The 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 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- L-ANE05and L-ANE05A 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- L-ANE05and L-ANE05A software is also indicated for documenting patient care related information.

The S/5™ Anesthesia Monitor with L-ANE05and L-ANE05A 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 wariety 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/57M Anesthesia Monitor: L-ANE05 and L-ANE05A: L-ANE05A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE05. There are two monitor frame options; the new 5-module F-CU5(P) monitor frame and the 8-module F-CU8 monitor 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/5TM Anesthesia Monitor with L-ANE05 and L ANE05A uses several types of plugin measurement modules. Currently, the legacy Datex-Ohmeda M-series measurement modules are used. In the future, the M-series modules will be replaced with the new E series modules, which are basically face-lifted versions of the corresponding M-series 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/5TM Anesthesia Monitor with L-ANE05and L-ANE05A 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-ANE05and L-ANE05A 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™ Anesthesia Monitor with L-ANE05and L-ANE05A 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-ANE05and L-ANE05A perform some module related tasks like arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, encrgy expenditure calculation, EEG spectrum analysis evoked potential response averaging and cutropy calculations. All the module communication is also handled in the main software. The software L-ANE05and L-ANE05A 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 keyboards and another is a hand-held Remote controller (REMCO) which is still directly connected to the S/5TM 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™ 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 upgraded to L-ANE05(A) software using the S/5 L.I.F.E. upgrade program that offers a means to continuously keeping products up-to-date, by upgrading modular anesthesia and critical care monitors and network products dating from back to 1992 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.

AI/ML Overview

This document (K051400) describes the GE Healthcare Datex-Ohmeda S/5™ Anesthesia Monitor. It's a premarket notification (510(k)) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a specific study report for novel performance claims.

Therefore, the requested information regarding acceptance criteria, device performance, study details, and ground truth establishment is largely not present in the provided text. The document primarily focuses on regulatory compliance through substantial equivalence.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Not present. The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the device's performance, especially for the improved arrhythmia detection algorithm. It states that the "arrhythmia analysis functionality...is the same as the functionality of the predicate device."
Instead of performance metrics, the document lists compliance with various international and national standards (e.g., IEC 60601-1, EN 60601-1-2, ANSI/AAMI EC57). These standards primarily relate to electrical safety, electromagnetic compatibility, and basic performance rather than specific clinical accuracy or diagnostic performance acceptance criteria.

2. Sample size used for the test set and the data provenance

Not present. The document does not describe a clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective).
The non-clinical testing described refers to "validation and verification of specifications" against standards, which typically involves engineering tests, not a clinical data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not present. Since there is no described clinical test set or study evaluating clinical performance, there is no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not present. No clinical test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not present. This document predates the widespread use of "AI" in medical devices as understood today (2006). The device is a patient monitor with software for physiological parameter analysis. It does not describe an AI-driven system that would involve human-in-the-loop performance or MRMC studies. The "improved arrhythmia detection and analysis algorithm" is a software change, not necessarily an AI system in the modern sense.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not present in a clinical sense. The device itself is a standalone monitor. However, the document does not describe a standalone clinical performance study of the algorithm in isolation. The "validation and verification of specifications" would include testing of the algorithm's functionality as part of the system, but not necessarily a separate performance study against a clinical ground truth.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not present. Given the absence of a described clinical performance study, there is no mention of the type of ground truth used. For a device like an arrhythmia detector, ground truth would typically come from adjudicated ECG recordings.

8. The sample size for the training set

Not present. As this document does not describe a machine learning or AI algorithm development, there is no discussion of a training set or its sample size. The "improved arrhythmia detection and analysis algorithm" is presented as a software change, likely developed through traditional signal processing and algorithm design, not necessarily machine learning requiring a "training set."

9. How the ground truth for the training set was established

Not present. (See point 8).

Summary of what the document does provide regarding "the study":

The "study" or rather, the basis for regulatory clearance, is a non-clinical testing program that assessed the device against a list of international and national standards:

Type of Study: Verification and validation of specifications against recognized consensus standards.
Purpose: To demonstrate that the device is safe and effective and substantially equivalent to its predicate device, primarily through compliance with engineering and safety standards.
Nature of Testing: Primarily electrical safety, electromagnetic compatibility, and basic functional performance checks as dictated by the listed standards (e.g., IEC 60601 series, ISO 9918, ANSI/AAMI EC57).
Conclusion: "The device has been thoroughly tested through validation and verification of specifications. ... there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE05 and L-ANE05A Software... as compared to the predicate device."

In essence, for this 510(k) submission, the "study" demonstrating adherence to acceptance criteria is the comprehensive non-clinical testing for compliance with established safety and performance standards for patient monitoring equipment, rather than a clinical performance study with specific diagnostic accuracy metrics. The improvement in the arrhythmia algorithm is noted as a change, but its specific performance metrics against clinical data are not detailed in this summary.

