The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal gas exchange support. This device can be used with a legally marketed thermal requlating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting up to six hours.

The CORx System is intended for use with Medtronic's Bio-medicus Bio-Console.

Device Description

The CardioVention CORx System is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. The CardioVention CORx System consists of an active venous air removal device (defoamer), a centrifugal blood pump, a membrane oxygenator, an AirVac Controller and a pump adapter. The AirVac Controller powers the detection and facilitates removal of entrained air in the air handling system (defoamer) of the disposable unit. The pump adapter, which is magnetic, allows the use of the Medtronic Biomedicus Bio-Console (K941921) with the CORx System. The Medtronic's Biomedicus Bio-Console drives the CORx System's centrifugal pump.

The following components of the CORx System disposable are provided sterile, for single use only:

Device	Description
Defoamer (Air Removal)	A device that replaces the air removalfunction of venous reservoirs by centralizingvenous line air and actively removing the air
Centrifugal Blood Pump	An eight-vaned impeller (centrifugal) pump
Oxygenator	A hollow fiber gas transfer device utilizingpolypropylene, double-mat, commerciallyavailable fiber

AI/ML Overview

The provided document describes the CardioVention CORx System, an extracorporeal hemodynamic and gas exchange support system. The submission focuses on device performance compared to predicate devices rather than a study with a test set, ground truth, or expert involvement typical of AI/ML device evaluations. Therefore, many of the requested categories are not applicable.

Here's the information that could be extracted and a note for non-applicable sections:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Blood Pathway Integrity- 6 hours	No leaks under worst-case conditions (pressure ≤ 750 mmHg) for 6 hours.	No failures of integrity detected at 750 mmHg (1.5X rated maximum pressure) for 6 hours.
Gas Pathway Integrity- 10 minutes	No leaks under worst-case conditions (pressure ≤ 30 mmHg) for 10 minutes.	No failures of integrity detected at 30 mmHg (1.5X rated maximum pressure) for 10 minutes.
Blood Pathway Volume	Static priming volume similar to predicate (not explicitly stated for acceptance, but determined for characterization).	Volume of the blood pathway was determined to be 328 mls.
Oxygen Transfer Rate- 6 hours	Oxygen transfer and outlet saturations must be greater than or equal to the predicate device at all blood/gas flow rates over 6 hours.	Oxygen transfer was greater than or equal to the predicate device at all blood/gas flow rates over 6 hours. Arterial saturation (outlet) was 100% at all conditions and timepoints. No loss in performance occurred over the 6 hours.
Carbon Dioxide Transfer Rate- 6 hours	Carbon dioxide transfer must be greater than or equal to the predicate device at all blood/gas flow rates over 6 hours.	Carbon dioxide transfer was greater than or equal to the predicate device at all blood/gas flow rates over 6 hours. No loss in performance occurred over the 6 hours.
Transmembrane Pressure Drop- 6 hours	Transmembrane pressure drop should be comparable to or lower than the predicate device, with no clinically significant increases.	Transmembrane pressure drop was lower than the predicate device. No clinically significant pressure increases occurred over the 6 hours.
Blood Cell Damage	Blood cell damage (plasma free hemoglobin, index of hemolysis, modified index of hemolysis, platelet count, white blood cell count) must be equal to or less than the predicate devices.	Blood cell damage (plasma free hemoglobin, index of hemolysis, modified index of hemolysis, platelet count, white blood cell count) was equal to or less than the predicate devices.
Air Handling	Arterial return bubble counts must be equal to or less than the predicate devices.	Arterial return bubble counts were equal or less than the predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document refers to "the CORx System" and "the predicate devices" in a general sense for testing, implying a certain number of units were tested but not providing specific counts.
Data Provenance: The tests appear to be laboratory-based physical characterization and performance testing of the device itself, comparing it to predicate devices. The country of origin and whether it was retrospective or prospective is not specified, but it would typically be prospective testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a medical device performance submission based on physical and functional testing, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth on a patient dataset.

4. Adjudication method for the test set:

Not Applicable. As above, no expert adjudication was involved in this type of device performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is not an AI-assisted diagnostic device, so no MRMC study involving human readers or AI assistance was conducted.

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

Not Applicable. This is a hardware medical device with mechanical and fluidic functions, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by the specifications and performance of the legally marketed predicate devices, against which the CORx System was compared for substantial equivalence. For instance, the "ground truth" for oxygen transfer is the performance profile of the Optimin Hollow Fiber Oxygenator.

