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 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 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

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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study plan that proves the device meets specific performance metrics in the format of a clinical or analytical validation study for an AI/ML medical device.

The document is a 510(k) Premarket Notification from the FDA, asserting substantial equivalence of the Philips Holter Analysis System to a predicate device (2010 Plus Holter for Windows, K010949). The information provided focuses on:

Device Description and Intended Use: The Philips Holter Analysis System analyzes ambulatory ECG data for various cardiac parameters. It incorporates updated algorithms (e.g., ST/AR AFIB algorithm's P wave detection, enhanced HRV reporting) and supports interoperability. It is intended for adult patients and trained clinicians.
Comparison to Predicate Device: Detailed tables compare the subject device's indications for use, target population, intended user, intended use environment, and various technological characteristics (e.g., Holter applications, EASI Hookup, supported channels, analysis configuration, arrhythmia and event detection, QT/ST analysis, Pacemaker analysis, Caliper, Important Events, Report Output, Supported ECG source) to the predicate.
Performance Data Summaries: It states that the device "successfully passed all the testing conducted, and the results demonstrated the Philips Holter Analysis System meets the performance claims and supports a determination of substantial equivalence to the predicate device."
Non-Clinical Tests - Standards: It lists compliance with several recognized standards (ISO 14971, IEC 62304, IEC 82304-1, IEC 62366-1, IEC 60601-2-47, AAMI EC57). These standards cover risk management, software lifecycle, health software safety, usability engineering, and requirements for ambulatory electrocardiographic systems.
Non-Clinical Bench Tests: It broadly states that the device was "evaluated against all applicable standards and internal procedures and successfully passed all verifications and validations. The results demonstrated that Philips Holter Analysis System meets all claims and supports a determination of substantial equivalence to the predicate."
Clinical Studies: It explicitly states that "The Philips Holter Analysis System, like the predicate device, does not require clinical trials."

Missing Information:

The document does not provide the following specifics required to answer your prompt:

A table of acceptance criteria and reported device performance: While it mentions "performance claims," the actual criteria (e.g., sensitivity, specificity, accuracy targets for specific arrhythmia detection) and the quantitative results are not in the document.
Sample size used for the test set and data provenance: No details on the size or origin of any specific test datasets used for performance evaluation of the algorithmic changes.
Number of experts used to establish ground truth and their qualifications: No information on how ground truth was established for any internal performance testing.
Adjudication method for the test set: No mention of adjudication.
Multi-reader multi-case (MRMC) comparative effectiveness study: The document clearly states no clinical trials were required. Thus, no MRMC study details are available.
Standalone (algorithm only) performance: While the document describes software updates, it does not explicitly provide standalone performance metrics for the AI/ML components (like the upgraded AFIB detection or enhanced HRV). The entire device is presented as assisting clinicians, not replacing them.
Type of ground truth used: No specific type of ground truth is detailed for performance evaluation, beyond stating it passed internal verification and validation against claims.
Sample size for the training set: No information on training data is provided.
How ground truth for the training set was established: No information on this.

Conclusion based on the provided text:

The Philips Holter Analysis System received 510(k) clearance based on substantial equivalence to a predicate device, supported by compliance with recognized standards and successful completion of non-clinical bench testing, software verification and validation, usability validation, and risk management activities. This regulatory pathway typically does not require extensive clinical trial data detailing specific algorithmic performance metrics or human-AI interaction studies as might be submitted for novel AI/ML devices with significantly different indications or technological characteristics. The document emphasizes adherence to engineering and quality standards, and broad performance claims rather than specific quantitative performance targets and studies.

Summary

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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"

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(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).

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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

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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)

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)

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510(k) Summary

I. SUBMITTER
Date Prepared	20 March 2025
Submitter/Owner	Company Name: Philips Medizin Systeme Böblingen GmbHFDA Establishment Number: 9610816Address: Hewlett-Packard Strasse 2, 71032 Böblingen, GERMANYPhone: +1 (949)-502-1823
Key Contact	Name: Cathy HongTitle: Senior RA SpecialistEmail 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: CardiovascularSubpart & Division: Medical magnetic tape recorder21 CFR: 21 CFR §870.2800Regulatory Class: Class IIProduct Code: MLO
III. PREDICATE DEVICE
Predicate Device	510(k) No.	Company NameDevice Name	ProductCode
	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

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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 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

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 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

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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

