The Minntech Corporation's EnGuard™ Cardioplegia Heat Exchanger is used to cool or warm cardioplegia solution prior to delivery to the patient through connected tubing sets which provide various ratios of cardioplegia solution to blood, depending upon the tubing set chosen.

Device Description

The administration of cardioplegia solution is commonly used to provide myocardial protection or controlled arrest of the heart during coronary bypass procedures. As the oxygenated blood enters the EnGuard™ device through the inlet blood port, it passes through the fiber bundle lumens where the temperature of the blood is cooled or warmed as desired by passing water of the desired temperature into the heater/cooler section of the device, which surrounds the fiber bundle. The water enters and leaves through standard Hansen connector ports molded into the polycarbonate case. The EnGuard™ heat exchanger must be used with separately purchased, sterile tubing sets attached as explained in the labeling. These tubing sets will determine the ratio of crystalloid to blood. The Minntech device will produce cardioplegia solution at ratios of 1:1, 2:1, 4:1 and 8:1 depending upon the chosen tubing set.

AI/ML Overview

Here's an analysis of the provided text regarding the EnGuard™ PHX Cardioplegia Heat Exchanger, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Safety	Biocompatibility (according to EN10993)	All materials evaluated and found acceptable.
Performance/Effectiveness	Functional testing for equivalent performance to predicates	Performed functional testing; found equivalent performance.
Durability	Shelf life	Evaluated to be 4 years.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The document primarily focuses on regulatory approval based on functional testing and comparison to predicate devices, rather than detailed clinical study results.

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

The text does not mention using experts to establish ground truth because the "study" described is functional testing comparing the device to predicates, not a diagnostic or AI-based system requiring expert interpretation of data.

4. Adjudication Method for the Test Set

The text does not mention an adjudication method, as it doesn't describe a process of expert review or consensus for establishing ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes functional testing and comparison against predicate devices for safety and equivalent performance, not a study involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The EnGuard™ PHX Cardioplegia Heat Exchanger is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance and "human-in-the-loop" is not applicable to this device.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for the functional testing would primarily be established by:

Engineering specifications and standards: The device's ability to cool/warm solution within set parameters, mix solutions at specified ratios, etc.
Performance data from predicate devices: The "ground truth" for performance equivalence is the established and accepted performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This refers to a physical device, not an AI/ML algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.

9. How the Ground Truth for the Training Set Was Established

As this is a physical device, the concept of a "training set" and establishing ground truth for it is not applicable. The device's design, manufacturing, and functional testing adhere to established engineering principles and regulatory standards.

Summary

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EnGuard™ PHX Cardioplegia Heat Exchanger

510(k) Summary of Safety and Effectiveness

Manufacturer:	Minntech Corporation
Address:	14605 28th Avenue NMpls, MN 55447USA
Official Contact:	Robert JohnsonVice President, Regulatory Affairs and Quality Assurance

Minntech Corporation has supplied the following information to the U.S. Food and Drug Administration to support the substantial equivalency of the EnGuard™ PHX Cardioplegia Heat Exchanger to other cardioplegia devices currently in commercial distribution in the United States.

1. Device Description

The EnGuard™ heat exchanger must be used with separately purchased, sterile tubing sets attached as explained in the labeling. These tubing sets will determine the ratio of crystalloid to blood. The Minntech device will produce cardioplegia solution at ratios of 1:1, 2:1, 4:1 and 8:1 depending upon the chosen tubing set.

Intended Use 2.
The Minntech Corporation's EnGuard™ Cardioplegia Heat Exchanger is used to facilitate mixing of a patient's blood with cardioplegia solution and to cool or warm this solution prior to delivery to the patient through connected tubing sets which provide various ratios of cardioplegia solution to blood, depending upon the tubing set chosen.
Comparison to Another Device in Commercial Distribution Within the United 3. States
The EnGuard™ PHX Cardioplegia Heat Exchanger is equivalent to other cardioplegia devices currently on the market. All of these devices are intended to

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heat or cool and facilitate delivery of a cardioplegia/blood solution. The Medtronic Corporation's CardioTherm™ Blood Cardioplegia System (K960755), Sorin Biomedical Vanguard™ BCD Advanced Blood Cardioplegia System (K925369) and the Avecor Cardiovascular's MyoTherm Cardioplegia Delivery System (K904171) are all substantially equivalent to the EnGuard.

4. Summary

Minntech Corporation has performed functional testing to show the 4.1 EnGuard™ is safe and has equivalent performance as the predicate devices.
All materials used in the product have been evaluated for biocompatibility 4.2 according to EN10993.
The shelf life of the product has been evaluated to be 4 years. 4.3
1. Summary of Substantial Equivalence

Minntech Corporation has provided the above information within the 510(k) to support the claim that the EnGuard™ PHX Cardioplegia Heat Exchanger is safe and effective when used in accordance to the device labeling.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in black, contrasting with the white background of the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 8 2000

Ms. Lynn Lueders Director of Regulatory Affairs Minntech Corp. 14605 28™ Ave. North Minneapolis, MN 55447

K991137 Re: Trade Name: Enguard PHX Cardioplegia Heat Exchanger Regulatory Class: II (two) Product Code: DTR Dated: March 15, 2000 Received: March 16, 2000

Dear Ms. Lueders:

We have reviewed your Section 510(k) notification of intent to market we have reviewed four and we have determined the device is the device forcemosalent (for the indications for use stated in the Subscancially of additionarketed predicate devices marketed in encrosure, co rogally Incelstate commerce proble of to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In accuratic with one pimay, therefore, market the device, subject to Cosmeral controls provisions of the Act. The general controls cnc general ochorized include requirements for annual registration, provisions of thes, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device 10 Class III (Premarket Approval), it may be subject to such controls) or class - Existing major regulations affecting your device additionar concerner of Federal Regulations, Title 21, Parts 800 can be round in che ally equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set with 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 inopotions. Failure to comply with the GMP regulation may result in as and organism. 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 obrigation you mBythe Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Lynn Lueders

This letter will allow you to begin marketing your device as described inio recei k) premarket notification. The FDA finding of substantial in your ore (n) pror device to a legally marketed predicate device equivalors 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 regaration (ei ers), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and 594 4040. Individe ice, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). Hibbiananty by Formation on your responsibilities under the Act may ocher general informatives of Small Manufacturers Assistance at its be obseries number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Bum E. Javen
James E. Dillard III
Director
Division of Cardiovascular and
Respiratory Devices

Office of Device Evaluation Center for Devices and Radioloqical Health

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Indications for Use

510(k) Number (if Known):

K991137

Device Name:

EnGuard™ PHX Cardioplegia Heat Exchanger

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per21 CFR 801.109)

Over-the Counter-use (Optional Format 1-1-96)

Pete G. Goerge

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K991637

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).