The Datex-Ohmeda S/5™ Cardiac Output and SvO2 module, E-COPSv and accessories is intended for use with Datex-Ohmeda modular monitors for cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2), and invasive blood pressure monitoring of hospitalized patients.

The Datex-Ohmeda S/5™ Cardiac Output and SvO2 module, E-COPSv and accessories is used for monitoring cardiac output (C.O.), right ventricular ejection (REF), mixed venous oxygen saturation (SvO2), and invasive blood pressure of hospitalized patients. The device is indicated for use by qualified medical personnel only.

Device Description

E-COPSv is a single-width plug-in parameter module for a Datex-Ohmeda S/5 modular monitoring system. E-COPSv is used for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF) and mixed venous oxygen saturation (SvO2) of hospitalized patients. Invasive pressure measurement is also available. All measurements are invasive. The E-COPSv module can be used in any of the four Datex-Ohmeda modular monitoring systems with 510(k) clearances: Anesthesia Monitor AM, Compact Anesthesia Monitor CAM, Critical Care Monitor CCM, or Compact Critical Care Monitor CCCM. The Cardiac Output, SvO2 or invasive pressure signal can be displayed on the monitor screen. The waveform size, color and sweep speed can be adjusted. The E-COPSv module calculate a number of parameters related to oxygenation or hemodynamics. All the calculated parameters can be selected on the display, and trended. The Cardiac Output and SvO2 accessories are the same for the E-COPSv module and the predicate device, the M- COPSv (K961063). Accessories that are in contact with the patient are CE-marked by Baxter and distributed by GE Healthcare.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Datex-Ohmeda S/5™ Cardiac Output and SvO2 Module, E-COPSv and accessories. This submission focuses on demonstrating substantial equivalence to a predicate device (Datex-Ohmeda M COPSv Module, K961063) rather than presenting a de novo study with acceptance criteria and device performance as typically understood for AI/ML or novel diagnostic devices.

Therefore, many of the requested categories (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or explicitly stated in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance results in terms of sensitivity, specificity, accuracy, etc., as would be common for AI/ML diagnostics. Instead, the "acceptance criteria" are implied by the conformity to various medical device standards and the demonstration of substantial equivalence to the predicate device.

Performance Metric (Implied)	Acceptance Criteria (Implied)	Reported Performance (Implied)
Safety & Effectiveness	Substantially equivalent to predicate device (K961063) and conformity to standards	"no new questions of safety and effectiveness" compared to predicate. "thoroughly tested through validation and verification of specifications."
Functional Equivalence	Identical intended use, fundamental scientific technology, operating principle, and parameter specifications as predicate.	Device E-COPSv shares these characteristics with the predicate M-COPSv.
Compliance with Standards	Conformity to relevant IEC, EN, UL, AAMI, and FDA guidances (listed in text).	Device has been "assessed against the standards below."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on nonclinical testing and comparison to a predicate device, not a clinical study with a distinct test set involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of a separate "test set" and no experts establishing ground truth in the context of a new diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physiological monitor, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable in the context of this device. The device itself is a standalone module for monitoring. Its "performance" is assessed through engineering validation and verification against its specifications and comparison to the predicate, rather than an algorithm's performance in isolation from a human operator. The document states it has been "thoroughly tested through validation and verification of specifications."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for AI/ML diagnostics is not present. The validation of this device relies on:

Engineering Specifications: The device's measurements (C.O., SvO2, invasive pressure) are compared against established engineering and physiological standards.
Predicate Device Comparison: The "ground truth" for demonstrating substantial equivalence is the previously cleared predicate device, M-COPSv (K961063), and its established safety and effectiveness.
Compliance with Standards: Adherence to a long list of international and national medical device standards (e.g., IEC 60601 series, ISO 14971).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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NOV 2 2 2005

K052977

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM Cardiac Output and SvO2 Module, E-COPSv and accessories

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

October 13, 2005

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Datex-Ohmeda S/5™ Cardiac Output and SvO2 Module, E-COPSv and accessories

COMMON NAME:

Cardiac Output, Invasive Pressure, and SvO2 Module

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

Product Code	Classification Name	CFR Section
DQK	Diagnostic, programmable computer	870.1425
DSK	Blood pressure computer	870.1110

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Datex-Ohmeda S/5™ Cardiac Output and SvO2 Module, E-COPSv and accessories is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M COPSv Module (K961063).

