QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING

K103191 · Maquet Cardiopulmonary, AG · DTZ · Mar 8, 2011 · Cardiovascular

Device Facts

• Record ID: K103191
• Device Name: QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTZ · Cardiovascular
• Decision Date: Mar 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The membrane oxygenator QUADROX-i Pediatric is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 2.8 l/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 QUADROX-i Pediatric (HMO 31000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um. The utilization period of this device is restricted to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

Device Story

The QUADROX-i Pediatric is a microporous membrane oxygenator with an integrated heat exchanger and optional arterial filter. It processes blood during extracorporeal circulation in pediatric cardiac surgery. The device receives venous blood, facilitates gas exchange (oxygenation and CO2 removal) across a membrane, regulates blood temperature via the heat exchanger, and optionally filters air bubbles and particles (>33 um) via a woven arterial filter. It is operated by perfusionists or surgeons in an OR setting. The device provides real-time blood gas and temperature management, supporting the patient's physiological needs during bypass. It is a single-use, sterile, non-pyrogenic device with a 6-hour usage limit.

Clinical Evidence

Bench testing only. Evaluation included integrity, performance, biocompatibility, and sterility testing in accordance with ISO 10993-1, ISO 7199, and ISO 15675. No clinical data presented.

Technological Characteristics

Microporous membrane oxygenator with integrated heat exchanger and optional 33-micron woven arterial filter. Effective gas exchange surface: 0.8 m²; heat exchanger surface: 0.15 m². Priming volume: 81 ml (standard) or 99 ml (with filter). Blood-contacting surfaces feature SOFTLINE or BIOLINE coatings. Sterile, single-use, non-pyrogenic. Complies with ISO 10993-1, ISO 7199, and ISO 15675.

Indications for Use

Indicated for pediatric patients undergoing cardiopulmonary bypass during cardiac surgery requiring extracorporeal circulation at blood flow rates of 0.2-2.8 l/min. Provides blood oxygenation, CO2 removal, and temperature regulation; models with integrated arterial filter provide filtration of air bubbles and particles >33 um. Restricted to 6-hour use.

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 Oxygenator with Ph.I.S.I.O. Coating (K072091)
• Capiox Arterial Filter, CX*AF02 (K943917)
• QUADROX-i Adult microporous membrane oxygenator with and without integrated arterial filter with SOFTLINE coating (K082117)
• QUADROX-i Adult Microporous Membrane Oxygenator with and without Arterial Filter with Bioline Coating (K090511)
• QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating (K100278)
• Medos Hilite Hollow Fiber Oxygenator, model 2800 LT (K090450)

Submission Summary (Full Text)

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MAQUET GETINGE GROUP

K103191

MAR - 8 2011

# 510 (K) Summary [as required by 21 CFR 807.92(c) ]

MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germany

Contact Person: Katrin Schwenkglenks Phone: [phone] [phone] Fax: E-mail: [e-mail]

Date Prepared:

Submitter:

October 22, 2010

Device Trade Name:

QUADROX-i Pediatric Microporous Membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE Coating and with BIOLINE Coating

Common/Usual name: Oxygenator with integrated heat exchanger and optional integrated arterial filter

Classification names:

Oxygenator, cardiopulmonary bypass Heat Exchanger, cardiopulmonary bypass Filter, blood, cardiopulmonary bypass, arterial line

Predicate Devices:

D101 KIDS Infant Hollow Eiber Oxygenator with Ph.J.S.I.O. Coating, Sorin Group Italia S.R.L., K072091,

Capiox Arterial Filter, CX*AF02, Terumo Cardiovascular Systems Corp., K943917,

QUADROX-i Adult microporous membrane oxygenator with and without integrated arterial filter with SOFTLINE coating, MAQUET Cardiopulmonary AG, K082117,

QUADROX-i Adult Microporous Membrane Oxygenator with and without Arterial Filter with Bioline Coating, MAQUET Cardiopulmonary AG, K090511,

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Image /page/1/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 logo is in black and white.

QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating, MAQUET Cardiopulmonary AG, K100278 .

Medos Hilite Hollow Fiber Oxygenator, model 2800 LT, Gish Biomedical Inc., K090450

#### Device Description:

The QUADROX-i Pediatric Oxygenator is a blood-gas exchanger with integrated heat exchanger and optional integrated arterial filter, intended for the treatment of pediatric patients (children). The Oxygenator is designed for a blood flow range from 0.2 to 2.8 I/min. Since these patients have a very small blood volume of their own, the small priming volume of the oxygenator is an important parameter. The priming volume is 81 ml for the version without integrated arterial filter. The version with integrated arterial filter has a priming volume of 99 ml.

