The PageWriter TC35 Cardiograph is intended 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. It is 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 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 PageWriter TC35 Cardiograph is intended to acquire, record, analyze and store multi-channel ECG signals from adult and pediatric patients through a body surface ECG electrode. The device is integrated with the cleared algorithm (K132068) to provide measurements, and interpretations for review by the clinical on an advisory basis. The interpretated ECG with measurement and interpretative statements are to be used in conjunction with clinician's knowledge of 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.

PageWriter TC35 Cardiograph has LCD display with touchscreen, keyboard and functional buttons. The device can be powered from AC power or through an embedded re-chargeable battery. The device contains built-in thermal printer for ECG report printing. The device contains USB ports, LAN port and optional WiFi interface for communications.

PageWriter TC35 Cardiograph has various configurations provided for the preference of the user, and it can be updated with the compatible options/modules from the corresponding upgrade Kit (the upgrade kit is not considered as a device kit, refer to the Table 10-2 for the details of configuration list) for use with all approved accessories and spare parts, including patient cables, print papers and trolleys. None of the accessories and spare parts are provided sterile.

Once configured, PageWriter TC35 cardiograph can provides integrated connectivity (wired or wireless) with the compatible Philips IntelliSpace ECG Management System, IntelliBridge Enterprise (IBE), DICOM for patient order download and ECG report transmission. The cybersecurity on PageWriter TC cardiograph is periodically and proactively improved according to the cybersecurity analysis and the routine device cyber maintenance plan.

AI/ML Overview

The provided text describes the Philips PageWriter TC35 Cardiograph, indicating that no clinical studies were required to demonstrate substantial equivalence to its predicate device, the PageWriter TC20 Cardiograph (K210560). Therefore, the document does not contain information related to specific acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or comparative effectiveness studies (MRMC) with human readers improvement against AI.

However, the document does list the non-clinical tests and standards that the device passed to demonstrate compliance and substantial equivalence.

Here's a summary of the information available based on the provided text, addressing your questions where possible:

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

The document doesn't provide a table of performance metrics with specific acceptance criteria and reported values. Instead, it states that the device "successfully passed all verifications, testing and validations" against harmonized standards and internal procedures.

Acceptance Criteria Category	Reported Device Performance
Safety	Passed all safety tests
Electromagnetic Compatibility	Passed all EMC tests
Cybersecurity	Passed all cybersecurity tests
Software Functionality	Passed software functional verification
Environment and Reliability	Passed environment and reliability tests
Mechanical and Hardware	Passed mechanical and hardware tests
Packaging	Passed packaging tests
Human Factors and Usability	Passed human factor and usability performance tests
Electrical Safety	Passed electrical safety tests

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

Sample Size for Test Set: Not specified. The document states "Non-clinical bench testing activities establish the performance, functionality, and reliability characteristics of the subject device... The PageWriter TC35 Cardiograph was evaluated against all applicable standards and internal procedures, and successfully passed all verifications, testing and validations." This implies a series of engineering tests rather than a clinical dataset.
Data Provenance: Not applicable, as this refers to non-clinical bench testing and verification against standards, not patient data.

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

Not applicable, as no expert-established ground truth from a clinical test set is mentioned. The device's performance was evaluated against technical standards.

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

Not applicable, as no clinical test set requiring expert adjudication is mentioned.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "The PageWriter TC35 Cardiograph like the predicate device (K210560), it did not require clinical studies to demonstrate substantial equivalence." The device provides "interpretations for review by the clinical on an advisory basis" and requires a "qualified physician is asked to over read and validate (or change) the computer-generated ECG interpretation," indicating a human-in-the-loop system where the AI provides advisory input.

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

The device's ECG interpretation algorithm (PH110C) is mentioned as a "cleared algorithm" and provides advisory interpretations to the clinician. The document does not describe standalone performance testing of this algorithm without human-in-the-loop, nor does it provide its specific performance metrics.

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

Not applicable for the non-clinical tests described. For the integrated ECG interpretation algorithm, the method for establishing its "ground truth" (during its own clearance, K132068, which is referenced in the device description) is not detailed in this document.

8. The sample size for the training set:

Not applicable. The document does not describe the training of an AI algorithm, but rather the performance validation of a medical device against technical standards. The integrated ECG algorithm (PH110C) is presented as a pre-existing "cleared algorithm."

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

Not applicable, as no training set for the current device is described. The ground truth for the previously cleared algorithm (K132068) is not detailed in this document.

Summary

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December 2, 2022

Medizin Systeme Boblingen GmbH Judy Yang Regulatory Affairs Manager Hewlett-Packard Strasse 2 Boblingen, 71032 Germany

Re: K221141

Trade/Device Name: PageWriter TC35 Cardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 2, 2022 Received: April 19, 2022

Dear Judy Yang:

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. 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 located 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.

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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).

