(50 days)
Not Found
No
The summary describes a standard cardiopulmonary bypass system with components like an oxygenator, pump, and heat exchanger. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is described as a "cardiopulmonary bypass system" intended for "extracorporeal hemodynamic and gas-exchange support" in surgical procedures, which are therapeutic interventions.
No
The device is described as a cardiopulmonary bypass system intended for extracorporeal hemodynamic and gas-exchange support during surgical procedures. Its components (oxygenator, blood pump, heat exchanger, defoamer) are for providing life support, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components (oxygenator, blood pump, heat exchanger, blood circuit defoamer) that are part of the system.
Based on the provided information, the CardioVention CORx System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "surgical procedures requiring extracorporeal hemodynamic and gas-exchange support." This describes a device used on a patient during surgery, not a device used to test samples from a patient in a lab setting.
- Device Description: The components listed (oxygenator, blood pump, heat exchanger, defoamer) are all parts of a system designed to manage blood flow and gas exchange outside the body during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The device's function is to support physiological processes during a procedure.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CardioVention CORx System does not fit this description.
N/A
Intended Use / Indications for Use
The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal hemodynamic and gas-exchange support. The device contains a thermal regulating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours. The CORx System is intended for use with the Medtronic Bio-Medicus Bio-Console and the CardioVention PowerBase Console.
Product codes (comma separated list FDA assigned to the subject device)
DTR, DTZ, DTP, KFM
Device Description
The CORx IOS-200 System is a cardiopulmonary bypass system consisting of an oxygenator (870.4350), a non-roller-type cardiopulmonary bypass blood pump (870.4360), a heat exchanger (870.4240) and a blood circuit defoamer (870.4230)
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)
Results of in-vitro testing demonstrate that the CardioVention CORx IOS-200 System is safe and effective for its intended function.
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.
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
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).
0
510(k) Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: July 2, 2003
K032068 510(k) number:
Applicant Information:
CardioVention. Inc. 3045 Stender Way Santa Clara, CA 95054
| Contact Person: | Tessa Yamut, Director of RA/QA |
|---|---|
| Phone Number: | (408) 844-5130 |
| Fax Number: | (408) 988-2309 |
Device Information:
| Classification: | Class III |
|---|---|
| ----------------- | ----------- |
CardioVention CORx IOS-200 System Trade Name:
- The CORx IOS-200 System is a cardiopulmonary Classification Name: bypass system consisting of an oxygenator (870.4350), a non-roller-type cardiopulmonary bypass blood pump (870.4360), a heat exchanger (870.4240) and a blood circuit defoamer (870.4230)
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the CardioVention CORx System [K012325].
Intended Use:
The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal hemodynamic and gas-exchange support. The device contains a thermal regulating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours. The CORx System is intended for use with the Medtronic Bio-Medicus Bio-Console and the CardioVention PowerBase Console.
1
1632068
Test Results:
Results of in-vitro testing demonstrate that the CardioVention CORx IOS-200 System is safe and effective for its intended function.
Summary:
Based on the intended use and product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed and unmodified predicate device.
2
AUG 2 2 2003
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiovention, Inc. c/o Ms. Tessa Yamut Director, RA/QA 3045 Stender Way Santa Clara, CA 95054
Re: K032068
CardioVention CORx IOS-200 System Regulation Number: 21 CFR 870.4240, 870.4350, 870, 4360, 870.4230 Regulation Name: Cardiopulmonary bypass (CPB) heat exchanger, CPB oxygenator, nonroller type CPB blood pump, CPB defoamer Regulatory Class: Class II (two) Product Code: DTR, DTZ, DTP, KFM Dated: July 2, 2003 Received: July 3, 2003
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.
3
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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ashley B. Boone
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
Indication for Use Statement
K032068 510(k) Number (if known): __________
CardioVention CORx IOS-200 System Device Name:
Indications for Use:
The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal hemodynamic and gas-exchange support. The device contains a thermal requlating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours. The CORx System is intended for use with the Medtronic Bio-Medicus Bio-Console and the CardioVention PowerBase Console.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-the Counter Use
Ashley B. Barnum
diovascular Devices
510(k) Number K632068
(Optional Format 1-2-96)