8. The sample size for the training set:

Not Applicable. This is a hardware medical device, not an AI/ML system that requires a traditional training set.

9. How the ground truth for the training set was established:

Not Applicable. As above.

Summary

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APR = 9 2002

CardioVention CORx System 510(k) Notification

CONFIDENTIAL

KO12325

CardioVention CORx System

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 808.87 and 807.92.

Date Prepared: June 16, 2001

ll.

510(k) number:

l. 510(k) Submitter Information

Tessa Yamut Name: Director of Quality Assurance / Regulatory Title: Affairs 3045 Stender Way Address: Santa Clara, CA 95054 Same as above Contact Person: Preparation Date of the June 16, 2001 510(k) Summary: Device Information CardioVention CORx System Device Name: CardioVention CORx System Trade Name: Oxygenator Common / Usual Centrifuqal Blood Pump Name: Venous Defoamer Classification Name: Cardiopulmonary Bypass Oxygenator Blood Pump, Non-roller type, Cardiopulmonary Bypass Cardiopulmonary Bypass Defoamer Class III Preamendments device for which FDA has Device Classification: not yet called for premarket approval applications.

510(k) Summary

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III. Device Description

The following components of the CORx System disposable are provided sterile, for single use only:

Device	Description
Defoamer (Air Removal)	A device that replaces the air removalfunction of venous reservoirs by centralizingvenous line air and actively removing the air
Centrifugal Blood Pump	An eight-vaned impeller (centrifugal) pump
Oxygenator	A hollow fiber gas transfer device utilizingpolypropylene, double-mat, commerciallyavailable fiber

IV. Predicate Devices

The CardioVention CORx System, which consists of an active venous air removal device (defoamer), a centrifugal blood pump, a membrane oxygenator, an AirVac Controller and a pump adapter, is substantially equivalent to a combination of three predicate devices.

The Predicate Device for the CardioVention CORx System Oxygenator is:

Name:	Optimin Hollow Fiber Oxygenator
Manufacturer:	Cobe
Status:	Post-enactment

510(k) Summary

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The Predicate Device for the CardioVention CORx System Centrifugal Pump, with the pump adaptor for use with Medtronic's Biomedicus Bio-Console is:

Name: Manufacturer: Status:

Sarns Delphin Centrifugal Blood Pump Terumo Sarns Post-enactment

The predicate device for the CardioVention CORx System Defoamer, with the AirVac Controller, is:

Name:

Manufacturer: Status:

HVR2200 Hard Shell Venous Reservoir (defoamer) Cobe Post-enactment

V. Indications for Use

The CORx System is intended for use with Medtronic's Bio-medicus Bio-Console.

Comparison to Predicate Devices

The CardioVention CORx System is used for patient support and duplicates the functionality of three separate disposable predicate devices. A summary comparison of the intended uses and generic specifications between the CORx System and the predicate systems is provided on the following page. For many of the plastic components, the CardioVention CORx System utilizes the same materials as the predicate devices.

The largest surface area component of the CORx System, the microporous membrane material, is the identical material as the predicate membrane oxygenator. Both the predicate and CORx System membrane oxygenators are blood outside the fiber, hollow fiber designs. The predicate oxygenator contains an integral heat exchanger while the CORx System is designed to work with ancillary heating / cooling products.

510(k) Summarv

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Both the predicate centrifugal blood pump and the centrifugal blood pump component of the CORx System are of the "impeller" type and incorporate similar materials.

VI. Summary of Physical Characterization / Integrity and Performance Testing

The table below summarizes the tests and results that were performed on the CORx System to ensure that it conforms to specificationsand is as safe and effective as the predicate devices:

