(260 days)
Not Found
No
The document describes a mechanical extracorporeal support system with components like a defoamer, pump, and oxygenator. There is no mention of AI, ML, or any software-driven decision-making or analysis beyond basic control of the air removal system. The performance studies focus on physical parameters and blood compatibility, not algorithmic performance.
Yes
The "Intended Use / Indications for Use" states that the device provides "extracorporeal gas exchange support", and the "Device Description" details components like a "membrane oxygenator" and "centrifugal blood pump", which are used to support physiological functions during surgical procedures. This directly addresses medical conditions and supports treatment, qualifying it as a therapeutic device.
No
The CardioVention CORx System is described as an "extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion," used in surgical procedures. Its components (defoamer, blood pump, oxygenator) are for maintaining blood flow and gas exchange, not for diagnosing a condition or disease.
No
The device description explicitly lists multiple hardware components, including a defoamer, centrifugal blood pump, membrane oxygenator, AirVac Controller, and pump adapter. It also mentions disposable components provided sterile for single use. This clearly indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the CardioVention CORx System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "surgical procedures requiring extracorporeal gas exchange support." This describes a system used outside the body to directly support physiological function (gas exchange in the blood).
- Device Description: The components listed (defoamer, centrifugal blood pump, membrane oxygenator) are all involved in the physical manipulation and processing of blood outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The device is actively treating the blood, not analyzing it for diagnostic purposes.
Therefore, the CardioVention CORx System falls under the category of an extracorporeal life support device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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 the Medtronic Bio-medicus Bio-Console.
Product codes (comma separated list FDA assigned to the subject device)
DTZ, KFM, DTP
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:
Defoamer (Air Removal): A device that replaces the air removal function of venous reservoirs by centralizing venous line air and actively removing the air
Centrifugal Blood Pump: An eight-vaned impeller (centrifugal) pump
Oxygenator: A hollow fiber gas transfer device utilizing polypropylene, double-mat, commercially available fiber
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed on the CORx System to ensure it conforms to specifications and is as safe and effective as the predicate devices:
- Blood pathway integrity- 6 hours: The blood pathway was exposed to pressures of 750 mmHg (1.5X rated maximum pressure) for 6 hours with no failures of integrity detected.
- Gas Pathway Integrity- 10 minutes: The gas pathway was exposed to pressures of 30 mmHg (1.5X rated maximum pressure) for 10 minutes with no failures of integrity detected.
- Blood Pathway Volume: The volume of the blood pathway was determined to be 328 mls.
- Oxygen Transfer Rate- 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 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 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) was equal to or less than the predicate devices.
- Air Handling: Arterial return bubble counts were equal or less than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
III. 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 removal |
| function of venous reservoirs by centralizing | |
| venous line air and actively removing the air | |
| Centrifugal Blood Pump | An eight-vaned impeller (centrifugal) pump |
| Oxygenator | A hollow fiber gas transfer device utilizing |
| polypropylene, double-mat, commercially | |
| available 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
2
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 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.
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
3
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 pathway | ||
| integrity- 6 hours | To ensure that the blood pathway | |
| does not leak under worst case | ||
| conditions | The blood pathway was | |
| exposed to pressures of 750 | ||
| mmHg (1.5X rated maximum | ||
| pressure) for 6 hours with no | ||
| failures of integrity detected. | ||
| Gas Pathway | ||
| Integrity- 10 | ||
| minutes | To ensure that the gas pathway | |
| does not leak under worst case | ||
| conditions | The gas pathway was | |
| exposed to pressures of 30 | ||
| mmHg (1.5X rated maximum | ||
| pressure) for 10 minutes with | ||
| no failures of integrity | ||
| detected. | ||
| Blood Pathway | ||
| Volume | To determine the static priming | |
| volume of the blood pathway | The volume of the blood | |
| pathway was determined to | ||
| be 328 mls. | ||
| Oxygen Transfer | ||
| Rate- 6 hours | To compare oxygen transfer and | |
| outlet saturations at minimum, | ||
| nominal, and maximum rated flow | ||
| rates to the predicate device. | 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 | To compare oxygen transfer and | |
| outlet saturations at minimum, | ||
| nominal, and maximum rated flow | ||
| rates to the predicate device. | 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. |
510(k) Summary
4
| Transmembrane
pressure drop- 6
hours | To compare transmembrane
pressure drop at minimum,
nominal, and maximum rated flow
rates to the predicate device. | Transmembrane pressure
drop was lower than the
predicate device. No
clinically significant pressure
increases occurred over the 6
hours. |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood Cell
Damage | To compare blood cell damage to
the predicate devices at their
respective maximum rated flow
rates. | 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 | To compare venous air handling
performance to the predicate
devices. | Arterial return bubble counts
were equal or less than the
predicate 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
5
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:
6
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.
7
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
8
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