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.

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)

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CardioVention CORx IOS-200 System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in a quantifiable manner (e.g., "oxygen transfer rate must be at least X ml/min," or "pressure drop must not exceed Y mmHg"). Instead, it provides a general statement about performance.

Acceptance Criteria (Implied)	Reported Device Performance
Safe and effective for its intended function (extracorporeal hemodynamic and gas-exchange support).	"Results of in-vitro testing demonstrate that the CardioVention CORx IOS-200 System is safe and effective for its intended function."
Substantially equivalent to the predicate device (CardioVention CORx System [K012325]).	"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. Sample Sizes and Data Provenance

Test Set Sample Size: The document does not specify a numerical sample size for the "in-vitro testing." It simply states "Results of in-vitro testing."
Data Provenance: The data is from "in-vitro testing," implying laboratory-based testing rather than clinical data from human subjects. The country of origin of the data is not specified, but the applicant (CardioVention, Inc.) is based in Santa Clara, CA, USA. The data is implicitly prospective as it was generated to support the 510(k) submission for this specific device.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: This information is not provided in the document.
Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method

Adjudication Method: This information is not provided in the document. Given that the testing was "in-vitro," an adjudication method by human experts (like 2+1 or 3+1) is unlikely to be applicable in the traditional sense for establishing ground truth, unless the "in-vitro" testing involved human assessment of certain parameters that aren't fully automated. However, the document does not elaborate on this.

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

MRMC Study Done: No. The device is a cardiopulmonary bypass system, not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, an MRMC study is not applicable or mentioned.
Effect Size of AI vs. Without AI Assistance: Not applicable. This device does not incorporate AI for interpretation or assistance in the way that diagnostic imaging devices might.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: Yes, implicitly. The "in-vitro testing" refers to the performance of the device itself (the CardioVention CORx IOS-200 System). This testing would have evaluated the device's technical specifications and functional performance in a controlled environment, essentially demonstrating its "standalone" capabilities without human interaction for its core function (extracorporeal hemodynamic and gas-exchange support). The results are summarized as "safe and effective for its intended function."

7. Type of Ground Truth Used

Type of Ground Truth: The document does not explicitly define "ground truth" as it would for a diagnostic device. However, for a medical device like a cardiopulmonary bypass system, the "ground truth" for its performance would be established through engineering specifications, validated physical and chemical measurements (e.g., oxygen transfer, heat exchange, blood flow, pressure drop), and compliance with recognized industry standards. These are assessed via the "in-vitro testing." It is not based on expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic tools, but rather on direct measurements of the device's functional parameters.

8. Sample Size for the Training Set

Training Set Sample Size: This information is not provided and is largely not applicable in the context of this traditional medical device. Training sets are primarily relevant for machine learning or AI-driven systems. This device is a mechanical and chemical system, not an algorithm that learns from data.

9. How Ground Truth for the Training Set was Established

Ground Truth for Training Set: This information is not provided and is not applicable for the same reasons mentioned in point 8.

Summary

{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:

{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)

Over-the Counter Use

Ashley B. Barnum

diovascular Devices

510(k) Number K632068

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).