QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
Device Facts
| Record ID | K150267 |
|---|---|
| Device Name | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators |
| Applicant | Maquet Cardiopulmonary, AG |
| Product Code | DTZ · Cardiovascular |
| Decision Date | May 7, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4350 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood 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 µm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Device Story
Blood-gas exchanger with integrated heat exchanger and optional arterial filter; used in cardiac surgery with heart-lung machine. Inputs: venous blood from patient. Transformation: oxygenation, CO2 removal, and temperature regulation via membrane exchange; integrated screen filter removes air bubbles/particles >40µm. Outputs: oxygenated, temperature-regulated blood returned to patient. Operated by perfusionists/clinicians in OR. Modification replaces previous holding clamp design with combined glued/screwed connection for blood inlet/outlet connectors. Benefits: maintains physiological gas exchange and temperature during bypass; reduces gaseous emboli/particulates.
Clinical Evidence
No clinical data. Bench testing only, including stability, axial stability, crash testing, blood cell damage, blood/heat exchanger side integrity, and sterile packaging integrity.
Technological Characteristics
Membrane oxygenator with integrated heat exchanger and optional screen filter. Materials: unspecified. Principle: gas exchange via microporous membrane. Connectivity: none. Sterilization: not specified. Software: none.
Indications for Use
Indicated for patients undergoing cardiac surgery requiring extracorporeal circulation during cardiopulmonary bypass. Supports blood flow rates of 0.5–7 L/min (Adult) or 0.5–5 L/min (Small Adult).
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 / Small Adult with Holding Clamp and QUADROX-iD Adult with Holding Clamp (K132829)
Related Devices
- K090511 — QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 · Maquet Cardiopulmonary, AG · Jun 12, 2009
- K082117 — QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 · Maquet Cardiopulmonary, AG · Feb 18, 2009
- K180448 — INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter · Sorin Group Italia S.R.L. · Mar 15, 2018
- K093522 — QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C · Maquet Cardiopulmonary, AG · Dec 7, 2009
- K082403 — MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT · Gish Biomedical, Inc. · May 15, 2009
Submission Summary (Full Text)
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2015
Maquet Cardiopulmonary AG % Whitney Torning Director, Regulatory Affairs Maquet Cardiovascular 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K150267
Trade/Device Name: QUADROX-i Adult Oxygenator with and without integrated Arterial Filter OUADROX-i Small Adult Oxygenator with and without integrated Arterial Filter QUADROX-iD Adult Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR, DTM Dated: March 6, 2015 Received: March 9, 2015
Dear Whitney Torning:
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.
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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); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
M. A. Hillebrand
for
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): K150267
Device Name: QUADROX-i Adult Oxygenator with and without integrated Arterial Filter
Intended Use:
The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
The blood flow rate is defined from 0.5 – 7 I/min.
Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood 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 µm.
The device's utilization period is limited to six hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Prescription Use Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___
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# Indications for Use
510(k) Number (if known): K150267
Device Name: QUADROX-i Small Adult Oxygenator with and without integrated Arterial Filter
Intended Use:
The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
The blood flow rate is defined from 0.5 – 5 I/min.
Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates blood temperature.
The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm.
The device's utilization period is limited to six hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Prescription Use X Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___
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# Indications for Use
510(k) Number (if known): K150267
Device Name: QUADROX-iD Adult Oxygenator
Intended Use:
The membrane oxygenator QUADROX-iD Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
The blood flow rate is defined from 0.5 - 7 I/min.
Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates the blood temperature.
