(200 days)
No
The document explicitly states the device uses the "clinically proven Philips DXL ECG Algorithm (K132068)" for analysis and interpretation. While algorithms are used, there is no mention of AI, ML, or any learning-based approach. The description focuses on established algorithmic analysis rather than adaptive or learning systems.
No
The device is described as an interpretive cardiograph intended to acquire, record, display, analyze, and store ECG signals for review and diagnosis, not to provide treatment or therapy.
Yes
The device acquires ECG signals, analyzes them with algorithms to provide measurements and interpretations, and these interpretations are used by healthcare professionals in conjunction with other clinical findings to understand the patient's condition. While the final diagnosis rests with a physician, the device provides critical information used in the diagnostic process.
No
The device description explicitly states that the Cardiac Workstation 5000 and 7000 consist of an "electrocardiograph device with integrated display and printer," indicating the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Cardiac Workstation acquires and analyzes electrical signals from the body surface (ECG electrodes). It does not analyze biological samples taken from the body.
- Intended Use: The intended use is to acquire, record, display, analyze, and store ECG signals for review by healthcare professionals. This is a physiological measurement, not an in vitro test.
Therefore, the Cardiac Workstation falls under the category of a medical device that measures physiological parameters, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cardiac Workstation 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. They are 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.
Product codes
DPS
Device Description
The Cardiac Workstation 5000 (aka: CW 5000) and Cardiac Workstation 7000 (aka: CW 7000) are 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. They are 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 for review by the user.
The interpreted ECG with measurements and interpretive statements are offered to the clinician on an advisory basis only. They are 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.
The CW 5000 and CW 7000 are mid- and high-range interpretive cardiographs, differing primarily in display size, the number of standard options. Both devices offer a full array of features built on the Linux operating system, with touch screen operation, a configurable feature set, and interpretation from the clinically proven Philips DXL ECG Algorithm (K132068). They provide a cardiograph solution for hospitals and cardiology clinics in processing large volumes of ECGs. The DXL ECG algorithm in the software analyzes up-to 18 leads of simultaneously acquired ECG waveform to interpret rhythm and morphology for a variety of patient populations. The measurements are then analyzed by the DXL ECG Algorithm. The resulting ECG reports may include ECG measurements, reasons, or analysis statements. The algorithm covers both adult and pediatric populations.
The CW 5000 and CW 7000 consist of the following:
- An electrocardiograph device with integrated display and printer. CW 5000 provides 12.1'' display . panel. CW 7000 provides 15.6″ and 18.5″ options for the display panel.
- Optional Trolley (ordered via a separate part number)
The subject devices are further structured with options relating to software. Ul language, keyboard locale, and a wide range of other configuration choices to optimize the user's experience with the devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
trained healthcare professionals / 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)
Non-Clinical Tests – Harmonized Standards
The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all safety, electromagnetic compatibility, and cybersecurity tests to demonstrate compliance with the harmonized standards listed.
Non-clinical Bench Tests
Non-clinical bench testing activities established the performance, functionality, and reliability characteristics of the subject Cardiac Workstation 5000 and Cardiac Workstation 7000. This testing covered verification of performance in the domains of software, environment, reliability, mechanical, hardware, packaging, human factors and usability performance. The Cardiac Workstation 5000 and Cardiac Workstation 7000 were evaluated against all applicable external standards and successfully passed all verifications and validations. The results demonstrate that Cardiac Workstation 5000 and Cardiac Workstation 7000 meet the performance claims and support a determination of substantial equivalence to the predicate PageWriter TC70 Cardiograph (K210560).
