The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes: ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), Invasive Blood Pressure (IBP), Non-Invasive Blood Pressure(NIBP), Blood Oxygenation (SpO2), Pulse Rate (PR), Respiration Rate (RESP), Respiration Gases(O2, CO2), Temperature(TEMP), Anesthetic Gases (AG), Cardiac Output(C.O.), Bispectral Index (BIS), and Hemodynamics.

The Panorama Patient Monitoring Network is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. The Panorama Patient Monitoring Network is not intended to the patient at any time or installed in a patient's vicinity.

The Panorama Network includes the Panorama Telemetry System which acquires and monitors physiological data for ambulating patients within a defined coverage area. The system processes the physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The Panorama Telemetry System is intended for installation in a hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.

The physiological parameters monitored through telemetry include ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, OT Analysis and heart rate(HR)), blood oxygenation (SpO2), Pulse Rate (PR), Received data is calculated at the Panorama Central Station, and can be displayed, trended, stored and printed at the Panorama Central Station.

The Panorama Patient Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.

Device Description

The subject Panorama Patient Monitoring Network includes eight Components:

o Panorama Central Station
Panorama Telemetry System
Panorama Telepack ●
Compatible Physiological Monitor(s) ●
o ViewStation
WorkStation ●
Web Viewer ●
Gateway ●
1、The Panorama Central Station is a device that monitors patients, collects and stores data.and performs alarm notification .The clinical data displayed at the Central Station is derived from compatible physiological monitor(s) or the Panorama Telepack.
2、The Panorama Telemetry System is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area.
3、The Panorama Telepack is a battery powered ambulatory monitoring device intended for use in a hospital/clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility. Data received from the Telepack is transmitted to the Panorama Telemetry System .
4、Mindray's cleared Compatible Physiological Monitors that transmit patient data to the Central Station include:
- · Passport 12M/17M Monitor(K143195)
- · Passport 8/12 Monitor(K132662)
- · T1(K143195)
- · Passport V Monitor(K091834)
- · V Series Monitor(K132026)
- · DPM 6/7 Monitor(K092449)
- · Spectrum/ Spectrum OR Bedside Monitor(K062098)
- · Passport 2 Bedside Monitor (K020550)
5、The Panorama ViewStation is a software application that allows the user to remotely display and print patient information from the Central Station.
6、The Panorama WorkStation is a software application that allows the user to remotely display and print patient information, enter or change patient demographic information, change alarm limits and responses, place patients in standby or discharge patients.
7、The Panorama Web Viewer is a software application that provides the user to remotely view patient information from the Central Station through a facilities intranet using a Microsoft Internet Explorer web browser.
8、The Panorama Gateway is an embedded Windows XP software application that allows translation of the Mindray proprietary network format into standard formats such as HL7.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and device performance:

Unfortunately, the provided text does not contain explicit details about specific acceptance criteria or a dedicated study proving performance against those criteria for the Panorama Patient Monitoring Network itself.

The document is a 510(k) summary for a medical device (Panorama Patient Monitoring Network). The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through clinical trials in the same way a PMA (Pre-Market Approval) does.

The closest statements related to testing are:

"The Panorama Network has been tested and complies with the following recognized consensus standards: ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-1-6, IEC60601-1-8, IEC60601-2-27, EC57, ISO80601-2-61"
"The Panorama Network was tested and complies with established parameter performance specifications."
"No clinical tests were performed on the Panorama Network. The clinical safety and effectiveness of the central monitoring networks has been long established through analysis of end-user experience and feedback gained through post-market analysis."
"The device's software has been verified and validated in accordance with the appropriate test requirements."

These statements indicate various types of testing (safety, performance to established specifications, software verification/validation) but do not present a structured study with defined acceptance criteria and reported device performance for specific clinical claims (e.g., accuracy of arrhythmia detection).

Therefore, I cannot populate the table and answer most of the questions as requested. However, I can infer some general information from the document:

Inferred Information from the Document:

While explicit acceptance criteria and a dedicated performance study are not detailed, the text states the device was tested and "complies with established parameter performance specifications." This implies that the device does have internal performance specifications which it met through testing, even if those specifications and the test results are not explicitly provided in this public summary.

The document emphasizes substantial equivalence to predicate devices, particularly regarding indications for use and technological characteristics. The addition of QT Analysis and Bispectral Index (BIS) monitoring seems to be the main technological expansion compared to the primary predicate, and performance for these would likely be shown by demonstrating equivalence to the specified predicate devices (Philips ST/AR ST and Arrhythmia software and Hypervisor central monitoring system, respectively).

