The Datex-Ohmeda S/5™ Cardiac Output module , E-COP and accessories are intended to be used for monitoring cardiac output (C.O.), right ventricular ejection (REF), and invasive blood pressure of hospitalized patients.

The Datex-Ohmeda S/5TM Cardiac Output module , E-COP and accessories are indicated for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), and invasive blood pressure of hospitalized patients.

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

Device Description

The Datex-Ohmeda S/5TM Cardiac Output module, E-COP is a single-width plug-in parameter module for a Datex-Ohmeda S/5 modular monitoring system. E-COP is used for monitoring cardiac output (C.O.) and right ventricular ejection fraction (REF) of hospitalized patients. Invasive pressure measurement is also available. All measurements are invasive. The Datex-Ohmeda Cardiac Output module, E-COP can be used with the following Datex-Ohmeda modular monitors with 510(k) clearances:

S/5TM Anesthesia Monitor (AM) with main software S-STD96(A) or S ARK96(A) or newer ●
S/5™ Compact Anesthesia Monitor (CAM) with main software S-STD96(A) or S-ARK96(A) . or newer
S/5TM Critical Care Monitor (CCM) with main software S-ICU97(A) or newer. .
S/5TM Compact Critical Care Monitor (CCCM) with main software S-ICU97(A) or newer. . The E-COP module can be used both with the legacy S/5 8-module monitor frame F CU8 and with the new 5-module monitor frame F-CU5(P) (submitted separately). The Cardiac Output or invasive pressure signal can be displayed on the monitor screen. The waveform size, color and sweep speed can be adjusted. The E-COP module calculates a number of parameters related to oxygenation or hemodynamics. All the calculated parameters can be selected on the display, and trended. Accessories that are in contact with the patient are CE-marked by Baxter and distributed by GE Healthcare

AI/ML Overview

The provided text details the Premarket Notification 510(k) Summary for the Datex-Ohmeda S/5™ Cardiac Output module, E-COP and accessories, which seeks substantial equivalence to a predicate device, the Datex-Ohmeda M-COP Module (K922876). This document is focused on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving that it meets specific, independently established acceptance criteria through a clinical study with detailed performance metrics.

However, based on the information provided, we can infer the "acceptance criteria" and how the device "meets" them in the context of a 510(k) submission.

1. Table of inferred "Acceptance Criteria" and Reported Device "Performance":

Since this is a 510(k) submission, the "acceptance criteria" are implicitly defined by the characteristics of the predicate device, and the "performance" is the new device's ability to achieve "substantial equivalence."

Acceptance Criteria (Inferred from Predicate Device Features)	Reported Device Performance (E-COP vs. M-COP)
Intended Use and Indications for Use	The same intended use and indications for use, with the addition of REF measurement.
Fundamental Scientific Technology	Identical fundamental scientific technology.
Operating Principle	Uses the same operating principle.
Accessories for Cardiac Output Measurement	Identical accessories for Cardiac Output measurement.
User Interface and Alarms	Same user interface at the monitor and alarms (can be used with the same monitor software).
Customer and Parameter Specifications	Same customer and parameter specifications.
Safety and Effectiveness	Same safety and effectiveness.
Manufacturing Processes	Manufactured using the same processes.
Compliance with Relevant Standards and Guidance	Assessed against and concluded to meet relevant standards (e.g., IEC 60601-1, AAMI ES1-1993, ISO 14971:2000) and FDA guidance documents.
Absence of New Questions of Safety and Effectiveness	"No new questions of safety and effectiveness" compared to the predicate device, despite minor physical and electronic changes, and software modifications.

2. Sample size used for the test set and the data provenance:

The document does not describe a traditional "study" with a test set in the sense of a clinical trial or performance evaluation with patient data. Instead, it relies on nonclinical testing (validation and verification of specifications against standards) to demonstrate equivalence. Therefore, there is no mention of a "sample size for the test set" or "data provenance" in terms of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As described above, there is no traditional "test set" with ground truth established by experts in the context of this 510(k) submission for demonstrating clinical performance. The assessment is based on engineering evaluations and compliance with standards.

4. Adjudication method for the test set:

Not applicable. No "test set" requiring adjudication by experts is described.

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. The device is a cardiac output and invasive pressure monitoring module, not an AI-assisted diagnostic tool for interpretation by human readers.

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

The document describes nonclinical testing, validation, and verification of the device's specifications and compliance with standards. This implicitly represents "standalone" performance testing of the device's functionality and safety, separate from human interaction, but not in the sense of an "algorithm only" performance study. The device is a monitor, not a pure algorithm.

7. The type of ground truth used:

For the nonclinical testing, the "ground truth" refers to established engineering specifications, published international and national standards (e.g., IEC 60601-1), and FDA guidance documents. The device's performance was compared to these defined requirements, rather than clinical outcomes or pathology.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that would require training data. The document describes a medical device seeking substantial equivalence to a predicate.

