(430 days)
Not Found
No
The device description and intended use focus on a physical heat exchange mechanism and do not mention any computational or data-driven processes indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is a heat exchanger for cardioplegia solution, which is used to cool or warm the solution prior to delivery to the patient. It does not directly treat a disease or condition in a patient, but rather prepares a solution that is then used in a therapeutic procedure.
No
The device is described as a heat exchanger used to cool or warm cardioplegia solution, which is then delivered to a patient. Its function is to modify the temperature of a solution for treatment purposes, not to diagnose a condition.
No
The device description clearly details a physical heat exchanger with ports, fiber bundles, and a polycarbonate case, indicating it is a hardware device, not software-only.
Based on the provided information, the Minntech Corporation's EnGuard™ Cardioplegia Heat Exchanger is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to cool or warm cardioplegia solution prior to delivery to the patient. This is a therapeutic or procedural function, not a diagnostic one.
- Device Description: The description details how the device physically alters the temperature of the cardioplegia solution and blood mixture. It does not describe any process of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples (blood, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is used in relation to the heart during a surgical procedure, which is a direct interaction with the patient's body, not an in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. The EnGuard™ device's function is to prepare a solution for administration to the patient during surgery, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for 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.
Product codes
DTR
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.
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)
Minntech Corporation has performed functional testing to show the EnGuard™ is safe and has equivalent performance as the predicate devices.
All materials used in the product have been evaluated for biocompatibility according to EN10993.
The shelf life of the product has been evaluated to be 4 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
EnGuard™ PHX Cardioplegia Heat Exchanger
510(k) Summary of Safety and Effectiveness
| Manufacturer: | Minntech Corporation |
|---|---|
| Address: | 14605 28th Avenue N |
| Mpls, MN 55447 | |
| USA | |
| Official Contact: | Robert Johnson |
| 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
1
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
-
- 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.
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 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
4
Indications for Use
510(k) Number (if Known):
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.
(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)
Pete G. Goerge
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K991637