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. DEVICE DESCRIPTION as required by 807.92(a)(4)

INTENDED USE as required by 807.92(a)(5)

Intended Use:

The Datex-Ohmeda S/5™ Cardiac Output and SvO2 module , E-COPSv and accessories is intended for use with Datex-Ohmeda modular monitors for cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2), and invasive blood pressure monitoring of hospitalized patients.

Indications for use:

. .

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda S/5TM Cardiac Output and SvO2 Module, E-COPSv and accessories is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M COPSv Module (K961063).

The E-COPSv module has the following similarities compared to the predicate M-COPSv (K961063):

identical intended use and essentially same indications for use (minor text changes for . consistency with all other S/5 modules and specifically added invasive blood pressure which was in the predicate device but inadvertly not mentioned in indications statement)
. identical fundamental scientific technology
. same electronic measurement board
. same module software (minor modification and version change)
. same monitor software related to Cardiac Output and SvO2
. use the same operating principle
. same accessories for Cardiac Output and SvO2
. have the same user interface at the monitor and alarms (can be used with the same monitor software)
. the parameter specifications are the same
. have the same safety and effectiveness
. are manufactured using the same processes

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The main differences between the new E-COPSv and the predicate M- COPSv (K961063) is primarily due to fact that the new E-COPSv module has the following changes:

new color, shape, and size and thus differing mechanics ●
The front panel and labeling have changed (new GE-type connector for invasive blood . pressure)
. New layout of electronic input board between module connector and measurement board
. New layout of electronic measurement board
. Minor software modification
. New invasive blood pressure accessories for the new GE-type connector

Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of the Datex-Ohmeda S/5™ Cardiac Output and Sv02 Module, E-COPSv are substantially equivalent to the predicate Datex-Ohmeda M-COPSv Module (K961063).

SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The Datex-Ohmeda S/5™ Cardiac Output and SvO2 Module, E-COPSv and accessories has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices .
FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993 ●
IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety)
EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + Amdt. ◆ 1:1991 + Amdt. 2:1995)
. CAN/CSA C22.2 No. 601.1-M90 + S1:1994 (Canadian deviations to IEC 60601-1:1988 + Amdt. 1:1991) + S2:1998 (=IEC Amdt 2:1995)
. UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. 2:1995)
. IEC 60601-1-2:2001 (Electromagnetic compatibility - Requirements and tests)
. AAMI ES1-1993 (Safe current limits for electromedical apparatus)
FDA/ODE Guidance for Content of Premarket Submission for Software Contained in Medical . Devices. (May 11, 2005)
. ISO 14971:2000, Application of risk management to medical devices
IEC 60601-2-34 Medical electrical equipment. Part 2: Particular requirements for the safety of ● Direct Blood Pressure Monitoring Equipment: 2000.
. IEC 60601-2-49 Medical electrical equipment. Part 2: Particular requirements for the safety of MultifunctionPatient Monitoring Equipment: 2001.

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5TM Cardiac Output and SvO2 Module, E-COPSv compared to the legally marketed (predicate) Datex-Ohmeda M COPSv Module (K961063).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

NOV 2 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Healthcare c/o Mr. Joel Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492

Re: K052977

: Trade Name: Datex-Ohmeda S/5 Cardiac Output and SvO2 Module, E-COPSv and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Computer, Diagnostic, Programmable Regulatory Class: II (two) Product Code: DQK Dated: October 17, 2005 Received: October 24, 2005

Dear Mr. Kent:

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.

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Page 2 - Mr. Joel Kent

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 or any I 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. product faction of 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 (240) 276-0120. 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/cdrb/industry/support/index.html.

Sincerely yours,

Blymmuta for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K0 5 2977

Device Name: The Datex-Ohmeda S/5™ Cardiac Output and SvO2 module, E-COPSv and accessories.

Indications for use:

The Datex-Ohmeda S/5™ Cardiac Output and SvO2 module, E-COPSv and accessories is used for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2), and invasive blood pressure monitoring of hospitalized patients.

The device is indicated for use by qualified medical personnel only.

Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Rimmuma
skip-on

f Cardiovascular Devices
Number K05d977

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Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).