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

Not applicable. As this is not an AI/machine learning device, there is no training set or ground truth in that context.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '052976'. The numbers are written in a simple, slightly slanted style, and the overall impression is that of a quickly jotted down code or identifier.

JAN I 3 2006

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5™ Cardiac Output module , E-COP 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 19, 2005

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

TRADE NAME:

Datex-Ohmeda S/5TM Cardiac Output module , E-COP and accessories

COMMON NAME:

Cardiac Output, Invasive Pressure 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 module, E-COP is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-COP Module (K922876).

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

S/5TM Anesthesia Monitor (AM) with main software S-STD96(A) or S ARK96(A) or newer ●
S/5™ Compact Anesthesia Monitor (CAM) with main software S-STD96(A) or S-ARK96(A) . or newer
S/5TM Critical Care Monitor (CCM) with main software S-ICU97(A) or newer. .

S/5TM Compact Critical Care Monitor (CCCM) with main software S-ICU97(A) or newer. . The E-COP module can be used both with the legacy S/5 8-module monitor frame F CU8 and with the new 5-module monitor frame F-CU5(P) (submitted separately). The Cardiac Output or invasive pressure signal can be displayed on the monitor screen. The waveform size, color and sweep speed can be adjusted. The E-COP module calculates a number of parameters related to oxygenation or hemodynamics. All the calculated parameters can be selected on the display, and trended. Accessories that are in contact with the patient are CE-marked by Baxter and distributed by GE Healthcare

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

Intended Use:

The Datex-Ohmeda S/5™ Cardiac Output module, E-COP and accessories are intended to be used for monitoring cardiac output (C.O.), right ventricular ejection (REF), and invasive blood pressure of hospitalized patients.

Indications for use:

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

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

The Datex-Ohmeda $/5™ Cardiac Output module, E-COP is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-COP Module (K922876). The E-COP module has the following similarities compared to the predicate M-COP (K922876):

. The same intended use and indications for use with the addition of the REF measurement
Identical fundamental scientific technology ●
Use the same operating principle .
. Identical accessories for Cardiac Output measurement
Have the same user interface at the monitor and alarms (can be used with the same . monitor software)
The Customer and 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-COP and the predicate M-COP (K922876) is primarily due to fact that the new E-COP 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)
There is no Cardiac Output test connector in the front panel .
New layout of electronic input board between module connector and measurement . board
. Electronic measurement board uses surface mounted instead of through-hole components
Minor modifications and corrections to the module software, and the addition of . the REF measurement.
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/51M Cardiac Output Module, E-COP are substantially equivalent to the predicate Datex-Ohmeda M-COP Module (K922876).

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

The Datex-Ohmeda S/5TM Cardiac Output Module, E-COP 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
. IEC60601-2-34 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 module, E-COP compared to the legally marketed (predicate) Datex-Ohmeda M-COP Module (K922876).

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Image /page/3/Picture/2 description: The image is a circular seal for the Department of Health and Human Services (USA). The seal features the department's logo, which is a stylized depiction of an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

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

K052976 Re:

KU32976
Trade Name: Datex-Ohmeda S/5™ Cardiac Output Module, E-COP and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: December 15, 2005 Received: December 16, 2005

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(x) premier is substantially equivalent (for the indications ferenced above and nave decembers and and marketed predicate devices marketed in interstate for use stated in the enclosure) to regars actiment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Lead Ford Ford. Day commerce prior to May 20, 1978, the enaouther with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Unit devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM alle Cosmetic Act (71ct) that to her require apperal controls provisions of the Act. The Tou may, therefore, market the device, economics for annual registration, listing of general controls provisions of use tice, 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 If your device is olassimod (600 world). 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 C. Kent

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issualled of a substained on the other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decernmation and your contrastered by other Federal agencies. You must or any rederal statutes and regulations aannadines but not limited to: registration and listing (21 comply with an the Act s requirements, mortaling practice requirements as set CFR Part 807), labeling (21 CFRT art 800), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control pro risens (ovetice as described in your Section 510(k) This letter will anow you to begin maneting your and equivalence of your device to a legally premarket notification. The PDA midning of Succession 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 If you desire specific advice for Jour act (240) 276-0120. Also, please note the regulation entitled, p Contact the Office of Compullion at (216) 216-678 Part 807.97). You may obtain Misolallung by icrerchee to premainteriorities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolisanhibi/Www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blymmma 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): _ _ 0 5 - 2 97 6

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

Indications for use:

The Datex-Ohmeda S/5™ Cardiac Output module , E-COP and accessories are indicated for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), and invasive blood pressure 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)

Page (_ of _

Bhumma

ardiov

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).