(200 days)
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.
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.
The Philips Cardiac Workstation 5000 and 7000 are ECG devices designed to acquire, record, display, analyze, and store multi-channel ECG signals for review. The analysis is performed by algorithms providing measurements, data presentations, graphical representations, and interpretations.
The study presented in the provided context for the Cardiac Workstation 5000 and 7000 is a non-clinical bench testing study, primarily focused on demonstrating substantial equivalence to a predicate device (PageWriter TC70 Cardiograph, K210560).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed as compliance with harmonized standards and successful completion of various bench tests, aiming to show performance similar to the predicate device. Specific quantitative performance metrics for the standalone algorithm are not detailed in the provided text, as the focus is on overall device equivalence.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Report) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with ANSI/AAMI ES60601-1:2005/A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (General requirements for basic safety and essential performance). | "The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all safety...tests to demonstrate compliance with the harmonized standards..." "The safety classification of both subject and predicate device (K210560) is class I, with CF type of applied part." |
| Electromagnetic Compatibility (EMC) | Compliance with ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] (EMC requirements and tests). | "The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all...electromagnetic compatibility...tests to demonstrate compliance with the harmonized standards..." "The EMC emission classification is Group I, Class B." |
| Electrocardiograph Specific Performance | Compliance with ANSI AAMI IEC 60601-2-25:2011/(R)2016 (Particular requirements for basic safety and essential performance of electrocardiographs). | "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." Also, improvements: ECG A/D signal processing resolution from 12 to 24 bit, digital data processing rate from 500 to 1000 SPS, ECG signal bandwidth from 0.05Hz |
| Usability | Compliance with IEC 60601-1-6: 2010+A1:2013+A2: 2020 (Usability) and IEC 62366-1: 2015+A1: 2020 (Application of usability engineering to medical devices). | "The subject 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..." |
| Software Life Cycle Processes | Compliance with ANSI AAMI IEC 62304:2006/A1:2016 (Medical device software - Software life cycle processes). | "The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all...software...tests to demonstrate compliance with the harmonized standards..." |
| Cybersecurity | Compliance with relevant cybersecurity risk control standards and best practices (implied by the focus on security enhancements). | "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 V2/V3." This improved performance is identical to the reference device, PageWriter TC35 (K221141). |
| Risk Management | Compliance with ISO 14971:2019 (Application of risk management to medical devices). | "Risk management activities have all been applied/conducted for the Cardiac Workstation 5000 and Cardiac Workstation 7000." |
| Wireless Coexistence | Compliance with ANSI C63.27:2021 (Evaluation of Wireless Coexistence) and AAMI TIR69:2017/(R2020) (Risk management of radio-frequency wireless coexistence). | "The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all...tests to demonstrate compliance with the harmonized standards..." "Compared to the predicate device...the wireless module used for the subject device provides updated compatibility to support communication protocol 802.11 ac (WiFi 5)." The wireless function, specification, transmitting data, and connecting system/application are the same as the reference device, Pagewriter TC35 (K221141). |
| Non-clinical Bench Test Performance | Verification of performance in software, environment, reliability, mechanical, hardware, packaging, human factors and usability performance. Demonstrated performance meets claims and supports substantial equivalence. | "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)." |
2. Sample Size for the Test Set and Data Provenance
The document does not detail specific sample sizes for a 'test set' in the traditional sense of a clinical or algorithm performance study. The evidence provided is primarily focused on bench testing against harmonized standards and comparison to a predicate device. Therefore, the "test set" would refer to the tests and evaluations conducted on the devices themselves rather than a dataset of patient ECGs.
The data provenance for any internal testing is not explicitly stated in terms of country of origin or retrospective/prospective nature regarding patient data. However, the harmonized standards (e.g., IEC, ANSI/AAMI, ISO, ASTM) are international or US-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No information is provided about experts establishing ground truth for a test set. This type of information would typically be present in a clinical or algorithm validation study. Since this is a substantial equivalence submission based on non-clinical bench testing, the ground truth refers to compliance with established technical specifications and standards rather than clinical diagnoses.
