(58 days)
Not Found
No
The summary describes a mechanical temperature control device with no mention of AI or ML.
No.
The device controls the temperature of water delivered to a heat exchanger, which then interacts with a cardioplegia solution. It does not directly provide a therapeutic effect to the patient.
No
The device is described as a "self-contained temperature control device designed to deliver cooled or heated water to a cardioplegia heat exchanger." Its function is to manage temperature, not to gather or analyze medical information for diagnosis.
No
The device description clearly indicates it is a "portable heating and cooling circulation system with mechanical controls," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for controlling the temperature of water delivered to a heat exchanger in a cardiopulmonary bypass circuit. This is a therapeutic/supportive function performed on the patient's blood during surgery, not a diagnostic test performed on a sample outside the body.
- Device Description: The description reinforces its function as a circulation system for temperature control, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a medical device used in a surgical setting to support a physiological process (cardiopulmonary bypass), not to perform a diagnostic test.
N/A
Intended Use / Indications for 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.
The Minntech Corporation's EnGUARD™ CHC Dual Reservoir Cardioplegia Heater/Cooler is intended to be used as a self-contained temperature control device to deliver cooled or heated water to a cardioplegia heat exchanger in the cardiopulmonary bypass circuit.
Product codes
DWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cincinnati Sub-Zero Hemotherm Model 400 Cooler/Heater
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 870.4250 Cardiopulmonary bypass temperature controller.
(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).
0
FEB 01 2002
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
Heater/Cooler |
|----------------------|-----------------------------------------------------------------------|
| Common name: | Heater-Cooler |
| Classification name: | Temperature Controller, Cardiopulmonary Bypass
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.
1
Technological Characteristics: 6.
A comparative summary of the EnGUARD™ CHC Heater/Cooler and predicate device is as follows:
| Characteristic | EnGUAR™ CHC Dual
Reservoir Cardioplegia
Heater/Cooler | Cincinnati Sub-Zero
Hemotherm Model 400
Cooler/Heater |
|------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Reservoirs/construction | Dual/plastic | Dual/plastic |
| Power requirements | 100, 115. 240 VAC | 100, 115. 240 VAC |
| Reservoir Capacity | Cool - 8 liters
Heat - 6 liters | Cool - 7.6 liters
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.
2
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
3
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 (301) 594-4646. 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" (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 (800) 638-2041 or (301) 443-6597 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
4
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