Clinical Studies
The Cardiac Workstation 5000 and Cardiac Workstation 7000, like the predicate device (K210560), did not require clinical studies to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2024
Philips Medizin Systeme Böblingen GmbH Angel Ya Regulatory Affairs Manager Hewlett-Packard Strasse 2 Böblingen, 71032 Germany
Re: K241556
Trade/Device Name: Cardiac Workstation (5000); Cardiac Workstation (7000) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: November 19, 2024 Received: November 19, 2024
Dear Angel Ya:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
0812(download) and "Dogiding Whon to Submit o 5100) fono Softwong
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Jennifer W. Shih -S
Jennifer 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
3
Indications for Use
Submission Number (if known)
Device Name
Cardiac Workstation (5000); Cardiac Workstation (7000)
Indications for Use (Describe)
The Cardiac Workstation 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. They are 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
510(k) Summarv
| 510(k) Summary | |||
|---|---|---|---|
| I. SUBMITTER | |||
| Date Prepared | 14 May 2024 | ||
| Submitter/Owner | Philips Medizin Systeme Böblingen GmbH | ||
| Hewlett-Packard Strasse 2 | |||
| 71032 Böblingen | |||
| GERMANY | |||
| Phone: +1 (949)-502-1823 | |||
| Key Contact | Angel Ya | ||
| Regulatory Affairs Mgr. | |||
| Email: angel.ya@philips.com | |||
| 510(k) Submission Type | This is a Traditional 510(k). | ||
| II. DEVICE | |||
| Trade Name | Cardiac Workstation 5000 (aka: CW 5000) | ||
| Cardiac Workstation 7000 (aka: CW 7000) | |||
| Common Name | Cardiograph | ||
| Classification Name | Review Panel: Cardiovascular | ||
| Regulation Description: Electrocardiograph | |||
| 21 CFR §870.2340 | |||
| Regulatory Class: II | |||
| Product Code: DPS | |||
| III. PREDICATE DEVICE | |||
| 510(k) No. | Company Name | ||
| Device Name | Product | ||
| Code | |||
| Predicate Device | K210560 | Philips Medical Systems | |
| PageWriter TC70 Cardiograph | DPS | ||
| Reference Device | K221141 | Philips Medizin Systeme | |
| Böblingen GmbH | |||
| PageWriter TC35 Cardiograph | DPS | ||
| The Philips Cardiac Workstation 5000 and Cardiac Worksation 7000 are substantially equivalent to the | |||
| legally marketed predicate, PageWriter TC70 Cardiograph (K210560). | |||
| IV. DEVICE DESCRIPTION | |||
| Cardiac Workstation 5000 and Cardiac Workstation 7000 – description of the device per 21 CFR |
Image /page/4/Picture/5 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and two stars, also in white. The overall design is simple and recognizable, representing the brand's identity.
5
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
807.92(a) (4)
The Cardiac Workstation 5000 (aka: CW 5000) and Cardiac Workstation 7000 (aka: CW 7000) are 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. They are 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 for review by the user.
The interpreted ECG with measurements and interpretive statements are offered to the clinician on an advisory basis only. They are 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.
The CW 5000 and CW 7000 are mid- and high-range interpretive cardiographs, differing primarily in display size, the number of standard options. Both devices offer a full array of features built on the Linux operating system, with touch screen operation, a configurable feature set, and interpretation from the clinically proven Philips DXL ECG Algorithm (K132068). They provide a cardiograph solution for hospitals and cardiology clinics in processing large volumes of ECGs. The DXL ECG algorithm in the software analyzes up-to 18 leads of simultaneously acquired ECG waveform to interpret rhythm and morphology for a variety of patient populations. The measurements are then analyzed by the DXL ECG Algorithm. The resulting ECG reports may include ECG measurements, reasons, or analysis statements. The algorithm covers both adult and pediatric populations.
The CW 5000 and CW 7000 consist of the following:
- An electrocardiograph device with integrated display and printer. CW 5000 provides 12.1'' display . panel. CW 7000 provides 15.6″ and 18.5″ options for the display panel.
- Optional Trolley (ordered via a separate part number)
The subject devices are further structured with options relating to software. Ul language, keyboard locale, and a wide range of other configuration choices to optimize the user's experience with the devices.
Image /page/5/Picture/11 description: The image shows the Philips logo, which is a blue shield with the word "PHILIPS" at the top. Inside the shield, there are two wavy lines and two four-pointed stars. The logo is simple and recognizable, representing the brand's identity.
6
Image /page/6/Picture/0 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 plain white, which makes the blue letters stand out.
V. INDICATIONS FOR USE
| Comparison of Indications for Uses for Subject Device and Predicate | ||
|---|---|---|
| PageWriter TC70 Cardiograph | ||
| Predicate, K210560 | Cardiac Workstation 5000 (aka: CW 5000) | |
| Cardiac Workstation 7000 (aka: CW 7000) | ||
| Subject Device | Description of | |
| differences | ||
| Philips PageWriter TC70 cardiograph is | ||
| intended to acquire multichannel 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 Cardiac Workstation 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. They are 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. | Identical except | |
| for change to | ||
| product name. | ||
| 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. |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Similarities | |
|---|---|
| Item of Comparison | Description/Rationale |
| Indications for use | The CW 5000 and CW 7000 subject devices and the currently marketed predicate |
| device (K210560) PageWriter TC70 Cardiograph have the identical indications for | |
| use. Both CW 5000 and CW 7000 and TC70 are intended to acquire multi-channel | |
| ECG signals from patient and to record, display and store those signals to be | |
| review by the user. The use environment is identical between CW 5000, the CW | |
| 7000, and the predicate device, TC70. They are all to be used in healthcare | |
| facilities by professionals. |
Image /page/6/Picture/7 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and two four-pointed stars. The logo is simple and recognizable, representing the brand's identity.
