(227 days)
Not Found
No
The summary describes a mechanical blood-gas exchanger and filter, with no mention of AI or ML capabilities.
Yes
The device replaces the function of lungs during surgery to maintain oxygen levels and remove carbon dioxide, thus aiding the patient's health during the procedure.
No
This device is an oxygenator used for cardiopulmonary bypass during cardiac surgery, which modifies blood composition (oxygenation, CO2 elimination, temperature regulation) rather than diagnosing a condition.
No
The device description clearly states it is a "blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter," which are physical hardware components. The performance studies also focus on testing the integrity, performance, biocompatibility, and sterility of this hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The QUADROX-i Small Adult is a membrane oxygenator used in extracorporeal circulation during cardiopulmonary bypass. Its function is to oxygenate blood, remove carbon dioxide, and regulate blood temperature during surgery, directly interacting with the patient's blood flow.
- Intended Use: The intended use clearly describes its role in supporting the patient's physiological functions during cardiac surgery, not in analyzing samples for diagnostic purposes.
The device is a therapeutic device used to support a patient's vital functions during a medical procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/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 µm. The device's utilization period is limited to six hours. The oxygenator is suitable for the 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
DTZ
Device Description
The QUADROX-i Small Adult is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter. The QUADROX-i Small Adult may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136).
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.
Cardiopulmonary bypass in cardiac surgery.
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)
Non-clinical Testing:
The QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating has been tested to and met the requirements of ISO 10993-1 Biologic Evaluation of Medical Devices as well as the requirements of ISO 7199: 1996 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators) as well as the requirements of ISO 15675: 2001 "Cardiovascular implants and artificial organs – Cardiopulmonary Bypass – Arterial line blood filters".
The following areas have been tested:
- Integrity
- Performance
- Biocompatibility
- Sterility
Conclusion:
The data given demonstrate that the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating is substantially equivalent to the named predicate devices which currently hold market clearance.
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
§ 870.4350 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
K040 689
MAQUET
OCT 2 9 2009
510 (K) Summary [as required by 21 CFR 807.92(c) ]
Submitter:
MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germany
Contact Person:
�
Dr. Ingrid Richter Phone: +49 7478 921-337 Fax: +49 7478 921-400 E-mail: ingrid.richter@maquet-cp.com
Date Prepared:
March 10, 2009
Device Trade Name:
Common/Usual name:
Classification names:
Predicate Devices:
QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating
Oxygenator with integrated heat exchanger and optional integrated arterial filter
Oxygenator, cardiopulmonary bypass Heat Exchanger, cardiopulmonary bypass Filter, blood, cardiopulmonary bypass, arterial line
QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (art. code HMO 70000/71000), K082117, manufactured by MAQUET Cardiopulmonary AG Quart Arterial Filter (art.code HBF 140), K001787 by MAQUET Cardiopulmonary AG and Capiox Fiber RX15 Hollow Oxygenator with/without Hardshell Reservoir with X-Coating from Terumo Cardiovascular Systems Corp., K051997
Device Description:
The QUADROX-i Small Adult is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.
1
MAQUET
The QUADROX-i Small Adult may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136).
Indications for Use:
The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/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 µm. The device's utilization period is limited to six hours. The oxygenator is suitable for the 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 Softline Coating is well comparable to the QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (art. code HMO 70000/71000), K082117, manufactured by MAQUET Cardiopulmonary AG regarding the design, principals of operation, biocompatibility and performance as well as regarding the Softline coating, the only difference is the size. It is also comparable to Capiox RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir with X-Coating from Terumo Cardiovascular Systems Corp., K051997, regarding intended use, as well as to the Quart Arterial Filter as related to the filter part.
Non-clinical Testing:
The QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating has been tested to and met the requirements of ISO 10993-1 Biologic Evaluation of Medical Devices as well as the requirements of ISO 7199: 1996 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators) as well as the requirements of ISO 15675: 2001 "Cardiovascular implants and artificial organs – Cardiopulmonary Bypass – Arterial line blood filters".
2
MAQUET
Determination of Substantial Equivalence
Testing and evaluation on safety and effectiveness was executed to demonstrate that the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating described in this submission is substantially equivalent to Capiox RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir with X-Coating from Terumo Cardiovascular Systems Corp., K051997, as related to the intended use, as well as to the Quart Arterial Filter (HBF 140), K001787, as related to the filter part.
It is also comparable to the QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (art. code HMO 70000/71000), K082117 regarding the constructional principle as well as the coating.
The following areas have been tested:
- Integrity
- Performance
- Biocompatibility
- Sterility
Conclusion
The data given demonstrate that the QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating is substantially equivalent to the named predicate devices which currently hold market clearance.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OCT 2 9 2009
Maquet Cardiopulmonary AG c/o Dr. Ingrid Richter Regulatory Affairs Manager Hechinger Strasse 38 D-72145 Hirringen Germany
Re: K090689
QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating Regulation Number: 21 CFR 870.4350 Regulation Name: Oxygenator, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DTZ Dated: October 16, 2009 Received: October 19, 2009
Dear Dr. Richter:
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 - Dr. Ingrid Richter
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/ResourcesforYou/Industry/default.htm.
Sincerely vours,
$\kappa/\omega$
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): K090689
QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating _
Indications for Use: .
The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/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 the 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.
Over-The-Counter Use Prescription Use × AND/OR (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)
K
tinyascular Devices
510(K) in.
09 0689
Page 1 of 1
(Posted November 13, 2003)
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