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

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) ●

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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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 ofComparison	Philips Holter Analysis System(Subject Device)	2010 Plus Holter for Windows(K010949)
Indicationsfor Use	The Philips Holter Analysis Systemprovides measurements, data, andreporting of parameters such as normalsinus rhythm, arrhythmias, QT and STmeasurements, paced beats analysis andHRV, that can be used by a qualifiedclinician for the evaluation of:Symptoms that may be related torhythm disturbances of the heart inadult patients Risk in patients with or withoutsymptoms of arrhythmia. QTmeasurement information isprovided to support this assessmentby a competent health professional. Efficacy of antiarrhythmic therapy Pacemaker function Symptoms that may be associatedwith myocardial ischemia The Philips Holter Analysis System is notintended for use for pediatric patients.The EASI derived 12-lead STmeasurements are not recommendedunless patients meet the followingparameters: Age: Between 33 to 82 years Height: Between 147 to 185 cm (58to 73 inches) Weight: Between 53 to 118 kg (117to 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 maybe related to rhythm disturbancesof the heart in patients frompediatric to adult age: patients withpalpitations. Assessment of risk in patients withor without symptoms of arrhythmia.Patients with symptomatic orasymptomatic idiopathichypertrophic cardiomyopathy andpostmyocardial infarction patientwith left ventricular dysfunctionusing arrhythmia, e.g.: ventricularectopy, as method of riskassessment. Assessment of efficacy ofAntiarrhythmia Therapy. Patientswith baseline high frequency,reproducible, sustained,symptomatic premature ventricularcomplexes, supraventriculararrhythmia or ventriculartachycardia. Assessment of Pacemaker Function.Evaluation of patients withparoxysmal symptoms, detection ofmyopotential inhibition, detectionof pacemaker mediated tachycardia,evaluation of anti-tachycardiapacing device function, evaluationof rate-responsive physiologicalpacing function. Detection of Myocardial ischemia,Patients with chest pain suggestiveof Prinzmetal's angina. Assessment of EASI derived 12-leadST measurements is recommended

	measurements are not intended for use.EASI derived 12-Lead ECGs and theirmeasurements are approximations toconventional 12-Lead ECGs and should notbe used for diagnostic interpretations.	for patients that meet the followingparameters.1. Ages: 33 to 82 years2. 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.
TargetPopulation	Adult patients	Adult and pediatric patients
IntendedUser	Trained clinicians	Trained clinicians
Intended UseEnvironment	The product is intended for use inhospitals, clinics including physicianoffices and/or Independent DiagnosticTesting Facility (IDTF)	The product is intended for use inhospitals, clinics including physicianoffices and/or Independent DiagnosticTesting Facility (IDTF)
Similarities
Item of Comparison	Description/Rationale
Holter PrimaryApplications, AvailableScreens, MainSoftware Views andHolter Scan Modes	Both the subject device, Philips Holter Analysis System, and thepredicate device (K010949) provide similar applications, screenviews and scan modes.Primary applications: Scanner, Central Link, Remote Link and ReportViewerAvailable screens: Startup screen, Scanning screen, Diagnosticwindow and Report summaryMain Software Views: Scan, Class, Detail, Review, Events, Graph, ST,Strips, ReportScan modes: Page Mode, Superimposition (SI) Mode, Retro Mode,QuickScan Mode
Support EASI Hookuptype	Both devices support EASI hookup type and provide for EASI-derived12-lead ECG display and EASI-derived 12-lead ST, 3D.
Supported Channel	Both devices support up to 2 to 3 ECG channels. The subject deviceoffers a UI selection for single-channel ECG input. The predicatedevice can also display and analyze a single channel if only onechannel's signal is available.
Configure Analysis andRule setting	Both devices support Atrial, Ventricular, ST , and Morphologyanalysis and rule setting for each type. The subject deviceincorporates a minor change to Ventricular Rule Setting by removingthe rule setting of 'Minimum Ventricular Run Rate'.
Class Edit	Both devices support class edits: Normal, Alternate Normal,Abnormal and Artifact.
Arrhythmia and EventDetection	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.
ST Analysis	Both devices support ST analysis to report ST Episodes and ST measurements.
Pacemaker Analysis	Both devices support Pacemaker analysis. The subject device reports:Sinus Beats, All Paced Beats, Atrial Paced Beats, Ventricular Paced Beats, Dual Paced Beats, Fusion Beats, FTO, FTS, FTC. There is no performance difference between the two devices, only a minor report format update.
Caliper	Both devices support the similar Caliper function, which can be used to measure typical distances (e.g., R-R', P-R, QRS, ST, QR, QT).Both devices support similar important events with minor change to add the longest R-to-R based on available measurements in the predicate device.
Important Events	• Heart Rates: Min/Max Heart Rate, Min/Max Ventricular Run, Min/Max Atrial Run, Max Atrial fibrillation, Max Tachycardia, Min Bradycardia• ST Extrema: Depression, Elevation• Longest Runs: Ventricular, Atrial, Tachycardia, Bradycardia• Other Longest Events: Longest NN, Drop/Late, Longest R – to-R
Report Output	Both devices provide similar report output-types. That includes available report sections, content for Analysis Summary, and format of the Analysis Summary.
Supported ECG source	Both devices support DigiTrak XT (DTXT) as ECG source inputs. The DTXT has obtained 510(k) clearances (K071733).
Differences
Item of Comparison	Description/Rationale
Operating system and Hardware Requirement	Philips Holter Analysis System supports Windows 10, Windows 11, Windows Server 2016 and Windows Server 2019 operating systems. The hardware platform requirement has been updated to ensure continued support of the software and strengthen cybersecurity.

