K Number

Device Name

PAGEWRITER TC 20, 30, 50, 70

Manufacturer

PHILIPS MEDICAL SYSTEMS

Date Cleared

2012-04-03

(161 days)

Product Code

DPS

Regulation Number

870.2340

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. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K080999

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary mentions "algorithms that provide measurements, data presentations, graphical presentations and interpretations" but does not use terms like AI, ML, or deep learning, nor does it describe training or test sets typically associated with AI/ML development. The analysis is described as "computer generated ECG interpretation" which is a broader term that doesn't necessarily imply AI/ML.

Therapeutic

No
The device is described as a cardiograph used for acquiring, recording, displaying, analyzing, and storing ECG signals for review. Its purpose is diagnostic, providing information for clinicians, not for direct therapeutic intervention.

Diagnostic

Yes
This device acquires, analyzes, and interprets ECG signals to assist clinicians in diagnosis, which is a characteristic function of a diagnostic device. The "Intended Use" specifically mentions "Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user." and clarifies that the interpreted ECG is "offered to the clinician on an advisory basis only," indicating its role in the diagnostic process.

SaMD (Software as a Medical Device)

The device description explicitly mentions hardware components like a "digital patient interface module," "largest display," and the device is described as a "cardiograph," which is a physical medical device. While it utilizes software for analysis, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
Device Function: The description clearly states the device acquires multi-channel ECG signals from the body surface using electrodes. This is a non-invasive measurement taken directly from the patient's body, not from a sample taken from the body.
Intended Use: The intended use is to acquire, record, display, analyze, and store ECG signals for review. This is a diagnostic tool for assessing the electrical activity of the heart in vivo.

Therefore, because the device operates by acquiring signals directly from the patient's body surface rather than analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DPS

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body surface (for ECG electrodes)

Indicated Patient Age Range

Adult and pediatric patients

Intended User / Care Setting

Trained healthcare professionals in healthcare facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Tests were conducted to Philips PageWriter TC20 cardiograph and the product meet specific acceptance criteria of the following FDA recognized standards: AAMI-EC11:1991, IEC 60601-1: 1990+A1 1991+A2 1995, IEC 60601-1-2: 2001+A1 2004, IEC 60601-2-25: 1993+A1:1999.

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.

Conclusion: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s):

PageWriter TC30/860306, K080999

Reference Device(s):

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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

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:

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 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

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

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. 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.

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

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

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
---------------	---------

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