The device's utilization period is limited to six hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Prescription Use ____X__ Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___________________________________________________________________________________________________________________________________________________________________
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#### 510(k) Summary
Prepared in accordance with 21 CFR Part 807.92
#### GENERAL INFORMATION
| Submitter's name and address: | MAQUET Cardiopulmonary AG |
|-------------------------------|---------------------------|
| | Kehler Straße 31 |
| | D-76437 Rastatt |
| | Germany |
Contact person and telephone number:
Whitney Törning Director, Regulatory Affairs MAQUET Cardiovascular 45 Barbour Pond Drive Wayne, NJ 07470 USA
| Phone: | 973-709-7994 |
|----------------|----------------------------|
| Fax: | 973-807-9210 |
| Email: | whitney.torning@maquet.com |
| Date prepared: | February 3, 2015 |
#### DEVICE INFORMATION:
| Trade Name: | QUADROX-i Adult / Small Adult Oxygenators | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------|
| | | QUADROX-iD Adult Oxygenators, | |
| | Common/Generic Name: Oxygenator with and without integrated arterial filter | | |
| Classification Name: | Oxygenator, cardiopulmonary bypass, heat<br>exchanger, cardiopulmonary bypass, filter, blood<br>cardiopulmonary bypass, arterial line | | |
| Main product code: | | | |
| | Code of Federal Regulations: | | 21 CFR 870.4350 |
| | Product Code: | | DTZ |
| Sub product codes: | | | |
| | Code of Federal Regulations: | | 21 CFR 870.4240 |
| | Product Code: | DTR | |
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(only applicable for QUADROX-i Adult / Small Adult Oxygenators with integrated arterial filter):
21 CFR 870.4260 Code of Federal Requlations: Product Code: DTM
## PREDICATE DEVICE INFORMATION:
The modified QUADROX-i Adult / Small Adult and QUADROX-iD Adult Oxygenators are substantially equivalent in function and intended use to predicate QUADROX-i Adult / Small Adult with Holding Clamp and QUADROX-iD Adult with Holding Clamp (K132829).
### DEVICE DESCRIPTION:
The QUADROX-i Small Adult / Adult and QUADROX-iD Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter (only available for QUADROX-I Small Adult / Adult). They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature.
The integrated arterial filter is intended to filter out air bubbles and particles larger than 40µm. It is used for removing gaseous embolisms and aggregates from blood components from the arterial blood during extracorporeal circulation. It is a screen filter with pre-post-de-airing mechanic.
### INDICATIONS FOR USE:
### QUADROX-i Adult Microporous Membrane Oxygenator with and without integrated Arterial Filter
The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 I/min.
Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood 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 µm.
The device's utilization period is limited to six hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
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#### QUADROX-i Small Adult Microporous Membrane Oxygenator with and without integrated Arterial Filter
The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 l/min.
Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates blood temperature.
The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm.
The device's utilization period is limited to six hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
# QUADROX-iD Adult Diffusion Membrane Oxygenator
The membrane oxygenator QUADROX-iD Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 I/min.
Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates the blood temperature.
The device's utilization period is limited to six hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATES:
The modified QUADROX-i Adult / Small Adult and QUADROX-iD Adult Oxygenators are substantially equivalent to the predicate QUADROX-i Adult / Small Adult with Holding Clamp and QUADROX-iD Adult with Holding Clamp (K132829). The modification essentially consists of modifying the blood inlet and outlet side from an exclusively glued connection to a combined connection of gluing and screwing. The reason of the redesign of the bonding between housing and blood inlet / outlet connectors is to replace the Holding Clamp.
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#### MAQUET Cardiopulmonary AG
## NON-CLINICAL TESTS:
Performance testing has resulted in data that demonstrates that the modified QUADROX-i Adult / Small Adult and QUADROX-iD Adult Oxygenators perform within its specifications and within the acceptable limits of the applied performance standards. The following performance characteristics of the modified QUADROX-i Adult / Small Adult and QUADROX-iD Adult Oxygenators were extensively compared with the predicate devices to determine substantial equivalence:
- -Stability
- Stability axial -
- -Crash test
- -Blood Cell Damage
- Blood side integrity -
- Heat exchanger side integrity -
- Sterile packaging integrity -
## CLINICAL TESTS:
No clinical evaluation of the modified device was conducted or required.
# CONCLUSION:
Based upon the information submitted in this Special 510(k) premarket notification, MAQUET Cardiopulmonary's modified QUADROX-i Adult / Small Adult and QUADROX-iD Adult Oxygenators are substantially equivalent to the currently marketed QUADROX-i Adult / Small Adult with Holding Clamp and QUADROX-iD Adult with Holding Clamp (K132829). The modified Oxygenators are similar to the predicate device in the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness.
