K Number

Device Name

DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE

Manufacturer

GE HEALTHCARE

Date Cleared

2006-05-15

(17 days)

Product Code

MHX

Regulation Number

870.1025

Intended Use

The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software is intended for multiparameter patient monitoring with optional patient care documentation. The S/5TM Compact Anesthesia Monitor with L-CANE05 and I -C ANE05A 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-CANE05 and L-CANE05A 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-CANE05 and L-CANE05A software is also indicated for documenting patient care related information. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05 A software is indicated for use by qualified medical personnel only.

Device Description

The S/5™ Compact Anesthesia Monitor with L-CANE05 and L CANE05A uses several types of plug-in measurement modules. Datex-Ohmeda M-series measurement modules or E-series modules are used. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A is operated by a keyboard. 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-CANE05 and L-CANE05A 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-CANE05 and L-CANE05A also include the option of creating patient care documentation. The trend informatically 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 keyboards and another is a hand-held Remote controller (K-CREMCO) which is still directly connected to the S/5TM Compact Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also supported, although the bar code reader is not manufactured anymore. The S/5™ Compact 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. Networking can be hardwired or wireless. The S/5 Compact Anesthesia Monitor can also be upgraded to L-CANE05(A) software using the S/5 L.I.F.E. upgrade program that offers a means to continuously keeping products upto-date, by upgrading modular anesthesia and critical care monitors and network products dating from back to 2000 to the latest S/5 software level. Upgrading of modular monitors and network products is performed with one of the available U-LIFE upgrade kits. The kit includes all hardware and software components needed to make the monitor or network product compatible with the latest main software being delivered.

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

K041790

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard signal processing and calculation functions typical of patient monitors, with no mention of AI or ML technologies.

Therapeutic

No.
The device is described as a "Monitor" that is "intended for multiparameter patient monitoring" and "indicated for monitoring" various physiological parameters. It collects and displays data, and documents patient care information. It does not provide any therapy or treatment.

Diagnostic

Yes
The device is described as a "multiparameter patient monitoring" system that monitors various physiological parameters (hemodynamic, respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy, and neurophysiological status) and performs analyses such as arrhythmia analysis, ST values calculation, and EEG spectrum analysis, all of which aid in diagnosing patient conditions.

SaMD (Software as a Medical Device)

The device description explicitly states that the S/5™ Compact Anesthesia Monitor uses "several types of plug-in measurement modules" and "patient cables are connected to the module plug in jacks". This indicates the presence of 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:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The S/5™ Compact Anesthesia Monitor is described as a patient monitoring device that measures physiological parameters directly from the patient (hemodynamic, respiratory, ventilatory, gastrointestinal/regional perfusion, BIS, Entropy, neurophysiological status). It uses plug-in modules and patient cables connected to the patient.
Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient. All measurements are taken on the patient.

Therefore, the S/5™ Compact Anesthesia Monitor falls under the category of patient monitoring devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A is intended for multiparameter patient monitoring with optional patient care documentation.

The S/5TM Compact Anesthesia Monitor with L-CANE05 and I -C ANE05A 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-CANE05 and L-CANE05A 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-CANE05 and L-CANE05A software is also indicated for documenting patient care related information. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05 A software is indicated for use by qualified medical personnel only.

Product codes (comma separated list FDA assigned to the subject device)

MHX, MLD, DSF

Device Description

The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A is operated by a keyboard. 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-CANE05 and L-CANE05A 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-CANE05 and L-CANE05A also include the option of creating patient care documentation. The trend informatically 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 keyboards and another is a hand-held Remote controller (K-CREMCO) which is still directly connected to the S/5TM Compact Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also supported, although the bar code reader is not manufactured anymore. The S/5™ Compact 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. Networking can be hardwired or wireless. The S/5 Compact Anesthesia Monitor can also be upgraded to L-CANE05(A) software using the S/5 L.I.F.E. upgrade program that offers a means to continuously keeping products upto-date, by upgrading modular anesthesia and critical care monitors and network products dating from back to 2000 to the latest S/5 software level. Upgrading of modular monitors and network products is performed with one of the available U-LIFE upgrade kits. The kit includes all hardware and software components needed to make the monitor or network product compatible with the latest main software being delivered.

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

qualified medical personnel only / hospital 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041790

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.

Summary

Image /page/0/Picture/0 description: The image shows the text "K061185" in a bold, handwritten style at the top. Below this, the text "Page 1 of 4" is printed in a smaller, more formal font. The text indicates that this is the first page of a four-page document, likely part of a larger set of records or a report.

