(205 days)
No
The description focuses on the physical components and function of a membrane oxygenator, with no mention of AI or ML.
Yes
The device is described as a "blood-gas exchanger with integrated heat exchanger" and its intended use is to "oxygenate the blood, eliminate carbon dioxide and regulate blood temperature" during cardiopulmonary bypass, which are therapeutic interventions.
No
The device is an oxygenator used for extracorporeal circulation during cardiopulmonary bypass, which provides therapeutic support (oxygenates blood, eliminates carbon dioxide, regulates temperature) rather than diagnosing a condition.
No
The device description clearly states it is a blood-gas exchanger with integrated hardware components (heat exchanger, optional arterial blood filter). The performance studies also focus on the physical and biological properties of the device, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "extracorporeal circulation during cardiopulmonary bypass in cardiac surgery." It oxygenates blood, eliminates carbon dioxide, regulates temperature, and filters blood. These are all functions performed outside the body on blood that has been removed from the patient.
- Device Description: The description confirms it's a "blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter." This aligns with the intended use of processing blood externally.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. IVDs are specifically designed to provide information for diagnostic purposes.
Therefore, the Quadrox-i Adult is a medical device used for therapeutic support during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 to 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 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 Adult is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.
The Quadrox-i Adult may be marketed both as single product and premounted 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
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)
Non-clinical testing demonstrated that the Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating met the requirements of ISO 10993-1 Biologic Evaluation of Medical Devices, ISO 7199: 1996 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators)", and ISO 15675: 2001 "Cardiovascular implants and artificial organs -Cardiopulmonary Bypass - Arterial line blood filters".
Testing and evaluation focused on integrity, performance, biocompatibility, and sterility to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Kor 2117
FEB 1 8 2009
MAQUET
. 510 (K) Summary [as required by 21 CFR 807.92(c) ]
| Submitter: | Maquet Cardiopulmonary AG
Hechinger Strasse 38
72145 Hirrlingen
Germany |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Katrin Schwenkglenks
Phone: +49 7478 921-151
Fax: +49 7478 921-400
E-mail: katrin.schwenkglenks@maquet-cp.com |
| Date Prepared: | July 18, 2008 |
| Device Trade Name: | Quadrox-i Adult Microporous Membrane
Oxygenator with and without Integrated Arterial
Filter with Softline Coating |
| Common/Usual name: | Oxygenator with integrated heat exchanger and
optional integrated arterial filter |
| Classification names: | Oxygenator, cardiopulmonary bypass
Heat Exchanger, cardiopulmonary bypass
Filter, blood, cardiopulmonary bypass, arterial line |
| Predicate Devices: | Quadrox Hollow Fiber Membrane Oxygenator with
Safeline Coating (art.code HMO 2030), K030264,
Quart Arterial Filter (art.code HBF 140), K001787
by Maquet Cardiopulmonary AG and
Synthesis Ph.I.S.I.O. Adult Membrane Oxygenator
With Integrated Arterial Filter with Ph.I.S.I.O.
Coating by Sorin Group Italia S.r.l., K073380. |
Device Description:
The Quadrox-i Adult is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.
The Quadrox-i Adult may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136).
1
MAQUET
Indications for Use:
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range. the device oxygenates the blood, eliminates carbon dioxide and requlates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 mm 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 Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating is well comparable to the Quadrox Hollow Fiber Membrane Oxygenator with Safeline Coating regarding the intended use. design, principals of operation, biocompatibility and performance as related to the oxygenator and heat exchanger part, as well as to the Quart Arterial Filter as related to the filter part. The Softline Coating is a biopassive coating comparable to other coatings on the market, as e.g. the Ph.I.S.I.O. Coating by the Sorin Group Italia S.r.I.
Non-clinical Testing
The Quadrox-i 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 ાડવ 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 Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating described in this submission is substantially equivalent to the Quadrox Hollow Fiber Membrane Oxygenator with Safeline Coating as well as to the Quart Arterial Filter with regards to the filter function.
The following areas have been tested:
- Integrity -
- Performance
- Biocompatibility
- Sterility
Conclusion
The data given demonstrate that the Quadrox-i 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the HHS emblem, which is a stylized depiction of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2009
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K082117
Quadrox-i Adult Microporous Membrane Oxygenatotor with and without Integrated Arterial Filter with Softline Coating
Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator
Regulatory Class: Class II (two)
Product Code: DTZ
Dated: February 12, 2009
Received: February 17, 2009
Dear Ms. Schwenkglenks:
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.
4
Page 2 - Ms. Katrin Schwenkglenks
Enclosure.
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 yours.
buna R. Laches
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices
Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): K082)17
Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating _
Indications for Use:
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood المهابة 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 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.
Prescription Use Over-The-Counter Use X 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)
Duna R. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number: K082117
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(Posted November 13, 2003)