(231 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on flow control and standard functional testing.
Yes
The device is described as a cardiopulmonary bypass flow control device used in surgical procedures requiring extracorporeal hemodynamic and gas exchange support, which directly treats a physiological condition.
No
Explanation: The device is described as a cardiopulmonary bypass flow control device used for extracorporeal hemodynamic and gas exchange support, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "cardiopulmonary bypass flow control device" and mentions "functional acceptance testing, ship testing, and software verification and validation," implying the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "cardiopulmonary bypass flow control device" used in "surgical procedures requiring extracorporeal hemodynamic and gas exchange support." This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description reinforces its function as a "cardiopulmonary bypass flow control device."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVDs are devices used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The CardioVention PowerBase™ Console's function is to manage blood flow during surgery, which is a therapeutic and supportive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. 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.
Product codes
DTQ
Device Description
Cardiopulmonary Bypass Console (21 CFR 870.4220)
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
Testing submitted in this premarket notification consists of functional acceptance testing, ship testing, and software verification and validation.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).
0
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: May 16, 2002
510(k) number: K021694
JAN 0 8 2003
l. Applicant Information:
CardioVention, Inc. 3045 Stender Way Santa Clara, CA 95054
Contact Person: Tessa Yamut Phone Number: (408) 844-5130 Fax Number: (408) 988-2309
II. Device Information:
Classification: Class II Trade Name: CardioVention PowerBase™ Console Classification Name: Cardiopulmonary Bypass Console (21 CFR 870.4220)
lll. Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the following:
| Name: | Bio-medicus Bio-Console |
|---|---|
| Manufacturer: | Medtronic |
| Status: | Post-enactment |
| 510(k) # | K936091 |
| Name: | Stockert Centrifugal Pump |
| Manufacturer: | Stockert Instrumente GmbH |
| Status: | Post-enactment |
| 510(k) # | K011838 |
| Name: | RotaFlow Centrifugal Pump System |
| Manufacturer: | Jostra Medizintechnik AG |
| Status: | Post-enactment |
| 510(k) # | K991864 |
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IV. Intended Use:
The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. 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.
V. Performance Testing Results:
Testing submitted in this premarket notification consists of functional acceptance testing, ship testing, and software verification and validation.
VI. Technological Characteristics and Substantial Equivalence:
The CardioVention PowerBase™ Console claims equivalence to cited predicate devices based on equivalence in indications for use, operational characteristics, and technological characteristics.
2
Image /page/2/Picture/2 description: The image shows a portion of a document with the word "DEPARTMENT" in bold, uppercase letters. To the left of the word, there is a graphic that appears to be a stylized seal or emblem. The rest of the document is not visible in the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2003
CardioVention, Inc. c/o Ms. Tessa Yamut Director of Quality Assurance/Regulatory Affairs 3045 Stender Way Santa Clara, CA 95054
Re: K021694
Trade Name: CardioVention PowerBase™ Console Regulation Number: 21 CFR 870.4220 Regulation Name: CPB Heart Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ Dated: December 4, 2002 Received: December 6, 2002
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 A.ct. The general controls provisions of the Act include requirements for annual registration. Iisting 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. 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) you may obtain. 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,
W. NQ. G. Tuth
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): k_OZ1694
Device Name: CardioVention PowerBase™ Console
Indications for Use:
The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. 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.
Prescription Use
(Per 21 CFR 801.109)
Kalen Tu
510(k) Numb
CardioVention, Inc.
CONFIDENTIAL