Who is the manufacturer of PAGEWRITER TC 20, 30, 50, 70?

Philips Medical Systems filed the 510(k) submission for PAGEWRITER TC 20, 30, 50, 70 (K113144).

What is the FDA product code for PAGEWRITER TC 20, 30, 50, 70?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for PAGEWRITER TC 20, 30, 50, 70?

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

Who can help prepare an FDA 510(k) submission like PAGEWRITER TC 20, 30, 50, 70?

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

PAGEWRITER TC 20, 30, 50, 70

K113144 · Philips Medical Systems · DPS · Apr 3, 2012 · Cardiovascular

Device Facts

Record ID	K113144
Device Name	PAGEWRITER TC 20, 30, 50, 70
Applicant	Philips Medical Systems
Product Code	DPS · Cardiovascular
Decision Date	Apr 3, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Indications for Use

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 Story

The PageWriter TC20 is a diagnostic electrocardiograph used in healthcare facilities by trained professionals. It acquires multi-channel ECG signals via body surface electrodes; samples at 8000 Hz; performs 12-bit or 16-bit A/D conversion. The device processes signals using internal algorithms to provide measurements, graphical presentations, and interpretive statements. Output is displayed on a 6.5-inch color touch screen or printed via a high-resolution thermal-array printer. Data can be stored internally or on USB media and transmitted via LAN/wireless connectivity. The device assists clinicians by providing advisory interpretations; a qualified physician must review and validate all computer-generated findings. The TC20 integrates the ECG circuit directly onto the main board, differing from the predicate TC30 which uses a separate Patient Interface Module (PIM), though both maintain identical isolation and signal processing principles.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing against FDA-recognized standards (AAMI-EC11, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25). The 12-lead ECG interpretation algorithm was previously cleared in prior submissions.

Technological Characteristics

Diagnostic electrocardiograph; 12-lead acquisition; 6.5-inch color LCD touch screen (640x480); thermal-array printer (200x500 dpi). Connectivity: 10/100 Base-T Ethernet, SDIO wireless LAN (802.11 b/g). Power: AC or Lithium-Ion battery. Sampling: 8000 samples/sec/lead. A/D conversion: 12/16-bit. Standards: AAMI-EC11, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25. Software: A.05.

Indications for Use

Indicated for adult and pediatric patients requiring ECG evaluation for diagnosis, treatment planning, treatment effectiveness monitoring, or symptom investigation. For use by trained healthcare professionals in healthcare facilities.

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 TC30 (K080999)

Submission Summary (Full Text)

{0}------------------------------------------------ ## 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 1. 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 {1}------------------------------------------------ ### 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) 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. 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: {2}------------------------------------------------ ## 5. Statement of the Indications for Use of the Device That is the Subject of the 510(k): 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. ## 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 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. | 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. | Same | | | 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. | 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. | | | Indications of use | Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms. | Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-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 | | Battery Chemistry | Lithium Ion battery | Lithium Ion battery (identical battery) | Same | | ECG Acquisition | 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 screen display | 640 x 480 pixel resolution 13.3 cm x 9.9 cm (6.5- inch diagonal) color LCD with Touch Screen | 640 x 480 pixel resolution 13.3 cm x 9.9 cm (6.5-inch diagonal) color LCD with Touch Screen | same | | Raw data acquisition | 8000 samples per seconds on individual leads for 12 lead ECG 8000 samples per seconds on individual leads for SAECG | 8000 samples per seconds on individual leads for 12 lead ECG 8000 samples per seconds on individual leads for SAECG | same | | Sampling rate on cardiograph | 500, 1000 and 2000 samples per second per electrode/lead. 12 bit and 16 bit A/D conversion provides 5µV, 2.5µV and 1µV resolution. | 500, 1000 and 2000 samples per second per electrode/lead. 12 bit and 16 bit A/D conversion 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 | | Printer resolution | High-resolution, digital- array printer using thermal-sensitive paper200 dpi (voltage axis) by 500 dpi (time axis) | High-resolution, digital- array printer using thermal- sensitive paper200 dpi (voltage axis) by500 dpi (time axis) | same | | Battery Operation | | | | | Capacity | Typically 50 ECGs and copies on a single charge or 40 minutes of continuous rhythm recordingFully charged 1 battery is to last up to 5 hours under normal usage | Typically 50 ECGs and copies on a single charge or 40 minutes of continuous rhythm recordingFully charged 1 battery is to last up to 5 hours under normal usage | same | | Networking | | | | | Networking connection | 10/100 Base-T IEEE 802.3 Ethernet via RJ45 connector (standard)SDIO wireless LAN connection supporting 802.11 b/g standards | 10/100 Base-T IEEE 802.3 Ethernet via RJ45 connector (standard)Compact Flash card wireless LAN connection supporting 802.11 a/b/g standards | Substantially Equivalent | | ECG storage | XML File Format (Schema 1.04)Up to 200 ECGs to internal flash memoryUp to 200 ECGs per USB Memory Stick | XML File Format (Schema 1.04)Up to 200 ECGs to internal flash memoryUp to 200 ECGs per USB Memory Stick | same | | Orders | Receive Orders from TraceMaster via the NetworkUp to 200 Orders stored in internal database | Receive Orders from TraceMaster via the NetworkUp to 200 Orders stored in internal database | same | | ECG file formats | XML (Schema 1.03 and 1.04, 1.04.01, 1.04.02) | XML (Schema 1.03 and 1.04. 1.04.01, 1.04.02) | same | | ECG leads and interpretation | | | | | ECG acquisition | 12-Lead ECG acquisition | 12-Lead ECG acquisition | same | | Feature/ Model | Philips PageWriter TC20 (New Device) | Philips PageWriter TC30 (Predicate) K080999 | Comparison | | Algorithm | • 12-Lead ECG Algorithm | • 12-Lead ECG Algorithm | same | | Patient information module (PIM) | No | Yes | See analysis on difference | | Patient cable | yes | No | See analysis on difference | {3}------------------------------------------------ {4}------------------------------------------------ . {5}------------------------------------------------ . ## 510(K) Summary for Philips PageWriter TC20, 30, 50, 70 Cardiograph {6}------------------------------------------------ #### 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. {7}------------------------------------------------ ### 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, including Amendment 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 and Tests including Amendment 1: 2004 | | IEC 60601-2-25: 1993+A1:1999 | Medical Electrical Equipment- Part 2: Particular Requirements for Safety and Electrocardiographs | ### 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. {8}------------------------------------------------ ### 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 {9}------------------------------------------------ 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 {10}------------------------------------------------ # 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

PAGEWRITER TC 20, 30, 50, 70

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Device Story

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Technological Characteristics

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Submission Summary (Full Text)

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PAGEWRITER TC 20, 30, 50, 70

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Indications for Use

Device Story

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Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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