7
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The image is simple and focuses solely on the brand name.
| Fundamental scientific
technologies and
performances | Both CW 5000 and CW 7000 and PageWriter TC70 Cardiograph are similar with
respect to the fundamental scientific technologies. They are
electrocardiographs that collect multi-channel ECG signals of adult and
pediatric patients 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 in K132068),
and prints the processed ECG signals for review by the clinical operator.
The CW 5000 and CW 7000 use the same fundamental design as the TC70, but
also contain improvements to the user's experience by deploying updated
hardware and software technologies. The devices also incorporate minor
changes to the ECG signal processing approach and security improvements to
comply with widely recognized standards. Both devices use the same cleared
ECG algorithm (PH110C) for ECG measurement and interpretation. | |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Patient Type | Adult and pediatric patients | |
| Patient Data Cable | The subject devices use the same patient cable cleared under K080999 with the
predicate device, PageWriter TC70 Cardiograph. The latest 510k for the
predicate device is K210560. | |
| Use Environment | The use environment is identical between the subject CW 5000 and CW 7000
devices and the predicate device (K210560) PageWriter TC70 Cardiograph. They
are intended for use in a professional healthcare facility. They are not for home
use, and not intended to be used together with any RF emitting equipment such
as high-frequency electrosurgical equipment, diathermy, or electrocautery. | |
| Connectivity | The subject CW 5000 and CW 7000, like the predicate device (K210560)
PageWriter TC70 Cardiograph, provide LAN and wireless connectivity. This
functionality is used to transmit ECG reports, patient order/ADT info, device
configuration details, and time sync between the Cardiac Workstation and ECG
Management Systems, Device Management Dashboard, and the hospital's EMR. | |
| ECG Performance | Compared to the predicate device (K210560), PageWriter TC70 Cardiograph, the
subject CW 5000 and CW 7000 devices provide similar performance on ECG
acquisition of up to 18 leads, algorithm interpretation, display accuracy, and ECG
report formats for printing and transmission purposes. | |
| Safety and EMC performance | The subject CW 5000, CW 7000, and predicate device (K210560) PageWriter
TC70 Cardiograph have the same level of safety and EMC performance. The
safety classification of both subject and predicate device (K210560) is class I, with
CF type of applied part. The EMC emission classification is Group I, Class B. | |
| Differences | | |
| Item of Comparison | Description/Rationale | |
| Physical features and parameters | The CW 5000 and CW 7000 device's physical features and size are similar to the predicate device (K210560) PageWriter TC70 Cardiograph. A picture of the subject devices and predicate is provided below. | |
| | Image: Cardiac Workstation 5000 | Image: Cardiac Workstation 7000 |
| | Image: Philips TC70 Cardiograph | |
| | Compared to the predicate device (K210560), the Cardiac Workstations have a similar product configuration, including an LCD touch screen, embedded printer, power supply module, PIM and Trolley. The CWs have an array of touchscreen options (12.1 in for CW5000, 15.6 in and 18.5 in for CW7000) and 2 optional trolley types: height-adjustable and fixed-height. The external ports are similar. The rear of the device provides the USB ports and connectors for LAN, PIM, and power cord. The right side houses the battery compartment door, and the left side has the paper drawer. | |
| ECG signal acquisition | Compared to the predicate device, PageWriter TC70 Cardiograph (K210560), the Cardiac Workstations provide improved ECG A/D signal processing resolution from 12 to 24 bit. The digital data processing rate has improved from 500 to 1000 SPS (Samples Per Second). ECG signal bandwidth has been improved from 0.05Hz150 Hz to 0.02Hz300 Hz. The subject device also supports the latest Philips ECG XML schema 1.04.04. The improved digital data processing and filter range are identical with reference device, Pagewriter TC35 (K221141). | |
| Radio connection | Compared to the predicate device, PageWriter TC70 Cardiograph (K210560), the wireless module used for the subject device provides updated compatibility to support communication protocol 802.11 ac (WiFi 5). The wireless module, wireless function, specification, transmitting data, and connecting system/application at the hospital environment are the same as the reference device, Pagewriter TC35 (K221141). | |
| Security Enhancement | Compared to the predicate device, PageWriter TC70 Cardiograph (K210560), the subject device provides improved cybersecurity risk control. The operating system has been changed from the "end of support" WinCE5/WinCE7 OS to the supported Linux OS. The device supports FIPS 140-2 for data encryption, user authentication, USB disk encryption and digital signature, and supports SMB | |
Image /page/7/Picture/4 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a sans-serif font above a stylized shield-like shape. The shield is blue and contains two wavy lines that resemble sound waves or water. There are also four stars within the shield, two above the waves and two below, adding a celestial or technological element to the design.
8
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in a large, sans-serif font. The word is written in a solid blue color. The letters are evenly spaced and the overall appearance is clean and modern.
Image /page/8/Picture/4 description: The image shows the Philips logo. The logo is a blue shield with the word "PHILIPS" in white at the top. Below the word are two wavy lines and two stars. The wavy lines are white, and the stars are white with a blue outline.
