(42 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 testing.
Yes
The device is described as a "cardiopulmonary bypass flow control device" intended for "extracorporeal hemodynamic and gas exchange support" in surgical procedures, which are therapeutic interventions.
No
Explanation: The device is described as a "cardiopulmonary bypass flow control device" used for "extracorporeal hemodynamic and gas exchange support" during surgical procedures. Its function is to manage blood flow and gas exchange, not to diagnose a medical condition.
No
The device description explicitly states it is a "cardiopulmonary bypass flow control device," which implies a physical hardware component for controlling blood flow. The summary of performance studies also mentions "in-vitro and software testing," further suggesting the presence of hardware.
Based on the provided information, the CardioVention PowerBase™ Console 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 on a patient during surgery, not a device used to test samples from a patient outside the body.
- Device Description: The description reinforces its function as a "cardiopulmonary bypass flow control device."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CardioVention PowerBase™ Console's function is entirely focused on supporting the patient's circulatory and respiratory systems during surgery.
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
Not Found
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
Results of in-vitro and software testing demonstrate that CardioVention PowerBase™ Console is safe and effective for its intended function.
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
510 (k) Summarv
FEB 2 6 2003
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: January 14, 2003
510(k) number: _______________________________________________________________________________________________________________________________________________________________
Applicant Information:
CardioVention, Inc. 3045 Stender Wav Santa Clara, CA 95054
| Contact Person: | Tessa Yamut |
|---|---|
| Phone Number: | (408) 844-5130 |
| Fax Number: | (408) 988-2309 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | CardioVention PowerBaseTM Console |
| Classification Name: | Cardiopulmonary Bypass Heart-Lung Machine Console |
| (21 CFR 870.4220) |
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the CardioVention PowerBase™ Console [K021694] and the CardioVention CORx System [K012325].
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.
Test Results:
Results of in-vitro and software testing demonstrate that CardioVention PowerBase™ Console is safe and effective for its intended function.
1
Summary:
Based on the intended use, product performance and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed and unmodified predicate device.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
FEB 2 6 2003
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: K030141
Trade Name: CardioVention PowerBaseTM Console Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ Dated: February 6, 2003 Received: February 7, 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. 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. 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,
KATHLEEN
Bram D. Zuckerman. M.D. Director Division of Cardiovascualr Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use Statement
KO30141 510(k) Number (if known): ________
CardioVention PowerBase™ Console Device Name:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K0314/ |
| Prescription Use | OR | Over-the Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)