does not directly treat a disease or condition itself.
No
The device is described as a cardioplegia delivery system for mixing, warming/cooling, and delivering blood/cardioplegia solution during cardiopulmonary bypass procedures, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly details physical components made of polycarbonate, polyvinyl chloride, and plastisol, including housing, tubing, and connectors. It also mentions a roller pump for delivery, indicating a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the delivery of blood/cardioplegia solution to the patient during a medical procedure (cardiopulmonary bypass). This is a therapeutic or procedural device, not a diagnostic one.
- Device Description: The description focuses on the physical components and materials used for mixing, warming/cooling, and delivering fluids. It doesn't mention any components or processes related to analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Language: The document does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement of analytes," "in vitro," or "specimen."
- Performance Studies: The performance studies described (Pressure Integrity, Burst, Port Break) are related to the physical integrity and function of the delivery system, not the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device operates on the patient during a procedure, not on a specimen taken from the patient.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DTR
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.
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping shapes suggesting multiple individuals or a sense of community.
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
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/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 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 devices with proposed labeling change to the marketed predicate devices.