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 describes a 510(k) premarket notification for the "CardioVention PowerBase™ Console," a cardiopulmonary bypass flow control device. However, it does not contain details about specific acceptance criteria, device performance metrics, or a formal study proving the device meets acceptance criteria in the way one would expect for an AI algorithm performance study.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through functional acceptance testing, ship testing, and software verification and validation. This is a common regulatory pathway for medical devices where the equivalence in indications for use, operational characteristics, and technological characteristics is the primary means of demonstrating safety and effectiveness.

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Testing submitted in this premarket notification consists of functional acceptance testing, ship testing, and software verification and validation." However, it does not explicitly list the quantitative acceptance criteria for these tests or specific reported performance metrics beyond the intended use parameters.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated, inferred from intended use/equivalence)	Reported Device Performance (Not explicitly stated, "Substantially Equivalent" declared)
Functional Performance	Ability to control cardiopulmonary bypass flow.	Demonstrated sufficient control to achieve substantial equivalence.
Maximum Blood Flow Rate	Support procedures requiring up to 6 liters/minute.	Meets intended use: capable of 6 liters/minute.
Procedure Duration	Support procedures lasting up to 6 hours.	Meets intended use: capable of supporting procedures up to 6 hours.
Ship Testing	Withstand shipping and handling conditions without compromising function.	Passed ship testing, implying device integrity and functionality post-transport.
Software V&V	Software performs as intended, free from critical bugs.	Software verified and validated, implying reliable operation.
Equivalence	Operational and technological characteristics equivalent to predicate devices (K936091, K011838, K991864).	Declared substantially equivalent to predicate devices.

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

Sample Size for Test Set: Not specified. The testing described (functional, ship, software V&V) typically involves internal product testing rather than a "test set" of clinical cases or data in the context of an AI algorithm.
Data Provenance: Not applicable in the context of clinical data. The performance testing is internal to the manufacturer.

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

Number of Experts: Not applicable. The "ground truth" for a mechanical device like this is its physical and software functionality against engineering specifications, not expert consensus on medical images or diagnoses.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Mechanical and software testing typically involves direct measurement and verification against specifications, rather than adjudicating conflicting interpretations.

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

MRMC Study Done: No. This is a device for controlling cardiopulmonary bypass flow, not an AI diagnostic or assistive imaging tool that would typically undergo an MRMC study.
Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: Yes, in an indirect sense. The "functional acceptance testing, ship testing, and software verification and validation" represent the device's standalone performance against its specifications and intended function. There is no "human-in-the-loop" concept in the performance evaluation described for this type of device, as it is a control system.

7. Type of Ground Truth Used

Type of Ground Truth: Engineering specifications, functional requirements, and safety standards for cardiopulmonary bypass equipment. The device's performance is measured against these established technical benchmarks.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a traditional electro-mechanical medical device with embedded software, not a machine learning or AI-driven system that requires a "training set" of data in the common understanding. The software development process would involve various stages of testing and refinement, but not a "training set" for model learning.

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

How Ground Truth Was Established: Not applicable, as there is no "training set" in the context of a machine learning algorithm. The software's "ground truth" is its design specifications and validated functionality.

Summary

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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:

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.

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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.

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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. 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:

Prescription Use
(Per 21 CFR 801.109)

Kalen Tu

510(k) Numb

CardioVention, Inc.

CONFIDENTIAL

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).