Table of Acceptance Criteria and Reported Device Performance:

Feature/Parameter	Acceptance Criteria (Inferred/Generic)	Reported Device Performance (Not explicit in document)
General Performance	Compliance with "established parameter performance specifications"	(Not specified)
Safety	Compliance with recognized safety standards (e.g., ANSI/AAMI ES60601-1)	(Not specified beyond "complies")
EMC	Compliance with recognized electromagnetic compatibility standards (e.g., IEC60601-1-2)	(Not specified beyond "complies")
Software Quality	Software verified and validated per appropriate requirements	(Not specified beyond "verified and validated")
Arrhythmia Detection	(Implied to be equivalent to predicate Arrhythmia Detector devices)	(Not specified)
ST Segment Analysis	(Implied to be equivalent to predicate ST Segment Monitor devices)	(Not specified)
QT Analysis	(Implied to be equivalent to Philips ST/AR ST and Arrhythmia software, K101521)	(Not specified)
Bispectral Index (BIS)	(Implied to be equivalent to Hypervisor central monitoring system, K132036)	(Not specified)
Physiological Parameter Monitoring (HR, IBP, NIBP, SpO2, PR, RESP, O2, CO2, TEMP, AG, C.O., Hemodynamics)	(Implied to meet performance of compatible physiological monitors and predicate central stations)	(Not specified)

Answers to Specific Questions:

A table of acceptance criteria and the reported device performance:
- See the table above. Most information is "Not specified" or "Implied" because the document focuses on substantial equivalence rather than explicit performance metrics for clinical claims.
Sample size used for the test set and the data provenance:
- Not specified. The document states "No clinical tests were performed on the Panorama Network." The performance is established through "analysis of end-user experience and feedback gained through post-market analysis" of predicate devices, and through technical standards compliance for the current device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Given that no clinical tests were performed and the device relies on substantial equivalence and compliance with technical standards, there is no mention of experts establishing ground truth for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / None specified. No clinical test set requiring adjudication is mentioned.
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:
- No. This device is a monitoring system and does not involve AI assistance for human readers in a diagnostic interpretation context. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The compliance with "established parameter performance specifications" and recognized standards (e.g., for arrhythmia detection) implies that the algorithms responsible for these functions were tested without human intervention to ensure they meet their design requirements. However, specific separate "standalone studies" with detailed metrics are not described in this document.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Primarily
  technical specifications and standards. For parameters like arrhythmia detection, the "ground truth" would come from reference ECG waveforms or simulated data with known events, against which the device's algorithms are benchmarked according to industry standards like IEC60601-2-27 and EC57. For new parameters like QT Analysis and BIS, the ground truth would be implicitly derived from the established performance of the named predicate devices.
The sample size for the training set:
- Not specified. This document does not discuss machine learning models, so there is no mention of training sets. The device's functionality is based on established algorithms and hardware.
How the ground truth for the training set was established:
- Not applicable. No training set is mentioned as the device does not appear to utilize machine learning in the conventional sense that would require a separate training dataset with established ground truth.

Summary

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human figures connected by flowing lines, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 2, 2015

Shenzhen Mindray Bio-medical Electronics Co., Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Rd South, Hi-tech Industrial Park Nanshan, Shenzhen 518057, P.R. China

Re: K150082 Trade/Device Name: Panorama Patient Monitoring Network Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DQA, DRG, MSX Dated: July 31, 2015 Received: August 5, 2015

Dear Yanhong Bai,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

{1}------------------------------------------------

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 of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

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

Enclosure

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

Indications for Use

K150082 510(k) Number (if known)

Page 1 of 2

Device Name

Panorama Patient Monitoring Network

Indications for Use (Describe)

The indications for use for the Panorama Patient Monitoring Network include:

· Viewing real time patient clinical and demographic data

· Graphical and numeric trending of clinical data
· Storing and printing of clinical and demographic data
· Setting independent alarm limits for data sent by the bedside monitor

The Panorama Patient Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--	--	--	--

اح Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

{3}------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

K150082 Page 2 of 2

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

5. 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Panorama Patient Monitoring Networks provided below.

