DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN

K092680 · GE Healthcare Finland Oy · MHX · Sep 23, 2009 · Cardiovascular

Device Facts

• Record ID: K092680
• Device Name: DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN
• Applicant: GE Healthcare Finland Oy
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for multiparameter patient monitoring with optional patient care documentation. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients. When the BIS module is used with the S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A, it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS module, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric population. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is also indicated for documenting patient care related information. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for use by qualified medical personnel only.

Device Story

Modular patient monitor for hospital use; collects physiological data via plug-in modules (ECG, blood pressure, pulse oximetry, temperature, EEG). Main software (L-ANE07/L-ANE07A) processes inputs to calculate arrhythmia, ST-segments, heart rate, impedance, respiration, energy expenditure, EEG spectrum, evoked potentials, and entropy. Displays numeric values, waveforms, and trends; provides audible/visual alarms. Operated via keyboard and ComWheel pointing device; supports optional remote controller. Enables patient care documentation by integrating trend data and manual event/medication entry. Stand-alone or networked configuration for central station viewing and archiving. Facilitates clinical decision-making by providing real-time physiological status and anesthetic effect monitoring. Benefits include continuous patient surveillance and streamlined documentation.

Clinical Evidence

No clinical studies required to support substantial equivalence. Evidence based on bench testing, including risk analysis, design reviews, unit-level verification, system integration testing, and final validation.

Technological Characteristics

Modular patient monitor; F-CU8 or F-CU5(P) frames; E-EXT extension and E-REC recorder modules. Software-based processing (L-ANE07/L-ANE07A). Connectivity: standalone or networked (central station/archiving). User interface: keyboard, ComWheel, remote controller. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for monitoring hemodynamic, respiratory, ventilatory, gastrointestinal/regional perfusion, Entropy, and neurophysiological status in all hospital patients (adult and pediatric). BIS module indicated for EEG signal acquisition to monitor brain state; BIS index indicated as adjunct for monitoring anesthetic agent effects in adults. Use restricted to qualified medical personnel.

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 ANESTHESIA MONITOR WITH L-ANE05 AND L-ANE05A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS AND E-EXT EXTENSION MODULE AND E-REC RECORDER MODULE (K051400)

Submission Summary (Full Text)

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# SEP 2 3 2009

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Comments of the

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GE Healthcare Finland Oy
Kuortaneenkatu 2, P.O. Box 900
Fl-00031 GE Finland
T: [phone]
F: [phone]

## 510(k) Summary

| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date:<br>Submitter: | August 21, 2009<br>GE Healthcare Finland Oy.<br>Kuortaneenkatu 2<br>Helsinki, Finland<br>FIN-00510 |
| Primary Contact Person: | FIN-00510<br>Päivi Roiha<br>Regulatory Affairs Leader<br>GE Healthcare Finland Oy<br>Kuortaneenkatu 2<br>Helsinki, Finland<br>FIN-00510<br>Phone: + 358 10 394 3731<br>Fax: [phone]<br>E-mail: [e-mail] |
| Secondary Contact Person:<br>Device:<br>Trade Name: | Robert Casarsa<br>Regulatory Affairs Leader<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail]<br>Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A<br>software, using F-CU8 or F-CU5(P) monitor frame options and E-EXT<br>extension module and E-REC recorder module |
| Common/Usual Name:<br>Classification Names:<br>Product Code: | Patient Monitor, Paper Chart Recorder (E-REC)<br>21 CFR 870.1025 Arrhythmia detector & alarm (MHX)<br>21 CFR 870.1025 Monitor ST-segment & alarm (MLD)<br>21 CFR 870.2810 Paper chart recorder (DSF) |
| Predicate Device(s): | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE05 AND L-ANE05A<br>SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS AND E-<br>EXT EXTENSION MODULE AND E-REC RECORDER MODULE (K051400) |
| Device Description: | The S/5 Anesthesia Monitor is a patient monitor, which displays the<br>measurement of patient physiological parameters in the hospital setting.<br>The measurement of patient physiological parameters is accomplished by<br>specialized measurement modules which, when plugged into the frame,<br>allow the modules to communicate with the monitor. The caregiver can<br>select from a variety of available measurements (parameters) and apply<br>those parameters that are best suited to patient care. Modules perform the<br>functions of parameter measurement and minor data processing. The S/5<br>Anesthesia Monitor displays parameters on screen, signals alarms and<br>performs advanced data processing. There are two software options<br>available for the S/5 Anesthesia Monitor: L-ANE07 and L-ANE07A: L-ANE07A<br>is equipped with extended arrhythmia analysis capability. Other than |

