(58 days)
The Minntech Corporation's 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 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.
The provided text describes the Minntech EnGUARD™ CHC Dual Reservoir Cardioplegia Heater/Cooler, a medical device. However, it does not include detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the way described in the prompt's request (e.g., using AI, test sets, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance).
The document is a 510(k) summary for a medical device submitted to the FDA, focusing on substantial equivalence to a predicate device for market clearance. The "Performance Testing" section is very high-level and only lists the types of tests conducted, not the specific criteria or results.
Therefore, I cannot provide the requested information. The document states:
- "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."
This statement does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size for test sets or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information about MRMC comparative effectiveness studies or human reader improvement with AI.
- Information about standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
The document primarily focuses on a comparison of technological characteristics to a predicate device, as shown in this table:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in the document as acceptance criteria. The table below represents a comparison of features and ranges between the proposed device and its predicate, which implicitly serves as meeting "acceptance" by demonstrating substantial equivalence.
| Characteristic | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (EnGUARD™ CHC) |
|---|---|---|
| Reservoirs/construction | Dual/plastic | Dual/plastic |
| Power requirements | 100, 115, 240 VAC | 100, 115, 240 VAC |
| Reservoir Capacity (Cool) | 7.6 liters | 8 liters |
| Reservoir Capacity (Heat) | 5.7 liters | 6 liters |
| Fluid Heating Range | 25°C to 42°C | 25°C to 42°C |
| Fluid Cooling Range | 32°C to 3°C | Ice Water temperatures |
| Connections | 1/2" Hansen Fittings | 1/2" Hansen Fittings |
| Hi Limit Temperature Control | 44°C | 43°C |
Further Breakdown of Requested Information (Not Available in Document):
- Sample size used for the test set and the data provenance: Not specified. The document refers to "Performance Testing" but does not detail the sample size or source of data for these tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This is a medical device, not an AI/diagnostic software. Ground truth in this context would refer to instrument calibration and measurement accuracy, not expert consensus on images or diagnostic outcomes.
- Adjudication method for the test set: Not applicable/specified.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating diagnostic performance with human readers, typically in the context of imaging or AI assistance. This document describes a physical medical device (heater/cooler).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used: Not specified. For a heater/cooler, "ground truth" would likely refer to calibrated thermometers and flow meters to verify temperature and flow accuracy.
- The sample size for the training set: Not applicable. There is no mention of an algorithm or training set for this physical device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text is a 510(k) summary for a physical medical device (a heater/cooler), which follows a different regulatory pathway and testing paradigm than the AI/diagnostic software performance evaluation outlined in your prompt questions. Therefore, most of the requested information regarding AI-specific criteria, expert adjudication, and ground truth establishment is not present or applicable.
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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 CardioplegiaHeater/Cooler |
|---|---|
| Common name: | Heater-Cooler |
| Classification name: | Temperature Controller, Cardiopulmonary Bypassper 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 DualReservoir CardioplegiaHeater/Cooler | Cincinnati Sub-ZeroHemotherm Model 400Cooler/Heater |
|---|---|---|
| Reservoirs/construction | Dual/plastic | Dual/plastic |
| Power requirements | 100, 115. 240 VAC | 100, 115. 240 VAC |
| Reservoir Capacity | Cool - 8 litersHeat - 6 liters | Cool - 7.6 litersHeat - 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 (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
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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
§ 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).