QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS by MAQUET CARDIOPULMONARY AG

The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide 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 um. The device's utilization period is limited to six hours.

The membrane oxygenator QUADROX-i Small Adult is intended for the 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 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 um. The device's utilization period is limited to six hours.

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.

The membrane oxygenator QUADROX-i Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 1.5 Vmin 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 Neonatal (HMO 11000) 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.

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.

The Diffusion Membrane Oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. 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 dicxide and regulates the blood temperature. The utilization period for this device is restricted to six hours.

Device Description

The only modification consists of adding a reusable stainless steel holding clamp as an interim protective safeguard / corrective action to prevent the inlet and/or outlet connector from disconnection. The holding clamp is applied by the perfusionist prior to use. The holding clamp is applicable to all QUADROX-i / -iD oxygenators which are subject to this submission.

AI/ML Overview

The given submission (K132829) is a Special 510(k) for a device modification of existing MAQUET oxygenators. The modification consists of adding a reusable stainless steel holding clamp. Due to the nature of this submission (a device modification for an existing, already cleared device), the study design and acceptance criteria differ significantly from submissions for novel AI/ML devices or diagnostic tools.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Holding Forces (Clamp in place)	The clamp will stay in place during its use, preventing disconnection of inlet/outlet connectors if bonding fails.	Demonstrated that the clamp can be mounted on the Oxygenator and will stay in place, preventing connector detachment even if the bonding to the housing fails.
Pull-off Forces (Clamp removal)	The clamp should not be easily removed by forces perpendicular to the clamping force, yet allow for intentional removal. (Implied, as the purpose is to "hold the clamp in place" and prevent accidental detachment).	No specific numerical performance is provided, but the document states these tests confirm the secure attachment.
Vibration Test with Shaker (up to 3G)	Secure attachment of the clamp under repeated impact forces of up to 3G.	Confirmed the secure attachment of the clamp under repeated impact forces up to 3G.
Vibration Test with Roller Pumps	Simulate influence of repeated tubing motions without compromising clamp security.	No specific numerical performance is provided, but these tests were relevant for QUADROX-i/iD products to simulate the influence of repeated motions of the tubing. (Implied successful simulation and secure attachment).
Leakage Test with Reduction Adapter	The clamp can be used with pediatric/neonatal reduction adapters (09844-s) without causing leakage or compromising their function.	Confirmed that the clamp can be used with the pediatric/neonatal reduction adapters. (Implied no leakage or functional compromise).
Usability Test (mounting the clamp)	The clamp can be mounted using the Instruction for Use. (Implied ease of use and clarity of instructions for perfusionists).	Evaluated as to whether the clamp could be mounted using the Instruction for Use. (Implied successful mounting and usability).

2. Sample Size for Test Set and Data Provenance:

The document describes non-clinical mechanical and usability tests for the holding clamp. This is not a study involving human subjects or medical data in the traditional sense of AI/ML device testing.
Sample Size: The specific number of clamps or oxygenators tested for each mechanical test is not provided in detail. The usability test was performed in "three hospitals," but the number of perfusionists or units tested within those hospitals is not specified.
Data Provenance: The tests were conducted by the manufacturer, MAQUET Cardiopulmonary AG. The country of origin for the data is implicitly Germany (headquarters of submitter) or potentially associated testing facilities. These are prospective tests performed specifically to support this regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This is not applicable in the context of this submission. "Ground truth" in the sense of expert consensus on medical images or patient outcomes is not relevant here.
For the Usability Test, "perfusionists" were involved. While not explicitly defined as "experts" establishing a "ground truth," their feedback on the ability to mount the clamp according to instructions serves as a form of expert user validation for a usability aspect. Their specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set:

Not applicable as there is no "test set" in the context of expert review of data for a diagnostic or prognostic decision. The non-clinical tests have pass/fail criteria based on engineering and safety standards, not expert adjudication. The usability test likely involved qualitative feedback or direct observation, but no formal adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or screening devices where the performance of human readers with and without AI assistance is compared. The device in this submission (a mechanical holding clamp for an oxygenator) does not involve human readers interpreting medical data or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, this is not applicable. The device is a mechanical accessory, not an algorithm. The "performance" is its mechanical function and usability, which is inherently tied to human interaction (mounting by a perfusionist) but does not involve an AI algorithm operating independently.

