K Number

Device Name

DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE

Manufacturer

DATEX-OHMEDA

Date Cleared

2003-05-21

(68 days)

Product Code

MHX

Regulation Number

870.1025

Intended Use

The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software is intended for multiparameter patient monitoring with optional patient care documentation. The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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 Anesthesia Monitor with L-ANE03 A software is also indicated for documenting patient care related information. The S/57M Anesthesia Monitor with L-ANE03 and L-ANE03A software is indicated for use by qualified medical personnel only.

Device Description

The S/5™ 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 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/5™ Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5TM Anesthesia Monitor: L-ANE03 and L-ANE03A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE03. The modifications to the device are: - Support for M-Entropy module has been added. M-Entropy has its own 510(k) clearance. - Improvement in the QRS detection with rather low QRS amplitude ECG, to avoid false Asystole alarms. - The definition for Ventricular Tachycardia have been modified: now 6 beats at a heart rate of 120 (previously 5 beats at a heart rate of 100). - Invasive pressure cursor added to the inv.bp waveform field. The cursor is used for marking the reference pressure levels during a monitoring period. - MAC (Mean Alveolar Concentration) age calculation added. User can select the calculation of age-dependent MAC values. - Invasive pressure Mean Arterial Pressure (Art mean) value added to vital parameters numerical trend page. - New catheter types added to the selection list for the Cardiac Output measurement. - Automatic case reset disabled during Cardio Pulmonary Bypass (CPB) mode. - Messages related to the communication between S/5 monitor and D-O Central have been modified. "HR limit changed" and "PVC rate changed" messages have been replaced with the message "Alarm setup changed from Central". - Menu and Data Card symbols and Network symbol have been modified. Layout changes have been done so that the same symbols can be displayed with all of the different display resolutions. - A 19" LCD display and a 43″ plasma display secondary display option have been added along with a display controller specific for the 19" LCD (B-DISP19).

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

K021279

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard physiological monitoring and data processing, with no mention of AI or ML technologies. The modifications listed are related to parameter calculations, display options, and alarm logic based on predefined thresholds, not learning algorithms.

Therapeutic

No
The device is a monitor that measures physiological parameters. It does not provide therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for multiparameter patient monitoring" and "is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy... and neurophysiological status of all hospital patients." Monitoring a patient's physiological status to detect conditions like arrhythmia or to assess the effects of anesthetic agents falls under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "patient monitor" that "displays the measurement of patient physiological parameters" and utilizes "specialized measurement modules" which are hardware components. While software is a part of the system, it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states that the device is for "multiparameter patient monitoring" and "monitoring of hemodynamic, respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy... and neurophysiological status of all hospital patients." These are all measurements taken directly from the patient's body, not from samples of bodily fluids or tissues in vitro (outside the body).
Device Description: The device description reinforces this by explaining that it "displays the measurement of patient physiological parameters in the hospital setting" and uses "specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor." This describes a system for direct patient monitoring.
Lack of IVD Characteristics: There is no mention of analyzing samples of blood, urine, tissue, or other bodily substances. The measurements described are all physiological signals obtained from the patient.

Therefore, the S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software is a patient monitoring device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Intended use:

The S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A software is intended for multiparameter patient monitoring with optional patient care documentation

Indications for use:

The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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 Anesthesia Monitor with L-ANE03 A software is also indicated for documenting patient care related information. The S/57M Anesthesia Monitor with L-ANE03 and L-ANE03A software is indicated for use by qualified medical personnel only.

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

MHX

Device Description

The modifications to the device are:

Support for M-Entropy module has been added. M-Entropy has its own 510(k) clearance 1 .
Improvement in the QRS detection with rather low QRS amplitude ECG, to avoid false Asystole 2. alarms.
1. The definition for Ventricular Tachycardia have been modified: now 6 beats at a heart rate of 120 (previously 5 beats at a heart rate of 100).
Invasive pressure cursor added to the inv.bp waveform field. The cursor is used for marking the 4. reference pressure levels during a monitoring period.
ൻ. MAC (Mean Alveolar Concentration) age calculation added. User can select the calculation of age-dependent MAC values.
1. Invasive pressure Mean Arterial Pressure (Art mean) value added to vital parameters numerical trend page.
New catheter types added to the selection list for the Cardiac Output measurement. 7.
1. Automatic case reset disabled during Cardio Pulmonary Bypass (CPB) mode.
1. Messages related to the communication between S/5 monitor and D-O Central have been modified. "HR limit changed" and "PVC rate changed" messages have been replaced with the message "Alarm setup changed from Central".
Menu and Data Card symbols and Network symbol have been modified. Layout changes have 10. been done so that the same symbols can be displayed with all of the different display resolutions.
A 19" LCD display and a 43″ plasma display secondary display option have been added along 11. with a display controller specific for the 19" LCD (B-DISP19).

