The Medtronic CardioTherm™ Blood Cardioplegia System, with or without Carmeda® BioActive Surface, is intended for use in procedures requiring the mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

Device Description

The Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface is coated with a non-leaching bioactive heparin surface which provides thromboresistant blood contact surfaces. The Carmeda® BioActive Surface is present on blood path materials.

Each Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios depending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient.

The Medtronic CardioTherm™ Blood Cardioplegia Heat Exchanger with Carmeda BioActive Surface consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or non-vented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery.

The heat exchanger housing contains non-porous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.

The flow of solution through the Medtronic CardioTherm™ Blood Cardioplegia Heat Exchanger with Carmeda® BioActive Surface is as follows:

Blood/Cardioplegia

The blood and/or cardioplegia solution enters the bottom of the device, flows up through the polypropylene hollow fibers, flows back down a center collecting tube, and exits the from the bottom of the device.

Water

The cooling/warming water enters a side port, passes around the outside walls of the polypropylene fibers, then exits through a parallel side port.

Heat exchange occurs as the blood/cardioplegia solution passes through the hollow fibers, while the temperature regulated cooling/warming water passes around the outside walls of the same fibers. The blood/cardioplegia solution is cooled/ warmed as it flows through the heat exchanger.

By connecting tubing of specific inner diameters to the heat exchanger, a predetermined approximate ratio of blood to cardioplegia solution may be delivered to the patient. The tubing sets are equivalent to the tubing sets which are currently used for the CardioTherm™ Blood Cardioplegia System (K960755)

Four of the various delivery ratios available are:

a tubing set for 1:1 ratio of blood to asanguineous cardioplegia. 1.
a tubing set for 2:1 ratio of blood to asanguineous cardioplegia. 2.
a tubing set for 4:1 ratio of blood to asanguineous cardioplegia.
a tubing set for 9:1 ratio of blood to asanguineous cardioplegia. 4.

These tubing ratios are identical to the commercially available CardioTherm™ Blood Cardioplegia Systems.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove that the device meets specific acceptance criteria through a clinical study with real-world patient data, as would typically be the case for novel AI/ML medical devices.

Instead, the submission focuses on comparing the modified device (with the Carmeda® coating) to existing predicate devices already approved for market, primarily through in-vitro bench testing and biocompatibility testing. The "acceptance criteria" here are implicitly related to demonstrating that the new technological characteristic (the Carmeda® coating) does not negatively affect safety or effectiveness and that the modified device remains substantially equivalent to its predicates.

Therefore, the requested information elements related to clinical studies, human readers, ground truth establishment, and training/test set sample sizes (common for AI/ML device evaluations) are not directly applicable or available in the provided document, as this is a modification to an existing device rather than a de novo submission for a new AI/ML diagnostic or therapeutic device.

Here's an interpretation based on the provided text's context:

Acceptance Criteria and Study Details for Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface

The "acceptance criteria" in this context are not explicit numerical thresholds from a clinical trial, but rather the demonstration of substantial equivalence to predicate devices through various tests. The device is considered to meet these criteria if the performance data from in-vitro bench testing and biocompatibility testing show that the addition of the Carmeda® BioActive Surface does not significantly affect safety and effectiveness compared to the predicate devices.

1. Table of "Acceptance Criteria" and Reported Device Performance

Given that this is a 510(k) for a device modification, the "acceptance criteria" are implied to be comparable performance to the predicate device across key characteristics, and absence of new safety/effectiveness questions. The "reported device performance" refers to the results of the in-vitro bench testing and biocompatibility studies conducted on the CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface.

