DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
Device Facts
| Record ID | K021376 |
|---|---|
| Device Name | DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE |
| Applicant | Datex-Ohmeda |
| Product Code | DSI · Cardiovascular |
| Decision Date | Jul 24, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
Indications for Use
The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A is intended for multiparameter patient monitoring.
Device Story
Modular patient monitor for hospital use; accepts plug-in measurement modules for ECG, invasive/non-invasive blood pressure, pulse oximetry, temperature, CO2, and BIS. Transforms physiological signals into numeric values, waveforms, and trends; performs advanced data processing including arrhythmia analysis, ST-segment calculation, heart rate, impedance/respiration rate, energy expenditure, drug calculations, EEG spectrum analysis, and evoked potential response averaging. Operated by clinicians via keyboard and ComWheel pointing device. Provides audible/visual alarms; supports networked configuration for central station viewing/archiving. Improved CPU and interface boards enhance data handling and alarm management. Benefits include real-time patient status visualization and clinical decision support for hemodynamic and anesthetic management.
Clinical Evidence
Bench testing only. Includes electrical safety, electromagnetic compatibility, mechanical/environmental tolerance, and software validation/verification. Compliance verified against standards including IEC 60601-1, IEC 60601-2-27 (ECG), IEC 60601-2-30 (BP), IEC 60601-2-34 (InvBP), and IEC 60601-2-40 (EEG). No clinical trial data presented.
Technological Characteristics
Modular multiparameter monitor; plug-in measurement modules. Hardware: B-CPU5 CPU board, B-UPI4NET interface board. Connectivity: Standalone or networked (central station/monitor-to-monitor). Software: L-ICU02/L-ICU02A (factory preloaded). Standards: IEC 60601-1, IEC 60601-1-2, ISO 9919, ISO 9918, ISO 7767, ANSI/AAMI EC57.
Indications for Use
Indicated for monitoring hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. When using BIS, it monitors brain state via EEG signal acquisition/processing to aid in monitoring effects of certain anesthetic agents. 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 CS/3 Critical Care Monitor with S-ICU99(A) software (K000168)
Submission Summary (Full Text)
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JUL 2 4 2002
# K021376
Page 1 of 5
## Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software
## 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: 781-449-8685 Fax: 781-433-1344
#### NAME OF CONTACT:
Mr. Joel Kent
DATE:
July 20, 2002
#### DEVICE NAME as required by 807.92(a)(2)
#### TRADE NAME:
Datex-Ohmeda S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software
#### COMMON NAME:
Patient Monitor
#### CLASSIFICATION NAME:
## The following Class III classification appears applicable:
| DSI | Arrhythmia detector & alarm | 870.1025 |
|-----|--------------------------------|----------|
| | MLD Monitor ST-segment & alarm | 870.1025 |
## NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIV ALENCE IS MADE as required by 807.92(a)(3)
The Datex-Ohmeda S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is substantially equivalent to the predicate Datex-Ohmeda CS/31M Cricical Care Mouitwawth S-ICU99(A) software (K000168).
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## DEVICE DESCRIPTION as required by 807.92(a){4)
The intended use and indications for use for the modified device, Datex-Obmeda S/STM Critical Care Monitor with L-ICU02 and L-ICU02A software is similar as the predicate Datex-Ohmeda CS/3TM Critical Care Monitor with S-ICU99(A) software (K000168).
There has been no change to the fundamental scientific technology from the predicate.
The device description of the Datex-Ohmeda S/5 TM Critical Care Monitor with L-ICU02 and L-ICU02A software is as follows:
The S/5™ Critical Care 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 care giver 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 Critical Care Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5 Critical Care Monitor with L-ICU02 and L-ICU02A.
L-ICU02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ICU02.
The modifications to the device are:
- Improved Central Processing Unit Board, B-CPU5, with increased memory 1. capability.
- Improved Universal Peripheral Interface Board, B-UPI4NET, which is a 2. combination of the previous B-UPI and B-NET boards.
- Rotating of the "ComWheel" now scrolls through different trend pages. 3.
- 4. Technical alarms such as "SpO2 probe off", "Leads off" (ECG), and "Px No transducer" (InvBP) transferred to the Central Station.
- 5. Changed to include support for alarm silencing and alarm limits adjustment from Central Station.
- 6. The alarm priority of "X module removed" message has been increased from note level to yellow level.
- 7. Software can additionally send request for recording to Central Station.
- Standby information is additionally sent to Central Station. 8.
- Snapshot printing speed 25 mm/s has been added. 9.
- Mean Arterial Pressure value replaces O2 F1 value in vital parameters numerical 10. trend.
- 11. The NMT cycle time selections have been changed to be:
- 20 s / 1 min / 5 min / 15 min / 30 min / 60 min / 120 min.
- 12. Lifetime of an old NIBP value has been changed from 60 min to 245 min.
- Support for M-BIS (Bispectral Index) module has been added. M-BIS is the 13. subject of a separate 510(k) premarket notification
- 14. Support for the M-miniC (CO2 module) module has been added. The Mini CO2 module M-miniC is the subject of a separate 510(k) premarket notification.
