(459 days)
Philips Electrocardiograph Page Writer TC cardiograph (TC20, TC30, TC70) is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, and store these ECG signals for review by the user. It is to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation.
Philips Electrocardiograph, PageWriter TC cardiograph is a product family intended to acquire, record, display, analyze and store multi-channel ECG signals from adult and pediatric patients through a body surface ECG electrode. It includes PageWriter TC20, PageWriter TC30, PageWriter TC50 and PageWriter TC70. Each device under this product family is integrated with the algorithms to provide measurements, data presentations, graphical presentations and interpretations for review by the clinician on an advisory basis. The interpreted ECG with measurements and interpretive statements are to be used in conjunction with 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.
PageWriter TC cardiograph can be operated on the battery when the AC power cord or AC power connector is not in an operable condition, depending on the model of the cardiograph (TC20 single battery only; TC30/TC50 - either one or two batteries; TC70 - two batteries only). When operating a PageWriter TC cardiograph with one battery or two, only the approved batteries with the same part number can be used.
PageWriter TC cardiograph has various configuration provided for the preference of the user, and can be updated with the compatible options/modules from the corresponding Upgrade Kit for use with all approved accessories and spare parts, including patient data cables, Patient Information Modules (PIM), lead sets, electrodes, print papers and trolleys. None of the accessories and spare parts are provided sterile.
Once configured, PageWriter TC cardiograph can provide integrated connectivity (wired or wireless) with the compatible Philips IntelliSpace ECG Management System, or other third party ECG system. for patient order download and ECG transmission. It also supports integrated connectivity with an ADT Order Update system to manage the patient demographic data, and transmit ECG reports in compliance with DICOM protocol once configured with DICOM option. The cybersecurity on PageWriter TC cardiograph is periodically and proactively improved according to the cybersecurity analysis and the routine device cyber maintenance plan.
This FDA 510(k) summary document focuses on modifications to existing medical devices (Philips PageWriter TC20, TC30, TC50, TC70 electrocardiographs) related to battery management and cybersecurity. It explicitly states that no clinical studies were required or conducted for this submission to demonstrate substantial equivalence. Therefore, some of the requested information cannot be provided as it pertains to clinical performance evaluation.
Based on the provided text, here's an analysis of the acceptance criteria and supporting evidence:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Continues meeting requirements |
| EMC | Compliance with IEC 60601-1-2 | Continues meeting requirements |
| Usability | Compliance with IEC 62366-1 | Continues meeting requirements |
| Software V&V | Compliance with FDA Guidance for Software in Medical Devices and IEC 62304:2006/A1:2015 for "moderate" level of concern | Software verification and validation conducted and documented |
| Cybersecurity | Compliance with FDA Guidance for Cybersecurity in Medical Devices, effective cybersecurity to assure device functionality and safety | Cybersecurity testing conducted and documented, enhancement does not raise new questions of safety/effectiveness |
| Battery Performance | Qualification through part and system level testing according to applicable industry and FDA consensus standards | Battery qualified, system verification tests showed all functionality and system specifications met (including battery lifecycle management) |
| Functionality | Maintained basic functionality and intended use equivalent to predicates | System verification testing showed all required functionality met, fundamental technology and intended use unchanged |
| No New Safety/Performance Questions | New modifications (software A.07.07) do not raise new questions of safety or performance | Testing results demonstrate no new questions of safety or performance raised |
2. Sample size used for the test set and the data provenance
- No specific "test set" in the context of clinical performance is mentioned. The testing described is primarily for engineering verification and validation (e.g., electrical safety, EMC, software, battery).
- Data provenance (country of origin, retrospective/prospective): Not applicable for the types of engineering tests reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The submission does not involve a clinical performance study requiring expert adjudication of ground truth for a test set. The "interpretation" of ECG signals is explicitly stated to be advisory and requires overread/validation by a qualified physician.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is described.
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. The document explicitly states: "This premarket submission did not require clinical studies to demonstrate substantial equivalence." The device includes algorithms for interpretation, but its performance with or without AI assistance for human readers was not evaluated in this submission. The interpretation is explicitly documented as "advisory" and subject to physician overread.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the algorithms provide "measurements, data presentations, graphical presentations and interpretations for review by the user." However, it does not provide details of a standalone (algorithm-only) performance evaluation. The interpretation is advisory and requires a qualified physician to overread.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical performance. For the engineering tests described, the "ground truth" would be the established standards (e.g., IEC standards for electrical safety), the device's design specifications for functionality, and cybersecurity threat models.
