MAXIMA FORTÉ" Hollow Fiber Oxygenator with Plasma Resistant Fiber is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from blood and is designed to operate at blood flow rates between 1 and 7 liters per minute for periods up to six hours.

Device Description

The Medtronic MAXIMA FORTE™ Hollow Fiber Oxygenator with Plasma Resistant Fiber is a single use, disposable, sterile, nonpyrogenic, gas exchange device with a self contained, venous side heat exchanger for regulating blood temperature. The MAXIMA FORTE" oxygenator consists of a polycarbonate outer case which incorporates an oxygenator fiber bundle and a self contained heat exchanger. The fiber bundle is separated from the self contained heat exchanger by a polycarbonate housing. The static priming volume of the oxygenator blood path is approximately 295 ml. The oxygenator is designed to operate at blood flow rates between 1 - 7 liters per minute for periods up to 6 hours.

AI/ML Overview

The provided text is a summary of safety and effectiveness for a medical device called the MAXIMA FORTÉ™ Hollow Fiber Oxygenator. It does not describe a study involving "acceptance criteria" and "device performance" in the typical sense of a clinical trial or a study assessing an AI algorithm's diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable to this document. I will extract the relevant information and explain why other sections cannot be filled based on the provided text.

Here's the information derived from the provided document:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for the MAXIMA FORTÉ™ device itself. Instead, it refers to "accepted scientific methods" from oxygenator standards (ISO/DIS 7199 and BG7199-1996) for assessing new technological characteristics. The "performance data" is used to demonstrate substantial equivalence to the predicate devices, rather than meeting specific, numerical acceptance criteria for the new device as a standalone.

The in-vitro bench testing aimed to show that the MAXIMA FORTÉ™ does not significantly affect safety and effectiveness when compared to predicate devices. The listed tests are the performance aspects evaluated.

Performance Aspect	Reported Device Performance
Plasma Resistant Fiber (Key innovation)	Implied to maintain effectiveness for up to six hours within the specified blood flow rates (1-7 LPM), similar to predicates. (Improved Plasma Resistant Fiber in predicate MAXIMA PLUS PRF)
Blood pathway integrity	Demonstrated to not significantly affect safety and effectiveness compared to predicate devices.
Heat exchanger pathway integrity	Demonstrated to not significantly affect safety and effectiveness compared to predicate devices.
Blood volumes	Lower priming volume (~295 ml) compared to some, but comparable to others (e.g., Terumo Capiox SX at ~270 ml), not significantly affecting safety/effectiveness.
Connectors	Demonstrated to not significantly affect safety and effectiveness compared to predicate devices.
Oxygenator and Carbon Dioxide Transfer Rates	Demonstrated to not significantly affect safety and effectiveness compared to predicate devices.
Heat Exchanger Performance Factor	Demonstrated to not significantly affect safety and effectiveness compared to predicate devices.
Blood Cell Damage	Demonstrated to not significantly affect safety and effectiveness compared to predicate devices.
Time Dependent Performance Changes	Demonstrated to not significantly affect safety and effectiveness compared to predicate devices.
Pressure Drop	Demonstrated to not significantly affect safety and effectiveness compared to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes in-vitro bench testing. This means the testing was performed in a laboratory setting, not on human patients or live animal models, for the purpose of demonstrating substantial equivalence to predicate devices.

Sample size: Not specified. Typical bench testing for devices like this involves a certain number of units tested to ensure repeatability and consistency, but the exact number of MAXIMA FORTÉ™ units or predicate units tested is not stated.
Data provenance: In-vitro bench testing data. No country of origin is specified, and it is inherently prospective for the device under review, but comparative to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept of "experts establishing ground truth" is not applicable to the described in-vitro bench testing of an oxygenator. The "ground truth" here is determined by physical measurements and engineering assessments according to established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for subjective assessments, often in clinical or diagnostic scenarios. In-vitro bench testing relies on objective measurements.

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 is not an AI or diagnostic imaging device.

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

Not applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the in-vitro bench testing, the "ground truth" would be established by:

Engineering measurements and performance specifications as defined by the oxygenator standards (ISO/DIS 7199 and BG7199-1996).
Comparative performance data from the predicate devices.
The goal was to demonstrate that the MAXIMA FORTÉ™ performs similarly and safely according to these objective measures, not that it aligns with a subjective expert judgment.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

K962641

COMPANY AND CONTACT PERSON

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

DEC 16 1996

Debra J. Kridner, Manager Regulatory Affairs

DEVICE NAME

MAXIMA FORTÉ™ Hollow Fiber Oxygenator with Plasma Resistant Fiber (Model:MAX-FTE)

NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

MAXIMA PLUS PRF Hollow Fiber Oxygenator with Improved Plasma Resistant Fiber . (K941473)
BARD® WILLIAM HARVEY® HF-5000 Membrane Oxygenator (K872107). .

