QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
Device Facts
| Record ID | K101153 |
|---|---|
| Device Name | QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD |
| Applicant | Maquet Cardiopulmonary, AG |
| Product Code | DTZ · Cardiovascular |
| Decision Date | Dec 8, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4350 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The QUADROX-iD Adult diffusion membrane oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Device Story
Blood-gas exchanger with integrated heat exchanger; used in extracorporeal circulation during cardiac surgery. Device oxygenates blood, removes carbon dioxide, and regulates blood temperature within specified flow rates. Operated by perfusionists or surgeons in clinical settings. Diffusive membrane technology facilitates gas exchange. Benefits include temporary respiratory and thermal support during bypass procedures. Application limited to 6 hours.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included integrity, performance, biocompatibility, and sterility evaluations per ISO 10993-1 and ISO 7199 standards.
Technological Characteristics
Blood-gas exchanger with integrated heat exchanger. Features diffusive oxygenation membrane. Biocompatible coatings (BIOLINE or SOFTLINE). Complies with ISO 10993-1 (biocompatibility) and ISO 7199 (blood-gas exchangers).
Indications for Use
Indicated for adult patients undergoing cardiac surgery requiring extracorporeal circulation during cardiopulmonary bypass for up to 6 hours.
Regulatory Classification
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.
Special Controls
*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.”
Predicate Devices
- QUADROX-i Adult microporous membrane Oxygenator with SOFTLINE Coating (K082117)
- QUADROX-i Adult microporous membrane Oxygenator with BIOLINE Coating (K090511)
- QUADROX-D diffusion membrane oxygenator with SAFELINE Coating (K061628)
- QUADROX-D diffusion membrane oxygenator with BIOLINE Coating (K071774)
Related Devices
- K082117 — QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 · Maquet Cardiopulmonary, AG · Feb 18, 2009
- K143073 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface · Medtronic, Inc. · Mar 25, 2015
- K954850 — BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR · C.R. Bard, Inc. · Oct 30, 1996
- K022115 — CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR · Terumo Corp. · Sep 27, 2002
- K202206 — AMG PMP Pediatric · Eurosets S.R.L · Apr 1, 2021
Submission Summary (Full Text)
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MAQUET
GETINGE GROUP
101123
· DEC - 8 2010
## 510(k) Summarv
[as required by 21 CFR 807.92(c)]
Submitter
MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germany
Contact Person
Katrin Schwenkglenks Phone: 011 49 7478 921 151 Fax: 011 49 7478 921 8667
Date Prepared
April 19, 2010
Device Trade Name
QUADROX-iD Adult diffusion membrane oxygenator with BIOLINE Coating and with SOFTLINE Coating
Common/Usual Name
Classification Names
Oxygenator with integrated heat exchanger
Cardiopulmonary bypass oxygenator (21 CFR 870.4350 - Product Code: DTZ) Cardiopulmonary bypass heat exchanger (21 CFR 870.4240 - Product Code: DTR)
Legally Marketed Devices
QUADROX-i Adult microporous membrane Oxygenator with SOFTLINE Coating (K082117),
QUADROX-i Adult microporous membrane Oxygenator with BIOLINE Coating (K090511), QUADROX-D diffusion membrane oxygenator with SAFELINE Coating (K061628) and with BIOLINE Coating (K071774).
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### Device Description
The QUADROX-iD Adult diffusion membrane oxygenator with BIOLINE Coating and with SOFTLINE Coating is a blood-gas exchanger with integrated heat exchanger.
#### Indications for Use
The QUADROX-iD Adult diffusion membrane oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
#### Statement of Technical Comparison
The QUADROX-iD Adult diffusion membrane oxygenator with BIOLINE Coating and with SOFTLINE Coating is comparable to the QUADROX-i Adult micropyrons membrane oxygenator with BIOLINE Coating and with Softline Coating with the only exception that the QUADROX-iD Adult diffusion membrane oxygenator has a diffusive oxygenation membrane instead of a microporous oxygenation membrane. However, the diffusion membrane is the same as with the QUADROX-D diffiusion membrane oxygenator. Besides this difference the QUADROX iD Adult diffusion membrane oxygenator with SOFTLINE Coating and with BIOLINE Coating is comparable in design, method of operation, components, packaging, and fundamental scientific technology as compared to the QUADROX, Adult microporous membrane oxygenator with Softline Coating and with BIOLINE Coating.
#### Non-clinical Testing
The QUADROX-iD Adult Diffusion Membrane Oxygenator with BIOLINE COATING and SOFLTINE Coating has been tested to and met the requirements of ISO 10993-1 Biological evaluation of medical devices · Padt 1: Evaluation and testing as well as the requirements of ISO 7199 Cardiovascular implants and artificial organs - Bloodgas exchangers (oxygenators).
#### Determination of Substantial Equivalence
Evaluation and testing on safety and effectiveness was executed to demonstrate that the QUADROX-ID Adult diffusion membrane oxygenator with SOFTLINE Coating and with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Adult microporous membrane Oxygenator with Softline Coating and with BIOLINE Coating.
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Image /page/2/Picture/0 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.
The following areas have been tested and / or evaluated:
- Integrity .
- Performance .
.
- Biocompatibility -
.
- . Sterility
#### Conclusion
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The data given demonstrate that the QUADROX-iD Adult diffusion membrane oxygenator with SOFLTINE Coating and with BIOLINE Coating is substantially equivalent to the named predicate devices which currently hold market clearance.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue i Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Hechinger Straße 38 D-72145 Hirrlingen, Germany
## DEC - 8 2010
Re: K101153
Trade/Device Name: QUADROX-iD Adult diffusion membrane oxygenator with BIOLINE Coating, art. codes: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA; and QUADROX-iD Adult diffusion membrane oxygenator with SOFTLINE Coating, art. codes: HMOD 70000-USA
Regulation Number: 21 CFR 870.4350
Regulation Name: Cardiopulmonary bypass oxygenator
Regulatory Class: II
Product Code: DTZ, DTR
Dated: November 30, 2010
Received: December 2, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Katrin Schwenkglenks
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
smma R.V.hmn
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
DEC - 8 2010
510(k) Number (if known): _ K10 |153
Device Name: QUADROX-iD Adult diffusion membrane oxygenator with BIOLINE Coating and with SOFTLINE Coating
Indications for Use:
The QUADROX-iD Adult diffusion membrane oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
DMAR R. Vic/m
(Division Sign-Off)
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Division of Cardiovascular Devices
510(k) Number k101153