9
Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
V2/V3. The improved performance is identical to the reference device, Pagewriter TC35 (K221141).
Substantial Equivalence Summary
Analysis of operational, technological and safety characteristics form the basis for the determination of substantial equivalence of the subject device, Cardiac Workstation 5000 and Cardaic Worksation 7000, with the legally marketed predicate device (K210560). The Cardiac Workstation 5000 and Cardiac Workstation 7000 are substantially equivalent to the predicate device.
PERFORMANCE DATA VII.
Non-Clinical Tests – Harmonized Standards
The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all safety, electromagnetic compatibility, and cybersecurity tests to demonstrate compliance with the harmonized standards below.
| Standard | FDA
Recognition # | Title |
|-----------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI ES60601-
1:2005/A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons.
Text) [Incl. AMD2:2021] | 19-46 | Medical electrical equipment. Part 1: General requirements for basic
safety and essential performance |
| ANSI AAMI IEC 60601-1-
2:2014 [Including AMD
1:2021] | 19-36 | Medical electrical equipment. Part 1-2: General requirements for
basic safety and essential performance. Collateral
standard: Electromagnetic compatibility. Requirements and tests |
| ANSI AAMI IEC 60601-2-
25:2011/(R)2016 | 3-105 | Medical electrical equipment - Part 2-25: Particular requirements for
the basic safety and essential performance of electrocardiographs |
| IEC 60601-1-6:
2010+A1:2013+A2: 2020 | 5-132 | Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard:
Usability |
| IEC 62366-1: 2015+A1:
2020 | 5-129 | Medical devices. Part 1: Application of usability engineering to
medical devices |
| ANSI AAMI IEC
62304:2006/A1:2016 | 13-79 | Medical device software - Software life cycle processes |
| ANSI C63.27:2021 | 19-48 | American National Standard for Evaluation of Wireless
Coexistence |
Image /page/9/Picture/10 description: The image shows the Philips logo, which is a blue shield shape with the word "PHILIPS" at the top. Inside the shield, there are two wavy lines and two four-pointed stars. The logo is simple and recognizable, representing the brand's identity.
10
Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
| AAMI
TIR69:2017/(R2020) | 19-22 | Technical Information Report Risk management of radio-frequency
wireless coexistence for medical devices and systems |
|----------------------------|--------|------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D4169:2022 | 14-576 | Standard Practice for Performance Testing of Shipping Containers and
Systems |
| ISO 14971:2019 | 5-125 | Medical devices - Application of risk management to medical devices |
| AIM 7351731:2021 | 19-45 | Medical Electrical Equipment and System Electromagnetic
Immunity Test for Exposure to Radio Frequency Identification
Readers |
| ISO 15223-1:2021 | 5-134 | Medical devices - Symbols to be used with information to be supplied
by the manufacturer - Part 1: General requirements |
| ISO 20417:2021 | 5-135 | Medical devices - Information to be supplied by the manufacturer |
Non-clinical Bench Tests
Non-clinical bench testing activities established the performance, functionality, and reliability characteristics of the subject Cardiac Workstation 5000 and Cardiac Workstation 7000. This testing covered verification of performance in the domains of software, environment, reliability, mechanical, hardware, packaging, human factors and usability performance. The Cardiac Workstation 5000 and Cardiac Workstation 7000 were evaluated against all applicable external standards and successfully passed all verifications and validations. The results demonstrate that Cardiac Workstation 5000 and Cardiac Workstation 7000 meet the performance claims and support a determination of substantial equivalence to the predicate PageWriter TC70 Cardiograph (K210560).
Clinical Studies
The Cardiac Workstation 5000 and Cardiac Workstation 7000, like the predicate device (K210560), 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 all been applied/conducted for the Cardiac Workstation 5000 and Cardiac Workstation 7000.
Based upon the design, indications for use, classification, usability, and safety testing, the Cardiac Workstation 5000 and Cardiac Workstation 7000 are substantially equivalent to the predicate device (K210560).
Image /page/10/Picture/10 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" in white letters at the top. Inside the shield, there are two white stars and two white wavy lines. The stars are positioned above and below the wavy lines.
11
Image /page/11/Picture/0 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.
VIII. CONCLUSIONS
The results of the substantial equivalence assessment, evaluated alongside non-clinical bench testing, electrical safety, electromagnetic compatibility, software verification, human factors and usability, demonstrate that the Cardiac Workstation 5000 and Cardiac Workstation 7000 can be considered to be substantially equivalent to the predicate device (K210560). The subject devices perform as intended and have performance characteristics that are substantially equivalent to the PageWriter TC70 Cardiograph predicate device (K210560).
Image /page/11/Picture/5 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. The word "PHILIPS" is written in blue at the top of the shield.