(24 days)
Not Found
No
The document describes a mechanical device (membrane oxygenator) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery to oxygenate blood, eliminate carbon dioxide, and regulate blood temperature, which are therapeutic actions.
No
Explanation: The device is a membrane oxygenator, which functions to oxygenate blood, eliminate carbon dioxide, regulate temperature, and filter air bubbles/particles during cardiopulmonary bypass. These are direct therapeutic and supportive functions, not diagnostic ones. It does not analyze patient data or provide information for diagnosis.
No
The device description clearly indicates it is a physical blood-gas exchanger with integrated components, not a software-only product.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used in "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, and filtration).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (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 used during surgery.
Therefore, the QUADROX-i Small Adult membrane oxygenator is a medical device used for extracorporeal support during surgery, not an IVD.
N/A
Intended Use / Indications for Use
The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 Vmin. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and requiates blood temperature.
The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm.
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 Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating is a blood-gas exchanger with integrated heat exchanger and optional 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
Small Adult
Intended User / Care Setting
attending physician
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 Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating as oxygenator and to the QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating regarding the BIOLINE 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): 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.
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
§ 870.4350 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
093527 AQUET GETINGE GROUP
510(k) Summary
יי
{as required by 21 CFR 807.92(c)]
| Submitter | MAQUET Cardiopulmonary AG
Hechinger Strasse 38
72145 Hirrlingen
Germany | DEC - 7 2009 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person | Frank Moehrke
Phone: 011 49 7478 921 229
Fax: 011 49 7478 921 8667 | |
| Date Prepared | November 10, 2009 | |
| Device Trade Name | QUADROX-i Small Adult Microporous
Membrane Oxygenator with and without
Integrated Arterial Filter with BIOLINE Coating | |
| Common/Usual Name | Oxygenator with integrated heat exchanger and
optional integrated arterial filter | |
| 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 Small Adult Microporous Membrane
Oxygenator with and without Integrated Arterial
Filter with Softline Coating (K090689), | |
| | QUADROX-i Adult Microporous Membrane
Oxygenator with and without Integrated Arterial
Filter with BIOLINE Coating (K000511) | |
Device Description
The QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating is a blood-gas exchanger with integrated heat exchanger and optional integrated arterial blood filter.
014
1
GETINGE GROUP
Indications for Use
The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 Vmin. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and requiates blood temperature.
The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm.
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 Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating is identical to the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating with the only exception that the QUADROX-i Small Adult Oxygenators with BIOLINE Coating have been coated with BIOLINE Coating instead of Softline Coating. However, the BIOLINE Coating is the same as with the QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating. Besides this difference the QUADROX-i Small 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 Small 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 Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating as oxygenator and to the QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating regarding the BIOLINE Coating.
2
MAQU GETINGE GROUP
The following areas have been tested and / or evaluated:
- Integrity -
- Performance -
- Biocompatibility -
- Sterility -
Conclusion
The data given demonstrate that the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filler with BIOLINE Coating is substantially equivalent to the named predicate devices which hold currently market clearance.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC - 7 2009
Maquet Cardiopulmonary AG c/o Mr. Frank Moehrke Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen Germany
Re: K093522
QUADROX-i Small Adult Microporous Membrane Oxygenator With and without Integrated Arterial Filter with BIOLINE Coating Regulation Number: 21 CFR 870.4350 Regulation Name: Oxygenator Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTZ, DTR, DTM Dated: November 10, 2009 Received: November 13, 2009
Dear Mr. Moehrke:
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 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.
4
Page 2 - Mr. Frank Moehrke
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Dina R. Vahner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Ko93522
Device Name:
QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating
Indications for Use:
The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature.
The QUADROX - i Small Adult (HMO 51000) 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.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D) (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)
bune R. Ladner
(Division Sign-Off) (Division Sign-Sil, vascular Devices
510(k) Number K093522
Page 1 of 1
013