K Number

Device Name

DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES

Manufacturer

GE HEALTHCARE

Date Cleared

2006-01-13

(81 days)

Product Code

DQK

Regulation Number

870.1425

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. 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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K922876

Reference Devices

Datex-Ohmeda M-COP Module (K922876)

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard cardiac output monitoring module and does not mention any AI or ML capabilities. The listed standards and testing methods are typical for traditional medical devices.

Therapeutic

No
The device is described as being for "monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), and invasive blood pressure," which are diagnostic and monitoring functions, not therapeutic.

Diagnostic

Yes

The device is intended for "monitoring cardiac output (C.O.), right ventricular ejection (REF), and invasive blood pressure of hospitalized patients." Monitoring these physiological parameters falls under the definition of a diagnostic device as it provides information for diagnosis.

SaMD (Software as a Medical Device)

The device is described as a "single-width plug-in parameter module" and mentions "accessories that are in contact with the patient," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use is for monitoring physiological parameters (cardiac output, right ventricular ejection fraction, and invasive blood pressure) of hospitalized patients. This involves direct measurement of parameters within the living body, not the examination of specimens taken from the body.
Device Description: The description details a plug-in module for a patient monitoring system that performs invasive measurements. This reinforces that it's monitoring parameters directly from the patient.
Lack of IVD Characteristics: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.

Therefore, the Datex-Ohmeda S/5™ Cardiac Output module, E-COP is a patient monitoring device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DQK, DSK

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

Datex-Ohmeda M-COP Module (K922876)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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).

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:

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 .

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)

. 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).

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.

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

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)

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