The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up 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-iR oxygenators which are subject to this submission.

AI/ML Overview

The provided document describes a Special 510(k) submission for a modification to the MAQUET QUADROX-iR Oxygenators. The modification consists of adding a reusable stainless steel holding clamp as an interim protective safeguard. The information provided heavily focuses on design verification testing rather than a clinical study with an acceptance criterion in the traditional sense of a performance metric for a disease. Instead, the "acceptance criteria" are related to the mechanical performance and usability of the new holding clamp.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a modification to add a holding clamp), the acceptance criteria are based on mechanical and usability performance.

Acceptance Criteria Category	Specific Test/Criterion	Reported Device Performance
Mechanical Integrity	Holding Forces: Clamp can be mounted and stays in place.	Tests designed to show the clamp stays in place during use.
	Pull Off Forces: Force required to remove the clamp from the housing perpendicular to clamping force.	Confirmed the clamp would not detach even if bonding failed.
	Vibration Test with Shaker: Simulate impact forces up to 3G; confirm secure attachment under repeated impact.	Confirmed secure attachment of the clamp under repeated impact forces.
	Vibration Test with Cardiohelp: Clamp stays securely fixed over the total application time (up to 6 hours).	Demonstrated the clamp stays securely fixed over the 6-hour application.
Usability	Usability Test: Clamp can be mounted using the Instruction for Use.	Evaluated whether the clamp could be mounted using the "Instruction for Use".

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state numerical sample sizes for the mechanical tests (e.g., number of clamps or oxygenators tested for holding forces, pull-off forces, or vibration tests). It only states "The modified device was subjected to design verification tests."

For the Usability Test:

Sample Size: "This test was performed in three hospitals." The number of individual users or attempts is not specified.
Data Provenance: Prospective (as it was a dedicated test for this modification). The country of origin of the data is not specified beyond "three hospitals," but given the manufacturer's location (Germany) and contact person in the US, it could be either.

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

Mechanical Tests: The "ground truth" for the mechanical tests is inherent in the objective measurements of forces, vibrations, and secure attachment as per engineering design and risk assessment. No human "experts" in the sense of clinical reviewers are mentioned for establishing ground truth for these physical tests.
Usability Test: While "three hospitals" performed the test, the number of individuals involved in evaluating the usability, or their specific qualifications (e.g., "perfusionists with X years of experience"), is not specified. The document states it was "evaluated as to whether the clamp could be mounted using the Instruction for Use," implying a practical assessment by users.

4. Adjudication Method for the Test Set

Mechanical Tests: No adjudication method is mentioned as these are objective measurements against defined engineering specifications.
Usability Test: No specific adjudication method (like 2+1 or 3+1 consensus) is described. The evaluation seems to be a direct assessment of whether the mounting was successful according to the instructions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is for a mechanical modification (a holding clamp) and not for an AI/imaging diagnostic device that would typically involve a MRMC study. The document explicitly states: "Clinical results are not required for this submission to support substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a medical device (oxygenator with a holding clamp), not an algorithm or AI system.

7. The Type of Ground Truth Used

Mechanical Tests: The ground truth is based on engineering specifications and objective measurements (e.g., force required to remove, stability under vibration).
Usability Test: The ground truth is based on the ability of users to successfully mount the clamp following the provided instructions for use. This is a practical, task-oriented ground truth.

8. The Sample Size for the Training Set

This question is not applicable. This submission is for a physical device modification, not a machine learning model, so there is no "training set."

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

This question is not applicable, as there is no training set for this device.