Characteristic	"Acceptance Criterion" (Implied)	Reported Device Performance (with Carmeda® BioActive Surface)
Carmeda® Performance	No significant impact on safety/effectiveness of the device due to the coating, and
demonstration of coating functionality as per established methods for other Carmeda®-coated products.	Bioactivity: Assessed (details not provided, but implicitly met as no new safety/effectiveness questions raised).Coating Coverage: Assessed (details not provided, implicitly met).Leaching: Assessed (details not provided, implicitly met to confirm non-leaching property).
Device Performance	Performance characteristics (pressure drop, blood trauma, heat exchange) comparable to predicate device (K960755).	Pressure Drop: Assessed (details not provided, implicitly comparable).Blood Trauma: Assessed (details not provided, implicitly comparable).Heat Exchange Performance: Assessed (details not provided, implicitly comparable).
Physical Characteristics	Physical integrity (blood pathway, heat exchanger water pathway) and priming volume comparable to predicate device.	Physical Integrity: Assessed (details not provided, implicitly comparable).Priming Volume: Assessed (details not provided, implicitly comparable).
Biocompatibility	Biocompatibility profile consistent with existing Carmeda®-coated products and no new biocompatibility concerns.	Biocompatibility testing demonstrated equivalence to predicate devices and no significant effect on safety/effectiveness.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of clinical patient data. The "test set" here refers to the in-vitro bench tests and biocompatibility tests conducted on the modified device and compared to the predicate. The specific number of devices or test runs for these in-vitro tests is not provided in the summary.
Data Provenance: The data primarily comes from in-vitro bench testing and biocompatibility testing performed by Medtronic, Inc. It is not patient data from a specific country or retrospective/prospective study in the clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. For this type of device modification submission, "ground truth" is established through engineering and scientific test methods (e.g., measuring pressure, analyzing coating, biological compatibility assessments), not through expert clinical consensus on patient cases.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This concept applies to expert review of ambiguous clinical cases, which is not relevant for this engineering and biocompatibility assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study assesses the impact of an AI algorithm on human reader performance, which is not relevant for a blood cardioplegia system with a bioactive surface coating.

6. Standalone Performance Study (Algorithm Only)

Standalone Study: No. This device is not an algorithm, and the concept of standalone performance does not apply to a physical medical device in this context. The closest analogy would be the in-vitro bench testing evaluating the device's physical and functional characteristics.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this submission is based on established scientific and engineering measurement standards for device performance (e.g., pressure drop, heat exchange efficiency) and biocompatibility assessment protocols. It is not pathology, expert consensus on patient outcomes, or clinical outcomes data. The acceptance is based on demonstrating that the new coating does not alter these "ground truths" of established performance and safety compared to the predicate.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that undergoes a training phase.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

COMPANY AND CONTACT PERSON

NOV 20 1997

Medtronic, Inc. Cardiopulmonary Division 4633 E. La Palma Avenue Anaheim, CA 92807 714-779-3700

Debra J. Kridner, Manager Regulatory Affairs

DEVICE NAME

CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface

NAME OF PREDICATE OR LEGALLY MARKETED DEVICE(S)

. Medtronic CardioTherm™ Blood Cardioplegia Systems (K960755)
Medtronic Extracorporeal Circuit with Carmeda® BioActive Surface (K891687) .
Medtronic MAXIMA PLUS® PRF Hollow Fiber Oxygenator with Carmeda . BioActive Surface (K941473)

DESCRIPTION OF DEVICE

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The flow of solution through the Medtronic CardioTherm™ Blood Cardioplegia Heat Exchanger with Carmeda® BioActive Surface is as follows:

Blood/Cardioplegia

Water

The cooling/warming water enters a side port, passes around the outside walls of the polypropylene fibers, then exits through a parallel side port.

Four of the various delivery ratios available are:

a tubing set for 1:1 ratio of blood to asanguineous cardioplegia. 1.
a tubing set for 2:1 ratio of blood to asanguineous cardioplegia. 2.
నా a tubing set for 4:1 ratio of blood to asanguineous cardioplegia.
a tubing set for 9:1 ratio of blood to asanguineous cardioplegia. 4.

These tubing ratios are identical to the commercially available CardioTherm™ Blood Cardioplegia Systems.

STATEMENT OF INTENDED USE

The Medtronic CardioTherm™ Blood Cardioplegia System, with or without Carmeda BioActive Surface, is intended for use in procedures requiring the mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

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STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES

The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

A table comparing the intended use and technological characteristics of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface with the substantially equivalent device is provided in Attachment 1. In addition, information regarding technological characteristic comparison is provided in the following section, "Determination of Substantial Equivalence".