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arrhythmia analysis capabilities, this software option is identical to L-ANE07. There are two monitor frame options; the 5-module F-CU5(P) monitor frame and the 8-module F-CU8 module frame which can be extended with an Extension Frame. F-EXT4, via the Extension Module E-EXT. The monitor can be equipped with a Recorder Module, E-REC. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A user several types of plugin measurement modules. Modules (with the exception of E-REC and E-EXT) are the subject of separate 510(k)'s and are not part of this notification. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures, pulse oximetry 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/5 Anesthesia Monitor with L-ANE07 and L-ANEO7A can display measurements in the form of numeric values, waveforms and trends. Audible and visual alorms are used to indicate patient status. The alarm priority of an alarm depends on the parameter. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A is operated by a keyboard. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then made easily from the menu using a unique designed pointing device on the keyboard called a ComWheel. The software L-ANE07 and L-ANE07A perform some module related tasks like arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation. EEG spectrum analysis evoked potential response averaging and entropy calculations. All the module communication is also handled in . the main software. The software L-ANE07 and L-ANE07A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthetic record, and the related events and medication can be easily entered with the same user interface as the monitor itself. There are various optional types of keyboards, some are like standard keyboard and another is a hand-held Remote Controller (REMCO) which is still directly connected to the S/5 Anesthesia Monitor via a long cord but provides flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper option, patient related care events are documented using the keyboard. The S/5 Anesthesia 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 as well as the patient care documentation can be sent via a network to a central computer for archiving. The S/5 Anesthesia Monitor can also be uparaded to L-ANEO7(A) software using the CARESCAPE Life Uparade Program that offers a means to continuously keeping products up-to-date, by upgrading modular anesthesia dating back to 1992 to the last S/5 software level. Upgrading of modular monitors is performed with one of the available U-LIFE upgrade kits. The kit includes all hardware and main software components needed to make the monitor compatible with the last main software being delivered.

Intended Use:

The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for multiparameter patient monitoring with optional patient care documentation.

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of hemodynamic (including arrhythmia and STseament analysis), respiratory, ventilatory, aastrointestinal/regional perfusion, Entropy (State Entropy and Response Entropy) and

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## neurophysiological status of all hospital patients.

When the BIS module is used with the S/5 Anesthesia Monitor with L-ANE07 and L-ANEO7A. it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS module. may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric population.

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is also . indicated for documenting patient care related information.

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for use by qualified medical personnel only.

The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A Technology: software, using F-CU8 or F-CU5(P) monitor frame options and E-EXT extension module and E-REC recorder module employs the same fundamental scientific technology as its predicate devices.

#### Summary of Non-Clinical Tests: Determination of Substantial Equivalence:

Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A

software, using F-CU8 or F-CU5(P) monitor frame options and E-EXT extension module and E-REC recorder module and its applications comply with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- Risk Analysis
- Requirements Reviews .
- Design Reviews
- Testing on unit level (B-CPU6 verification)
- Integration testing (System verification) .
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
- Environmental testing

### Summary of Clinical Tests:

The subject of this premarket submission, Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software, using F-CU8 or F-CU5(P) monitor frame options and E-EXT extension module and E-REC recorder module, did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software, using F-CU8 or F-CU5(P) monitor frame options and E-EXT extension module and E-REC recorder module to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, flowing manner.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

GE Healthcare Finland OY c/o Mr. Paivi Roiha Regulatory Affairs Leader Kuortaneenkatu 2 Helsinki, FIN-00510 Finland

## SEP 2 3 2009

Re: K092680

> Trade/Device Name: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software, using F-CU8 or F-CU5 (P) monitor frame options and E-EXT extension module and E-REC recorder module

Regulatory Number: 21 CFR 870.1025

Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two)

Product Code: MHX Dated: August 30, 2009

Received: September 1, 2009

Dear Mr. Roiha:

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 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. Paivi Roiha

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W. M. F.

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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K09 2680

Device Name: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software, using F-CU8 or F-CU5(P) monitor frame options and E-EXT extension module and E-REC recorder module

Indications for Use:

The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for multiparameter patient monitoring with optional patient care documentation

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory; gastrointestinal/regional perfusion, Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients. When the BIS module is used with the S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A. it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG. signals. The... Bispectral index (BIS), a processed EEG variable, and one component of the BIS module, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric

population. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is also indicated for documenting patient care related information.

The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for use by qualified medical personnel only.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)

のお、

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CORE, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K072580