7. The Type of Ground Truth Used:

For the mechanical tests (Holding Forces, Pull-off Forces, Vibration Tests, Leakage Test): The "ground truth" is derived from predefined engineering specifications, safety requirements, and risk assessment. The tests are designed to demonstrate that the clamp maintains structural integrity, remains securely attached, and does not compromise the primary function or safety of the oxygenator under simulated use conditions.
For the Usability Test: The "ground truth" is the successful and correct mounting of the clamp by perfusionists following the provided Instructions for Use.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set in the conventional sense. The "training" for such a device would be its engineering design and iterative development, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML algorithm. The design and manufacturing processes of medical devices inherently follow quality management systems and engineering principles, but this is distinct from establishing ground truth for machine learning.

Summary

{0}------------------------------------------------

MAQUET Cardiopulmonary AG

Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-i, QUADROX-iD

510 (k) Summary [As required by 21 CFR 807.92(c)]

Date:	September 06th, 2013
Submitter:	MAQUET Cardiopulmonary AGKehler Straße 3176437 RastattGermany
Contact Person:	Whitney TörningDirector of RegulatoryMAQUET Cardiovascular45 Barbour Pond DriveWayne, NJ 07470Phone: 973-709-7994Fax: 973-807-9210OCT 08 2013
Device Trade Names:	QUADROX-i Adult / Small Adult / Pediatric / NeonatalMicroporous Membrane Oxygenators, with and w/ofilter;QUADROX-iD Adult Diffusion Membrane Oxygenatorswith and w/o filter;QUADROX-iD Pediatric Diffusion MembraneOxygenators, w/o filter
Common/Usual name:	Oxygenator with and without integrated arterial filter
Classification Name:	Oxygenator, cardiopulmonary bypass, heat exchanger,cardiopulmonary bypass, filter, blood cardiopulmonarybypass, arterial line, non-roller type blood pump,cardiopulmonary bypass.

{1}------------------------------------------------

Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-i, QUADROX-iD

Device Modification

Legally marketed MAQUET Predicate Devices:

QUADROX-i Adult Microporous Membrane Oxygenators K082117 & K090511; QUADROX-i Small Adult Microporous Membrane Oxygenators K090689 & K093522, QUADROX-i Pediatric Microporous Membrane Oxygenator K103191, QUADROX-i Neonatal Microporous Membrane Oxygenator K102464, QUADROXiD Adult Diffusion Membrane Oxygenator K101153, QUADROX-iD Pediatric Diffusion Membrane Oxygenator K100278

Device Description:

Holding Clamp - Interim protective safequard and component of the QUADROX-i / -iD

The holding clamp is applicable to all QUADROX-i / -iD oxygenators which are subject to this submission. The following table provides an overview of the holding clamps suitable for QUADROX-i / -iD Oxygenator models.

{2}------------------------------------------------

Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-i, QUADROX-iD

Catalogue number	Holding clamp - picture	suitable for*
HKH 3570	Image: Holding clamp	HMO 71000 USA - Quadrox i Adult with filterHMO 70000 USA - Quadrox i Adult w/o filterHMO 51000 USA - Quadrox i Small Adult with filterHMO 50000 USA - Quadrox i Small Adult w/o filterHMOD 71000 USA - Quadrox iD Adult with filterHMOD 70000 USA - Quadrox iD Adult w/o filter
HKH 3571	Image: Holding clamp	HMO 30000 USA - Quadrox i pediatric w/o filterHMO 31000 USA- Quadrox i pediatric with filterHMO 10000 USA - Quadrox i neonatal w/o filterHMO 11000 USA - Quadrox i neonatal with filterHMOD 30000 USA - Quadrox iD pediatric w/o filter

The above listed devices refer to the QUADROX-i / - iD Oxygenator models which may also be provided with BIOLINE Coating and may be sold in combination with other devices as described in the original 510(k) of each device.

The following picture shows exemplarily the holding clamp in combination with the QUADROX-i Oxygenator:

Image /page/2/Picture/7 description: The image shows a piece of industrial equipment. The equipment is made of metal and has a cylindrical shape. There are several pipes and valves attached to the equipment. The equipment appears to be used for processing or storing liquids or gases. The image is a black and white photograph.

QUADROX-i Adult Microporous Membrane Oxygenator with and without integrated Arterial Filter

{3}------------------------------------------------

. →

Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-i, QUADROX-iD

regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. 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-i Small Adult Microporous Membrane Oxygenator with and without integrated Arterial Filter

The membrane oxygenator QUADROX-i Small Adult is intended for the 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 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-i Pediatric Microporous Membrane Oxygenator with and without integrated Arterial Filter

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.