Device Common Name:	Central Station Monitor and Telemetry System
Device Proprietary Name:	Panorama Patient Monitoring Network
Submitter:	SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680
Contact:	Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, Nanshan518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Date Prepared:	January 8, 2014
Classification Regulation:	21 CFR 870.1025, Class II, Arrhythmia detectorand alarm (including ST-segment measurement andalarm)
Panel:	Cardiovascular

ProductCode	RegulationNumber	Panel	Regulation Description	Device Common Name
Primary
MHX	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (including ST-segment measurementand alarm)	monitor, physiological,patient (with arrhythmiadetection or alarms)
Secondary

{5}------------------------------------------------

510(k) Premarket Notification

ProductCode	RegulationNumber	Panel	Regulation Description	Device Common Name
DSI	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (including ST-segment measurementand alarm)	detector and alarm,arrhythmia
MLD	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (including ST-segment measurementand alarm)	monitor, st segment withalarm
DRT	21 CFR870.2300	Cardiovascular	Cardiac Monitor(includingcardiotachometer andrate alarm)	monitor, cardiac (incl.cardiotachometer & ratealarm)
DQA	21 CFR870.2700	Cardiovascular	Oximeter	Oximeter
DRG	21 CFR870.2910	Cardiovascular	Radiofrequencyphysiological signaltransmitter and receiver.	transmitters and receivers,physiological signal,radiofrequency
MSX	21 CFR870.2300	Cardiovascular	Cardiac monitor(includingcardiotachometer andrate alarm).	system,network andcommunication,physiologicalmonitors

Predicate Device: Panorama Patient Monitoring Network (K142601)

Hypervisor central monitoring system(including telemetry monitoring system.tms-6016) (K132036)

Philips ST/AR ST and Arrhythmia software (K101521)

Indications for Use:

The indications for use for the Panorama Patient Monitoring Network include:

Viewing real time patient clinical and demographic data ●
Graphical and numeric trending of clinical data o
. Storing and printing of clinical and demographic data
o Setting independent alarm limits for data sent by the bedside monitor

The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes: ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), Invasive Blood Pressure (IBP), Non-Invasive Blood Pressure(NIBP), Blood Oxygenation (SpO2), Pulse Rate (PR), Respiration Rate (RESP), Respiration Gases(02,CO2), Temperature(TEMP), Anesthetic Gases(AG), Cardiac Output(C.O.), Bispectral Index (BIS), and Hemodynamics.

{6}------------------------------------------------

The Panorama Patient Monitoring Network is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. The Panorama Patient Monitoring Network is not intended to be directly connected to the patient at any time or installed in a patient's vicinity.

The physiological parameters monitored through telemetry include ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), blood oxygenation (SpO2), Pulse Rate (PR). Received data is calculated at the Panorama Central Station, and can be displayed, trended, stored and printed at the Panorama Central Station.

The Panorama Patient Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.

Device Description:

The subject Panorama Patient Monitoring Network includes eight Components:

o Panorama Central Station
Panorama Telemetry System
Panorama Telepack ●
Compatible Physiological Monitor(s) ●
o ViewStation
WorkStation ●
Web Viewer ●
Gateway ●
1、The Panorama Central Station is a device that monitors patients, collects and stores data.and performs alarm notification .The clinical data displayed at the Central Station is derived from compatible physiological monitor(s) or the Panorama Telepack.
2、The Panorama Telemetry System is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area.
3、The Panorama Telepack is a battery powered ambulatory monitoring device intended for use in a hospital/clinical environment to provide clinicians with patient

{7}------------------------------------------------

physiological data, while allowing for patient mobility. Data received from the Telepack is transmitted to the Panorama Telemetry System .

4、Mindray's cleared Compatible Physiological Monitors that transmit patient data to the Central Station include:
- · Passport 12M/17M Monitor(K143195)
- · Passport 8/12 Monitor(K132662)
- · T1(K143195)
- · Passport V Monitor(K091834)
- · V Series Monitor(K132026)
- · DPM 6/7 Monitor(K092449)
- · Spectrum/ Spectrum OR Bedside Monitor(K062098)
- · Passport 2 Bedside Monitor (K020550)
5、The Panorama ViewStation is a software application that allows the user to remotely display and print patient information from the Central Station.
6、The Panorama WorkStation is a software application that allows the user to remotely display and print patient information, enter or change patient demographic information, change alarm limits and responses, place patients in standby or discharge patients.
7、The Panorama Web Viewer is a software application that provides the user to remotely view patient information from the Central Station through a facilities intranet using a Microsoft Internet Explorer web browser.
8、The Panorama Gateway is an embedded Windows XP software application that allows translation of the Mindray proprietary network format into standard formats such as HL7.

