(131 days)
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.
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.
The provided text describes a 510(k) premarket notification for the QUADROX-i Pediatric Microporous Membrane Oxygenator, a medical device. However, it does not contain any information about acceptance criteria, device performance, or a study specifically designed to prove the device meets acceptance criteria.
The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons, and compliance with various ISO standards (ISO 10993-1, ISO 7199, ISO 15675) for aspects like biocompatibility and integral functionality.
Therefore, I cannot provide the requested information from the given text.
Here's a breakdown of why I cannot fulfill your request based on the provided document:
- Acceptance criteria and reported device performance: These are not mentioned in a table or discussed in detail. The document states that "The products met these requirements" for the ISO standards, but does not provide specific performance metrics or thresholds for acceptance.
- Sample size and data provenance: No information on sample sizes for testing or data provenance is provided.
- Number of experts and qualifications: No information on experts establishing ground truth is present.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned. The focus is on a standalone substantial equivalence claim.
- Standalone performance: While the device was tested to meet ISO standards, specific standalone performance data (beyond "met these requirements") is not provided.
- Type of ground truth: Not applicable in this context as no ground truth for diagnostic accuracy is being established. The testing seems to be for functional and safety compliance.
- Sample size for training set: Not applicable as this is not a machine learning device that requires a training set.
- Ground truth for training set: Not applicable.
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MAQUET GETINGE GROUP
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: +49 7478 921-151 +49 7478 921-400 Fax: E-mail: katrin.schwenkglenks@maquet-cp.com
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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
h R. hohmen
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
Page 1 of 1
§ 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.”