Test Type	Purpose	Summary of Results
Blood pathwayintegrity- 6 hours	To ensure that the blood pathwaydoes not leak under worst caseconditions	The blood pathway wasexposed to pressures of 750mmHg (1.5X rated maximumpressure) for 6 hours with nofailures of integrity detected.
Gas PathwayIntegrity- 10minutes	To ensure that the gas pathwaydoes not leak under worst caseconditions	The gas pathway wasexposed to pressures of 30mmHg (1.5X rated maximumpressure) for 10 minutes withno failures of integritydetected.
Blood PathwayVolume	To determine the static primingvolume of the blood pathway	The volume of the bloodpathway was determined tobe 328 mls.
Oxygen TransferRate- 6 hours	To compare oxygen transfer andoutlet saturations at minimum,nominal, and maximum rated flowrates to the predicate device.	Oxygen transfer was greaterthan or equal to the predicatedevice at all blood/gas flowrates over 6 hours. Arterialsaturation (outlet) was 100%at all conditions andtimepoints. No loss inperformance occurred overthe 6 hours.
Carbon DioxideTransfer Rate- 6hours	To compare oxygen transfer andoutlet saturations at minimum,nominal, and maximum rated flowrates to the predicate device.	Carbon dioxide transfer wasgreater than or equal to thepredicate device at allblood/gas flow rates over 6hours. No loss inperformance occurred overthe 6 hours.

510(k) Summary

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Transmembranepressure drop- 6hours	To compare transmembranepressure drop at minimum,nominal, and maximum rated flowrates to the predicate device.	Transmembrane pressuredrop was lower than thepredicate device. Noclinically significant pressureincreases occurred over the 6hours.
Blood CellDamage	To compare blood cell damage tothe predicate devices at theirrespective maximum rated flowrates.	Blood cell damage (plasmafree hemoglobin, index ofhemolysis, modified index ofhemolysis, platelet count,white blood cell count) wasequal to or less than thepredicate devices.
Air Handling	To compare venous air handlingperformance to the predicatedevices.	Arterial return bubble countswere equal or less than thepredicate devices.

Based on a descriptive comparison of the CORx System and its predicate systems and the performance data summarized above, the CORx System is substantially equivalent to the currently marketed predicate systems for its intended use.

510(k) Summary

Page 5 of 5

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Class III Summary and Certification

CardioVention, Inc. certifies to the best of our knowledge that a reasonable search of all information known or otherwise available about the types and causes of safety or information known of other the arbeen reported for the nonroller-type cardiopulmonary encouvenous problems that here ertify that we are aware of the types of complications to which the device is susceptible and that, to the best of our knowledge, the following which the afthe types and causes of safety or effectiveness problems about the nonroller-type cardiopulmonary bypass blood pump is complete and accurate.

Problem	Potential Causes
Blood Leak	Compromised physical integrity
Inadequate pumping	Bearing / seal failure, decoupling
Biocompatibility	Material selection
Blood damage	Heat generation, bearing / seal failure,sheer stresses

The section below includes citations of the materials upon which the above summary is based:

Kolff J, RN Ankney, D Wurzel, R Devineni. Centrifugal pump failures. J Extra Corpor 트 Technol 1996 Sep; 28(3)118-22.
Curtis JJ, TM Boley, JT Walls, TL Demmy, and RA Schmaltz. Frequency of seal . disruption with Sarns centrifugal pump in postcardiotomy circulatory assist. Artif Organs 1994 Mar; 18(3):225-7.
Curtis JJ, JT Walls, CC Wagner-Mann, RA Schmaltz, TL Demmy, CA NcKenney, FA 트 Mann. Centrifugal pumps: description of devices and surgical techniques.
Crane TN. Causes of cardiopulmonary bypass accidents 1996. 트 http://www.perfusion.com/perfusion/articles/general/9610-accidents.html

Tessa Yamut Director of QA/RA

uyanut

Date of Submission:

July 20, 2001

510(k) Number:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 9 2002

Ms. Tessa Yamut Director of Quality Assurance/Regulatory Affairs CardioVention, Inc. 3045 Stender Way Santa Clara, CA 95054

Re: K012325

Trade Name: CardioVention CORx System, Model FG0001 Regulation Number: 21 CFR 870.4350, 870.4360, 870.4230 Regulation Name: Oxygenator, Pump, Defoamer Regulatory Class: Class III (three) Product Code: DTZ, KFM, DTP Dated: November 7, 2001 Received: November 9, 2001

Dear Ms. Yamut:

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 such 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.

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Page 2 - Ms. Tessa Yamut

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L. DeRatt, M.D.

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

Enclosure

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INDICATIONS FOR USE STATEMENT IV.

510(k) Number (if known): _k @/ 232 5

Device Name: CardioVention CORx System

Indications for Use:

The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal gas exchange support. This device can be used with a legally marketed thermal regulating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting up to six hours.

The CORx System is intended for use with the Medtronic Bio-medicus Bio-Console.

✓

21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012325

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.