The effective gas exchange surface is 0.8 m²; the one for the heat exchanger is 0.15 m². The integrated arterial filter is composed of a planar area from a woven 33 micron filter. The filter surface is 55 cm2.

The blood contacting surfaces are coated with SOFTLINE coating or with BIOLINE Coating.

The QUADROX-i Pediatric oxygenator is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.

#### Indications for Use:

The membrane oxygenator QUADROX-i Pediatric is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 2.8 l/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 requlates the blood temperature.

The QUADROX-i Pediatric (HMO 31000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um.

The utilization period of this device is restricted to six hours.

Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

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#### Statement of Technical Comparison:

QUADROX-i Pediatric Microporous Membrane The Oxygenator ાં ક comparable to the QUADROX-i Adult Microporous Membrane Oxygenator regarding the design principles, biocompatibility and sterility process. Both products come with and without an Integrated Arterial Filter with Softline Coating. The Softline Coating and the BIOLINE Coating are the same coatings contained in the QUADROX-i Adult Oxygenator.

#### Non-clinical Testing:

The QUADROX-i Pediatric Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating and with BIOLINE Coating have been tested or evaluated for compliance to ISO 10993-1 Biologic Evaluation of Medical Devices, ISO 7199 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators) as well as the requirements of ISO 15675 "Cardiovascular implants and artificial organs -Cardiopulmonary Bypass - Arterial line blood filters". The products met these requirements.

#### Determination of Substantial Equivalence

Testing and evaluation on safety and effectiveness was conducted to demonstrate that the QUADROX-i Pediatric Microporous Membrane Oxygenator with and without Integrated Arterial Filter with SOFTLINE Coating and BIOLINE Coating is substantially equivalent to the D101 KIDS Infant Hollow Fiber Oxygenator with Ph.I.S.I.O. Coating from Sorin as well as to the Capiox Arterial Filter, CX*AF02 from Terumo.

The following areas have been tested or evaluated:

- Indications for Use
- Integrity
- Performance
- Biocompatibility
- Sterility .

#### Conclusion

The data given demonstrate that the QUADROX-i Pediatric Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating and with BIOLINE Coating is substantially equivalent to the named predicate devices which currently hold market clearance.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 emblem featuring a stylized eagle or bird-like figure with three curved lines representing its wings or feathers. The emblem is black, and the text is also in black against a white background.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Hechinger Strasse 38 D-72145 Hirrlingen, Germany

## MAR - 8 2011

Re: K103191

Trade/Device Name: QUADROX-i Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with SOFTLINE COATING (HMO 31000), QUADROX-i Pediatric Microporous Membrane Oxygenator with SOFTLINE COATING (HMO 30000), QUADROX-i Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with BIOLINE COATING (BE-HMO 31000, BEQ-HMO 31000), and Artonal Price Microporous Membrane Oxygenator with BIOLINE COATING (BEQ-HMO 30000, BE-HMO 30000) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: II Product Code: DTZ, DTR, DTM Dated: February 21, 2011

Received: February 24, 2011

Dear Ms. Schwenkglenks:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosure) to regally the Medical Device Amendments, or to commerce pror to May 20, 1977, 1978, in accordance with the provisions of the Federal Food, Drug, devices mat have been require approval of a premarket approval application (PMA). alle Costience Act (710) that do not require to the general controls provisions of the Act. The r ou may, merciors, manter att a Act include requirements for annual registration, listing of general controls provinces of the ling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Tease note: ODTET doss not be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 above) institute major regulations affecting your device can be may be subject to additional controls: "Intering and one" - "
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I casia. Registerning your device in the Federal Register.

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#### Page 2 - Ms. Katrin Schwenkglenks

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 (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h R. hohmen

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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):

### Device Name: QUADROX-i Pediatric Microporous Membrane Oxygenator with and without integrated Arterial Filter

Indications for Use:

The membrane oxygenator QUADROX-i Pediatric is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It 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 QUADROX-i Pediatric (HMO 31000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um.

The utilization period of 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)

s R.V. Aumer

on Sign-Off (Division Sigm-Sign-Silver Devices

510(k) Number KID 21 Ju

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