8. The sample size for the training set
- Not applicable. This submission focuses on modifications to existing devices, primarily related to battery management and cybersecurity. It does not describe the development or training of new algorithms for ECG interpretation, nor does it refer to a training set for such algorithms.
9. How the ground truth for the training set was established
- Not applicable. As no training set is mentioned in this submission, the method for establishing its ground truth is not provided.
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September 29, 2020
Philips Medical Systems Hong Zhu Sr. Regulatory Affairs Manager Building A2, #718 Lingshi Road, Jingan District Shanghai, China 200072
Re: K191738
Trade/Device Name: PageWriter TC20, TC30, TC50, TC70 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: September 29, 2019 Received: October 2, 2019
Dear Hong Zhu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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).
Sincerely,
for
Jennifer Shih Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Philips Electrocardiograph PagerWriter TC20, TC30, TC50, TC70
Indications for Use (Describe)
Phillips Electrocardiograph Page Writer TC cardiograph (TC20, TC30, TC70) is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, and store these ECG signals for review by the user. It is to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SUBMITTER I.
Philips Healthcare-VSS-Shanghai CDC A division of Philips Medical Systems Building A2, #718 Lingshi Road, Jingan District, Shanghai, China 200072
Contact: Hong Zhu Sr. Regulatory Affairs Manager Telephone: +86 18501616553 Email: hong.zhu 2@philips.com
Dated Prepared: August 18, 2020
DEVICE II.
PageWriter TC20, TC30, TC50, TC70 Trade Name: Common Name: Cardiograph Catalogue Number: TC20 (860332), TC30 (860306), TC50 (860310), TC70 (860315) Classification Name: Electrocardiograph Class II, 21 CFR § 878.2340 Class/Regulation: Product Code: DPS
III. PREDICATE DEVICE
Philips PageWriter TC20, TC30, TC50, TC70
The devices are subject to a firm-initiated recall due to the over-heat of the battery when used beyond the end of the battery's life. This 510(k) Notification is to address the battery life.
IV. DEVICE DESCRIPTION
Philips Electrocardiograph, PageWriter TC cardiograph is a product family intended to acquire, record, display, analyze and store multi-channel ECG signals from adult and pediatric patients through a body surface ECG electrode. It includes PageWriter TC20, PageWriter TC30, PageWriter TC50 and PageWriter TC70. Each device under this product family is integrated with the algorithms to provide measurements, data presentations, graphical presentations and interpretations for review by the clinician on an advisory basis. The interpreted ECG with measurements and interpretive statements are to be used in conjunction with 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.
PageWriter TC cardiograph can be operated on the battery when the AC power cord or AC power connector is not in an operable condition, depending on the model of the cardiograph (TC20 single battery only; TC30/TC50 - either one or two batteries; TC70 - two batteries only). When
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operating a PageWriter TC cardiograph with one battery or two, only the approved batteries with the same part number can be used.
PageWriter TC cardiograph has various configuration provided for the preference of the user, and can be updated with the compatible options/modules from the corresponding Upgrade Kit for use with all approved accessories and spare parts, including patient data cables, Patient Information Modules (PIM), lead sets, electrodes, print papers and trolleys. None of the accessories and spare parts are provided sterile.
Once configured, PageWriter TC cardiograph can provide integrated connectivity (wired or wireless) with the compatible Philips IntelliSpace ECG Management System, or other third party ECG system. for patient order download and ECG transmission. It also supports integrated connectivity with an ADT Order Update system to manage the patient demographic data, and transmit ECG reports in compliance with DICOM protocol once configured with DICOM option. The cybersecurity on PageWriter TC cardiograph is periodically and proactively improved according to the cybersecurity analysis and the routine device cyber maintenance plan.
MODIFICATIONS
This bundled Traditional 510(k) Notification proposes the device modification under software A.07.07 to PageWriter TC cardiograph family, PageWriter TC20, TC30, TC50, and TC70 under the same intended use and indication for use statement.