QUADROX-1 Neonatal Microporous Membrane Oxygenator with and without integrated Arterial Filter

{4}------------------------------------------------

Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-i, QUADROX-iD

pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature.

The QUADROX-i Neonatal (HMO 11000) 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.

QUADROX-iD Adult Diffusion Membrane Oxygenator

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

QUADROX-iD Pediatric Diffusion Membrane Oxygenator

The Diffusion Membrane Oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. 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 dicxide 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.

{5}------------------------------------------------

Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-i, QUADROX-iD

Technological Characteristics:

The modified devices as mentioned above are identical to the originally cleared devices, with the exception that an added reusable stainless steel holding clamp is applied by the perfusionist prior to use as an interim protective safeguard in the unlikely event that the inlet and/or outlet connector would become loose. Besides this difference, the proposed devices are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as the predicate devices.

Non-clinical Tests:

The modified devices were subjected to design verification tests which are based on the risk assessment. The tests are designed to show that the clamp can be mounted on the Oxygenator, so that the clamp will stay in place during its use, and in the unlikely event that the bonding of the connectors to the housing would fail the connector would not detach from the housing.

The tests simulate relevant mechanical conditions in the use of the Oxygenators. The following mechanical tests were performed:

{6}------------------------------------------------

Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-i, QUADROX-iD

Holding Forces Force applied to the connectors to hold the clamp in ﮯ place
Pull off Forces Force to remove the holding clamp from the housing : perpendicular to the clamping force.
. Vibration Test with Shaker - Simulate impact forces up to 3G and confirm the secure attachment of the clamp under repeated impact.
Vibration Test with Roller Pumps Relevant for QUADROX-i / iD products ﺑﺎ to simulate the influence of repeated motions of the tubing.
. Leakage Test with Reduction Adapter - Relevant only to the Quadrox-i pediatric/neonatal products used in combination with 1/4" x 3/16" reduction adapters 09844-s. The test confirmed that the clamp can be used with the pediatric/neonatal reduction adapters.
Usability test This test was performed in three hospitals and evaluated i as to whether the clamp could be mounted using the Instruction for Use.

The holding clamp as an external component of the cleared QUADROX-i does not affect the performance specifications related to the intended use.

Based on the tests listed above, the modified devices are safe and effective according to the intended use and are substantially equivalent to the originally cleared device.

Clinical Tests:

Clinical results are not required for this submission to support substantial equivalence.

Conclusion:

Based on the risk analysis, MAQUET Cardiopulmonary AG has conducted the appropriate design verification activities and believes that the modified devices are substantially equivalent to the cleared MAQUET predicate devices.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 8, 2013

MAQUET Cardiopulmonary AG Whitney Torning Director of Regulatory 45 Barbour Pond Drive Wayne, ND 07470

Re: K132829

Trade/Device Name: QUADROX-i Microporous Membrane Oxygenators QUADROX-iD Diffusion Membrane Oxygenators Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTR, DTM Dated: September 6, 2013 Received: September 9, 2013

Dear Ms. Törning:

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 cither class 11 (Special Controls) or class 111 (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 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

{8}------------------------------------------------

Page 2 - Ms. Whitney Törning

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M. A. Dykes

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{9}------------------------------------------------

510(k) Number (if known): _K132829

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

Indications for Use:

The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide 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 um. 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 (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)

Page of of 6

{10}------------------------------------------------

510(k) Number (if known): _K132829

Device Name: QUADROX-i Small Adult Microporous Membrane Oxygenator with and without integrated Arterial Filter

Indications for Use:

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

Prescription 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)

Page 2 of 6

{11}------------------------------------------------

510(k) Number (if known): _K132829

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

Indications for Use:

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.

Over-The-Counter Use Prescription Use × Prescription 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)

Page 3_ of 6

{12}------------------------------------------------

510(k) Number (if known): _ K132829

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

Indications for Use:

The QUADROX-i Neonatal (HMO 11000) 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 × Over-The-Counter Use Prescription 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)

Page 4 of 6

{13}------------------------------------------------

510(k) Number (if known): __ K132829

Device Name: QUADROX-iD Adult Diffusion Membrane Oxygenator

Indications for Use:

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

Over-The-Counter Use Prescription Use x Prescription 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)

Page 5 of 6

{14}------------------------------------------------

510(k) Number (if known): _K132829

Device Name: QUADROX-iD Pediatric Diffusion Membrane Oxygenator

Indications for Use:

The Diffusion Membrane Oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The oxygenator 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 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 × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Page 6 of 6

. Afillem

05-7

Regulation Number and Section

§ 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.”