Who is the manufacturer of Philips Holter Analysis System?

Philips Medizin Systeme Böblingen GmbH filed the 510(k) submission for Philips Holter Analysis System (K241890).

What is the FDA product code for Philips Holter Analysis System?

MLO. It is classified under 21 CFR 870.2800 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Philips Holter Analysis System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Philips Holter Analysis System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Philips Holter Analysis System

K241890 · Philips Medizin Systeme Böblingen GmbH · MLO · Mar 21, 2025 · Cardiovascular

Device Facts

Record ID	K241890
Device Name	Philips Holter Analysis System
Applicant	Philips Medizin Systeme Böblingen GmbH
Product Code	MLO · Cardiovascular
Decision Date	Mar 21, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2800
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of: - Symptoms that may be related to rhythm disturbances of the heart in adult patients - Risk in patients with or without symptoms of arrhythmia. QT measurement information is provided to support this assessment by a competent health professional. - Efficacy of antiarrhythmic therapy - Pacemaker function - Symptoms that may be associated with myocardial ischemia The Philips Holter Analysis System is not intended for use for pediatric patients. The EASI derived 12-lead ST measurements are not recommended unless patients meet the following parameters: - Age: Between 33 to 82 years - Height: Between 147 to 185 cm (58 to 73 inches) - Weight: Between 53 to 118 kg (117 to 261 lbs) - Height to Weight Ratio: Between 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) If patients do not meet these parameters, the EASI derived 12-lead ST measurements are not intended for use. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations.

Device Story

Standalone software installed on general-purpose PCs; analyzes ambulatory ECG data (24 hours to 7 days) downloaded from compatible recorders (e.g., DigiTrak XT). Uses Zymed/CAlg-Holter algorithm to process raw ECG signals; detects arrhythmias (PVCs, atrial fibrillation, etc.), ST/QT anomalies, and pacemaker function. Provides HRV (time/frequency domain, nonlinear) and EASI-derived 12-lead ECG display. Used in hospitals, clinics, and IDTFs by trained clinicians. Output includes analysis reports, heart rate strips, and full disclosure for physician review/diagnosis. Assists clinical decision-making by characterizing heart rhythm and ischemia; does not replace physician overread. Benefits include improved diagnostic efficiency for cardiac rhythm disturbances.

Clinical Evidence

No clinical data. Bench testing only. Performance validated against IEC 60601-2-47:2012 and AAMI EC57:2012 standards. Software verification and validation performed per IEC 62304 and IEC 82304-1. Usability testing conducted per IEC 62366-1.

Technological Characteristics

Standalone software for Windows 10/11/Server. Analyzes 2-3 channel ECG. Features: Zymed/CAlg-Holter algorithm, ST/AR AFIB detection, linear/nonlinear HRV, EASI-derived 12-lead display. Connectivity: Networked via PIIC, ISECG, IBE, and DICOM. Standards: IEC 60601-2-47, AAMI EC57, IEC 62304, IEC 82304-1, IEC 62366-1, ISO 14971.

Indications for Use

Indicated for adult patients for evaluation of heart rhythm disturbances, arrhythmia risk, antiarrhythmic therapy efficacy, pacemaker function, and symptoms of myocardial ischemia. Not for pediatric use. EASI-derived 12-lead ST measurements restricted to patients aged 33-82, height 147-185 cm, weight 53-118 kg, and specific height-to-weight ratios.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

2010 Plus Holter for Windows (K010949)

Reference Devices

DigiTrak XT (K071733)
Philips ST/AR ST and Arrhythmia Software (K101521)
EASI derived 12-lead display function (K020456)
Philips IntelliVue Information Center (PIIC) (K153702)
IntelliSpace ECG Management System (ISECG) (K120855)

