(107 days)
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No
The summary describes a mechanical system for mixing and delivering cardioplegia solution using a roller pump. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
This device is intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution to a patient through a cardioplegia delivery system and appropriate cannula, which is a therapeutic intervention.
No
The device is described as a system for mixing, warming/cooling, and delivering blood/cardioplegia solution, and testing focuses on cellular damage and operational characteristics. There is no mention of it acquiring, analyzing, or interpreting biological signals, images, or data for diagnostic purposes.
No
The device description explicitly mentions a "single occlusive roller pump" and a "heat exchanger," which are hardware components. The performance studies also focus on hardware-related aspects like blood trauma and heat exchanger performance.
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... delivered to the patient". This describes a device used directly on or with the patient for therapeutic purposes (delivering cardioplegia during cardiac surgery).
- Device Description: The description reiterates the delivery of blood/cardioplegia solution to the patient.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) to provide diagnostic information about a patient's health or condition. IVDs are used in vitro (outside the body) to examine specimens.
- Performance Studies: The performance studies focus on the device's operational characteristics (heat exchange, pressure drop, air management, structural integrity) and its impact on blood cells during circulation through the device, not on analyzing patient samples for diagnostic purposes.
In summary, the AVECOR MYOtherm™ XP Cardioplegia Delivery System is a medical device used for delivering a therapeutic solution to a patient during surgery, not for performing diagnostic tests on patient samples.
N/A
Intended Use / Indications for Use
The AVECOR 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. 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
74 DTN
Device Description
The AVECOR MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardion in a predetermined ratio. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
SAFETY TESTING: Blood trauma was assessed by comparison of cellular damage during in vitro perfusion through the MYOtherm XP Cardioplegia Delivery System to the cell damage generated by the similar commercially available MYOtherm Cardioplegia Delivery System. The measurement of cellular depletion and hemolysis (plasma hemoglobin generation) was determined by utilizing fresh heparinized bovine blood circulated at specified constant flow rates for a six hour period. Cardioplegia delivery systems of each type were tested using in vitro test circuits. The test circuits with the MY Otherm systems were constructed as closely as possible to the test circuits containing the MYOtherm XP systems. Any differences in the design of the test circuits were due to differences between the MY Otherm and MYOtherm XP Cardioplegia Delivery Systems. A static pool of blood was simultaneously sampled with the test circuits to demonstrate acceptable hematologic parameters during the test period.
The cellular damage observed in the cardioplegia delivery systems were compared through T-tests to measure significant differences between the systems. Cellular damage to blood as measured by platelet and white blood cell depletion, (reported as a percentage of baseline values) and plasma hemoglobin generation (mg/dl) was not significantly different among the systems.
Material utilized in the production of the MYOtherm XP Cardioplegia Delivery System have been tested for biocompatibility and was found acceptable. The test results may be found in Section V of this submission.
EFFECTIVENESS INFORMATION: Effectiveness of the MYOtherm XP Cardioplegia Delivery System was determined by evaluating its operational characteristics as defined by the following tests:
- Heat exchanger performance
- Pressure drop
- Gross air management
- Structural integrity
Performance by the above testing shows that the MYOtherm XP Cardioplegia Delivery System is effective and meets all functional requirements of a cardioplegia delivery system.
Key Metrics
Cellular damage to blood as measured by platelet and white blood cell depletion, (reported as a percentage of baseline values) and plasma hemoglobin generation (mg/dl) was not significantly different among the systems.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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SECTION III
JUL | | | 1997
SAFETY AND EFFECTIVENESS SUMMARY
FOR THE AFFINITY
MYOTHERM™ XP CARDIOPLEGIA DELIVERY SYSTEM
The AVECOR MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardion in a predetermined ratio. 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.
SAFETY TESTING
Blood trauma was assessed by comparison of cellular damage during in vitro perfusion through the MYOtherm XP Cardioplegia Delivery System to the cell damage generated by the similar commercially available MYOtherm Cardioplegia Delivery System. The measurement of cellular depletion and hemolysis (plasma hemoglobin generation) was determined by utilizing fresh heparinized bovine blood circulated at specified constant flow rates for a six hour period. Cardioplegia delivery systems of each type were tested using in vitro test circuits. The test circuits with the MY Otherm systems were constructed as closely as possible to the test circuits containing the MYOtherm XP systems. Any differences in the design of the test circuits were due to differences between the MY Otherm and MY Otherm XP Cardioplegia Delivery Systems. A static pool of blood was simultaneously sampled with the test circuits to demonstrate acceptable hematologic parameters during the test period.
The cellular damage observed in the cardioplegia delivery systems were compared through T-tests to measure significant differences between the systems. Cellular damage to blood as measured by platelet and white blood cell depletion, (reported as a percentage of baseline values) and plasma hemoglobin generation (mg/dl) was not significantly different among the systems.
Material utilized in the production of the MYOtherm XP Cardioplegia Delivery System have been tested for biocompatibility and was found acceptable. The test results may be found in Section V of this submission.
1
EFFECTIVENESS INFORMATION
Effectiveness of the MYOtherm XP Cardioplegia Delivery System was determined by evaluating its operational characteristics as defined by the following tests:
- Heat exchanger performance
- Pressure drop
- Gross air management
- Structural integrity ←
Performance by the above testing shows that the MYOtherm XP Cardioplegia Delivery System is effective and meets all functional requirements of a cardioplegia delivery system.
Dennis E. Hogan
Dennis E. Steger Director Regulatory Affairs/ Quality Assurance
2
Image /page/2/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a stacked formation.
JUL 11 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dennis E. Steger Director Requlatory Affairs/ Ouality Assurance AVECOR Cardiovascular, Inc. 7611 Northland Drive Minneapolis, Minnesota 55428
K971105 Re: Myotherm XP Cardioplegia Delivery System Requlatory Class: II (Two) Product Code: 74 DTN Dated: April 11, 1997 Received: April 14, 1997
Dear Mr. Steger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Dennis E. Steger
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
870, 4400- DTN II-CARDIGPLEGIA RESERVOIR
510(k) Number (if known): K 971105
Device Name: MYOTHERN IN XP DELIVERY SYS CARDIO PLEGIA
Indications For Use:
The AVECOR MYOtherm™ XP Cardioplegia Delivery System is a device intended.
The AVECOR MYOtherm™ Carder of coursemented blood/cardioplegia The AVECOR MYOmening Cooling, and delivery of oxygenated blood/cardioplegia
for the mixing, warming/cooling, and delivery of oxygenated blood/card to the for the mixing, warming county, and ach or a carry of only of the solution in a predecemblied ratio. Brood cardroprog.
patient through the cardioplegia delivery system and appropriate cannula by the pation of a single occlusive roller pump.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K971105
Prescription Use > (Per 21 CFR 801.109)
OR
Over-The-Counter Use
:
(Optional Format 1-2-5