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

all hospital patients

Intended User / Care Setting

qualified medical personnel, hospital setting

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)

The Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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. 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(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/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 .
The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software as compared to the predicate device.

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.

K021279

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 "K030812" in a handwritten style. Below this text, the phrase "Page 1 of 4" is printed in a smaller, more formal font. The text appears to be a page number or document identifier.

Image /page/0/Picture/1 description: The image is a logo that features a stylized letter 'D' inside of a circle. The letter 'D' is white, while the rest of the circle is black. There is a small black square in the upper right corner of the circle, which gives the impression of a camera. The logo is simple and modern.

MAY 21 2003

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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:

March 12, 2003

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

TRADE NAME:

Datex-Ohmeda S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A software

COMMON NAME:

Patient Monitor

CLASSIFICATION NAME:

The following Class III classifications appear 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 EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE03 A software is substantially equivalent in safety and effectiveness to the legally marketed predicate Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software (K021279).

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

The modifications to the device are:

Support for M-Entropy module has been added. M-Entropy has its own 510(k) clearance 1 .
Improvement in the QRS detection with rather low QRS amplitude ECG, to avoid false Asystole 2. alarms.
1. The definition for Ventricular Tachycardia have been modified: now 6 beats at a heart rate of 120 (previously 5 beats at a heart rate of 100).
Invasive pressure cursor added to the inv.bp waveform field. The cursor is used for marking the 4. reference pressure levels during a monitoring period.
న్. MAC (Mean Alveolar Concentration) age calculation added. User can select the calculation of age-dependent MAC values.
1. Invasive pressure Mean Arterial Pressure (Art mean) value added to vital parameters numerical trend page.
New catheter types added to the selection list for the Cardiac Output measurement. 7.
1. Automatic case reset disabled during Cardio Pulmonary Bypass (CPB) mode.
1. Messages related to the communication between S/5 monitor and D-O Central have been modified. "HR limit changed" and "PVC rate changed" messages have been replaced with the message "Alarm setup changed from Central".
Menu and Data Card symbols and Network symbol have been modified. Layout changes have 10. been done so that the same symbols can be displayed with all of the different display resolutions.
A 19" LCD display and a 43″ plasma display secondary display option have been added along 11. with a display controller specific for the 19" LCD (B-DISP19).

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

Intended use:

The S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A software is intended for multiparameter patient monitoring with optional patient care documentation

Indications for use:

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE03 A software is substantially equivalent to the predicate Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software (K021279).

The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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™ Anesthesia Monitor with L-ANE03 A software is also indicated for documenting patient care related information. The S/57M Anesthesia Monitor with L-ANE03 and L-ANE03A software is indicated for use by qualified medical personnel only.

The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software is a modular multiparameter patient monitor providing connections to measurement modules. The general construction, intended use of the S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A software are the same as for the predicate S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software (K021279). The indications for use for the Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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.

Based on the above and a detailed analysis in this 510(k) and attachments it is evident that the main features and indications for use of the S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software is substantially equivalent to the predicate $/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software (K021279).

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

. 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(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/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™ Anesthesia Monitor with L-ANE03 and L-ANE03A software as compared to the predicate device.

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with its head tilted upwards. The figure is composed of three overlapping profiles, creating a sense of depth and dimension. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

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

Re: K030812

Trade Name: Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANEØ3 and L-ANE03A software Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: March 13, 2003 Received: March 14, 2003

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.

Page 2 – Mr. Joel C. Kent

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 (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. 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 801), please contact the Office of Compliance at (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

K030812
page 1 of 1

Page 1 of 1

510(k) Number (if known):

Device Name: S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software

The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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™ Anesthesia Monitor with L-ANE03 and L-ANE03A software is also indicated for documenting patient care related information.

The S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A 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 ✗
OR
Over-The-Counter Use __
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030812