(114 days)
Intended Use:
The intended use of the CAIg-STR exercise ECG analysis algorithm is to analyze multi-channel ECG waveforms acquired from a patient and produce measurements such as heart rate, detect ventricular arrhythmias, form representative beats, and calculate ST segment deviation (elevation or depression) and ST slope for review by a trained physician or clinician in determining a diagnosis. The measurements should not be used as a sole means for determining a patient's diagnosis.
Indications for Use:
The analysis algorithm is indicated for use in exercise ECG testing where the clinician decides to evaluate the electrocardiogram of patients at 10 years or older, as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms. The analysis algorithm is not intended to be used as a physiological monitor.
The CAlg-STR Exercise ECG Analysis Algorithm is a software module which may be integrated into a stress exercise system. It is used to analyze ECG waveforms to find and classify heart beats to calculate heart rate, detect arrhythmias and calculate ST deviation and ST slope when an adult or pediatric patient is undergoing cardiac stress testing.
The exercise ECG Analysis Algorithm takes up to 16 ECG leads as input and provides analysis and measurements. The Exercise ECG Analysis Algorithm analyzes up to 3 leads of ECG waveforms to find and classify the heart beats and calculate heart rate. The beat classifications are then used to calculate arrhythmias. The beats with similar morphology are averaged to from representative beats for up to 16 leads. The representative beats are used to measure ST deviation and slope for up to 16 leads. Those measurements are used for display and report in the host device. The algorithm does not supply an interpretation of the data.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
CAlg-STR Exercise ECG Analysis Algorithm Performance Data
This device is a software module designed to analyze multi-channel ECG waveforms during cardiac stress testing to calculate heart rate, detect ventricular arrhythmias, form representative beats, and measure ST segment deviation and slope.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric/Performance Standard | Acceptance Criteria (Set by ANSI/AAMI/ISO EC57:1988/(R)2008) | Reported Device Performance (CAlg-STR) |
|---|---|---|
| Overall Performance | Meet the requirements of ANSI/AAMI/ISO EC57:1988/(R)2008 | Performed consistently and meets the requirements of ANSI/AAMI/ISO EC57:1988/(R)2008 for testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms. |
| Cardiac Rhythm Measurement | Defined by ANSI/AAMI/ISO EC57:1988/(R)2008 | Met the requirements of the standard, demonstrating consistent performance. |
| ST-Segment Measurement (Deviation/Slope) | Defined by ANSI/AAMI/ISO EC57:1988/(R)2008 | Met the requirements of the standard, demonstrating consistent performance. |
Study Details:
The performance data demonstrated that the CAlg-STR Exercise ECG Analysis Algorithm met its design specifications by being tested against the ANSI/AAMI/ISO EC57:1988/(R)2008: Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms standard.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the country of origin of the data. It indicates that the testing was conducted to prove adherence to a recognized international standard (ANSI/AAMI/ISO EC57:1988/(R)2008), which typically specifies the types and quantities of data required for such validation. The data provenance (retrospective or prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided text does not specify the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor does it discuss the effect size of human readers improving with or without AI assistance. The device is described as an "analysis algorithm" that "produces measurements... for review by a trained physician or clinician," suggesting a standalone analysis component rather than an AI-assisted interpretation tool for human readers in a comparative study.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was explicitly conducted. The text states: "The performance data demonstrated that the CAIg-STR Exercise ECG Analysis Algorithm meet with the design specifications of the algorithm." This implies the algorithm was tested on its own to determine if its outputs (heart rate, arrhythmia detection, ST deviation/slope) conformed to the established standard.
7. Type of Ground Truth Used
The ground truth was based on the requirements and specifications outlined in the ANSI/AAMI/ISO EC57:1988/(R)2008: Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms standard. This standard typically defines methods for generating or validating reference measurements for ECG analysis. While not explicitly stated, it can be inferred that the ground truth for rhythm and ST-segment measurements would align with the established and accepted methodologies within this standard.
8. Sample Size for the Training Set
The provided text does not mention the sample size for any training set. As this is an older submission (2012), it's possible the algorithm was developed using more traditional signal processing techniques rather than contemporary machine learning that explicitly defines "training sets" in the same way.