Summary

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K05 1400

Page 1 of 4

JAN 2 0 2006

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM 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.

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

COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare が 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

May 27, 2005

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

TRADE NAME:

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.

COMMON NAME:

Patient Monitor Paper Chart Recorder (E-REC)

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

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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-ANE05and L-ANE05A software is The Date.x-Onlineda Dr. - Theodicola Monton Monton S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A software (K030812).

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

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 wariety 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/57M Anesthesia Monitor: L-ANE05 and L-ANE05A: L-ANE05A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE05. There are two monitor frame options; the new 5-module F-CU5(P) monitor frame and the 8-module F-CU8 monitor 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-ANE05 and L ANE05A uses several types of plugin measurement modules. Currently, the legacy Datex-Ohmeda M-series measurement modules are used. In the future, the M-series modules will be replaced with the new E series modules, which are basically face-lifted versions of the corresponding M-series 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/5TM Anesthesia Monitor with L-ANE05and L-ANE05A 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-ANE05and L-ANE05A 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™ Anesthesia Monitor with L-ANE05and L-ANE05A 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-ANE05and L-ANE05A perform some module related tasks like arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, encrgy expenditure calculation, EEG spectrum analysis evoked potential response averaging and cutropy calculations. All the module communication is also handled in the main software. The software L-ANE05and L-ANE05A 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 keyboards and another is a hand-held Remote controller (REMCO) which is still directly connected to the S/5TM 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™ 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 upgraded to L-ANE05(A) software using the S/5 L.I.F.E. upgrade program that offers a means to continuously keeping products up-to-date, by

{2}------------------------------------------------

upgrading modular anesthesia and critical care monitors and network products dating from back to 1992 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.

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

Intended use:

The S/5™ Anesthesia Monitor with L-ANE05and L-ANE05A is intended for multiparameter patient monitoring with optional patient care documentation. Indications for use:

The S/5™ Anesthesia Monitor with L-ANE05and L-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/5TM Anesthesia Monitor with L- L-ANE05and L-ANE05A 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- L-ANE05and L-ANE05A software is also indicated for documenting patient care related information.

The S/5™ Anesthesia Monitor with L-ANE05and L-ANE05A 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 Anesthesia Monitor with L-ANE05 and L-ANE05A software is substantially equivalent to the predicate device S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A software (K030812). The general construction, including hardware, mechanics and software, indications for use, and intended use of the S/57M Anesthesia Monitor with L-ANEOS and L-ANE05A software are similar to the predicate device S/5TM Anesthesia Monitor with L-ANE03 and L-ANE03A software (K030812). The main difference between the AM Monitor with L-ANE05(A) software and the predicate is that the L-ANE05(A) software also supports the new 5module F-CU5(P) frame option.

The new L-ANE05(A) software is based on the predicate L-ANE03(A) (K030812) and has basically the same functionality and the same user interface. The main differences between the the L-ANEOS(A) and its predicate are (i) a new improved arrhythmia detection and analysis algorithm (ii) dynamic module addressing for some new 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 N-DISVENT and N-DISPICCO (v) other enhancements in communication between the monitor and other devices. The arrhythmia analysis and detection algorithm of the S/5™ Anesthesia Monitor with L-ANE05A has changed compared to the predicate device (K030812). However, the arrhythmia analysis functionality of the S/5™ Anesthesia Monitor with L-ANE05A is the same as the functionality of the predicate device S/5™ Anesthesia Monitor with L ANE03A (K030812). The S/5™ Anesthesia Monitor with L-ANE05A and the predicate alarms for the same arrhythmias in a similar manner. The S/5™ Anesthesia Monitor with L-ANE05 and L-ANE05A software is a modular multiparameter patient monitor providing connections to measurement modules. The general construction and intended use of the S/5TM Anesthesia Monitor with L-ANE05 and L-ANE05A software are the same as for the predicate S/5™ Anesthesia Monitor with L-ANE03 and L-ANE03A software (K030812).

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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/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 have 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 + Соп. 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 12470-4:2000 .
. 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-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 as compared to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 2006

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

Re: K051400

Trade Name: 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. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: MHX Dated: December 21, 2005 Received: December 23, 2005

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.

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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 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 (240) 276-0210. 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/industry/support/index.html.

Sincerely yours.

Brimmer for

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): KO51400

Device Name: 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.

Indications for Use:

The S/5™ Anesthesia Monitor with L- L-ANE05and L-ANE05A software is also indicated for documenting patient care related information.

The S/5™ Anesthesia Monitor with L-ANE05and L-ANE05A software is indicated for use by qualified medical personnel only.

Over-The-Counter Use _ Prescription Use X 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)

Bhumanna

Page _ | of __

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K051400

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.