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This premarket notification is being submitted for a modification to the Medtronic CardioTherm™ Blood Cardioplegia Systems. This modification is for the Carmeda coating of the Medtronic CardioTherm™ Blood Cardioplegia Systems.

This premarket notification submission provides substantial equivalence information and rationale which addresses the introduction to commercial distribution of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems with Carmeda® BioActive Surface.

The Medtronic CardioTherm™ Blood Cardioplegia Systems are devices which are currently in commercial distribution. The CardioTherm™ Blood Cardioplegia Systems (K960755) were deemed substantially equivalent to other blood cardioplegia devices on May 23, 1996.

In determining substantial equivalence of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems with Carmeda® BioActive Surface (further references will state CardioTherm™), the decision-making process follows the 510(k) "Substantial Equivalence" flow diagram and is presented as follows:

The Carmeda® CardioTherm™ is being "compared to the following Marketed Devices":

. Medtronic CardioTherm™ Blood Cardioplegia Systems (K960755)
. Medtronic Extracorporeal Circuit with Carmeda® BioActive Surface (K891687)
Medtronic MAXIMA PLUS® PRF Hollow Fiber Oxygenator with Carmeda® . BioActive Surface (K941473)

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The Carmeda® CardioTherm™ has the "same indications statement and intended uses" as the:

CardioTherm™ Blood Cardioplegia Systems (K960755) e
The Carmeda® CardioTherm™ has "new technological characteristics (e.g., design, materials and manufacturing processes)" from the current Medtronic CardioTherm™ Blood Cardioplegia Systems. These technological characteristics include;
Carmeda® BioActive Surface .
This technological characteristics is common to other Medtronic Carmeda® . coated products currently in commercial distribution as follows;
- Medtronic Extracorporeal Circuit with Carmeda® Bio-Active Surface . (K891687)
- Medtronic MAXIMA PLUS® PRF Hollow Fiber Oxygenator with Carmeda® . BioActive Surface (K941473)

These technological characteristics "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 accepted scientific methods which exist for assessing effects of these new technological characteristics". These scientific methods are identical to the method used for other Medtronic Carmeda® coated products.

"Performance data to assess the effects of these new technological characteristics" has been obtained through in-vitro bench testing. These "performance data demonstrate" that the CardioTherm™ Blood Cardioplegia Systems with Carmeda® BioActive Surface are substantially equivalent to marketed devices.

In addition, the modes of operation of the CardioTherm™ Blood Cardioplegia Systems with Carmeda® BioActive Surface are either identical or substantially equivalent to other blood cardioplegia systems in commercial distribution. The function of the Medtronic CardioTherm™ Blood Cardioplegia Systems with Carmeda® BioActive Surface is mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

A table comparing the intended use, performance characteristics, technological characteristics and mode of operation of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems with Carmeda® BioActive Surface with the noted substantially equivalent device is provided in Attachment 1.

These data support that the blood cardioplegia systems with Carmeda® BioActive Surface do not significantly affect safety and effectiveness and are substantially equivalent to another commercially distributed blood cardioplegia system.

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The biocompatibility testing and in-vitro bench testing demonstrated that when compared to the predicate devices the CardioTherm™ Blood Cardioplegia Systems with Carmeda BioActive Surface do not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed devices. The in-vitro bench testing included analysis of:

Carmeda® Performance Characteristic Testing .
- Bioactivity .
- . Coating Coverage
- . Leaching
Performance Characteristic Testing .
- Pressure Drop ●
- Blood Trauma .
- Heat Exchange Performance .
Physical Characteristic Testing ●
- Physical Integrity ●
  - Blood Pathway .
  - . Heat Exchanger Water Pathway
- . Priming Volume

