PageWriter TC35 Cardiograph

K221141 · Medizin Systeme Boblingen GmbH · DPS · Dec 2, 2022 · Cardiovascular

Device Facts

• Record ID: K221141
• Device Name: PageWriter TC35 Cardiograph
• Applicant: Medizin Systeme Boblingen GmbH
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Device acquires multi-channel ECG signals via body surface electrodes; signals amplified, digitized, and processed; uses PH110C algorithm for measurements and interpretations; output displayed on LCD touchscreen, printed via thermal printer, or transmitted to management systems (IntelliSpace, IBE, DICOM) via LAN/WiFi. Used in healthcare facilities by trained professionals; provides advisory interpretations for physician validation. Benefits include standardized ECG analysis and integrated clinical workflow connectivity. Features include Linux-based OS, FIPS 140-2 encryption, role-based access, and USB disk encryption.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including software verification, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 62366-1), and cybersecurity assessments.

Technological Characteristics

Electrocardiograph; 12-lead acquisition; 1000 samples/sec; 0.02-300 Hz bandwidth. Features LCD touchscreen, keyboard, thermal printer, USB/LAN/WiFi connectivity. Powered by AC or rechargeable battery. Software: PH110C algorithm. Safety: Class I, CF applied part. EMC: Group I, Class B. Standards: IEC 60601-1, IEC 60601-2-25, IEC 62304, ISO 14971.

Indications for Use

Indicated for adult and pediatric patients requiring multi-channel ECG signal acquisition, recording, display, analysis, and storage in healthcare facilities by trained professionals.

Regulatory Classification

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.

Predicate Devices

• PageWriter TC20 Cardiograph (K210560)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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 Systeme<br>Böblingen GmbH<br>Hewlett-Packard Strasse 2<br>71032 Böblingen<br>GERMANY<br>Phone: [phone] | | |
| Key Contact | Judy Yang<br>Regulatory Affairs Mgr.<br>Email: [e-mail] | | |
| 510(k) Submission Type | This is a Traditional 510(k). | | |
| II. DEVICE | | | |
| Trade Name | PageWriter TC35 | | |
| Common Name | Cardiograph | | |
| Classification Name | Review Panel: Cardiovascular<br>Regulation Description: Electrocardiograph<br>21 CFR §870.2340<br>Regulatory Class: II<br>Product Code: DPS | | |
| III. PREDICATE DEVICE | | | |
| Predicate Device | 510(k) No. | Company Name<br>Device Name | Product<br>Code |
| | K210560 | Philips Medical Systems<br>PageWriter TC20 Cardiograph | DPS |
| The PageWriter TC35 Cardiograph is substantially equivalent to the legally marketed predicate,<br>PageWriter TC20 Cardiograph (K210560). | | | |
| IV. DEVICE DESCRIPTION | | | |

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

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

Image /page/3/Picture/7 description: The image shows the Philips logo, which consists of a blue shield with the word "PHILIPS" at the top. Inside the shield, there are three wavy lines and two four-pointed stars. Below the logo, the text "K221141" is printed.

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Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.

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.

#### V. INDICATIONS FOR USE

| Comparison of Indications for Uses for Subject Device and Predicate | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| PageWriter TC20 Cardiograph<br>Predicate, K210560 | PageWriter TC35 Cardiograph<br>Subject Device |
| Philips Electrocardiograph, Page Writer TC cardiograph (TC20) is<br>intended to acquire multichannel ECG signals from adult and<br>pediatric patients from body surface ECG electrodes and to<br>record, display, analyze and store these ECG signals for review by<br>the user. It is to be used in healthcare facilities by trained<br>healthcare professionals. Analysis of the ECG signals is<br>accomplished with algorithms that provide measurements, data<br>presentations, graphical presentations and interpretations for<br>review by the user. | Identical |
| The interpreted ECG with measurements and interpretive<br>statements is offered to the clinician on an advisory basis only. It<br>is to be used in conjunction with the clinician's knowledge of the<br>patient, the results of the physical examination, the ECG tracings,<br>and other clinical findings. A qualified physician is asked to over<br>read and validate ( or change) the computer generated ECG<br>interpretation. | |

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

Image /page/4/Picture/10 description: The image shows the Philips logo, which consists of a blue shield with a white wave pattern and four stars inside. The word "PHILIPS" is written in white at the top of the shield. Below the logo, the text "K221141" is printed in black.

