DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE

K041790 · Datex-Ohmeda · MHX · Jul 23, 2004 · Cardiovascular

Device Facts

• Record ID: K041790
• Device Name: DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
• Applicant: Datex-Ohmeda
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A is intended for multiparameter patient monitoring with optional patient care documentation. Indications for use: The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy and Response entropy) and neurophysiological status of all hospital patients. The S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents. The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is also indicated for documenting patient care related information. The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for use by qualified medical personnel only.

Device Story

Modular multiparameter patient monitor; displays physiological parameters in hospital settings. Inputs: specialized measurement modules (ECG, pressure, respiratory, BIS, Entropy). Operation: modules perform data acquisition/minor processing; monitor performs advanced data processing/alarm signaling. Output: screen display of numerical/waveform data; alarms. Used by clinicians for real-time patient status assessment and care documentation. Modifications from predicate: M-Entropy module support; improved QRS detection for low-amplitude ECG; updated Ventricular Tachycardia definition; invasive pressure cursor; trend page parameter updates; new cardiac output catheter types; CPB mode case reset disable; communication message updates; reduced ECG beep volume; SpO2 error message change; hardware updates (Intel microprocessor, LCD display).

Clinical Evidence

Bench testing only. Verification and validation of specifications performed. Compliance with IEC 60601 series, ISO 9918, ISO 9919, ISO 7767, ISO 11196, and FDA Class II Special Controls Guidance for Arrhythmia Detector and Alarm.

Technological Characteristics

Modular multiparameter monitor; Intel microprocessor; LCD display. Connectivity: measurement modules, D-O Central, iCentral. Software: L-CANE03/L-CANE03A (extended arrhythmia analysis). Standards: IEC 60601-1, IEC 60601-2-27 (ECG), IEC 60601-2-30 (pressure), IEC 60601-2-34 (invasive pressure), IEC 60601-2-40 (EMG/neuro), ISO 9919 (SpO2).

Indications for Use

Indicated for monitoring hemodynamic, respiratory, ventilatory, gastrointestinal/regional perfusion, BIS, Entropy, and neurophysiological status in all hospital patients. Used as an aid in monitoring anesthetic agent effects via EEG signal processing. For use by qualified medical personnel only.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (K022485)

Reference Devices

• M-ENTROPY module (K023459)

Submission Summary (Full Text)

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# Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software

14-796

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

# COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: [phone] Fax: [phone]

#### NAME OF CONTACT:

Mr. Joel Kent

DATE:

July 1, 2004

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

#### TRADE NAME:

Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software

#### COMMON NAME:

Patient Monitor

#### CLASSIFICATION NAME:

The following Class II classifications appear applicable:

Monitor, Physiological,Patient (With Arrhythmia Detection or Alarm) 870.1025 MHX Monitor, ST segment with Alarm 870.1025 MLD

## 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™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software (S/5™ CAM) is substantially equivalent to the predicate Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (K022485).

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

The intended use for the device, Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software, is identical to the predicate Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (K022485). The indications for use for the Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software are essentially the same as the predicate the only difference being that the new device supports the M-ENTROPY module and therefore Entropy has been added to the list of monitoring parameters. There has been no change to the fundamental scientific technology from the predicate. The S/5™ Compact Anesthesia Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The caregiver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5TM Compact Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5 Compact Anesthesia Monitor: L-CANE03 and L-CANE03A. L-CANE03A is equipped with extended arthythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-CANE03.

The modifications to the device are:

- Support for M-Entropy module has been added. M-Entropy has its own 510(k) clearance 1. (K023459).
- Improvement in the QRS detection with rather low QRS amplitude ECG, to avoid false 2. Asystole alarms.
- The definition for Ventricular Tachycardia has been modified: 3. now 6 beats at a heart rate of 120 (previously 5 beats at a heart rate of 100).
- 4. Invasive pressure cursor added to the InvBP waveform field. The cursor is used for marking the reference pressure levels during a monitoring period.
- న్. Invasive pressure Mean Arterial Pressure (Art mean) value has replaced FiAA value and NIBP mean value has replaced FiO2 value in the vital parameters numerical trend page.
- New catheter types added to the selection list for the Cardiac Output measurement. 6.
- Automatic case reset disabled during Cardio Pulmonary Bypass (CPB) mode. 7.
- Messages related to the communication between S/5 monitor and D-O Central have been 8. modified. "HR limit changed" and "PVC rate changed" messages have been replaced with the message "Alarm setup changed from Central".
- 9. Enhancements for the iCentral communication added.
- 10. ECG beep volume steps 1-5 have been modified to output less volume.
- The SpO2 error message "Poor signal" has been replaced with message "Low perfusion" 11. when M-PRESTN module is used.
- The recorder in Compact Monitor CMREC1..01 has been changed to be an option in 12. CM1.02.
- The AMD microprocessor in the S4CPU has been replaced with the Intel microprocessor. 13.
- The LCD display (LQ121S1DG31) has been replaced with LCD display 14. (LQ121S1DG41).

