To acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. To be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.

The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation.

Device Description

The TC series of cardiographs all provide the same basic functionality and utilize the same software code to provide different features. For example the TC 70 cardiograph has a digital patient interface module, the largest display, has the complete set of clinical features and the latest ECG data management capabilities.

The TC 20 cardiograph is the newest addition to the TC family of cardiographs. It provides the following basic feature set for diagnostic cardiographs: 12 lead ECG acquisition and analysis, rhythm printing of ECG, 12 lead ECG report, battery and line operated power, ECG storage and LAN / wireless connectivity.

AI/ML Overview

1. Acceptance Criteria and Device Performance:

The provided document describes the Philips PageWriter TC20 Electrocardiograph and its substantial equivalence to the predicate device, PageWriter TC30. It does not present specific numerical acceptance criteria for a clinical study comparing an AI algorithm's performance against a human or a predefined benchmark. Instead, it focuses on demonstrating that the TC20, including its ECG circuit and embedded algorithm, meets safety and effectiveness standards by comparing its technological characteristics to a legally marketed predicate device (TC30) and complying with recognized FDA standards.

Therefore, there is no direct table of acceptance criteria and reported device performance in the context of an AI algorithm's diagnostic accuracy. The key "acceptance criteria" here are:

Technological equivalence to the predicate device.
Compliance with recognized FDA standards for medical electrical equipment and electrocardiographic devices.

Table of Acceptance Criteria and Device Performance (in terms of substantial equivalence):

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (PageWriter TC20)
Intended Use	Same as predicate device (TC30)	Same as predicate device
Indications for Use	Same as predicate device (TC30)	Same as predicate device
Basic Functionality	Acquisition, display, analysis, storage of multi-channel ECG signals from adult and pediatric patients	Same as predicate device
Advisory Nature of Interpretation	ECG interpretation for review by user, advisory only, to be over-read by qualified physician	Same as predicate device
Power	AC or battery	Same as predicate device
Battery Chemistry	Lithium Ion battery (identical)	Same as predicate device
ECG Acquisition	AUTO (12 leads), RHYTHM (up to 12 leads), DISCLOSE (1 to 12 leads)	Same as predicate device
Keyboard	¾-size qwerty keyboard	Same as predicate device
Touch Screen Display	640 x 480 pixel resolution, 13.3 cm x 9.9 cm (6.5-inch diagonal) color LCD with Touch Screen	Same as predicate device
Raw Data Acquisition	8000 samples/sec on individual leads for 12-lead ECG and SAECG	Same as predicate device
Sampling Rate	500, 1000, 2000 samples/sec per electrode/lead; 12-bit and 16-bit A/D conversion (5µV, 2.5µV, 1µV resolution)	Same as predicate device
Filters	AC noise, Baseline wander, Artifact	Same as predicate device
Printer Resolution	High-resolution, digital-array printer; 200 dpi (voltage axis) by 500 dpi (time axis)	Same as predicate device
Battery Operation Capacity	Typically 50 ECGs/copies or 40 min continuous rhythm recording; 5 hours under normal usage	Same as predicate device
Networking Connection	10/100 Base-T IEEE 802.3 Ethernet via RJ45 (standard)	Standard with SDIO wireless LAN (802.11 b/g)
ECG Storage	XML File Format (Schema 1.04); Up to 200 ECGs to internal flash/USB Memory Stick	Same as predicate device
Orders (Receive/Store)	Receive Orders from TraceMaster via Network; Up to 200 Orders stored in internal database	Same as predicate device
ECG File Formats	XML (Schema 1.03, 1.04, 1.04.01, 1.04.02)	Same as predicate device
ECG Leads & Interpretation	12-Lead ECG Acquisition	Same as predicate device
Algorithm	12-Lead ECG Algorithm	Same as predicate device
Patient Information Module (PIM)	Yes (for TC30)	No (ECG circuit on main PCA for TC20, considered equivalent)
Patient Cable	No (for TC30)	Yes (for TC20)
Safety and Performance Standards	Compliance with AAMI-EC11:1991, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25	Complies with all listed standards

2. Sample Size for the Test Set and Data Provenance:

The document states, "The PageWriter TC20 cardiograph is not required to do clinical test for determination of substantial equivalence. The ECG 12 lead algorithm used for interpretive statements was cleared in a previous 510(K) submittal."

