(71 days)
No
The document describes a passive medical device (oxygenator) that facilitates gas exchange through a membrane. There is no mention of any computational or algorithmic components, let alone AI/ML.
Yes.
The device is used to oxygenate blood and remove carbon dioxide, which directly treats the patient by supporting an essential physiological function during open-heart surgery.
No
The device is used for oxygenating blood and removing carbon dioxide during cardiopulmonary bypass, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical, sterile, single-use membrane oxygenator used in extracorporeal circulation, which is a hardware component.
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 open-heart surgery." This describes a device used outside the body to support physiological function during surgery, not a device used to test samples in vitro (in a lab setting).
- Device Description: The description details a "component in the extracorporeal perfusion circulation system, for oxygenation of blood and removal of carbon dioxide." This further reinforces its role in supporting the patient's circulation during surgery, not in performing diagnostic tests on samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a medical device used in vivo (within the living body, albeit extracorporeally) to perform a physiological function during surgery.
N/A
Intended Use / Indications for Use
The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
The Quadrox D Safeline 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 heartlung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Safeline 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 Safeline Diffusion Membrane Oxygenator is a model of the Quadrox Safeline Hollow Fiber Membrane Oxygenator. In contrast to the Quadrox, a tight diffusive membrane instead of a microporous membrane is used for the gas exchange.
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 diffusive membrane has the same outer diameter as the open-pored membrane. The outer diameters are 1.8 m² gas exchange surface and 0.6 m² heat exchanger surface available.
The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.
The complete construction, priming volume and the connections are the same for the Quadrox D Safeline as well as for the Quadrox Safeline Oxygenator.
It may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to Jostra Quadrox Safeline Oxygenator (K992559). The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator will be provided with a Jostra Manifold Sampling Line.
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)
The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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).
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): 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
K061628
Page 1 of 3
AUG 2 2 2006
MAQUET
510 (K) Summary [as required by 21 CFR 807.92(c) ]
| Submitter: | Maquet Cardiopulmonary AG
Hechinger Strasse 38
72145 Hirrlingen
Germany |
|-----------------------|--------------------------------------------------------------------------------------|
| Contact Person: | James Collie
Phone: 215-491-5245
Fax: 215-491-5942
E-mail: jrcollie@msn.com |
| Date Prepared: | June 09, 2006 |
| Device Trade Name: | Jostra Quadrox D Safeline Diffusion Membrane
Oxygenator |
| Common/Usual name: | Quadrox D |
| Classification names: | Oxygenator, cardiopulmonary bypass
Heat Exchanger, cardiopulmonary bypass |
| Predicate Devices: | Jostra Quadrox Safeline Hollow Fiber Membrane
Oxygenator (K992559, K030264) |
Device Description:
The Quadrox D Safeline 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 heartlung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Safeline 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
206/628
Page 2 of 3
MAQUET
The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is a model of the Quadrox Safeline Hollow Fiber Membrane Oxygenator. In contrast to the Quadrox, a tight diffusive membrane instead of a microporous membrane is used for the gas exchange.
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 diffusive membrane has the same outer diameter as the open-pored membrane. The outer diameters are 1.8 m² gas exchange surface and 0.6 m² heat exchanger surface available.
The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.
The complete construction, priming volume and the connections are the same for the Quadrox D Safeline as well as for the Quadrox Safeline Oxygenator.
It may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to Jostra Quadrox Safeline Oxygenator (K992559). The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator will be provided with a Jostra Manifold Sampling Line.
Indications for Use:
The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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.
Statement of Technical Comparison:
The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator has the same intended use, design, principals of operation, and performance as the Jostra Quadrox Safeline Oxygenator. The only difference is that the Jostra Quadrox D Safeline Diffusion Membrane Oxygenator uses a tight diffusive membrane instead of a microporous membrane for the gas exchange.
2
KC61628
Page 3 of 3
MAQUET
Non-clinical Testing:
The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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 Safeline Diffusion Membrane Oxygenator described in this submission is substantially equivalent to the Jostra Quadrox Safeline 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 Safeline Diffusion Membrane Oxygenator is substantially equivalent to the named predicate device which holds currently market clearance.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2006
Maquet Cardiopulmonary AG c/o Mr. James R. Collie J.R. Collie Associates, Inc. 414 Maryjoe Way Warrington, PA 18976
Re: K061628
Quadrox D Safeline Diffusion Membrane Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: August 7, 2006 Received: August 8, 2006
Dear Mr. Collie:
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 haft or bin 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. James R. Collie
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I DTC issuazes or our device complies with other requirements of the Act that I DA has made a detel masulations administered by other Federal agencies. You must of any I catal stutures and registments, including, but not limited to: registration and listing (21 comply with an the 10t 3 requirements)01); good manufacturing practice requirements as set CITY art 607); laboring (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This letter will anow you to begin mailioning of substantial equivalence of your device to a legally promatics notification: "The PDF interessification 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 If you desire specific at not 10. Jose (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Comphance as (21 transmit (21CFR Part 807.97). You may obtain Milsolalling of Yelerone to premainsnibilities under the Act from the Division of Small other general information on your response in its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Bram D. Zudkerman M
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): ____________________________________________________________________________________________________________________________________________________
Device Name: Jostra Quadrox D Safeline Diffusion Membrane Oxygenator_
Indications for Use:
The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator 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.
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)
(Division Sign-Off)
Division of card
510(k) Number K061625
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