Summary

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K133265

NOV 1 2 2013

MAQUET Cardiopulmonary AG

Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-iR Oxygenators

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

Date:

October 22, 2013

Submitter:

MAQUET Cardiopulmonary AG Kehler Straße 31 76437 Rastatt Germany

Contact Person:

Whitney Törning Director of Regulatory MAQUET Cardiovascular 45 Barbour Pond Drive Wayne, NJ 07470 Phone: 973-709-7994 Fax: 973-807-9210

Device Trade Names: QUADROX-iR Adult / Small Adult Common/Usual name: Oxygenator with integrated centrifugal pump and with / without integrated Arterial Filter

Classification Name: Oxygenator, cardiopulmonary bypass, heat exchanger, cardiopulmonary bypass, filter, blood cardiopulmonary bypass, arterial line, non-roller type blood pump, cardiopulmonary bypass

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Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-iR Oxygenators

Device Modification

Legally marketed MAQUET Predicate Devices:

Primary predicate device: QUADROX-iR Adult K102726, QUADROX-iR Small Adult K102726

Secondary predicate devices: QUADROX-i Adult Microporous Membrane Oxygenators K132829. QUADROX-i Small Adult Microporous Membrane Oxygenators K132829, QUADROX-i Pediatric Microporous Membrane Oxygenator K132829, QUADROX-i Neonatal Microporous Membrane Oxygenator K132829, QUADROX-iD Adult Diffusion Membrane Oxygenator K132829 and QUADROX-iD Pediatric Diffusion Membrane Oxygenator K132829.

Device Description:

Holding Clamp - interim protective safequard and component of the QUADROX-iR Oxygenator

The holding clamp is applicable to all QUADROX-iR oxygenators which are subject to this submission. The following table provides an overview of the QUADROX-iR oxygenator models and the suitable holding clamp.

Catalogue number	Holding clamp - picture	suitable for*
HKH 3572	Image: Holding clamp	HMO 70100 USA - Quadrox iR Adult w/o filterHMO 71100 USA- Quadrox iR Adult with filterHMO 50100 USA - Quadrox iR Small Adult w/o filterHMO 51100 USA - Quadrox iR Small Adult with filter

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Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-iR Oxygenators

The above listed QUADROX-iR Oxygenator models may also be provided with BIOLINE Coating and may be sold in combination with other devices as described in the original 510(k) (K102726).

Image /page/2/Picture/3 description: The image shows a machine part, possibly from an engine or motor. The part is made of metal and has a cylindrical shape at the top, with a more complex structure below. There are various pipes, tubes, and other components attached to the main body of the part, suggesting it is involved in fluid or gas transfer. The image is a black and white rendering, possibly a technical drawing or a 3D model.

Picture: QUADROX-iR with Holding Clamp

QUADROX-iR (disposable) as part of the CARDIOHELP System, the indications for use is as follows:

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

1 (Note: This section of the indications for use statement does not refer to the HLS/HIT Set Advanced (K102726) and therefore it is not subject to this Special 510(k)).

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Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-iR Oxygenators

Technological Characteristics:

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

Non-clinical Tests:

The modified device was 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:

-Holding Forces - Force applied to the connectors to hold the clamp in 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 Cardiohelp Test to demonstrate that the clamp t stays securely fixed over the total application time of up to 6 hours.
Usability test This test was performed in three hospitals and evaluated as to whether the clamp could be mounted using the Instruction for Use.

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

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

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Premarket Notification Special 510(k) - Change due to recall/corrective action Modified QUADROX-iR Oxygenators

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 device is substantially equivalent to the cleared MAQUET primary predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES USA

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-Gb(19 Silver Spring, MD 20993-0002

November 12, 2013

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

Re: K133265

Trade/Device Name: CARDIOHELP System with the QUADROX-iR Adult Oxygenator (Models 70100 and 70110 Bioline and Softline Coated) and the QUADROX-iR Small Adult Oxygenator (Models 50100 and 50110 Bioline and Softline Coated) Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller type cardiopulmonary bypass blood pump

Regulatory Class: Class III

Product Code: KFM, DTZ, DTZ, DTM

Dated: October 22, 2013

Received: October 23, 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 10 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.

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

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Page 2 - Ms. Whitney Torning

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/ResourcesforYou/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 yours,

M& Zillehenn

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): K133265

Device Name: CARDIOHELP System (including QUADROX-iR)

Indications for Use The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

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)

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M.A. Hillmann

05-2

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.