4. Adjudication Method for the Test Set
Not applicable, as the provided document describes non-clinical bench testing and compliance with standards, not a study involving expert adjudication of clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The document explicitly states: "The Cardiac Workstation 5000 and Cardiac Workstation 7000, like the predicate device (K210560), did not require clinical studies to demonstrate substantial equivalence." The algorithm ("Philips DXL ECG Algorithm", K132068) is mentioned as previously cleared. This submission focuses on the hardware device's equivalence and updated features, not new claims about AI performance or human-AI interaction.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The document states that the devices use the "clinically proven Philips DXL ECG Algorithm (K132068)" or "same cleared ECG algorithm (PH110C) for ECG measurement and interpretation." This implies that the algorithm's standalone performance was likely established in its original K132068 submission. This current submission for the Cardiac Workstation 5000/7000 leverages that existing clearance and does not provide new standalone algorithm performance data. The mention of the algorithm being "advisory basis only" and requiring "a qualified physician to over-read and validate (or change) the computer-generated ECG interpretation" confirms it is not intended for standalone diagnostic use without human oversight.
7. The Type of Ground Truth Used
For the specific non-clinical bench tests described in this document, the "ground truth" is compliance with harmonized technical standards and internal specifications. For the underlying DXL ECG algorithm, its original clearance (K132068) would have established its ground truth, likely using expert consensus ECG interpretations, and potentially clinical outcomes or pathology, but details are not provided in this document.
8. The Sample Size for the Training Set
The document does not provide a sample size for the training set. This information would pertain to the development of the DXL ECG algorithm, which was already cleared under K132068. This submission is for the Cardiac Workstation devices incorporating the already cleared algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. It would have been part of the original submission for the Philips DXL ECG Algorithm (K132068).
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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"
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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).
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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
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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)
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510(k) Summarv
| 510(k) Summary | |||
|---|---|---|---|
| I. SUBMITTER | |||
| Date Prepared | 14 May 2024 | ||
| Submitter/Owner | Philips Medizin Systeme Böblingen GmbHHewlett-Packard Strasse 271032 BöblingenGERMANYPhone: +1 (949)-502-1823 | ||
| Key Contact | Angel YaRegulatory 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: CardiovascularRegulation Description: Electrocardiograph21 CFR §870.2340Regulatory Class: IIProduct Code: DPS | ||
| III. PREDICATE DEVICE | |||
| 510(k) No. | Company NameDevice Name | ProductCode | |
| Predicate Device | K210560 | Philips Medical SystemsPageWriter TC70 Cardiograph | DPS |
| Reference Device | K221141 | Philips Medizin SystemeBöblingen GmbHPageWriter TC35 Cardiograph | DPS |
| The Philips Cardiac Workstation 5000 and Cardiac Worksation 7000 are substantially equivalent to thelegally 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.
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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.
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V. INDICATIONS FOR USE
| Comparison of Indications for Uses for Subject Device and Predicate | ||
|---|---|---|
| PageWriter TC70 CardiographPredicate, K210560 | Cardiac Workstation 5000 (aka: CW 5000)Cardiac Workstation 7000 (aka: CW 7000)Subject Device | Description ofdifferences |
| Philips PageWriter TC70 cardiograph isintended to acquire multichannel ECGsignals from adult and pediatric patientsfrom body surface ECG electrodes and torecord, display, analyze and store these ECGsignals for review by the user. It is to be usedin healthcare facilities by trained healthcareprofessionals. Analysis of the ECG signals isaccomplished with algorithms that providemeasurements, data presentations,graphical presentations and interpretationsfor review by the user. | The Cardiac Workstation is intended to acquiremulti-channel ECG signals from adult and pediatricpatients from body surface ECG electrodes, and torecord, display, analyze and store these ECGsignals for review by the user. They are to be usedin healthcare facilities by trained healthcareprofessionals. Analysis of the ECG signals isaccomplished with algorithms that providemeasurements, data presentations, graphicalpresentations and interpretations for review bythe user. | Identical exceptfor change toproduct name. |
| The interpreted ECG with measurements andinterpretive statements is offered to theclinician on an advisory basis only. It is to beused in conjunction with the clinician'sknowledge of the patient, the results of thephysical examination, the ECG tracings, andother clinical findings. A qualified physician isasked to over read and validate (or change)the computer generated ECG interpretation. | The interpreted ECG with measurements andinterpretive statements is offered to the clinicianon an advisory basis only. It is to be used inconjunction with the clinician's knowledge of thepatient, the results of the physical examination,the ECG tracings, and other clinical findings. Aqualified physician is asked to over-read andvalidate (or change) the computer-generated ECGinterpretation. |
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 predicatedevice (K210560) PageWriter TC70 Cardiograph have the identical indications foruse. Both CW 5000 and CW 7000 and TC70 are intended to acquire multi-channelECG signals from patient and to record, display and store those signals to bereview by the user. The use environment is identical between CW 5000, the CW7000, and the predicate device, TC70. They are all to be used in healthcarefacilities 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.