The modifications under software A.07.07 will provide incremental improvements on the battery lifecycle management while maintaining the same basic functionality and intended use. The design improvements related to battery management are common to all cardiographs and listed below.
- Battery overcharge protection
- Battery overheating protection
- Battery lifecycle management
- Battery abnormality reporting and logging ●
- Updates to labeling including re-phrasing and relocation of precautions and warnings
The proposed modifications under software A.07.07 also include the design enhancement for the purpose of remote service maintenance and post-market cybersecurity.
V. INDICATIONS FOR USE
Philips Electrocardiograph, PageWriter TC cardiograph (TC20, TC30, TC50, and TC70) is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. It is to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.
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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 Indication for Use statement for PageWriter TC20, TC30, TC50, and TC70 with the proposed software version is identical to the predicates. There is no change to the indication for use statement in this submission.
VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH TH PREDICATE DEVICE
Philips Electrocardiograph, PageWriter TC20, TC30, TC70, TC70 with the proposed modifications under software A.07.07 has similar technological and performance characteristics as the predicate devices cleared under K113144 and K080999.
It is intended to acquire, record, display, analyze, store and print the multi-channel ECG signals from adult and pediatric patients through a body surface ECG electrode. It is integrated with algorithm that provide measurements, data presentations, graphical presentations and interpretations for review by the clinician on an advisory basis. The basic technological and performance characteristics are kept same for the subject devices with the proposed modifications and the predicates.
- ECG Acquisition
- ECG Quality Monitor
- ECG Memory and Transfer ●
- ECG Interpretation
- Print Preview Capability
- Clinical Workflow Networked Orders ●
- Display Formats ●
The cardiographs with the proposed change under software A.07.07 provides incremental improvements over the predicates regarding the battery lifecycle management while maintaining the same basic functionality and intended use. These improvements are summarized below, including the labeling update.
- Battery overcharge protection
- Battery overheating protection
- Battery lifecycle management ●
- . Battery abnormality reporting and logging
- Updates to labeling including re-phrasing and relocation of precautions and warnings ●
The proposed change under software A.07.07 also provides the enhancements for the subject devices to perform service maintenance remotely and to improve the post market cybersecurity.
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PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety, Electromagnetic Compatibility (EMC) and Usability
The changes were evaluated for impact on electrical safety, electromagnetic compatibility (EMC) and usability according to the consensus standards and determined that the proposed changes on the battery lifecycle management did not require additional electrical safety, EMC and usability testing. PageWriter TC20, TC30, TC50, TC70 cardiographs continue meeting the requirements of those consensus standards, including IEC 60601-1, IEC 60601-2-25, IEC 60601-1-2 and IEC 62366-1.
Software Verification and Validation Testing
Software verification and validation testing was conducted and documented as provided in according with FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices and IEC 62304:2006/A1:2015, Medical Device Software - Software Life Cycle Processes. The software for the subject device was considered as a "moderate" level of concern, since the modified software would not directly result in serious injury or death to the patient or operator.
Cybersecurity
Cybersecurity testing was conducted and documented for the proposed change in accordance with FDA's Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, and demonstrated an effective cybersecurity is in place to assure the device functionality and safety. The enhancement made for the service purpose and post market cybersecurity does not raise the new questions of safety and effectiveness.
Battery and Functional Testing
The battery was qualified through testing at the part level and the system level when integrated into the host device according to the applicable industry and FDA consensus standards. System verification testing showed that each device under PageWriter TC cardiograph family meets all required functionality including the battery lifecycle management and meets its system specifications as it's intended.
Clinical Studies
This premarket submission did not require clinical studies to demonstrate substantial equivalence.
VIII. CONCLUSIONS
The verification and validation activities demonstrate that Philips Electrocardiograph, PageWriter TC20, TC30, TC50, TC70 with software A.07.07 is substantial equivalent to the predicate PageWriter TC20. TC30. TC50 and TC70 cleared through K113144 and K080999.
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The fundamental technology and intended use of PageWriter TC20, TC30, TC50, TC70 cardiographs has not changed. Moreover, the results of testing demonstrate that the device modifications under software A.07.07 do not raise the new question of the safety or performance of the cardiographs.
§ 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).