DESCRIPTION OF DEVICE

The MAXIMA FORTE™ oxygenator is placed in the cardiopulmonary bypass extracorporeal circuit for gas exchange. Venous blood enters the bottom of the oxygenator and flows through the nonporous polypropylene hollow tubes of the heat exchanger. These nonporous polypropylene hollow tubes are supported on their exterior by a polypropylene screen and contained within the polycarbonate heat exchanger housing. The polypropylene tubes run vertically through the polycarbonate chamber of the heat exchanger. The walls of these tubes provide a barrier between the venous blood and the cooling/warming water.

MAXIMA FORTÉ™ Hollow Fiber Oxygenator with Plasma Resistant Fiber July 3, 1996

Confidential Appendix IV Page 2

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The flow of venous blood and water through the MAXIMA FORTÉ™ Heat Exchanger portion of the oxygenator is as follows:

Venous Blood

Venous blood enters the blood inlet port on the bottom/center of the oxygenator. This blood flows up through the polypropylene nonporous hollow tubes, exits the top of the tubes and flows radially into the outer polycarbonate housing containing the microporous fiber bundle.

Water

The cooling/warming water enters the water inlet port. The water is directed towards the top of the heat exchanger, then flows downward passing around the outside walls of the nonporous polypropylene tubes, then exits through the water outlet port. The water outlet and inlet ports are located on the side of the oxygenator parallel to each other.

Heat exchange in the oxygenator occurs as the venous blood passes through the nonporous hollow tubes, while the temperature regulated cooling/warming water passes around the outside walls of the same tubes. The venous blood is cooled/ warmed as it flows through the heat exchanger prior to entering the outer polycarbonate case containing the microporous hollow fiber bundle (oxygenation portion of the oxygenator).

The flow of blood and gas through the MAXIMA FORTÉ™ oxygenation portion of the oxygenator is as follows:

Blood

Venous blood (oxygen depleted) exits from the top of the heat exchanger chamber and flows radially outward while passing into the outer polycarbonate case, which contains microporous polypropylene hollow fibers. These fibers have been wound a plastic core to produce a fiber bundle. This fiber bundle is encased in a clear polycarbonate case. The venous blood enters the fiber bundle and flows around the microporous polypropylene fibers. As blood flows over the microporous hollow fibers carbon dioxide/oxygen gas exchange occurs. Oxygenated arterial blood exits through the blood outlet port on the side of the oxygenator.

Gas

Gas enters through the gas inlet port on the top of the oxygenator and passes through the inside of the microporous hollow fibers. As the gas flows through the microporous hollow fibers gas transfer occurs. The gas exits from the gas outlet port on the side near the bottom of the oxygenator. Gas vents are located on the bottom of the oxygenator to prevent over-pressurization and under-pressurization..

510(k) Notification
Medtronic, Inc.
Medtronic Cardiopulmonary

MAXIMA FORTÉ™ Hollow Fiber Oxygenator with Plasma Resistant Fiber July 3, 1996

Confidential Appendix IV Page 3

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Gas exchange (transfer) occurs by diffusion of carbon dioxide and oxygen, across the wall of the microporous hollow fiber membrane between the blood and gas phases. When blood passes over the exterior of the microporous hollow fibers, while gas passes through these same fibers, gas

exchange occurs. The blood is oxygenated and carbon dioxide removed as the blood flows over the fibers prior to exiting from the oxygenator to the patient.

STATEMENT OF INTENDED USE

STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES

The MAXIMA PLUS PRF Hollow Fiber Oxygenator with Improved Plasma Resistant Fiber (Model Number: MAX-PRF) is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from blood during cardiopulmonary bypass and is designed to operate at blood flow rates between 1 and 7 LPM for periods up to six hours.

The BARD® WILLIAM HARVEY® HF-5000 Membrane Oxygenator provides blood oxygen and carbon dioxide gas transfer. In addition, it provides heat exchange in order to maintain or adjust the blood temperature as desired.

STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

A table comparing the intended use and technological characteristics of the Medtronic Cardiopulmonary MAXIMA FORTE® Hollow Fiber Oxygenator with Plasma Resistant Fiber with the two noted substantially equivalent devices 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

In determining substantial equivalence of the MAXIMA FORTE™ Hollow Fiber Oxygenator with Plasma Resistant Fiber (Model: MAX-FTE), the decision-making process follows the 510(k) "Substantial Equivalence" flow diagram as follows:

The MAXIMA FORTÉ™ Hollow Fiber Oxygenator with Plasma Resistant Fiber (Model: MAX-FTE). is being "compared to the following two Marketed Devices"

MAXIMA PLUS" PRF Hollow Fiber Oxygenator with Improved Plasma ●

510(k) Notification	MAXIMA FORTÉ™ Hollow Fiber Oxygenatorwith Plasma Resistant Fiber	ConfidentialAppendix IVPage 4
Medtronic, Inc.Medtronic Cardiopulmonary	July 3, 1996

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Resistant Fiber (K941473)

BARD® WILLIAM HARVEY® HF-5000 Membrane Oxygenator (K872107). .
The MAXIMA FORTÉ™ Hollow Fiber Oxygenator with Plasma Resistant Fiber (Model: MAX-FTE). has the "same indications statement and intended uses" as the
MAXIMA PLUS" PRF Hollow Fiber Oxygenator with Improved Plasma . Resistant Fiber (K941473)
The MAXIMA FORTÉ" Hollow Fiber Oxygenator with Plasma Resistant Fiber (Model: MAX-FTE), has "new technological characteristics (e.g., design, materials and manufacturing processes)" from the currently Medtronic adult oxygenators. These technological characteristics include:
Polypropylene heat exchanger .
. Transparent polycarbonate housing
. Lower priming volume (~295 ml)
Blood flow bottom to top heat exchanger, then top to bottom fiber bundle .
. Microporous hollow fiber has a smaller inner diameter

These technological characteristics are common to other adult oxygenators currently in commercial distribution as follows:

Plastic heat exchanger BARD® WILLIAM HARVEY® HF-5000 Membrane Oxygenator . (K872107).
. Transparent polycarbonate housing - BARD® WILLIAM HARVEY® HF-5000 Membrane Oxygenator (K872107).
0 Lower priming volume (~270 ml) - Terumo Medical Corporation Capiox SX Hollow Fiber Oxygentaor (K922799).
Blood flow bottom to top heat exchanger, then top to bottom fiber bundle Avecor . Cardiovascular Affinity Hollow Fiber Oxygenator (K932252).
Microporous hollow fiber has a smaller inner diameter of microporous hollow . fiber for other non-Medtronic adult oxygenators is unknown. Data demonstrates that this new technological characteristic does not present any new types of safety or effectiveness questions.

These technological characteristics "could affect the safety and effectiveness of the device". However these "new technological characteristics do not raisc 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 provided in the following oxygenator standards:

. ISO/DIS 7199 (ISO/TC 150/SC 2) 1995 Draft International Standard titled "Cardiovascular implants and artificial organs - Blood-gas exchangers"
BG7199-1996 (proposed new American National Standard) titled, "Cardiovascular implants . and artificial organs - Blood-gas exchangers (oxygenators)"

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"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the MAXIMA FORTE" Hollow Fiber Oxygenator with Plasma Resistant Fiber is substantially equivalent to marketed devices.

In addition, the modes of operation of the MAXIMA FORTÉ™ Hollow Fiber Oxygenator with Plasma Resistant Fiber are either identical or substantially equivalent to other hollow fiber oxygenators currently in commercial distribution. The function of the Medtronic MAXIMA FORTE" Hollow Fiber Oxygenators is the extracorporeal oxygenation of and carbon dioxide removal from blood during cardiopulmonary bypass. The MAXIMA FORTE" Hollow Fiber Oxygenators are designed to operate at blood flow rates between 1 and 7 LPM for periods up to six hours.

The predicate/marketed device is:

MAXIMA PLUS® PRF Hollow Fiber Oxygenator with Improved Plasma Resistant Fiber . (K941473)
A table comparing the intended use and technological characteristics of the MAXIMA FORTÉ Hollow Fiber Oxygenator with Plasma Resistant Fiber with the two noted substantially equivalent devices is provided in Attachment 1.

The biocompatibility testing and in-vitro bench testing demonstrated that when compared to the predicate devices the MAXIMA FORTE™ Hollow Fiber Oxygenator with Plasma Resistant Fiber do not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed hollow fiber oxygenators. The in-vitro bench testing included analysis of.

. Blood pathwav integrity
. Heat exchanger pathway integrity
. Blood volumes
Connectors .
Oxygenator and Carbon Dioxide Transfer Rates .
o Heat Exchanger Performance Factor
. Blood Cell Damage
Time Dependent Performance Changes .
Pressure Drop .

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”