Related Devices

K201921 — Spacelabs Lifescreen PRO Analyzer · Spacelabs Healthcare, Ltd. · Mar 26, 2021
K031466 — IQMARK DIGITAL HOLTER · Brentwood Medical Technology Corp. · Jun 11, 2003
K992197 — MODIFICATION TO ZYMED HOLTER 2000 · Zymed Medical Instrumentation · Jul 28, 1999
K003940 — 2010 PLUS HOLTER FOR WINDOWS · Agilent Technologies · Feb 8, 2001
K062088 — PREMIER 11 HOLTER · Diagnostic Monitoring Software · Aug 25, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 21, 2025 Philips Medizin Systeme Böblingen GmbH Cathy Hong Senior RA Specialist Hewlett-Packard Strasse 2 Böblingen, 71034 Germany Re: K241890 Trade/Device Name: Philips Holter Analysis System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MLO Dated: May 31, 2024 Received: June 28, 2024 Dear Cathy Hong: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, # Kimberly N. Digitally signed by Kimberly N. Crowley -S-crowley -S-Crowley -S For: Jennifer Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241890 Device Name Philips Holter Analysis System Indications for Use (Describe) The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, OT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of: - · Symptoms that may be related to rhythm disturbances of the heart in adult patients - · Risk in patients with or without symptoms of arthythmia. QT measurement information is provided to support this assessment by a competent health professional. - · Efficacy of antiarrhythmic therapy • Pacemaker function - · Symptoms that may be associated with myocardial ischemia The Philips Holter Analysis System is not intended for use for pediatric patients. The EASI derived 12-lead ST measurements are not recommended unless patients meet the following parameters: · Age: Between 33 to 82 years · Height: Between 147 to 185 cm (58 to 73 inches) · Weight: Between 53 to 118 kg (117 to 261 lbs) · Height to Weight Ratio: Between 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) If patients do not meet these parameters, the EASI derived 12-lead ST measurements are not intended for use. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is the only element in the image and it is centered. # 510(k) Summary | I. SUBMITTER | | | | |-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------| | Date Prepared | 20 March 2025 | | | | Submitter/Owner | Company Name: Philips Medizin Systeme Böblingen GmbH FDA Establishment Number: 9610816 Address: Hewlett-Packard Strasse 2, 71032 Böblingen, GERMANY Phone: +1 (949)-502-1823 | | | | Key Contact | Name: Cathy Hong Title: Senior RA Specialist Email Address: Cathy.HONG@philips.com | | | | 510(k) Submission Type | This is a Traditional 510(k) | | | | II. DEVICE | | | | | Trade Name | Philips Holter Analysis System | | | | Classification Name | Panel & Name: Cardiovascular Subpart & Division: Medical magnetic tape recorder 21 CFR: 21 CFR §870.2800 Regulatory Class: Class II Product Code: MLO | | | | III. PREDICATE DEVICE | | | | | Predicate Device | 510(k) No. | Company Name Device Name | Product Code | | | K010949 | 2010 Plus Holter for Windows | MLO | | The Philips Holter Analysis System is substantially equivalent to the legally marketed predicate, 2010 Plus Holter for Windows (K010949). | | | | #### IV. DEVICE DESCRIPTION The Philips Holter Analysis System (hereinafter known as Philips HAS) is offered as standalone software. It is intended to be installed into a user's PC (general purpose computing platform). The product evaluates the heart rhythms of ambulatory ECG data over an extended period and generates a preliminary analysis for physician's review. The ECG data is downloaded from compatible ambulatory ECG recorders. It is to be used by trained personnel. The Philips Holter Analysis System accepts ECG recordings from DigiTrak XT recorders (K071733) and analyzes the patient's heart activity for the recorded period, typically from 24 hours up to 7 days. The {5}------------------------------------------------ analysis is not performed in real time. The DigiTrak XT recorder collects up to 168 hours (7 days) of ambulatory ECG. The software can analyze up to 168 hours (7 days) of contiguous ECG data. The algorithm (Zymed Algorithm, also internally referred to as the CAlg-Holter Algorithm) used in Holter Analysis System was first developed and approved for use in the Holter Scanner Model 1210. It was continually updated and subsequently cleared for use in more Holter Models. It includes Heart Rate Variability (Time Domain) as a standard software report configuration in March 1996. The operating system converted from a DOS operating system to a Windows operating system in April 1999. Heart Rate Variability Frequency Domain was added in February 2001. The QT analysis was added in September 2001. The most recent 510(k) including above features and functions is under K010949. The