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

#### Intended use:

The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A is intended for multiparameter patient monitoring with optional patient care documentation. Indications for use:

The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy and Response entropy) and neurophysiological status of all hospital patients.

<041790

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The S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software when using BIS is for monitoring the state of the brain by data acquisition and processing of

electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents.

The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is also indicated for documenting patient care related information.

The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software 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 Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software (\$/5TM CAM) is substantially equivalent to the predicate Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (K022485). The new device with different software options, S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A, is compared to predicate as outlined below. The basic model of the monitor is the S/5TM Compact Anesthesia Monitor with L-CANE03, which is a new revision of the predicate devices, S/5TM Compact Anesthesia Monitor with L-CANE02 software (K022485). The S/5™ Compact Anesthesia Monitor with L-CANE03 may be equipped with extended bedside arrhythmia analysis capability and in this case the monitor is called S/5TM Compact Anesthesia Monitor with L-CANE03A. The arrhythmia analysis functionality of the S/5TM Compact Anesthesia Monitor with L-CANE03A is substantially equivalent to the functionality of the predicate device S/5TM Compact Anesthesia Monitor with L-CANE02A software (K022485).

The S/5™ CAM is a modular multiparameter patient monitor providing connections to measurement modules. The general construction, indications for use and intended use of the S/5™ CAM are the same as for the predicate S/5TM Compact Anesthesia Monitor with L-CANE02, L-CANE02A software (K022485). Based on the above and other documentation included in this 510(k) notification and attachments, it is evident that the main features and indications for use of the S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software are essentially the same as the predicate the only difference being that the new device supports the M-ENTROPY module and therefore Entropy has been added to the list of monitoring parameters.

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

Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:

- IEC 60601-1:1988+ Amdt.:1:1991 + Amdt. 2:1995 . .
- EN 60601-1: 1990 + A1:1993+A2:1995+A13:1996 . ·
- CAN/CSA-C22.2 No.601.1-M90 +S1:1994+Amdt. 2:1998 .
- IEC 60601-2-27:1994/EN 60601-2-27:1994 . .
- IEC 60601-2-30:1995/EN 60601-2-30:1995
- IEC 60601-2-34:1994/EN 60601-2-34:1994 ·
- IEC 60601-2-40:1998 . ・
- IEC 60601-1-2(1993)/EN 60601-1-2 · .
- IEC 60601-1-4: 1996+Amdt. 1:1999/EN 60601-1-4 · .
- ISO 9918:1993/EN 864:1996 . ·
- · ISO 9919:1992/EN865:1997 .
- ISO 7767:1997/EN12598:1999 · .
- ISO 11196:1995 + Corr. 1:1997/EN ISO11196:1997 ・ .
- IEC 601-2-10:1987/HD 395.2.10:1988 + Am.1:2000 . ·
- IEC 60601-2-26:1994/EN60601-2-26 · .
- IEC 60068-2 . .
- . . UL 2601-1:1997
- ANSI/AAMI ES-1:1993 . .
- ANSI/AAMI EC57:1998 .
- FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm . Document issued on: October 28, 2003
- FDA 21 CFR 898.12 .

#### CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software as compared to the predicate device.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

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

Re: K041790

K041790
Trade Name: Datex-Ohmeda S/5 ™ Compact Anesthesia Monitor L-CANE03 and L-CANE 03A Software Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: July 1, 2004 Received: July 2, 2004

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to togally and exament date of the Medical Device Amendments, or to Conninered pror to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been recuse in quire approval of a premarket approval application (PMA). and Cosmeter For (110) that the device, subject to the general controls provisions of the Act. The I ou may, dierelove, mains of the Act include requirements for annual registration, listing of general controls provisions 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 may be subject to back adderal 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 does not mean I lease be advised that I Drivisation that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I ederal states and states and submited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fat 607); accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic for the quality by tool provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of the rest free resimmarketing your device as described in your Section 510(k) I mis letter will and w you'ls cognified of substantial equivalence of your device to a legally prematics notification "The 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 other general intermational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil Rx Ogden

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): _KD41790

Device Name: Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software

Indications for Use:

The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients.

The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents.

The S/5 ™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is also indicated for documenting patient care related information. The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software 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)

Neil R.P. Ogden

(Division Sian-Division of Cardiovascular Devic

510(k) Number_

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