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.

Device Description

The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device.

AI/ML Overview

The provided text is a 510(k) Summary for the CardioVention PowerBase™ Console. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically found in clinical trials for AI/software devices. Therefore, much of the requested information is not explicitly available in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Safety and Effectiveness: CardioVention PowerBase™ Console is safe and effective for its intended function.	Results of in-vitro and software testing demonstrate that CardioVention PowerBase™ Console is safe and effective for its intended function. Substantial equivalence to the currently marketed and unmodified predicate device (CardioVention PowerBase™ Console [K021694] and the CardioVention CORx System [K012325]) for its intended use, product performance, and software.
Intended Use Parameters: Used with CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support.	The device is described as a cardiopulmonary bypass flow control device intended for the stated use.
Maximum Blood Flow Rate: Six liters/minute.	The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute.
Procedure Duration: Up to six hours.	The device is indicated for use in procedures lasting for up to six hours.

2. Sample Size Used for the Test Set and the Data Provenance

The document states "Results of in-vitro and software testing," but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This is common for submissions focused on substantial equivalence of hardware and software components, where bench testing and verification are emphasized over clinical trial-like data for initial market clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. Given the nature of the device (a cardiopulmonary bypass console) and the testing described (in-vitro and software), it's more likely that performance was verified against engineering specifications and industry standards rather than a "ground truth" established by medical experts in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or indicated. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to compare human performance with and without AI assistance. The CardioVention PowerBase™ Console is a control device, not an interpretive one.

6. Standalone Performance Study

The document states "Results of in-vitro and software testing demonstrate that CardioVention PowerBase™ Console is safe and effective for its intended function." This implies a form of standalone testing of the device's functionality and safety, but it is not a "standalone (i.e., algorithm only without human-in-the-loop performance)" in the context of an AI algorithm's diagnostic accuracy. It refers to the device's operational performance independent of human error in its direct use.

7. Type of Ground Truth Used

The "ground truth" for this type of device would likely be based on engineering specifications, established physiological parameters for cardiopulmonary bypass, and recognized industry standards for safety and performance of such medical devices. The document does not specify "pathology" or "outcomes data" as ground truth.

8. Sample Size for the Training Set

This information is not provided. Given that this is a 510(k) for a cardiopulmonary bypass console cleared in 2003, it predates the widespread use of deep learning and large-scale AI models requiring extensive "training sets" in the modern sense. The "software testing" likely refers to traditional software verification and validation, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

As there's no mention of a "training set" in the context of machine learning, this information is not applicable/provided. If "training set" refers to data used to develop the software, it would be internal development data validated against engineering requirements, but no details are given.

Summary

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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:

Test Results:

Results of in-vitro and software testing demonstrate that CardioVention PowerBase™ Console is safe and effective for its intended function.

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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.

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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.

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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), 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

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Indication for Use Statement

KO30141 510(k) Number (if known): ________

CardioVention PowerBase™ Console Device Name:

Indications for Use:

(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)

Regulation Number and Section

§ 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).