(106 days)
No
The summary describes a mechanical device (membrane oxygenator) for extracorporeal circulation. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies focus on physical and biological properties, not algorithmic performance.
Yes
The device is used during cardiopulmonary bypass in cardiac surgery to oxygenate blood, eliminate carbon dioxide, and regulate blood temperature, which are therapeutic actions.
No
This device, a membrane oxygenator, is used for oxygenating blood, eliminating carbon dioxide, regulating blood temperature, and filtering in extracorporeal circulation during cardiac surgery. These are therapeutic functions, not diagnostic ones.
No
The device description clearly indicates it is a physical medical device (membrane oxygenator with integrated heat exchanger and optional arterial filter) used in extracorporeal circulation. It is not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. This involves directly interacting with the patient's blood outside the body for therapeutic purposes (oxygenation, CO2 removal, temperature regulation, filtering).
- Device Description: The device is described as a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter. This aligns with a therapeutic device used in surgery.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such diagnostic testing on specimens. It is a therapeutic device that processes the patient's blood during surgery.
Therefore, the QUADROX-i Adult membrane oxygenator is a medical device used in a surgical setting, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature.
The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.
The device's utilization period is limited to six hours. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Product codes (comma separated list FDA assigned to the subject device)
DTZ, DTR, DTM
Device Description
The QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.
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 and testing on safety and effectiveness was executed to demonstrate that the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating as oxygenator and to the QUART Arterial Filter with BIOLINE Coating regarding the BIOLINE coating.
The following areas have been tested and / or evaluated:
- Integrity
- Performance
- Biocompatibility
- Sterilitv
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
0
MAQUET
510(k) Summarv
[as required by 21 CFR 807.92(c)]
JUN 1 2 2009
Submitter
MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germanv
Contact Person
Frank Moehrke Phone: 011 49 7478 921 229 011 49 7478 921 400 Fax:
Filter with BIOLINE Coating
February 24, 2009
Date Prepared
Device Trade Name
Common/Usual Name
Oxygenator with integrated heat exchanger and optional integrated arterial filter
QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial
Classification Names
Cardiopulmonary bypass oxygenator (21 CFR 870.4350 - Product Code: DTZ) Cardiopulmonary bypass heat exchanger (21 CFR 870.4240 - Product Code: DTR) Cardiopulmonary bypass arterial line blood filter (21 CFR 870.4260 - Product Code: DTM)
Legally Marketed Devices QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117), QUART Arterial Filter with BIOLINE Coating (K082544)
Device Description
The QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.
Indications for Use
The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature.
1
The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.
The device's utilization period is limited to six hours. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Statement of Technical Comparison
The QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is identical to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating with the only exception that the QUADROX-i Adult with BIOLINE Coating have been coated with BIOLINE Coating instead of Softline Coating. However, the BIOLINE Coating is the same as with the QUART Arterial Filter with BIOLINE Coating. Besides this difference the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating.
Determination of Substantial Equivalence
Evaluation and testing on safety and effectiveness was executed to demonstrate that the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating as oxygenator and to the QUART Arterial Filter with BIOLINE Coating regarding the BIOLINE coating.
The following areas have been tested and / or evaluated:
- Integrity
- Performance
- Biocompatibility
- Sterilitv
Conclusion
The data given demonstrate that the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is substantially equivalent to the named predicate devices which hold currently market clearance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2009
Maquet Cardiopulmonary AG c/o Mr. Frank Mohrke Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K090511
Quadrox-i Adult Microporous Membrane Oxygenatotor with and without Integrated Arterial Filter with Bioline Coating Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II (two) Product Code: DTZ . Dated: May 13, 2009 Received: May 15, 2009
Dear Mr. Mohrke:
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.
3
Page 2 - Mr. Frank Mohrke
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 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
suma R. Vohrer
- Bram D. Zuckerman, M.D. 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): K0905) |
Device Name:
QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating
Indications for Use:
The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature.
The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.
The device's utilization period is limited to six hours. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1 of 1
Duana R. Vachner
Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K090511
012