(208 days)
No
The document describes a passive membrane oxygenator and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
The device is used for extracorporeal circulation during cardiopulmonary bypass to oxygenate blood and remove carbon dioxide, which directly supports and maintains vital physiological functions during open-heart surgery.
No
The device is an oxygenator used for extracorporeal circulation during cardiopulmonary bypass to oxygenate blood and remove carbon dioxide, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical oxygenator, a component in an extracorporeal perfusion system, and mentions materials, sterilization, and physical characteristics like a membrane.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "extracorporeal circulation during cardiopulmonary bypass in the field of openheart surgery." This describes a device used on the patient's blood outside the body for therapeutic purposes (oxygenation and CO2 removal), not for diagnostic testing of a sample.
- Device Description: The description reinforces its role as a component in an "extracorporeal perfusion circulation system" for oxygenating blood and removing carbon dioxide.
- Lack of Diagnostic Purpose: There is no mention of analyzing blood or other biological samples to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to modify the blood itself during surgery, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Membrane Oxygenator Jostra Quadrox D is used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours. The application and use of the oxygenator is the sole responsibility of the attending physician.
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.
Product codes
DTZ
Device Description
The Quadrox D Bioline is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.
In open heart surgery it is used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Bioline is therefore a component in the extracorporeal perfusion circulation system, for oxygenation of blood and removal of carbon dioxide. The utilization period of this device is restricted to six hours.
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different. The new device comes with a Bioline coating, the already cleared device comes with the Safeline Coating.
With this diffusive membrane the gas exchange takes place by diffusion through the membrane wall. This membrane has no pores, therefore a passover of air bubbles or plasma leakage is not possible.
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
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:
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline 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).
Determination of Substantial Equivalence
Testing and evaluation on safety and effectiveness was executed to demonstrate that the Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating described in this submission is substantially equivalent to the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator.
The following areas have been tested:
- Integrity
- Performance
- Stability of the Coating
- Biocompatibility
- Sterility
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
K071774 MAQUET
JAN 2 3 2008
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: | June 22, 2007 |
| Device Trade Name: | Jostra Quadrox D Diffusion Membrane
Oxygenator with Bioline Coating |
| Common/Usual name: | Quadrox D Bioline |
| Classification names: | Oxygenator, cardiopulmonary bypass
Heat Exchanger, cardiopulmonary bypass |
| Predicate Device: | Jostra Quadrox D Safeline Hollow Fiber
Membrane Oxygenator (K061628) |
Device Description:
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
:
The Quadrox D Bioline is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.
In open heart surgery it is used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Bioline is therefore a component in the extracorporeal perfusion circulation system, for oxygenation of blood and removal of carbon dioxide. The utilization period of this device is restricted to six hours.
1
MAQUET
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different. The new device comes with a Bioline coating, the already cleared device comes with the Safeline Coating.
With this diffusive membrane the gas exchange takes place by diffusion through the membrane wall. This membrane has no pores, therefore a passover of air bubbles or plasma leakage is not possible.
The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.
The Quadrox D Bioline may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to the Jostra Quadrox D Safeline (K061628).
Indications for Use:
The Membrane Oxygenator Jostra Quadrox D is used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours. The application and use of the oxygenator is the sole responsibility of the attending physician.
Statement of Technical Comparison:
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating has the same intended use, design, principals of operation, and performance as the Jostra Quadrox D Safeline Oxygenator. Only difference is that the new device comes with a Bioline coating, the already cleared device comes with the Safeline Coating.
Non-clinical Testing:
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline 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).
2
MAQUET
Determination of Substantial Equivalence
Testing and evaluation on safety and effectiveness was executed to demonstrate that the Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating described in this submission is substantially equivalent to the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator.
The following areas have been tested:
- Integrity
- Performance
- Stability of the Coating
- Biocompatibility
- Sterility
Conclusion
The data given demonstrate that the Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is substantially equivalent to the named predicate device which holds currently market clearance.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JAN 2 3 2008
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K071774
Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating Regulation Number: 21 CFR 870.43500 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: January 14, 2008 Received: January 18, 2008
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
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,
Dana R. bochner
ABram 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): ¸¼០ገ | 774
Device Name: Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating Coating ______________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is used for extracorporeal circulation during cardiopulmonary bypass in the field of openheart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.
The application and use of the oxygenator is the sole responsibility of the attending physician.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. Vales
Page 1 of 1
Division of Cardiovascular Devices
(Division Sign-Off
510(k) Number_K02) 774
(Posted November 13, 2003)
Confidential
033