QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA

K100278 · Maquet Cardiopulmonary, AG · DTZ · Apr 30, 2010 · Cardiovascular

Device Facts

• Record ID: K100278
• Device Name: QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTZ · Cardiovascular
• Decision Date: Apr 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Extracorporeal blood-gas exchanger with integrated heat exchanger; used in pediatric cardiopulmonary bypass. Device receives venous blood flow; performs gas exchange (oxygenation/CO2 removal) and temperature regulation via diffusion membrane; returns oxygenated blood to patient. Operated by perfusionists/clinicians in clinical settings. Downsized version of predicate QUADROX D; optimized for pediatric priming volumes and surface area requirements. BIOLINE coating applied to blood-contacting surfaces to improve biocompatibility. Clinical benefit: provides temporary respiratory and circulatory support during pediatric procedures.

Clinical Evidence

Bench testing only. Device evaluated for integrity, performance, biocompatibility, and sterility per ISO 10993-1 and ISO 7199 standards.

Technological Characteristics

Diffusion membrane oxygenator with integrated heat exchanger. Features BIOLINE coating. Designed for pediatric flow rates (0.2-2.8 L/min). Complies with ISO 7199 (blood-gas exchangers) and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for pediatric patients requiring extracorporeal perfusion support at blood flow rates between 0.2 and 2.8 L/min for a duration of up to six 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

• D101 KIDS Infant Hollow Fiber Membrane Oxygenator with phosphorylcholine coating (Ph.I.S.I.O. coating) (K072091)
• Quadrox D Diffusion Membrane Oxygenator with BIOLINE COATING (K071774)

Submission Summary (Full Text)

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K100278

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 AG<br>Hechinger Strasse 38<br>72145 Hirrlingen<br>Germany | APR 30 2010 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person | Katrin Schwenkglenks<br>Phone: [phone]<br>Fax: [phone] 8667 | |
| Date Prepared | January 29, 2010 | |
| Device Trade Name | QUADROX-iD Pediatric<br>Diffusion Membrane Oxygenator<br>with BIOLINE COATING | |
| Common/Usual Name | Oxygenator with integrated heat exchanger | |
| Classification Names | Cardiopulmonary bypass oxygenator<br>(21 CFR 870.4350 - Product Code: DTZ)<br>Cardiopulmonary bypass heat exchanger<br>(21 CFR 870.4240 - Product Code: DTR) | |
| Predicate Devices | D101 KIDS Infant Hollow Fiber Membrane<br>Oxygenator with phosphorylcholine coating<br>(Ph.I.S.I.O. coating), Sorin Group Italia S.r.l.<br>(K072091)<br><br>Quadrox D Diffusion Membrane Oxygenator with<br>BIOLINE COATING,<br>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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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 [phone] or [phone] 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)

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una D. V. Annes

ion Sign-Off) (Division Sign-Oll)
Division of Cardiovascular Devices

K100278 510(k) Number_