Sincerely,

Shruti N. Mistry -S

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K221141

Device Name

PageWriter TC35 Cardiograph

Indications for Use (Describe)

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) Summarv

510(k) Summary
I. SUBMITTER
Date Prepared	8 April 2022
Submitter/Owner	Philips Medizin SystemeBöblingen GmbHHewlett-Packard Strasse 271032 BöblingenGERMANYPhone: +1 (949)-502-1823
Key Contact	Judy YangRegulatory Affairs Mgr.Email: judy.yang_1@philips.com
510(k) Submission Type	This is a Traditional 510(k).
II. DEVICE
Trade Name	PageWriter TC35
Common Name	Cardiograph
Classification Name	Review Panel: CardiovascularRegulation Description: Electrocardiograph21 CFR §870.2340Regulatory Class: IIProduct Code: DPS
III. PREDICATE DEVICE
Predicate Device	510(k) No.	Company NameDevice Name	ProductCode
	K210560	Philips Medical SystemsPageWriter TC20 Cardiograph	DPS
The PageWriter TC35 Cardiograph is substantially equivalent to the legally marketed predicate,PageWriter TC20 Cardiograph (K210560).
IV. DEVICE DESCRIPTION

PageWriter TC35 Cardiograph - description of the device per 21 CFR 807.92(a) (4)

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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.

V. INDICATIONS FOR USE

Comparison of Indications for Uses for Subject Device and Predicate
PageWriter TC20 CardiographPredicate, K210560	PageWriter TC35 CardiographSubject Device
Philips Electrocardiograph, Page Writer TC cardiograph (TC20) isintended to acquire multichannel ECG signals from adult andpediatric patients from body surface ECG electrodes and torecord, display, analyze and store these ECG signals for review bythe user. It is to be used in healthcare facilities by trainedhealthcare professionals. Analysis of the ECG signals isaccomplished with algorithms that provide measurements, datapresentations, graphical presentations and interpretations forreview by the user.	Identical
The interpreted ECG with measurements and interpretivestatements is offered to the clinician on an advisory basis only. Itis to be used in conjunction with the clinician's knowledge of thepatient, the results of the physical examination, the ECG tracings,and other clinical findings. A qualified physician is asked to overread and validate ( or change) the computer generated ECGinterpretation.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

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Philips GSC

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Similarities
Item of Comparison	Description/Rationale
Indications for use	The subject device PageWriter TC35 Cardiograph and the currently marketedpredicate device (K210560) PageWriter TC20 Cardiograph have the identicalindications for use. Both TC35 and TC20 are intended to acquire multi-channelECG signals from patient and to record, display and store those signals to bereview by the user. The use environment is identical between TC35 and thepredicate device TC20, to be used in healthcare facilities by professional user.
Fundamental scientifictechnologies andperformances	Both PageWriter TC35 Cardiograph and PageWriter TC20 Cardiograph aresimilar with respect to the fundamental scientific technologies. They areElectrocardiographs to collect multi-channel ECG signals of adult and pediatricpatients from body surface ECG electrodes. These ECG signals are amplified,digitized, and processed in the digital domain. The cardiograph records,displays, analyzes (through the cleared ECG algorithm), and prints theprocessed ECG signals for review by the clinical operator.PageWriter TC35 Cardiograph uses the similar design including software featureand hardware feature with minor change on ECG signal acquisition and securityimprovement. They are use the same cleared ECG algorithm PH110C for ECGmeasurement and interpretation.
Patient Type	Adult and Pediatric patients
Use Environment	The use environment is identical between subject device PageWriter TC35Cardiograph and the predicate device (K210560) PageWriter TC20 Cardiograph.They are intended to be used in the professional healthcare facilityenvironment. Not for home use, and not intended to be used together with anyRF emitter equipment such as high-frequency electrosurgical equipment,diathermy, or electrocautery.
Physical features andparameters	The PageWriter TC35 Cardiograph device physical feature and physical size isidentical as the predicate device (K210560) PageWriter TC20 Cardiograph. Apicture of the subject device and predicate is provided below.Image: PageWriter TC35 CardiographImage: PageWriter TC20 CardiographSame as the predicate device (K210560), the subject device provides the samesize of LCD touch screen, keyboard, embedded printer, power module andbattery. The provided external ports are also the same, rear side of the deviceprovide Patient Cable connector, LAN connector, USB port and power cordconnector, while right side of the device provide another USB port, and batterycompartment door.
Connectivity	The subject PageWriter TC35 Cardiograph and the predicate device (K210560)PageWriter TC20 Cardiograph both provide LAN and Wireless connection. The
LAN and wireless function for both TC35 and TC20 are used to transmit the ECGreports, patient order/ADT, device configuration and time sync between theCardiograph and the external device like ECG management system, DICOM,Dashboard and hospital servers.
ECG Performance	Compared to the predicate device (K210560) PageWriter TC20 Cardiograph, thesubject PageWriter TC35 Cardiograph provide the same performance on 12-lead ECG acquisition, algorithm interpretation, display accuracy, and ECG reportformats for printing and transmitting purpose.
Safety and EMC performance	The subject PageWriter TC35 Cardiograph and the predicate device (K210560)PageWriter TC20 Cardiograph have the same level of safety and EMCperformance.The safety classification of both subject and predicate device (K210560) is classI, with CF type of applied part. And the EMC emission classification is Group I,Class B.
Differences
Item of Comparison	Description/Rationale
Patient Data Cable	The subject device uses different part number of patient cable to connect tothe electrode to transmit ECG signal. The patient cable is form, fit andfunctionally identical to the predicate device (K210560) as cleared togetherwith PageWriter TC20 Cardiograph, the minor difference is on the thumb screwto match the mechanical connector at the Cardiograph end.989803184921 12-Lead Patient Cable (IEC), Standard Length989803184931 12-Lead Patient Cable (AAMI), Standard Length989803184941 12-Lead Patient Cable (IEC), Long989803184951 12-Lead Patient Cable (AAMI), Long
ECG signal acquisition	PageWriter TC35 Cardiograph provide improved performance on ECG signalprocess. The sampling rate of the subject device have been improved to 1000samples per second, while the predicate device (K210560) PageWriter TC20Cardiograph sampling rate is 500 samples per second. TC35 provide ECG signalbandwidth from 0.02Hz~~300 Hz, while TC20 bandwidth is 0.05Hz~~150 Hz.
Radio connection	Compared to the predicate device (K210560), the wireless module to be usedon the subject device provides compatibility to the latest version of 802.11standard.
Security Enhancement	Compared to the predicate device (K210560), the subject device providedimprovement on cybersecurity risk control. The operating system has changedfrom the end of supported WinCE5 to Linux. The device support of FIPS 140-2for data encryption, provide role-base access management, USB disk encryptionand digital signature, support SMB V2/V3.