MAY 15 9003

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE05 and L-CANE05A Software

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:

April 26, 2006

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

TRADE NAME:

Datex-Ohmeda S/57M Compact Anesthesia Monitor with L-CANE05 and L-CANE05A Software

COMMON NAME:

Patient Monitor

CLASSIFICATION NAME:

The following Class II and Class I classifications appear applicable:

Product Code	Classification Name	CFR Section
MHX	Arrhythmia detector & alarm	870.1025
MLD	Monitor ST-segment & alarm	870.1025
DSF	Paper Chart Recorder	870.2810

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-CANE05 and L-CANE05A software is substantially equivalent to the predicate Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software (K041790).

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

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

Intended Use:

The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A is intended for multiparameter patient monitoring with optional patient care documentation.

Indications for use:

with L-CANE05 and L-CANE05A software is also indicated for documenting patient care related information. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05 A software is indicated for use by qualified medical personnel only.

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as reguired by 807.92(a)(6)

The Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE05 and L-CANEOSA software is substantially equivalent to the predicate Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software (K041790).

The general construction, including hardware, mechanics and software, indications for use, and intended use of the S/5TM Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software are similar to the predicate device S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software (K041790). The main difference between the CAM Monitor with L-CANE05(A) software and the predicate is the new improved arrhythmia detection and analysis algorithm. There are two software options available for the S/5™ Compact Anesthesia Monitor:

L-CANE05 and L-CANE05A (collectively referred to as L-CANE05(A). (Note: L- refers to software license.) Only one software can be used at any given time in the monitor. The Monitor software is preloaded in the factory. The predicate device also had two software options available (L-CANE03 and L-CANE03A). The new device with two different software options. S/5TM Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software, is compared to the predicate by comparing the L-CANE05 to L-CANE03 and L-CANE05A to L-CANE03A. The new L-CANE05(A) software is based on the predicate L-CANE03(A) (K041790) and has basically the same functionality and the same user interface. The main differences between the L-CANE05(A) and its predicate are (i) a new improved arrhythmia detection and analysis algorithm (ii) dynamic module addressing for some newer modules not included in this submission) (iii) a modification to the UPI software part to get the direct ECG waveform from the module communication, (iv) added support for the new DIS modules (v) other enhancements in communication between the monitor and other devices.

Based on the above and a detailed analysis in other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of the S/5M Compact Anesthesia Monitor with L-CANE05 and L-CANE05 A software is substantially equivalent to the predicate S/57M Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software (K041790).

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

The Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-C ANE05 and L-C ANE05 software has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

. 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 60601-2-30:1999/EN 60601-2-30:2000

IEC 60601-2-34:2001/EN 60601-2-34:2000
IEC 60601-2-40:1998
IEC 60601-2-49:2001
IEC 60601-1-2(2001)/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/EN 60601-2-10:2000 + Amd.1:2001 . .
IEC 60601-2-26:2002/EN60601-2-26 . .
. EN 1060-1:1995 / EN-1060-3:1997 .
EN 12470-4: 1992 . .
. IEC 60068-2
UL 2601-1:1997 .
ANSVAAMI 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™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05 software compared to the legally marketed (predicate) Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software (K041790).

Image /page/4/Picture/1 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 AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 15 2006

Mr. Joel Kent GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492

Re: K061185

Trade Name: Datex-Ohmeda S/5 Compact Anethesia Monitor with L-Cane05A Regulation Number: 21 CFR 870.1025 Regulation Name: 21 CFF of OFF of OFF CEST and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dated: April 27, 2006 Received: April 28, 2006

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined 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 entrebute) 77 the enactment date of the Medical Device Amendments, or to conninered prices that have been recordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelory mains of the Act include requirements for annual registration, listing of general controls proficious gractice, 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 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.

Page 2 - Mr. Joel Kent

Please be advised that FDA's issuance of a substantial equivalence determination does notile of Please be advised that I DA 5 issuation of our device complies with other requirements of the Act that TDA has made a decisions administered by other Federal agencies. You must of ally it edital statutes and regaritients sincluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, 11/2, good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 801), good if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections over device as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your This letter will anow you to begin mains of substantial equivalence of your device to a legally premits that in the 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 If you desire specific acrise to: your 276-0120. Also, please note the regulation entitled, Colliact the Office of Compuners as (21 trip Part 807.97). You may obtain Misoranung of reference to premaintentibilities under the Act from the Division of Small other general 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/industry/support/index.html.

Sincerely yours,

いたいと思いました。この時間があると

10 30 31 10 3 3 3 3 3 8 8 1 1 8 8 1 1

Brimmer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

K061185

Indications for Use

510(k) Number (if known): K06 || 85

Device Name: Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A Software.

Indications for use:

The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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-CANE05 and L-CANE05A 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-CANE05 and L-CANE05A software is also indicated for documenting patient care related information.

The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software is indicated for use by qualified medical personnel only.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Abrammo

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