This implies that no new clinical (test set) study was performed for this specific 510(k) submission (K113144) to evaluate the diagnostic accuracy of the ECG interpretation algorithm with new data. The focus was on demonstrating hardware and software equivalence to an already cleared device and adherence to recognized standards. Therefore, information regarding sample size, data provenance, and ground truth establishment for a new test set is not provided here.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Not applicable for this 510(k) since no new clinical study (test set evaluation) for the algorithm's diagnostic performance was conducted as part of this submission. The algorithm itself was previously cleared.

4. Adjudication Method for the Test Set:

Not applicable for this 510(k) as no new clinical test set evaluation for diagnostic performance was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or referenced as part of this 510(k) submission for the PageWriter TC20. The submission relies on substantial equivalence to a predicate device and compliance with standards, not on demonstrating improved human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study:

A standalone study for the interpretive statements (algorithm) was performed historically, as it states, "The ECG 12 lead algorithm used for interpretive statements was cleared in a previous 510(K) submittal." However, the details of that previous standalone study (e.g., specific metrics, dataset size, ground truth methodology) are not provided in this document. This 510(k) focused on the device (PageWriter TC20) incorporating an already cleared algorithm.

7. Type of Ground Truth Used (for the Algorithm's previous clearance):

The document does not explicitly state the type of ground truth used for the previously cleared ECG 12-lead algorithm. Typically, for ECG interpretation algorithms, ground truth involves expert consensus by cardiologists, sometimes supported by clinical outcomes or invasive procedures for specific diagnoses.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for training the ECG 12-lead algorithm, as this algorithm was previously cleared.

9. How Ground Truth for the Training Set Was Established:

The document does not provide information on how the ground truth for the training set of the ECG 12-lead algorithm was established, as this algorithm was previously cleared under a different submission.

Summary

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510(k) Summary

abbreviated 510(k) Premarket Notification

For

Philips Medical Systems

Image /page/0/Picture/6 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The text is black and appears to be slightly pixelated or distressed, giving it a textured look. The background is white, providing a high contrast that makes the word easily readable despite the pixelation.

Philips Electrocardiograph

PageWriter TC20, 30, 50, 70

Submitter's Name, Address, Telephone Number:

Name: Philips Medical Systems

Address: 3000 Minuteman Road

Andover, MA 01810, U.S.A.

Phone Number: (978) 659-2404

Contact Person:

Paul Schrader Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 Tel. 978-659-2404 Fax 978-659-3610 Paul.Schrader@philips.com

The Date the Summary was Prepared:

18 October, 2011

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2. The Name of the Device:

PageWriter TC20/860332 Electrocardiograph

Classification Name: Electrocardiograph.
CFR: $870.2340

Product Code: DPS

II Class:

Panel: Cardiovascular

3. The identification of the Legally Marketed Device (s) to Which the Submitter Claims Equivalence:

PageWriter TC30/860306

4. Description of the Device that is the Subject of the 510(k)

A detailed comparison with the existing TC 30 cardiograph (predicate device) can be found in section 6 of this 510(K) summary.

Item	Part number
PW6L CBL 10-Lead Patient Cable IEC	989803175891
PW6L CBL 10-Lead Patient Cable AHA	989803175901
PW6L CBL Long 10-Lead Patient Cable IEC	989803175911
PW6L CBL Long 10-Lead Patient Cable AHA	989803175921

New accessories for analog front end:

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5. Statement of the Indications for Use of the Device That is the Subject of the 510(k):

6. Summary of the Technological characteristics of the New Device in Comparison to Those of the Predicate Device

PageWriter TC20 has the same technological characteristics as the predicate device PageWriter TC30.

Following table provides the Technological characteristics of the New Device in Comparison to Those of the Predicate Device.

