(85 days)
To analyze multi-channel ECG signals from adult and pediatric patients 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.
Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.
The Philips DXL 12/16-lead ECG Algorithm provides an analysis of the amplitudes, durations, electrical axis, and morphologies of the ECG waveforms and associated rhvthms.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or corresponding reported device performance values. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All defined reliability requirements and performance claims | "The Philips ECG Algorithm software meets all defined reliability requirements and performance claims." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "standard ECG databases" but does not specify the sample size for the test set or the country of origin of the data. It's also not stated whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. It mentions that "physicians are required to over read each ECG report."
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions that "A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation," suggesting a single physician review rather than a multi-reader consensus process for adjudication within the context of the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance. The device is referred to as an "advisory" tool that clinicians review and validate (or change), implying human-in-the-loop, but no comparative study to quantify improvement is described.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was implied as the device "provides an analysis of the amplitudes, durations, electrical axis, and morphologies of the ECG waveforms and associated rhvthms" and "interpretive ECG analysis programs are used as in an advisory nature." However, specific metrics of standalone performance are not provided. The study's focus, as described, seems to be on the overall validation of the algorithm's output which is then reviewed by a physician.
7. Type of Ground Truth Used
The document implies that the ground truth for the "standard ECG databases" was established by physician interpretation, as it states that "physicians are required to over read each ECG report and also consider the ECG waveforms: the patient's clinical history before agreeing with the ECG analysis program statement." Thus, it can be inferred that expert consensus (physician interpretation) was the basis for ground truth, or at least the standard against which the device's output was compared.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. Given the context of ECG analysis, it would likely also involve expert physician interpretation of ECGs, possibly with consideration of patient outcomes or other clinical findings, but this is not detailed.
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K132068 P 1/2
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. $807.92.
The submitter of this pre-market notification is Philips Medical Systems Theresa Poole Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099
Tel: 978 659 7621 Fax: 978 685 5624 Email: theresa.poole@philips.com SEP 2 6 2013
1
This summary was prepared on 1 July 2013
The name of this device is the Philips ECG algorithm Software Release PH100C. Classification names are as follows:
Classification Pro Code Description Unclassified, Class II 74 LOS ECG Analysis System 870.2340.11 74 DPS Electrocardiograph
The new device is substantially equivalent to the previously cleared Philips ECG Algorithm software cleared under K020708 and K052049.
The Philips DXL 12/16-lead ECG Algorithm provides an analysis of the amplitudes, durations, electrical axis, and morphologies of the ECG waveforms and associated rhvthms.
The new device has the same Indications for Use as the legally marketed predicate device.
Intended Use:
To analyze multi-channel ECG signals from adult and pediatric patients 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.
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K132068 P 2/2
Indications for Use:
Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.
The new device has the same technological characteristics as the legally marketed predicate device.
The modification also incorporates a subset of the diagnostic statement changes recommended in Wagner GS, Macfarlane P, Wellens H, Josephson M, Gorgels A, Mirvis DM, Pahlm O, Surawicz B, Kligfield P, Childers R, Gettes LS. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part VI: acute ischemia/infarction: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Circulation. 2009; 119:e262- e270.
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new algorithm with respect to the predicate. Testing involved use of standard ECG databases, system level tests, integration tests, and verification of risk mitigation identified in the hazard analysis. Results from interpretive ECG analysis programs are used as in an advisory nature. Physicians are required to over read each ECG report and also consider the ECG waveforms: the patient's clinical history before agreeing with the ECG analysis program statement. The Philips ECG Algorithm software meets all defined reliability requirements and performance claims.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
September 26, 2013
Philips Medical Systems c/o Ms. Theresa Poole Regulatory Specialist 3000 Minuteman Rd Andover, MA 01810 US
Re: K132068
Trade/Device Name: Philips DXL 12/16-Lead ECG Algorithm Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, LOS Dated: August 28, 2013 Received: August 29, 2013
Dear Ms. Theresa Poole:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be 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.
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Page 2 - Ms. Theresa Poole
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices · Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use
510(k) Number (if known):
Philips DXL 12/16-lead ECG Algorithm Device Name:
To analyze multi-channel ECG signals from adult and pediatric patients 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.
Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-
Over-The-Counter Use N/A (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page
Digitally signed by
Owen P. Faris -S
Date: 2013.09.26
16:09:27-04'00'
CONFIDENTIAL
§ 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).