DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES

K052977 · GE Healthcare · DQK · Nov 22, 2005 · Cardiovascular

Device Facts

• Record ID: K052977
• Device Name: DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
• Applicant: GE Healthcare
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

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.

Device Story

E-COPSv is a single-width plug-in module for Datex-Ohmeda S/5 modular monitoring systems (Anesthesia/Critical Care monitors). It processes invasive signals to monitor cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2), and invasive blood pressure. The module transforms raw invasive sensor inputs into hemodynamic and oxygenation parameters; these are displayed on the monitor screen as waveforms and numerical values. Clinicians adjust waveform size, color, and sweep speed via the monitor interface. The device provides real-time monitoring and trending of parameters to assist healthcare providers in clinical decision-making for hospitalized patients. It utilizes the same accessories and operating principles as the predicate M-COPSv module.

Clinical Evidence

No clinical data. The device was assessed through bench testing, verification, and validation of specifications against recognized safety and performance standards, including IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-34.

Technological Characteristics

Single-width plug-in module for modular patient monitoring systems. Features invasive pressure, C.O., REF, and SvO2 sensing. Connectivity via proprietary module connector. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-34, and IEC 60601-2-49. Software-based parameter calculation and signal processing. Powered by host monitor.

Indications for Use

Indicated for monitoring cardiac output, right ventricular ejection fraction, mixed venous oxygen saturation, and invasive blood pressure in hospitalized patients. For use by qualified medical personnel only.

Regulatory Classification

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.

Predicate Devices

• Datex-Ohmeda M-COPSv Module (K961063)

Submission Summary (Full Text)

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Page 1 of 3

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: [phone] Fax: [phone]

## 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)

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.

# 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:

. .

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.

## 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 [phone]. 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 [phone] or [phone] 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
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f Cardiovascular Devices
Number K05d977

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