	Philips	Philips
Feature/Model	PageWriter TC20(New Device)	PageWriter TC30(Predicate)K080999	Comparison
	Philips	Philips
Feature/Model	PageWriter TC20(New Device)	PageWriter TC30(Predicate)K080999	Comparison
Intended use	To acquire multi-channel ECGsignals from adult and pediatricpatients from body surface ECGelectrodes and to record, display,analyze and store these ECGsignals for review by the user. Tobe used in healthcare facilities bytrained healthcare professionals.Analysis of the ECG signals isaccomplished with algorithmsthat provide measurements, datapresentations, graphicalpresentations and interpretationsfor review by the user.	To acquire multi-channel ECGsignals from adult and pediatricpatients from body surface ECGelectrodes and to record, display,analyze and store these ECGsignals for review by the user. Tobe used in healthcare facilities bytrained healthcare professionals.Analysis of the ECG signals isaccomplished with algorithms thatprovide measurements, datapresentations, graphicalpresentations and interpretationsfor review by the user.	Same
	The interpreted ECG withmeasurements and interpretivestatements is offered to theclinician on an advisory basisonly. It is to be used inconjunction with the clinician'sknowledge of the patient, theresults of the physicalexamination, the ECG tracings,and other clinical findings. Aqualified physician is asked toover read and validate (or change)the computer generated ECGinterpretation.	The interpreted ECG withmeasurements and interpretivestatements is offered to theclinician on an advisory basis only.It is to be used in conjunction withthe clinician's knowledge of thepatient, the results of the physicalexamination, the ECG tracings,and other clinical findings. Aqualified physician is asked to overread and validate (or change) thecomputer generated ECGinterpretation.
Indications ofuse	Where the clinician decides toevaluate the electrocardiogram ofadult and pediatric patients as partof decisions regarding possiblediagnosis, potential treatment,effectiveness of treatment or torule-out causes for symptoms.	Where the clinician decides toevaluate the electrocardiogram ofadult and pediatric patients as partof decisions regarding possiblediagnosis, potential treatment,effectiveness of treatment or torule-out causes for symptoms.	Same
	Philips	Philips
Feature/Model	PageWriter TC20(New Device)	PageWriter TC30(Predicate)K080999	Comparison
Power	AC or battery	AC or battery	Same
BatteryChemistry	Lithium Ion battery	Lithium Ion battery (identicalbattery)	Same
ECGAcquisition	AUTO (12 leads) RHYTHM (up to 12 leads) DISCLOSE (1 to 12 leads)	AUTO (12 leads) RHYTHM (up to 12 leads) DISCLOSE (1 to 12 leads)	same
Keyboard	¾-size qwerty keyboard	¾-size qwerty keyboard	same
Touch screendisplay	640 x 480 pixel resolution 13.3 cm x 9.9 cm (6.5-inch diagonal) color LCDwith Touch Screen	640 x 480 pixel resolution 13.3 cm x 9.9 cm (6.5-inchdiagonal) color LCD withTouch Screen	same
Raw dataacquisition	8000 samples per secondson individual leads for 12lead ECG 8000 samples per secondson individual leads forSAECG	8000 samples per secondson individual leads for 12lead ECG 8000 samples per secondson individual leads forSAECG	same
Sampling rateon cardiograph	500, 1000 and 2000samples per second perelectrode/lead. 12 bit and 16 bit A/Dconversion provides 5µV,2.5µV and 1µVresolution.	500, 1000 and 2000samples per second perelectrode/lead. 12 bit and 16 bit A/Dconversion provides 5µV,2.5µV and 1µV resolution.	same
Filters	AC noise Baseline wander Artifact	AC noise Baseline wander Artifact	same
Printer
	Philips	Philips
Feature/Model	PageWriter TC20(New Device)	PageWriter TC30(Predicate)K080999	Comparison
Printerresolution	High-resolution, digital-array printer usingthermal-sensitive paper200 dpi (voltage axis) by500 dpi (time axis)	High-resolution, digital-array printer using thermal-sensitive paper200 dpi (voltage axis) by500 dpi (time axis)	same
BatteryOperation
Capacity	Typically 50 ECGs andcopies on a single chargeor 40 minutes ofcontinuous rhythmrecordingFully charged 1 battery isto last up to 5 hours undernormal usage	Typically 50 ECGs andcopies on a single chargeor 40 minutes ofcontinuous rhythmrecordingFully charged 1 battery isto last up to 5 hours undernormal usage	same
Networking
Networkingconnection	10/100 Base-T IEEE802.3 Ethernet via RJ45connector (standard)SDIO wireless LANconnection supporting802.11 b/g standards	10/100 Base-T IEEE802.3 Ethernet via RJ45connector (standard)Compact Flash cardwireless LAN connectionsupporting 802.11 a/b/gstandards	SubstantiallyEquivalent
ECG storage	XML File Format(Schema 1.04)Up to 200 ECGs tointernal flash memoryUp to 200 ECGs per USBMemory Stick	XML File Format (Schema1.04)Up to 200 ECGs to internalflash memoryUp to 200 ECGs per USBMemory Stick	same
Orders	Receive Orders fromTraceMaster via theNetworkUp to 200 Orders storedin internal database	Receive Orders fromTraceMaster via theNetworkUp to 200 Orders storedin internal database	same
ECG fileformats	XML (Schema 1.03 and1.04, 1.04.01, 1.04.02)	XML (Schema 1.03 and1.04. 1.04.01, 1.04.02)	same
ECG leadsandinterpretation
ECGacquisition	12-Lead ECGacquisition	12-Lead ECG acquisition	same
Feature/Model	PhilipsPageWriter TC20(New Device)	PhilipsPageWriter TC30(Predicate)K080999	Comparison
Algorithm	• 12-Lead ECG Algorithm	• 12-Lead ECG Algorithm	same
Patientinformationmodule (PIM)	No	Yes	See analysison difference
Patient cable	yes	No	See analysison difference