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Attachment 1

DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS

	Medtronic, Inc.CardioTherm™Blood Cardioplegia System withCarmeda® BioActive Surface	Medtronic, Inc.CardioTherm™Blood Cardioplegia System
510(k) Number:	This submission	K960755
Catalog Number(s):	CBCT-XXX SeriesCBCT-XXXBR Series	CT-XXX SeriesCT-XXXBR Series
Intended Use:	To mix, cool, warm and deliveroxygenated blood/cardioplegiasolution.	To mix, cool, and deliveroxygenated blood/cardioplegiasolution.
Performance Characteristics:
Heat ExchangerPriming Volume (ml)Maximum Flow Rate (lpm)Fluid Path Pressure (max)Water Path Pressure (max)	461500 mmHg45 psi	461500 mmHg45 psi
Technological Characteristics:
Configuration
Heat ExchangerVent PortBubble ChamberTemperature WellPressure Monitoring LinePatient Delivery LineTubing Sets	YesYesYesYesYesYesYes	YesYesYesYesYesYesYes
Materials
Heat ExchangerHousingHeat Exchanger	PolycarbonatePolypropylene	PolycarbonatePolypropylene
Tubing Sets	Polyvinyl chloridePolycarbonate	Polyvinyl chloridePolycarbonate
Carmeda® BioActive Surface*	Yes	No
	Medtronic, Inc.CardioTherm™Blood Cardioplegia System withCarmeda® BioActive Surface	Medtronic, Inc.CardioTherm™Blood Cardioplegia System
Specifications
Tubing Set Ratios	Separate sets(1:1, 2:1, 4:1 and 9:1)	Separate sets(1:1, 2:1, 4:1 and 9:1)
Tubing Inner Diameter	1/12 inch to 1/4 inch	1/12 inch to 1/4 inch
Ratio Capability	Variable (w/bridge clamps)(all blood, 1:1, 2:1, 4:1, 9:1,and all crystalloid withvarious tubing sets)	Variable (w/bridge clamps)e(all blood, 1:1, 2:1, 4:1, 9:1,and all crystalloid withvarious tubing sets)
Mode of Operation	This blood/cardioplegia systemis used in the extracorporealcircuit for mixing, cooling,warming and delivery ofoxygenated blood and/orcardioplegia solution. Themultiple configurations allowthe clinician the capability ofproviding varying ratios ofblood to cardioplegia solutionas warranted by clinical need.	This blood/cardioplegia systemis used in the extracorporealcircuit for mixing, cooling,warming and delivery ofoxygenated blood and/orcardioplegia solution. Themultiple configurations allowthe clinician the capability ofproviding varying ratios ofblood to cardioplegia solutionas warranted by clinical need.

ﺎ ﻟﻠ Medtronic Extracorporeal Circuit with Carmeda® BioActive Surface).

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Attachment 1

DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS

Confidential

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DEPARTMENT OF HEALTH & HUMAN SERVICES = = = = = = = =

Public Health Service

Image /page/7/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the symbol.

Rockville MD 20857

NOV 20 1997

Ms. Debra J. Kridner Sr. Manager, Regulatory Affairs/Clinicals Cardiac Surgery Medtronic, Inc. Cardiopulmonary Division 4633 East La Palma Avenue Anaheim, California 92807

Re: K973475 CardioTherm™ Blood Cardioplegia Systems with Carmeda® BioActive Surface Regulatory Class: II (Two) Product Code: _ 74 DTR _____ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ September 10, 1997 Dated: Received: September 12, 1997

Dear Ms. Kridner:

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 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, 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 Requlations, 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 requlation (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 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 - Ms. Debra J. Kridner

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.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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4240 - D13 --

J. 2

INDICATIONS FOR USE

510(k) Number: . _ L 9 7 34 75 _______________________________________________________________________________________________________________________________________________

Device Name: CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface

Indications for use:

(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	K973475
Prescription Use	X
	OR Over-The-Counter-Use
(Per 21 CFR 801.109	(Optional Format 1-2-96)

510(k) Notification Medtronic, Inc. Medtronic Cardiopulmonary

APPENDIX IV CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface September 10, 1997

Confidential

Regulation Number and Section

§ 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).