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Philips GSC

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Substantial Equivalence Summary

Operational, technological and safety characteristics form the basis for the determination of substantial equivalence of the subject device, PageWriter TC35 Cardiograph, with the legally marketed predicate device (K210560). The PageWriter TC35 Cardiograph is substantially equivalent to the predicate devices.

PERFORMANCE DATA VII.

Non-Clinical Tests – Harmonized Standards

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Philips GSC

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The subject PageWriter TC35 Cardiograph has passed all safety, electromagnetic compatibility, and cybersecurity tests to demonstrate compliance with the harmonized standards below.

Standard	FDARecognition #	Title #
ANSI/AAMIES60601-1:2005/A1:2012	19-4	Medical electrical equipment. Part 1: General requirements forbasic safety and essential performance
IEC 60601-1-2Edition 4.02014-02	19-8	Medical electrical equipment. Part 1-2: General requirements forbasic safety and essential performance. Collateral standard:Electromagnetic compatibility. Requirements and tests
IEC 60601-2-25Edition 2.02011-10	3-105	Medical electrical equipment - Part 2-25: Particular requirementsfor the basic safety and essential performance ofelectrocardiographs
IEC 60601-1-6Edition 3.12013-10	5-89	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability
IEC 62366-1Edition 1.02015-02	5-114	Medical devices. Part 1: Application of usability engineering tomedical devices
IEC 62304Edition 1.12015-06	12-79	Medical device software - Software life cycle processes
AAMITIR69:2017	19-22	Technical Information Report Risk management of radiofrequencywireless coexistence for medical devices and systems
ANSI IEEEC63.27- 2017	19-29	American National Standard for Evaluation of WirelessCoexistence
ASTM D4169-16	14-499	Standard Practice for Performance Testing of Shipping Containersand Systems
ANSI AAMIEC53:2013	3-129	ECG trunk cables and patient lead-wires
ISO 14971:2019	5-125	Medical devices - Application of risk management to medicaldevices
AIM7351731:2017	19-30	Medical Electrical Equipment and System ElectromagneticImmunity Test for Exposure to Radio Frequency IdentificationReaders

Non-clinical Bench Tests

Non-clinical bench testing activities establish the performance, functionality, and reliability characteristics of the subject device, PageWriter TC35 Cardiograph. Tests included software functional

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verification, environment and reliability, mechanical and hardware, packaging, human factor and usability performance.

The PageWriter TC35 Cardiograph was evaluated against all applicable standards and internal procedures, and successfully passed all verifications, testing and validations. The results demonstrated that Philips PageWriter TC35 Cardiograph meets all safety, effectiveness and performance claims and supports a determination of substantial equivalence to the predicate PageWriter TC20 Cardiograph (K210560).

Clinical Studies

The PageWriter TC35 Cardiograph like the predicate device (K210560), it did not require clinical studies to demonstrate substantial equivalence.

FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have been conducted for the PageWriter TC35 Cardiograph.

Based upon the design, indications for use, classification, usability, and safety testing, the PageWriter TC35 Cardiograph is substantially equivalent to the predicate device (K210560).

VIII. CONCLUSIONS

The results of the substantial equivalence assessment, evaluated alongside non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation, and human factors and usability demonstrate that the PageWriter TC35 Cardiograph does not raise different questions of safety and effectiveness when compared to the predicate (K210560). The subject device performs as intended, and has performance characteristics that are substantially equivalent to the PageWriter TC20 Cardiograph predicate device (K210560).

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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).