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510(K) Summary for Philips PageWriter TC20, 30, 50, 70 Cardiograph

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Analysis of difference:

For TC20, the ECG circuit is on the main PCA board of the cardiograph; for TC30, the ECG circuit is on the PIM. The TC20 ECG circuit and TC30 PIM have similar basic functions which are to collect the analog signals from the electrode-lead wires, convert the signals to digital signals and send the digital signals to FPGA/processor for processing. The TC30 PIM and TC20 ECG circuit provide isolation between the mains and the patient circuit using the same scientific principles and technical design.

The above table and the analysis demonstrate that the ECG circuit of the TC20 is substantially equivalent with PIM of TC30, from both effectiveness and safety point of view.

Using the FDA "510(k) SUBSTANTIAL EQUIVALENCE DECISIO-MAKING PROCESS", we conclude that the new device, Philips PageWriter TC20 w/ A.05 SW, is substantially equivalent with the predicate, Philips PageWriter TC30.

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7. Brief Discussion of the Nonclinical Tests

Tests were conducted to Philips PageWriter TC20 cardiograph and the product meet specific acceptance criteria of the following FDA recognized standards:

Standard number	Description of Standard
AAMI-EC11:1991	Diagnostic Electrocardiographic Device
IEC 60601-1: 1990+A1 1991+A2 1995	Medical electrical equipment -Part 1: General requirements for safety, includingAmendment 1 (1991) and Amendment 2 (1995).
IEC 60601-1-2: 2001+A1 2004	Medical Electrical Equipment -Part 1: General Requirements for Safety;Electromagnetic Compatibility Requirements andTests including Amendment 1: 2004
IEC 60601-2-25: 1993+A1:1999	Medical Electrical Equipment-Part 2: Particular Requirements for Safety andElectrocardiographs

8. Clinical Test

The PageWriter TC20 cardiograph is not required to do clinical test for determination of substantial equivalence. The ECG 12 lead algorithm used for interpretive statements was cleared in a previous 510(K) submittal.

9. Conclusion that PageWriter TC20 is as safe and effective as TC30

The PageWriter TC20 cardiograph has been tested to FDA recognized standards and it complies with the standards. We conclude that TC20 is as safe, as effective, and performs at least as safely and effectively as Page Writer TC30 cardiograph.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

APR - 3 2012

Philips Medical Systems c/o Ms. Dawn Tibodeau Senior Reviewer TUV SUD America, Inc. 1775 Old Highway 8 NW New Brighton, MN 55112

Re: K113144 Trade/Device Name: Phillips Electrocardiograph, Page Writer TC20 Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: March 15, 2012 Received: March 16, 2012

Dear Ms. Tibodeau:

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

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Page 2 - Ms. Dawn Tibodeau

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 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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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113144

Indications for Use Statement

510(k) Number: K113144

Device Name: Philips Electrocardiograph, PageWriter TC20 (860332)

To acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG 10 acquire multi-chamer DCG signals in and store these ECG signals for review by the user. To electrodes and to record, unsplay, and beathere professionals. Analysis of the ECG signals be used in healthoute tacmises of hat provide measurements, data presentations, graphical presentations and interpretations for review by the user.

The interpreted ECG with measurements and interpretive statements is offered to the clinician on The Interpreted LCG with measurements conjunction with the clinician's knowledge of the all advisory basis only. It is to be assu interest the ECG tracings, and other clinical findings. A patient, the results of the physical enammand validate (or change) the computer generated ECG interpretation.

X Prescription Use

AND/OR

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

(21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K113144
---------------	---------

Page 2 of 8

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).