Zymed Algorithm in the HAS incorporates the following enhancements in the subject device: - . Upgraded AFIB detection by replacing the current algorithm with the Philips ST/AR AFIB algorithm's P wave detection feature. The feature was cleared in K101521 with Philips ST/AR ST and Arrhythmia Software. - . Enhanced HRV reporting by replacing current calculations with advanced data warehouse calculations from PhysioNet. Incorporated Nonlinear HRV to provide more characterization of heart rate variability that linear methods could miss. - Incorporated bug fix, and code security - Upgraded compiler The EASI derived 12-lead display function was cleared in K020456. It remains unchanged in the subject device. Philips does not incorporate any additional usage in the subject device beyond these clearances. The EASI 12-lead is only for display purposes, allowing end users to visualize EASI lead ECG recordings in a traditional 12-lead format. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations. No automatic functions or analyses utilize this data. The Zymed Algorithm performs its analysis on the raw ECG signal and does not use the EASI derived 12-lead in that analysis. The Philips Holter Analysis System requires operator's intervention during and after the initial analysis. The Philips HAS allows the operator to view and print out an analysis report, individual heart rate strips, as well as a full disclosure report for physician's review, diagnoses, and observations. It is intended to assist the qualified medical professional in the interpretation of the recorded data; it is not intended to serve as a substitute for the review and overread of the recorded ECG data. The Philips Holter Analysis System provides viewing, printing, and report capabilities as listed below: - A view of the data and a summary of the heart events that have taken place - Detection of anomalies such as ventricular ectopy and supraventricular ectopy - Patency of the pacemaker and pacemaker anomalies - Advanced scanning techniques, such as determining ST and QT anomalies - Heart rate data and heart rate variability - Full disclosure reports {6}------------------------------------------------ The Philips Holter Analysis System can operate in a networked environment that includes the following devices and interfaces to transfer orders and Holter reports. - Philips IntelliVue Information Center (PIIC) (K153702) - A fleet of Holter Remote Links and one or more Holter Central Links - IntelliSpace ECG Management System (ISECG) (K120855) - An IntelliBridge Enterprise (IBE) data interface engine / brokering system - DICOM-based enterprise systems PIC , Holter Remote Links, and Holter Central Links provide alternate ECG input mechanisms for Holter analysis. ISECG Central Link, Report Viewer, and IBE can accept Holter reports. IBE can provide Orders and ADT information for HAS. DICOM-based systems support patient orders via DICOM Modality Worklist and accept exported DICOM Encapsulated PDF reports. The Philips Holter Analysis System provides three models with different configurations for customers to select: Series 3000, Series 5000, and Series 7000. #### V. INDICATIONS FOR USE The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of: - Symptoms that may be related to rhythm disturbances of the heart in adult patients. - Risk in patients with or without symptoms of arrhythmia. QT measurement information is provided to support this assessment by a competent health professional. - . Efficacy of antiarrhythmic therapy - Pacemaker function ● - Symptoms that may be associated with myocardial ischemia ● The Philips Holter Analysis System is not intended for use for pediatric patients. The EASI derived 12-lead ST measurements are not recommended unless patients meet the following parameters: - Age: Between 33 to 82 years - Height: Between 147 to 185 cm (58 to 73 inches ) - Weight: Between 53 to 118 kg (117 to 261 lbs) - Height to Weight Ratio: Between 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) ● If patients do not meet these parameters, the EASI derived 12-lead ST measurements are not intended for use. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE {7}------------------------------------------------ # PHI The following tables compare Philips Holter Analysis System to the predicate device with respect to indications for use and technological characteristics to provide information regarding the basis for the determination of substantial equivalence. | Item of Comparison | Philips Holter Analysis System (Subject Device) | 2010 Plus Holter for Windows (K010949) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of: Symptoms that may be related to rhythm disturbances of the heart in adult patients Risk in patients with or without symptoms of arrhythmia. QT measurement information is provided to support this assessment by a competent health professional. Efficacy of antiarrhythmic therapy Pacemaker function Symptoms that may be associated with myocardial ischemia The Philips Holter Analysis System is not intended for use for pediatric patients. The EASI derived 12-lead ST measurements are not recommended unless patients meet the following parameters: Age: Between 33 to 82 years Height: Between 147 to 185 cm (58 to 73 inches) Weight: Between 53 to 118 kg (117 to 261 lbs) Height to Weight Ratio: Between $1.41$ to $2.99$ cm/kg ( $0.25$ to $0.54$ in/lb) If patients do not meet these parameters, the EASI derived 12-lead ST | Assessment of symptoms that may be related to rhythm disturbances of the heart in patients from pediatric to adult age: patients with palpitations. Assessment of risk in patients with or without symptoms of arrhythmia. Patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia, e.g.: ventricular ectopy, as method of risk assessment. Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, reproducible, sustained, symptomatic premature ventricular complexes, supraventricular arrhythmia or ventricular tachycardia. Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of anti-tachycardia pacing device function, evaluation of rate-responsive physiological pacing function. Detection of Myocardial ischemia, Patients with chest pain suggestive of Prinzmetal's angina. Assessment of EASI derived 12-lead ST measurements is recommended | | | | | | | measurements are not intended for use. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations. | for patients that meet the following parameters. 1. Ages: 33 to 82 years 2. Heights: 147 to 185 cm (58 to 73 in) 3. Weights: 53 to 118 kg (117 to 261 lb) 4. Height to Weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb.) • QT measurements can be used by the physician in the risk assessment process indicated for patients with and without symptoms of arrhythmia. QT measurement is intended to be used by competent health professionals in hospital or clinic environment. Composite QT measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements. | | Target Population | Adult patients | Adult and pediatric patients | | Intended User | Trained clinicians | Trained clinicians | | Intended Use Environment | The product is intended for use in hospitals, clinics including physician offices and/or Independent Diagnostic Testing Facility (IDTF) | The product is intended for use in hospitals, clinics including physician offices and/or Independent Diagnostic Testing Facility (IDTF) | | Similarities | | | | Item of Comparison | Description/Rationale | | | Holter Primary Applications, Available Screens, Main Software Views and Holter Scan Modes | Both the subject device, Philips Holter Analysis System, and the predicate device (K010949) provide similar applications, screen views and scan modes. Primary applications: Scanner, Central Link, Remote Link and Report Viewer Available screens: Startup screen, Scanning screen, Diagnostic window and Report summary Main Software Views: Scan, Class, Detail, Review, Events, Graph, ST, Strips, Report Scan modes: Page Mode, Superimposition (SI) Mode, Retro Mode, QuickScan Mode | | | Support EASI Hookup type | Both devices support EASI hookup type and provide for EASI-derived 12-lead ECG display and EASI-derived 12-lead ST, 3D. | | | Supported Channel | Both devices support up to 2 to 3 ECG channels. The subject device offers a UI selection for single-channel ECG input. The predicate device can also display and analyze a single channel if only one channel's signal is available. | | | Configure Analysis and Rule setting | Both devices support Atrial, Ventricular, ST , and Morphology analysis and rule setting for each type. The subject device incorporates a minor change to Ventricular Rule Setting by removing the rule setting of 'Minimum Ventricular Run Rate'. | | | Class Edit | Both devices support class edits: Normal, Alternate Normal, Abnormal and Artifact. | | | Arrhythmia and Event Detection | Both devices supported the arrhythmia detection as listed below. PVC (Isolated PVC and Interpolated PVC) Single Ventricular Ectopic Ventricular Couplet Ventricular Triplet Ventricular Runs Ventricular Bigeminy Ventricular Trigeminy R-on-T Late Ventricular Ventricular Tachycardia Atrial Runs Atrial Pairs Atrial Tachycardia Atrial Bigeminy Atrial Trigeminy | | | • | Atrial Fibrillation | | | • | Premature Atrial Contraction (PAC) | | | • | Late beat | | | • | Dropped beat | | | • | Bradycardia | | | The subject device made enhancement to AFIB detection by replacing the predicate algorithm with the ST/AR AFIB algorithm featuring P wave detection. The feature was cleared in K101521. | | | | QT Analysis | Both devices support QT measurement, it reports minimum/average/maximum HR, QT and QTc. |…