Philips GSC

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| Similarities | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item of Comparison | Description/Rationale |
| Indications for use | The subject device PageWriter TC35 Cardiograph and the currently marketed<br>predicate device (K210560) PageWriter TC20 Cardiograph have the identical<br>indications for use. Both TC35 and TC20 are intended to acquire multi-channel<br>ECG signals from patient and to record, display and store those signals to be<br>review by the user. The use environment is identical between TC35 and the<br>predicate device TC20, to be used in healthcare facilities by professional user. |
| Fundamental scientific<br>technologies and<br>performances | Both PageWriter TC35 Cardiograph and PageWriter TC20 Cardiograph are<br>similar with respect to the fundamental scientific technologies. They are<br>Electrocardiographs to collect multi-channel ECG signals of adult and pediatric<br>patients from body surface ECG electrodes. These ECG signals are amplified,<br>digitized, and processed in the digital domain. The cardiograph records,<br>displays, analyzes (through the cleared ECG algorithm), and prints the<br>processed ECG signals for review by the clinical operator.<br>PageWriter TC35 Cardiograph uses the similar design including software feature<br>and hardware feature with minor change on ECG signal acquisition and security<br>improvement. They are use the same cleared ECG algorithm PH110C for ECG<br>measurement and interpretation. |
| Patient Type | Adult and Pediatric patients |
| Use Environment | The use environment is identical between subject device PageWriter TC35<br>Cardiograph and the predicate device (K210560) PageWriter TC20 Cardiograph.<br>They are intended to be used in the professional healthcare facility<br>environment. Not for home use, and not intended to be used together with any<br>RF emitter equipment such as high-frequency electrosurgical equipment,<br>diathermy, or electrocautery. |
| Physical features and<br>parameters | The PageWriter TC35 Cardiograph device physical feature and physical size is<br>identical as the predicate device (K210560) PageWriter TC20 Cardiograph. A<br>picture of the subject device and predicate is provided below.<br><br>Image: PageWriter TC35 Cardiograph<br><br>Image: PageWriter TC20 Cardiograph<br><br>Same as the predicate device (K210560), the subject device provides the same<br>size of LCD touch screen, keyboard, embedded printer, power module and<br>battery. The provided external ports are also the same, rear side of the device<br>provide Patient Cable connector, LAN connector, USB port and power cord<br>connector, while right side of the device provide another USB port, and battery<br>compartment door. |
| Connectivity | The subject PageWriter TC35 Cardiograph and the predicate device (K210560)<br>PageWriter TC20 Cardiograph both provide LAN and Wireless connection. The |
| LAN and wireless function for both TC35 and TC20 are used to transmit the ECG<br>reports, patient order/ADT, device configuration and time sync between the<br>Cardiograph and the external device like ECG management system, DICOM,<br>Dashboard and hospital servers. | |
| ECG Performance | Compared to the predicate device (K210560) PageWriter TC20 Cardiograph, the<br>subject PageWriter TC35 Cardiograph provide the same performance on 12-<br>lead ECG acquisition, algorithm interpretation, display accuracy, and ECG report<br>formats for printing and transmitting purpose. |
| Safety and EMC performance | The subject PageWriter TC35 Cardiograph and the predicate device (K210560)<br>PageWriter TC20 Cardiograph have the same level of safety and EMC<br>performance.<br>The safety classification of both subject and predicate device (K210560) is class<br>I, with CF type of applied part. And the EMC emission classification is Group I,<br>Class B. |
| Differences | |
| Item of Comparison | Description/Rationale |
| Patient Data Cable | The subject device uses different part number of patient cable to connect to<br>the electrode to transmit ECG signal. The patient cable is form, fit and<br>functionally identical to the predicate device (K210560) as cleared together<br>with PageWriter TC20 Cardiograph, the minor difference is on the thumb screw<br>to match the mechanical connector at the Cardiograph end.<br>989803184921 12-Lead Patient Cable (IEC), Standard Length<br>989803184931 12-Lead Patient Cable (AAMI), Standard Length<br>989803184941 12-Lead Patient Cable (IEC), Long<br>989803184951 12-Lead Patient Cable (AAMI), Long |
| ECG signal acquisition | PageWriter TC35 Cardiograph provide improved performance on ECG signal<br>process. The sampling rate of the subject device have been improved to 1000<br>samples per second, while the predicate device (K210560) PageWriter TC20<br>Cardiograph sampling rate is 500 samples per second. TC35 provide ECG signal<br>bandwidth 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 used<br>on the subject device provides compatibility to the latest version of 802.11<br>standard. |
| Security Enhancement | Compared to the predicate device (K210560), the subject device provided<br>improvement on cybersecurity risk control. The operating system has changed<br>from the end of supported WinCE5 to Linux. The device support of FIPS 140-2<br>for data encryption, provide role-base access management, USB disk encryption<br>and digital signature, support SMB V2/V3. |