Graph (Event Histograms)	Both devices support Graphs: R-R Intervals, N-N Intervals, N-V IntervalsV-N Intervals, V-V Intervals, N-N-N percentage and Other Histogramssuch as 12 lead ST (EASI derived, 3D), QT.The subject device also provides Lorenz plot, which is a scatter plotof each R-R interval based on the preceding R-R interval.
Heart Rate Variability	Both devices provide HRV reporting in time domain and frequencydomain. Enhancement was made to the HRV analysis reporting byreplacing current calculations with advanced data warehousecalculations from PhysioNet and by incorporating Nonlinear HRV toprovide more characterization of heart rate variability that linearmethods could miss.
Interoperability	Holter supports interoperability with Philips IntelliVue InformationCenter (PIIC) Classic and PIIC iX, IntelliSpace ECG ManagementSystem, IntelliBridge Enterprise, and DICOM-based systems. Testingwas conducted to demonstrate the connections perform asdesigned and expected.

Table 1-Comparison of Indications for Use

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Table 2 provides a high-level summary of the technological characteristics between the subject device and predicate device.

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Table 2: Technological Characteristics Comparison

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Substantial Equivalence Summary

Operational and technological characteristics form the basis for the determination of substantial equivalence of the Philips Holter Analysis System with the legally marketed predicate device 2010 Plus Holter for Windows (K010949). The Philips Holter Analysis System is substantially equivalent to the predicate devices.

VII. PERFORMANCE DATA

Performance Data Summaries

The Philips Holter Analysis System has successfully passed all the testing conducted, and the results demonstrated the Philips Holter Analysis System meets the performance claims and supports a determination of substantial equivalence to the predicate device.

Non-Clinical Tests - Standards

The performance testing has been conducted for the Philips Holter Analysis System according to IEC 60601-2-47: 2012 and AAMI EC57: 2012 standards. Human Factors and Usability testing has been conducted for the Philips Holter Analysis System according to IEC 62366-1:2015/AMD 1:2020 standard and FDA's Guidance for Industry and FDA Staff Applying Human Factors and Usability Engineering to Medical Devices, dated February 2016. Software validation was conducted according to IEC 62304:2006/ A1:2015 and IEC 82304-1: 2016 standards.

Standard	FDARecognition #	Title #
ISO 14971 Third Edition2019-12	5-125	Medical devices - Applications of risk management tomedical devices
IEC 62304 Edition 1.1 2015-06 CONSOLIDATEDVERSION	13-79	Medical device software – Software Life-cycle Process
IEC 82304-1 Edition 1.02016-10	13-97	Health software - Part 1: General requirements forproduct safety
IEC 62366-1 Edition 1.12020-06 CONSOLIDATEDVERSION	5-129	Medical devices - Part 1: Application of usabilityengineering to medical devices
IEC 60601-2-47 Edition 2.02012-02	3-155	Medical electrical equipment -- Part 2-47: Particularrequirements for the basic safety and essentialperformance of ambulatory electrocardiographicsystems
EC57:2012	3-118	Testing and reporting performance results of cardiac

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		rhythm and ST-segment measurement algorithms
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The following tests are not applicable as the subject device is a software-only device:

Biocompatibility
. Mechanical Testing
Electrical Safety and Electromagnetic Compatibility (EMC)

Non-clinical Bench Tests

Non-clinical bench testing activities establish the performance and functionality of the subject device. Philips Holter Analysis System was evaluated against all applicable standards and internal procedures and successfully passed all verifications and validations. The results demonstrated that Philips Holter Analysis System meets all claims and supports a determination of substantial equivalence to the predicate. Testing has demonstrated that the Philips Holter Analysis System is safe and effective as compared to the predicate for its intended use, intended users, and use environment.

No new issues of safety or effectiveness are introduced as a result of using this device.

Clinical Studies

The Philips Holter Analysis System, like the predicate device, does not require clinical trials.

FDA recognized standards, software verification and validation, usability validation, and risk management activities have taken place for the Philips Holter Analysis System.

Based upon the design, indications for use, classification, usability and performance testing, the Philips Holter Analysis System is substantially equivalent to the listed predicate device.

No new issues of safety or effectiveness are introduced as a result of using this device.

VIII. CONCLUSIONS

The results of the substantial equivalence assessment, taken together with performance testing, software verification and validation, human factors and usability validation demonstrate that the Philips Holter Analysis System does not raise different questions of safety and effectiveness when compared to the predicate device (K010949). The subject device performs as intended and has performance characteristics that are substantially equivalent to the predicate device (K010949).

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
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.(b)
Classification. Class II (performance standards).