Summary of performance testing

The Panorama Network has been tested and found to be in compliance with ● recognized safety, performance and electromagnetic compatibility standards.
A risk analysis has been developed to identify potential hazards and document the o mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements.
The Panorama Network has been tested and complies with the following recognized ● consensus standards:
V ANSI/AAMI ES60601-1
IEC60601-1-2
IEC60601-1-6
IEC60601-1-8
A IEC60601-2-27
EC57

{8}------------------------------------------------

A ISO80601-2-61

o The Panorama Network was tested and complies with established parameter performance specifications.
o No clinical tests were performed on the Panorama Network. The clinical safety and effectiveness of the central monitoring networks has been long established through analysis of end-user experience and feedback gained through post-market analysis.

Substantial Equivalence:

Comparison of Indications -

The Panorama Patient Monitoring Network/K142601 shall serve as the primary predicate device respecting Indications for Use, performance specifications and technology.

The Hypervisor Central Monitoring System /K132036 is provided as a predicate device supporting bispectral index (BIS) that has been added to the subject Panorama. Section 12.4.4 includes additional details related to this new parameter.

The Philips ST/AR ST and Arrhythmia software/K101521 is provided as a predicate device supporting QT analysis that has been added to the subject Panorama. Section 12.4.1 includes additional details related to this new parameter.

The subject Panorama considered substantially equivalent to the predicate devices respecting the indications for use.

Comparison of Technological Characteristics –

The table below compares the key technological feature of the subject devices to the primary predicate device 。

Technology	Subject /Panorama PatientMonitoring Network	Predicate /Panorama PatientMonitoring Network(K142601)
Central StationTelemetry ServerKeyboardMouse	2U (Horizontal) or Vertical2U (Horizontal) TowerYesYes	2U (Horizontal) or Vertical2U (Horizontal) TowerYesYes
DisplayOperating SystemLongview-VGA extender	Touch screenWindows XP (embedded)Yes	Touch screenWindows XP (embedded)Yes
Telemetry SystemTIM TransceiverFrequencyRepeater	2U (horizontal rack mount)4U (horizontal rack mount)WMTSYes	2U (horizontal rack mount)4U (horizontal rack mount)WMTSYes

{9}------------------------------------------------

Antenna	Radio Frequency	Radio Frequency
Telepack	Telepack-608(WMTS)	Telepack-608(WMTS)
Compatible PhysiologicalMonitors	Passport 12M/17MMonitor(K143195)Passport 8/12Monitor(K132662)T1(K143195)Passport VMonitor(K091834)V Series Monitor(K132026)DPM 6/7Monitor(K092449)Spectrum/ Spectrum ORBedside Monitor(K062098)Passport 2 Bedside Monitor(K020550)	Passport 12M/17MMonitor(K143195)Passport 8/12Monitor(K132662)T1(K143195)Passport VMonitor(K091834)V Series Monitor(K132026)DPM 6/7Monitor(K092449)Spectrum/ Spectrum ORBedside Monitor(K062098)Passport 2 BedsideMonitor (K020550)
ViewStation	Yes	Yes
WorkStation	Yes	Yes
Web Viewer	Yes	Yes
Gateway	Yes	Yes
Monitoring Parameters	ECG (Lethal and Non-Lethal ArrhythmiaDetection, ST SegmentAnalysis, QT Analysis andheart rate(HR)), InvasiveBlood Pressure (IBP), Non-Invasive BloodPressure(NIBP), BloodOxygenation (SpO2), PulseRate (PR), Respiration Rate(RESP), RespirationGases(02,CO2),Temperature(TEMP),Anesthetic Gases(AG),Cardiac Output(C.O.),Bispectral Index (BIS), andHemodynamics.	ECG (Lethal and Non-Lethal ArrhythmiaDetection, ST SegmentAnalysis, and heartrate(HR)), Invasive BloodPressure (IBP), Non-Invasive BloodPressure(NIBP), BloodOxygenation (SpO2), PulseRate (PR), RespirationRate (RESP), RespirationGases(02,CO2),Temperature(TEMP),Anesthetic Gases(AG),Cardiac Output(C.O.), andHemodynamics.

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.