The Trillium™ 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 Trillium™ MYOtherm™ XP Cardioplegia Delivery System is designed to mix arterial blood from oxygenators with asanguineous cardioplegja solution. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient.

AI/ML Overview

The Trillium™ MYOtherm™ XP Cardioplegia Delivery System is a modification of the existing MYOtherm™ XP Cardioplegia System, with the primary change being the addition of a Trillium™ biopassive surface coating to blood contact surfaces. The study aimed to demonstrate that this modification does not significantly affect the safety and effectiveness of the device compared to predicate devices.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Performance Measure)	Reported Device Performance (vs. Predicate Devices)
Biocompatibility	Demonstrated no significant effect on safety and effectiveness.
Coating Characteristics (Coating)	Assessed and found acceptable.
Coating Characteristics (Leaching)	Assessed and found acceptable.
Physical Characteristics (Pressure Integrity)	Assessed and found acceptable.
Physical Characteristics (Priming Volume)	Assessed and found acceptable.
Performance Characteristics (Ease of Prime)	Assessed and found acceptable.
Performance Characteristics (Heat Exchanger Performance)	Assessed and found acceptable.
Performance Characteristics (Pressure Drop)	Assessed and found acceptable.
Performance Characteristics (Blood Trauma)	Assessed and found acceptable.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for the in vitro bench testing or provide details on data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance data" and "in vitro bench testing" without giving quantitative details for the tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for a test set in the context of human interpretation of results. The evaluation appears to be based on direct measurements and comparisons of physical and performance characteristics in bench testing.

4. Adjudication method for the test set

Not applicable. The study involved in vitro bench testing and comparison against predicate devices, not subjective interpretation by multiple experts.

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

Not applicable. This device is a medical apparatus, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

Not applicable. The device is a physical system, not an algorithm. The "standalone" performance would refer to the device's operational characteristics, which were tested in vitro.

7. The type of ground truth used

The ground truth was established by:

Predicate Device Performance: The primary comparison was against the performance of the predicate devices (MYOtherm™ XP Cardioplegia System (K971105) and AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)).
Established Scientific Methods: The document states that "acceptable scientific methods exist for assessing effects of these new technological characteristics," implying standard laboratory testing methods for medical device components and performance.
Biocompatibility Standards: Biocompatibility testing would have been conducted against recognized standards for medical device materials.

8. The sample size for the training set

Not applicable. This document describes a medical device, not an AI or machine learning model that requires a training set. The "training" here refers to the design and development process of the device itself.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI model for this device. The design and development of the Trillium™ coating and the cardioplegia delivery system relied on established engineering principles, material science, and prior knowledge from the predicate devices.

Summary

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JUL = 9 2001

SUMMARY OF SAFETY AND EFFECTIVENESS

COMPANY AND CONTACT PERSON

Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: ... (763) 391-9136 FAX: (763) 391-9603

Stephani K. Ayala, Regulatory Affairs Specialist, Regulatory Affairs

DEVICE NAME

Trillium™ MYOtherm™ XP Cardioplegia Delivery System

NAME OF PREDICATED OR LEGALLY MARKETED DEVICE

MYOtherm™ XP Cardioplegia Delivery System (K971105) AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

DESCRIPTION OF DEVICE

STATEMENT OF INTENDED USE

STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE

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. 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.

STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".

Special 510 (k) Notification Medtronic, Inc. Medtronic Perfusion Systems Trillium™ MYOtherm™ XP Cardioplegt Delivery System June 8, 2001

Confidential

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DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This "SPECIAL 510(k)" is being submitted for a modification to the MYOtherm" XP Cardioplegia System. The modification to the current MYOtherm " XP Cardioplegia System is to coat the blood contact surfaces with Trillium".

The Trillium™ MYOtherm" XP Cardioplegia Delivery System is being compared to the following Marketed Devices:

MYOtherm™ XP Cardioplegia System (K971105) .
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

The Trillium™ MYOtherm" XP Cardioplegia Delivery System has the same indications statement and intended uses as the:

MYOtherm™ XP Cardioplegia System (K971105) .
The Trillium™ MYOtherm™ XP Cardioplegia Delivery System has "no new technological characteristics (e.g., materials and manufacturing processes)" from the MYOtherm Cardioplegia System. The technological characteristic is solely the coating material of the blood pathway:
Trillium™ .
The technological characteristic of the Trillium™ Biopassive Surface is common to other hollow fiber oxygenators currently in commercial distribution as follows:
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)
This technological characteristic "could affect the safety and effectiveness of the device". However, these "new technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".

"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the Trillium" MYOtherm XP Cardioplegia Delivery System is substantially equivalent to other marketed cardioplegia delivery systems.

Special 510 (k) Notification Medtronic, Inc. Medtronic Perfusion Systems Trillium " MYOtherm" XP Cardioplegla Delivery System June 8, 2001

Confidential

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K011864
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The biocompatibility and in vitro bench testing demonstrated that when compared to the
predicate devices, the Trillium™ MYOtherm™ XP Cardioplegia Delivery System does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed cardioplegia delivery system. The in vitro bench testing included analysis of:

Coating Characteristics

Coating .
Leaching .

Physical Characteristics

Pressure integrity .
Priming volume ●

Performance Characteristics

Ease of prime .
Heat exchanger performance .
Pressure drop 4
Blood trauma 대

Special 510 (k) Notification Medtronic, Inc. Medtronic Perfusion Systems Trillium™ MYOtherm™ XP Cardioplegia Delivery System June 8, 2001

Confidential

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus-like symbol, with three figures representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2001

Medtronic Perfusion Systems c/o Ms Marie Holm Associate Product Regulations Manager 7611 Northland Drive N Minneapolis, MN 55428.1088

Re: K011864

Trade Name: Trillium™ MYOtherm™ XP Cardioplegia Delivery System (Models: XP41T and XP41BT) Regulation Number: 870.4400 Regulatory Class: II (Two)

Product Code: DTN Dated: July 5, 2001 Received: July 5, 2001

Dear Ms. Holm:

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 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). 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 requirements, 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 regulatory 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

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Page 2 - Ms Marie Holm

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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, (301) 59 reter the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

[signature]

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

K011864

Device Name: Trillium™ MYOtherm™ XP Cardioplegia Delivery System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109

Over-The-Counter-Use

pöller

Division of Cardiovascular & Respiratory Devices
510(k) Number K011864

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.