(296 days)
Not Found
No
The summary describes a physical heat exchanger and does not mention any AI or ML components or functionalities.
No
The device is used to maintain the temperature of cardioplegic solutions, which are drugs used to stop the heart during surgery. It does not exert a therapeutic effect on the patient itself.
No
The device is described as a heat exchanger used to maintain the temperature of solutions during extracorporeal circulation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "cardioplegia heat exchanger with integrated bubble trap," indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to set and maintain the temperature of blood and crystalloid cardioplegic solutions during extracorporeal circulation. This is a process performed outside the body, but it's not for the purpose of diagnosing a condition.
- Device Description: It's described as a cardioplegia heat exchanger with an integrated bubble trap. This is a therapeutic or supportive device used during a medical procedure, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device's function is to prepare solutions for use in a medical procedure.
N/A
Intended Use / Indications for Use
The PLEGIOX Heat Exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation.
The product is designed for single use only, for an application period of no longer than 6 hours.
Product codes
DTR
Device Description
The PLEGIOX is a cardioplegia heat exchanger with integrated bubble trap. It is delivered in a pyrogen-free and sterile status.
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)
Evaluation on safety and effectiveness was executed to demonstrate that the PLEGIOX Cardioplegia Heat Exchanger with Softline Coating described in this submission is substantially equivalent to the PLEGIOX Cardioplegia Heat Exchanger with and without Safeline Coating as heat exchanger and to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating regarding the Softline Coating.
The following areas have been tested and / or evaluated:
- Integrity .
- Performance .
- Biocompatibility .
- Sterility
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
K.O.9.0.333
MAQUET
510(k) Summary
[as required by 21 CFR 807.92(c)]
DEC 2 3 2009
| Submitter | MAQUET Cardiopulmonary AG
Hechinger Strasse 38
72145 Hirrlingen
Germany |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Frank Moehrke
Phone: 011 49 7478 921 229
Fax: 011 49 7478 921 400 |
| Date Prepared | February 26, 2009 |
| Device Trade Name | PLEGIOX Cardioplegia Heat Exchanger
with Softline Coating |
| Common/Usual Name | Cardioplegia heat exchanger |
| Classification Names | Cardiopulmonary bypass heat exchanger
(21 CFR 870.4240 - Product Code: DTR) |
| Legally Marketed Devices | PLEGIOX Cardioplegia Heat Exchanger
with and without Safeline Coating (K072583)
QUADROX-i Adult microporous membrane
Oxygenator with and without integrated
Arterial Filter with Softline Coating (K082117) |
Device Description
The PLEGIOX is a cardioplegia heat exchanger with integrated bubble trap. It is delivered in a pyrogen-free and sterile status.
Indications for Use
The PLEGIOX Heat Exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation.
The product is designed for single use only, for an application period of no longer than 6 hours.
1
MAQUET
Statement of Technical Comparison
The PLEGIOX Cardioplegia Heat Exchanger with Softline Coating is identical to the PLEGIOX Cardioplegia Heat Exchanger with and without Safeline Coating with the only exception that the PLEGIOX Cardioplegia Heat Exchanger with Softline Coating has been coated with Softline Coating instead of Safeline Coating and no coating respectively. However, the Softline Coating is the same as with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating. Besides this difference the PLEGIOX Cardioplegia Heat Exchanger with Softline Coating is the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the PLEGIOX Cardioplegia Heat Exchanger with and without Safeline Coating.
Determination of Substantial Equivalence
Evaluation on safety and effectiveness was executed to demonstrate that the PLEGIOX Cardioplegia Heat Exchanger with Softline Coating described in this submission is substantially equivalent to the PLEGIOX Cardioplegia Heat Exchanger with and without Safeline Coating as heat exchanger and to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating regarding the Softline Coating.
The following areas have been tested and / or evaluated:
- Integrity .
- Performance .
- Biocompatibility .
- Sterility
Conclusion
The data given demonstrate that the PLEGIOX Cardioplegia Heat Exchanger with Softline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN 2 1 2010
Maquet Cardiopulmonary AG c/o Mr. Frank Moehrke Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirringen Germany
Re: K090555
Maquet PLEGIOX Cardioplegia Heat Exchanger with Softline Coating Regulation Number: 21 CFR 870.4240 Regulation Name: Heat-Exchanger, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTR Dated: December 23, 2009
Dear Mr. Moehrke:
This letter corrects our substantially equivalent letter of December 23, 2009.
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 (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 additional controls. Existing major regulations affecting your
3
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
R. lehner
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
PLEGIOX Cardioplegia Heat Exchanger with Softline Coating
Indications for Use:
The PLEGIOX Heat Exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation.
The product is designed for single use only, for an application period of no longer than 6 hours.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.W.P.
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510(k) Number