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- Support for the N-DIS external device interfacing modules for interfacing of the 15. following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines has been added. The N-DIS modules is the subject of a separate 510(k) premarket notification.
- Uses arrhythmia analysis version which has an improved vfib algorithm 16. compared to arthythmia analysis version submitted in the predicate 510(k).
The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A uses several types of plugin measurement modules. Modules are the subject of separate 510(k)'s and are not part of this notification.
The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A is typically furnished with a module that measures BCG, invasive and non-invasive blood pressures, pulse oximerry and temperature. Modules are placed in the S/5™ monitor frame and are automatically recognized by the monitor. The patient cables are connected to the module plug in jacks and then monitoring can begin. The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A can display measurements in the form of numeric values, traces and trends. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A is overated by a kevboard. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. The software L-ICU02 and L-ICU02A perform some module related tasks like arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, drug calculation, EEG spectrum analysis and evoked potential response averaging. All the module communication is also handled in the main software. There are various optional types of keyboards, some are like standard keyboards and another is a hand-held Remote controller (K-REMCO) which is still directly connected to the S/5TM Critical Care Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. The S/5™ Critical Care Monitor can be in a stand-alone or networked configuration. If networked, measurements are sent to the network for central station or monitor-to-monitor viewing. Trends can also be sent via a network to a central computer for archiving.
#### INTENDED USE as required by 807.92(a)(5)
Intended use:
The \$/5"M Critical Care Monitor with L-ICU02 and L-ICU02A is intended for multiparameter patient monitoring.
#### Indications for use:
The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A 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*. (*Gan TJ, Glass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index Monitoring Allows Faster Ernergence and Improved Recovery from Propofol, Alfertanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:808-15.) The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for use by qualified medical personnel only.
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#### SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The Datex-Ohmeda S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is substantially equivalent to the predicate Datex-Ohmeda CS/37M Critical Care Monitor with S-ICU99(A) software (K000168).
The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A 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* (*Gan TJ, Glass P, Windsor A, Pavne F. Rosow C. Sebel P. Manberg P. Bispectral Index Monitoring Allows Faster Emergence and Improved Recovery from Propofol. Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:308-15.) The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for use by qualified medical personnel only. There are two software options available for the S/5TM Critical Care Monitor: L-ICU02 and L-ICU02A (collectively referred to as L-ICU02(A) ). (Note: Lrefers to software license). Only one software can be used at any given time in the monitor. The software is preloaded in the factory. The new device with different software options, S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A, is compared to predicates as outlined below. The basic model of the monitor is the S/5TM Critical Care Monitor with L-ICU02, which is a new revision of the predicate devices, CS/37M Critical Care Monitor with S-ICU99 (K000168). The S/5TM Critical Care Monitor with L-ICU02 may be equipped with extended bedside arrhythmia analysis capability and in this case the monitor is called S/51M Critical Care Monitor with L-ICU02A. The arrhythmia analysis functionality of the S/5TM Critical Care Monitor with L-ICU02A is substantially equivalent to the functionality of the predicate device CS/3™ Critical Care Monitor with S-ICU99A (K000168). The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A is a modular multiparameter patient monitor providing connections to measurement modules. The general construction, indications for use and intended use of the S/57M Critical Care Monitor with L-ICU02 and L-ICU02A are similar compared to the predicate CS/3TM Critical Care Monitor with S-ICU99(A) (K000168).
Based on the above and a detailed analysis in other documentation included in this 510(k) notification it is evident that the main features and indications for use of the S/504 Critical Care Monitor with L-ICU02 and L-ICU02A software is substantially equivalent to the predicate CS/3TM Critical Care Monitor with S-ICU99(A) software (K000168) ..
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## SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
The Datex-Ohmeda S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verifications. Verifications. 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 .
- 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 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™ Critical Care Monitor with L-ICU02 and L-ICU02A software as compared to the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2002
Datex-Ohmeda c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492
Re: K021376
Trade Name: Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A Software Regulation Name: Arrhythmia Detector and Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: DSI Dated: April 29, 2002 Received: May 1, 2002
Dear Mr. Kent:
This letter corrects our substantially equivalent letter of July 24, 2002, regarding the incorrect Indications for Use.
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.
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Page 2 - Mr. Joel C. Kent
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 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 comply 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you 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 80) and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html
Sincerely vou
Elias Mallés
Image /page/6/Picture/7 description: The image shows a close-up of a handwritten signature. The signature appears to be in cursive and is written with a dark ink on a white background. The signature is somewhat stylized and difficult to read, but it seems to start with a loop and then continues with a series of connected strokes.
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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K021376 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
## Device Name: Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software
## Indications For Use:
The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and STsegment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients.
The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A 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/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for use by qualified medical personnel only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
| Division of Cardiovascular & Respiratory Doctor: | |
|--------------------------------------------------|---------|
| Group Number | K021375 |
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