Image /page/5/Picture/4 description: The image features the Philips logo, which consists of the word "PHILIPS" above a stylized emblem. The emblem is a blue circle containing wavy lines and four stars. Below the logo is the alphanumeric code "K221141".

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

Image /page/6/Picture/8 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a sans-serif font above a shield-like shape. Inside the shield, there are three wavy lines representing water and four stars. Below the logo, there is the alphanumeric code "K221141".

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 | FDA<br>Recognition # | Title # |
|------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI<br>ES60601-<br>1:2005/A1:2012 | 19-4 | Medical electrical equipment. Part 1: General requirements for<br>basic safety and essential performance |
| IEC 60601-1-2<br>Edition 4.0<br>2014-02 | 19-8 | Medical electrical equipment. Part 1-2: General requirements for<br>basic safety and essential performance. Collateral standard:<br>Electromagnetic compatibility. Requirements and tests |
| IEC 60601-2-25<br>Edition 2.0<br>2011-10 | 3-105 | Medical electrical equipment - Part 2-25: Particular requirements<br>for the basic safety and essential performance of<br>electrocardiographs |
| IEC 60601-1-6<br>Edition 3.1<br>2013-10 | 5-89 | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability |
| IEC 62366-1<br>Edition 1.0<br>2015-02 | 5-114 | Medical devices. Part 1: Application of usability engineering to<br>medical devices |
| IEC 62304<br>Edition 1.1<br>2015-06 | 12-79 | Medical device software - Software life cycle processes |
| AAMI<br>TIR69:2017 | 19-22 | Technical Information Report Risk management of radiofrequency<br>wireless coexistence for medical devices and systems |
| ANSI IEEE<br>C63.27- 2017 | 19-29 | American National Standard for Evaluation of Wireless<br>Coexistence |
| ASTM D4169-16 | 14-499 | Standard Practice for Performance Testing of Shipping Containers<br>and Systems |
| ANSI AAMI<br>EC53:2013 | 3-129 | ECG trunk cables and patient lead-wires |
| ISO 14971:2019 | 5-125 | Medical devices - Application of risk management to medical<br>devices |
| AIM<br>7351731:2017 | 19-30 | Medical Electrical Equipment and System Electromagnetic<br>Immunity Test for Exposure to Radio Frequency Identification<br>Readers |

## 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

Image /page/7/Picture/7 description: The image shows the Philips logo, which consists of a blue shield shape with the word "PHILIPS" at the top. Inside the shield, there are wavy lines and four stars. Below the logo, there is the text "K221141".

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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).

Image /page/8/Picture/11 description: The image shows the Philips logo, which consists of the word "PHILIPS" above a stylized shield-like shape. Inside the shield, there are three horizontal wavy lines and four stars. Below the logo, there is the text "K221141".