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| Fundamental scientifictechnologies andperformances | Both CW 5000 and CW 7000 and PageWriter TC70 Cardiograph are similar withrespect to the fundamental scientific technologies. They areelectrocardiographs that collect multi-channel ECG signals of adult andpediatric patients from body surface ECG electrodes. These ECG signals areamplified, digitized, and processed in the digital domain. The cardiographrecords, 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, butalso contain improvements to the user's experience by deploying updatedhardware and software technologies. The devices also incorporate minorchanges to the ECG signal processing approach and security improvements tocomply with widely recognized standards. Both devices use the same clearedECG 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 thepredicate device, PageWriter TC70 Cardiograph. The latest 510k for thepredicate device is K210560. | |
| Use Environment | The use environment is identical between the subject CW 5000 and CW 7000devices and the predicate device (K210560) PageWriter TC70 Cardiograph. Theyare intended for use in a professional healthcare facility. They are not for homeuse, and not intended to be used together with any RF emitting equipment suchas 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. Thisfunctionality is used to transmit ECG reports, patient order/ADT info, deviceconfiguration details, and time sync between the Cardiac Workstation and ECGManagement Systems, Device Management Dashboard, and the hospital's EMR. | |
| ECG Performance | Compared to the predicate device (K210560), PageWriter TC70 Cardiograph, thesubject CW 5000 and CW 7000 devices provide similar performance on ECGacquisition of up to 18 leads, algorithm interpretation, display accuracy, and ECGreport formats for printing and transmission purposes. | |
| Safety and EMC performance | The subject CW 5000, CW 7000, and predicate device (K210560) PageWriterTC70 Cardiograph have the same level of safety and EMC performance. Thesafety classification of both subject and predicate device (K210560) is class I, withCF 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 0.05Hz | |
| 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.
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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.
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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 | FDARecognition # | 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 basicsafety and essential performance |
| ANSI AAMI IEC 60601-1-2:2014 [Including AMD1:2021] | 19-36 | Medical electrical equipment. Part 1-2: General requirements forbasic safety and essential performance. Collateralstandard: Electromagnetic compatibility. Requirements and tests |
| ANSI AAMI IEC 60601-2-25:2011/(R)2016 | 3-105 | Medical electrical equipment - Part 2-25: Particular requirements forthe 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 forbasic safety and essential performance - Collateral standard:Usability |
| IEC 62366-1: 2015+A1:2020 | 5-129 | Medical devices. Part 1: Application of usability engineering tomedical devices |
| ANSI AAMI IEC62304:2006/A1:2016 | 13-79 | Medical device software - Software life cycle processes |
| ANSI C63.27:2021 | 19-48 | American National Standard for Evaluation of WirelessCoexistence |
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| AAMITIR69:2017/(R2020) | 19-22 | Technical Information Report Risk management of radio-frequencywireless coexistence for medical devices and systems |
|---|---|---|
| ASTM D4169:2022 | 14-576 | Standard Practice for Performance Testing of Shipping Containers andSystems |
| ISO 14971:2019 | 5-125 | Medical devices - Application of risk management to medical devices |
| AIM 7351731:2021 | 19-45 | Medical Electrical Equipment and System ElectromagneticImmunity Test for Exposure to Radio Frequency IdentificationReaders |
| ISO 15223-1:2021 | 5-134 | Medical devices - Symbols to be used with information to be suppliedby 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.
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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.
§ 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).