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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AVECOR MYOtherm™ XP Cardioplegia Delivery System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric	Reported Device Performance
Safety Testing	Blood Trauma:
	Platelet depletion (percentage of baseline)	Not significantly different compared to the commercially available MYOtherm system.
	White blood cell depletion (percentage of baseline)	Not significantly different compared to the commercially available MYOtherm system.
	Plasma hemoglobin generation (mg/dl)	Not significantly different compared to the commercially available MYOtherm system.
	Biocompatibility	Materials utilized were tested and found acceptable.
Effectiveness Testing	Operational Characteristics:
	Heat exchanger performance	Meets functional requirements.
	Pressure drop	Meets functional requirements.
	Gross air management	Meets functional requirements.
	Structural integrity	Meets functional requirements.
Overall Conclusion	Substantial Equivalence to Predicate Device (K971105)	The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices, for the stated indications for use. This indicates it meets the regulatory requirements for safety and effectiveness comparable to a legally marketed predicate device. The performance by all testing shows the system is effective and meets all functional requirements.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of devices. The study compares the MYOtherm XP Cardioplegia Delivery System to the "similar commercially available MYOtherm Cardioplegia Delivery System." It mentions "Cardioplegia delivery systems of each type were tested." This implies at least one of each type, but likely more for statistical comparison.
- Data Provenance: The blood trauma study involved in vitro perfusion using "fresh heparinized bovine blood." This indicates the data is from an in vitro laboratory setting rather than human clinical data, and the origin of the blood is bovine. The effectiveness tests (heat exchanger, pressure drop, etc.) were laboratory tests on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. The studies described are in vitro and engineering performance tests on the device itself, rather than human diagnostic performance studies that would typically require expert ground truth. The "ground truth" for blood trauma was measured directly (platelet/WBC depletion, plasma hemoglobin). The "ground truth" for effectiveness was based on engineered performance metrics.
Adjudication method for the test set:
- This information is not applicable and therefore not provided in the text. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical outcomes where discrepancies among experts need resolution. The studies described are objective measurements of device performance.
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:
- This information is not applicable and therefore not provided in the text. MRMC studies are relevant for evaluating AI's impact on human diagnostic performance. This submission is for a medical device (cardioplegia delivery system), not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and therefore not provided in the text. This is a medical device, not a software algorithm or AI. The performance tests (blood trauma, heat exchanger, etc.) are inherently "standalone" in the sense that they measure the device's intrinsic function without human intervention in the measurement process itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Blood Trauma Study: The "ground truth" was established by direct quantitative measurements of blood parameters: platelet counts, white blood cell counts, and plasma hemoglobin levels. This is an objective, laboratory-derived ground truth.
- Effectiveness Studies: The "ground truth" for heat exchanger performance, pressure drop, gross air management, and structural integrity was established against predefined functional requirements and engineering specifications for a cardioplegia delivery system. This is an objective, engineering-based ground truth.
The sample size for the training set:
- This information is not applicable and therefore not provided in the text. This is a traditional medical device, not a machine learning model that requires a "training set."
How the ground truth for the training set was established:
- This information is not applicable and therefore not provided in the text for the same reason as above.

Summary

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K971105

SECTION III

JUL | | | 1997

SAFETY AND EFFECTIVENESS SUMMARY

FOR THE AFFINITY

MYOTHERM™ XP CARDIOPLEGIA DELIVERY SYSTEM

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.

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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

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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

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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)

Over-The-Counter Use

(Optional Format 1-2-5

Regulation Number and Section

§ 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.