ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER

K991137 · Minntech Corp. · DTR · Jun 8, 2000 · Cardiovascular

Device Facts

• Record ID: K991137
• Device Name: ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
• Applicant: Minntech Corp.
• Product Code: DTR · Cardiovascular
• Decision Date: Jun 8, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4240
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

The EnGuard™ PHX Cardioplegia Heat Exchanger is a medical device used during coronary bypass procedures to provide myocardial protection or controlled heart arrest. It functions by receiving oxygenated blood through an inlet port, which then passes through fiber bundle lumens. A heater/cooler section surrounding the fiber bundle circulates water to adjust the blood temperature. The device requires separately purchased, sterile tubing sets to mix blood with cardioplegia solution at specific ratios (1:1, 2:1, 4:1, or 8:1). It is operated by clinical staff in a surgical setting. The device output is a temperature-controlled cardioplegia/blood solution delivered to the patient, which facilitates myocardial protection during surgery.

Clinical Evidence

Bench testing only. Functional testing performed to demonstrate safety and performance equivalent to predicate devices. Biocompatibility evaluated per EN10993. Shelf life validated at 4 years.

Technological Characteristics

Polycarbonate case with standard Hansen connector ports for water circulation. Fiber bundle heat exchanger design. Biocompatible materials per EN10993. Non-electronic, mechanical heat exchange system.

Indications for Use

Indicated for use during coronary bypass procedures to facilitate mixing of blood with cardioplegia solution and to cool or warm the solution prior to delivery to the patient.

Regulatory Classification

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.

Predicate Devices

• CardioTherm™ Blood Cardioplegia System (K960755)
• Sorin Biomedical Vanguard™ BCD Advanced Blood Cardioplegia System (K925369)
• Avecor Cardiovascular's MyoTherm Cardioplegia Delivery System (K904171)

Submission Summary (Full Text)

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# EnGuard™ PHX Cardioplegia Heat Exchanger

510(k) Summary of Safety and Effectiveness

| Manufacturer: | Minntech Corporation |
|-------------------|----------------------------------------------------------------------------|
| Address: | 14605 28th Avenue N<br>Mpls, MN 55447<br>USA |
| Official Contact: | Robert Johnson<br>Vice 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 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.

- 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
- 5. 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 [phone]. Additionally, for questions on the promotion and 594 4040. Individe ice, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "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 [phone] or [phone] 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:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per21 CFR 801.109)

OR

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