(88 days)
The diffusion membrane oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The utilization period for this device is restricted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING is a blood-gas exchanger with integrated heat exchanger. It is a sterile and non-pyrogenic medical device which is intended for the treatment of pediatric patients.
The provided document is a 510(k) summary for a medical device (QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific clinical acceptance criteria through a study as might be done for a novel AI device or a device requiring a PMA.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/imaging devices, is not present in this document.
However, I can provide information about the non-clinical testing performed as described in the document.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported performance values in a table. It states that the device was tested to and met the requirements of certain ISO standards.
| Testing Area | Standard/Requirement Met |
|---|---|
| Biocompatibility | ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing |
| Performance | ISO 7199 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) |
| Integrity | Implied to meet safety and effectiveness standards, likely covered by ISO 7199 and internal tests. |
| Sterility | Implied to meet safety and effectiveness standards, likely covered by ISO 10993 and internal tests. |
| Overall | Substantial Equivalence to predicate devices (K072091, K071774) demonstrated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device clearance based on substantial equivalence, not a clinical study on human data with a test set in the traditional sense of AI/diagnostic device validation. The testing referred to is non-clinical (laboratory/bench testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a test set is not a concept relevant to this 510(k) submission, which relies on engineering and biological safety testing against established standards and comparisons to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" relates to compliance with engineering specifications, material properties, and performance against established international standards (ISO 10993-1, ISO 7199), rather than a diagnostic 'ground truth.'
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device's submission.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for Maquet Getinge Group. The word "MAQUET" is in large, bold, sans-serif font on the top line. Below that, "GETINGE GROUP" is in a smaller, sans-serif font.
510(k) Summary
[as required by 21 CFR 807.92(c)]
| Submitter | MAQUET Cardiopulmonary AGHechinger Strasse 3872145 HirrlingenGermany | APR 30 2010 |
|---|---|---|
| Contact Person | Katrin SchwenkglenksPhone: 011 49 7478 921 151Fax: 011 49 7478 921 8667 | |
| Date Prepared | January 29, 2010 | |
| Device Trade Name | QUADROX-iD PediatricDiffusion Membrane Oxygenatorwith BIOLINE COATING | |
| Common/Usual Name | Oxygenator with integrated heat exchanger | |
| Classification Names | Cardiopulmonary bypass oxygenator(21 CFR 870.4350 - Product Code: DTZ)Cardiopulmonary bypass heat exchanger(21 CFR 870.4240 - Product Code: DTR) | |
| Predicate Devices | D101 KIDS Infant Hollow Fiber MembraneOxygenator with phosphorylcholine coating(Ph.I.S.I.O. coating), Sorin Group Italia S.r.l.(K072091)Quadrox D Diffusion Membrane Oxygenator withBIOLINE COATING,MAQUET Cardiopulmonary AG (K071774) |
Device Description
The QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING is a blood-gas exchanger with integrated heat exchanger. It is a sterile and non-pyrogenic medical device which is intended for the treatment of pediatric patients.
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MAQUET GETINGE GROUP
Indications for Use
The diffusion membrane oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The utilization period for this device is restricted to six hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Statement of Technical Comparison
The QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING is comparable to the QUADROX D Diffusion Membrane Oxygenator with BIOLINE COATING (art. code BE-HMOD 2000, BEQ-HMOD 2030) from MAQUET Cardiopulmonary AG, K071774, regarding the design, principals of operation, biocompatibility and performance as well as regarding the BIOLINE Coating. The main difference is the size of the oxygenator. The basic elements were downsized to fit the needs of pediatric patients. Thereby priority is given to the preservation of the approved functionality of the oxygenator and to the acquirement of new advantages regarding priming volume, foreign surface and pressure force.
The QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING is also comparable to the D101 Kids Infant Hollow Fiber Oxygenator with Ph.I.S.I.O. Coating, Sorin Group Italia S.r.I., K072091, regarding performance and indications for use.
Non-clinical Testing
The QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING has been tested to and met the requirements of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing as well as the requirements of ISO 7199 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
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MAQUET GETINGE GROUP
Determination of Substantial Equivalence
Evaluation and testing on safety and effectiveness was executed to demonstrate that the QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING described in this submission is substantially equivalent to the QUADROX D Diffusion Membrane Oxygenator with BIOLINE COATING from MAQUET Cardiopulmonary AG (K071774) and to the D101 KIDS Infant Hollow Fiber Membrane Oxygenator with Ph.I.S.I.O. coating from Sorin Group Italia S.r.I. (K072091).
The following areas have been tested and / or evaluated:
- Integrity ・
- Performance -
- Biocompatibility -
- Sterility .
Conclusion
The data given demonstrate that the QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING is substantially equivalent to the named predicate devices which hold currently market clearance.
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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" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its head facing left and its wings stylized in a flowing, curved design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 3 0 2010
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strabe 38 D-72145 Hirrlingen, Germany
Re: K100278
Trade/Device Name: Quadrox-iD Pediatric Diffusion Membrane Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: January 29, 2010 Received: February 1, 2010
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 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. 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
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Page 2 – Ms. Katrin Schwenkglenks
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 (OS) 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 yours,
Duna D. bodner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K | 0 0 278
Device Name:
QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE COATING
Indications for Use:
The diffusion membrane oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 -- 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature.
The utilization period for this device is restricted to six hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1 of 1
una D. V. Annes
ion Sign-Off) (Division Sign-Oll)
Division of Cardiovascular Devices
K100278 510(k) Number_
§ 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.”