ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

K014016 · Minntech Corp. · DWC · Feb 1, 2002 · Cardiovascular

Device Facts

• Record ID: K014016
• Device Name: ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
• Applicant: Minntech Corp.
• Product Code: DWC · Cardiovascular
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Minntech EnGUARD™ CHC Dual Reservoir Cardioplegia Heater/Cooler is intended to be used as a self-contained temperature control device designed to deliver cooled or heated water to a cardioplegia heat exchanger in the cardiopulmonary bypass circuit.

Device Story

Portable heating and cooling circulation system; provides temperature-controlled water to cardioplegia heat exchangers in cardiopulmonary bypass circuits. Device features dual reservoirs (cool and heat) with mechanical controls. Used in clinical settings (e.g., OR) by perfusionists or surgical staff. Operates by circulating water through external heat exchanger devices to manage patient cardioplegia temperature during bypass. Output is thermal energy transferred via water flow; healthcare providers monitor and adjust settings to maintain target temperatures for myocardial protection.

Clinical Evidence

Bench testing only. Performance testing included heating and cooling system effectiveness, electrical safety testing, and water bath management.

Technological Characteristics

Dual-reservoir, plastic-constructed heater/cooler. Power: 100, 115, 240 VAC. Connections: 1/2" Hansen fittings. Heating range: 25°C to 42°C. High-limit temperature control: 43°C. Mechanical control system. Standalone device.

Indications for Use

Indicated for use as a self-contained temperature control device to deliver cooled or heated water to a cardioplegia heat exchanger within a cardiopulmonary bypass circuit.

Regulatory Classification

Identification

A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.

Predicate Devices

• Cincinnati Sub-Zero Hemotherm Model 400 Cooler/Heater

Submission Summary (Full Text)

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FEB 01 2002

K014016

# 510(k) SUMMARY

#### 1. Submitter Information:

| Name: | Minntech Corporation |
|-----------------|-------------------------------------------------------|
| Address: | 14605 28th Avenue North, Minneapolis, Minnesota 55447 |
| Contact Person: | Mark Murphy |
| Date Prepared: | November 1, 1999 |

#### 2. Device Name:

| Proprietary name: | Minntech EnGUARD™ CHC Dual Reservoir Cardioplegia<br>Heater/Cooler |
|----------------------|-----------------------------------------------------------------------|
| Common name: | Heater-Cooler |
| Classification name: | Temperature Controller, Cardiopulmonary Bypass<br>per 21 CFR 870.4250 |

#### 3. Predicate Device:

Cincinnati Sub-Zero Hemotherm Model 400 Cooler/Heater

#### 4. Device Description:

The Minntech EnGUARD ™ CHC Dual Reservoir Cardioplegia Heater/Cooler is a portable heating and cooling circulation system with mechanical controls for delivery of warm or cool water to flow through type water pathway cardioplegia heat exchanger devices.

### રા Intended Use:

The Minntech EnGUARD™ CHC Dual Reservoir Cardioplegia Heater/Cooler is intended to be used as a self-contained temperature control device designed to deliver cooled or heated water to a cardioplegia heat exchanger in the cardiopulmonary bypass circuit.

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# Technological Characteristics: 6.

A comparative summary of the EnGUARD™ CHC Heater/Cooler and predicate device is as follows:

| Characteristic | EnGUAR™ CHC Dual<br>Reservoir Cardioplegia<br>Heater/Cooler | Cincinnati Sub-Zero<br>Hemotherm Model 400<br>Cooler/Heater |
|------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Reservoirs/construction | Dual/plastic | Dual/plastic |
| Power requirements | 100, 115. 240 VAC | 100, 115. 240 VAC |
| Reservoir Capacity | Cool - 8 liters<br>Heat - 6 liters | Cool - 7.6 liters<br>Heat - 5.7 liters |
| Fluid Heating Range | 25°C to 42°C | 25°C to 42°C |
| Fluid Cooling Range | Ice Water temperatures | 32°C to 3°C |
| Connections | 1/2" Hansen Fittings | 1/2" Hansen Fittings |
| Hi Limit Temperature Control | 43°C | 44°C |

## 7. Performance Testing:

The following performance testing was conducted to determine device effectiveness as a cardioplegia heater/cooler: Heating and Cooling Systems performance, Electrical Safety Testing and Water Bath Management.

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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Ms. Lynn Lueders Director, Regulatory Affairs Minntech® Corporation 14605 28th Ave. N. Minneapolis, MN 55447

- Re: K014016
Trade Name: EnGUARD™ CHC Dual reservoir Cardioplegia Heater/Cooler Regulation Number: 21 CFR 870.4250 Regulation Name: Cardiopulmonary bypass temperature controller. Regulatory Class: Class II (two) Product Code: DWC Dated: November 27, 2001 Received: December 5, 2001

Dear Ms. Lueders:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality

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Page 2 - Ms. Lynn Lueders

systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

signature

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular And Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if Known):

EnGUARD™ CHC Dual Reservoir Cardioplegia Heater/Cooler Device Name:

Indications for Use:

The Minntech Corporation's EnGUARD™ CHC Dual Reservoir Cardioplegia The Millinoon Origoration o be used as a self-contained temperature control device to Heater/Cooler is meeticed to be assu as a would secure security of the cardiopulmonary bypass circuit.

(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) OR

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

Division of Cardiovascular & Respiratory Devices
510(k) Number K014026