9. How the Ground Truth for the Training Set Was Established
The provided text does not describe how the ground truth for any training set was established, as a training set is not explicitly mentioned. If the algorithm relies on specific parameters or rules, these would have likely been derived from expert knowledge, physiological models, and existing ECG data, rather than a labeled training set in the modern sense.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JAN 2 6 2012
Appendix I
510(k) Summary
As required by 21 CFR 807.87(h), a 510(k) Summary for this Premarket Notification submission is provided below.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
CAlg-STR Exercise ECG Analysis Algorithm
Submitter's Name and Address
| Submitter's Name: | Philips Healthcare |
|---|---|
| Division: | Diagnostic ECG |
| Address: | 1525 Rancho Conejo Boulevard Suite 100 |
| City, State, and Zip: | Thousand Oaks, CA 91320 |
| Contact Name: | Gretel Lumley/Quality and Regulatory Engineer |
| Telephone / Fax: | ( 805 ) 214-5101 / (805) 214-5129 |
Manufacturers' Information: Establishment Registration Number Establishment name:
Address:
Establishment Registration No.
Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 1218950
Device Details
| New Product | Predicate | |
|---|---|---|
| Proprietary orTrade Name: | CAlg-STR ExerciseECG AnalysisAlgorithm | Case Cardiac TestingSytem/CS CardiacTesting System |
| CommonName: | ECG Analysis System | ECG Analysis Computer |
| Device Class: | II | II |
| DeviceProCodes: | DPS | DQK |
| Device CFR: | 870.2340 | 870.1245 |
| ClassificationPanel: | 74 Cardiovascular | 74 Cardiovascular |
| ClassificationName: | ECG Analysis System | Programmablediagnostic computer |
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K112959 pg 20f5
Intended Use
The intended use of the CAlg-STR Exercise ECG Analysis Algorithm is to analyze multi-channel ECG waveforms acquired from a patient and produce measurements such as heart rate, detect ventricular arrhythmias, form representative beats, and calculate ST segment deviation (elevation or depression) and ST slope for review by a trained physician or clinician in determining a diagnosis. The measurements should not be used as a sole means for determining a patient's diagnosis.
Device Description
The CAlg-STR Exercise ECG Analysis Algorithm is a software module which may be integrated into a stress exercise system. It is used to analyze ECG waveforms to find and classify heart beats to calculate heart rate, detect arrhythmias and calculate ST deviation and ST slope when an adult or pediatric patient is undergoing cardiac stress testing.
The exercise ECG Analysis Algorithm takes up to 16 ECG leads as input and provides analysis and measurements. The Exercise ECG Analysis Algorithm analyzes up to 3 leads of ECG waveforms to find and classify the heart beats and calculate heart rate. The beat classifications are then used to calculate arrhythmias. The beats with similar morphology are averaged to from representative beats for up to 16 leads. The representative beats are used to measure ST deviation and slope for up to 16 leads. Those measurements are used for display and report in the host device. The algorithm does not supply an interpretation of the data.
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Product Comparison:
| Specification/Feature | CAlg-STR ExerciseECG AnalysisAlgorithm | CASE Cardiac Testing System/CS CardiacTesting System | Comparison |
|---|---|---|---|
| Intended Use: | Intended Use:The intended use ofthe CAlg-STRexercise ECG analysisalgorithm is toanalyze mult-channelECG waveformsacquired from apatient and producemeasurements such asheart rate, detectventriculararrhythmias, formrepresentative beats,and calculate STsegment deviation(elevation ordepression) and STslope for review by atrained physician orclinician indetermining adiagnosis. Themeasurements shouldnot be used as a solemeans fordetermining apatient's diagnosis. | Intended Use:CASE Cardiac Testing System and the CSCardiac Testing System are intended to be used bytrained operators under direct supervision of alicensed health care practitioner on adult andpediatric patients. The CASE Cardiac TestingSystem and the CS Cardiac Testing System aredesigned to acquire, process, record, archive,analyze and output (12 and 15 lead) ECG dataduring a period of physiologic stress or during aresting ECG test, acquire data from ancillarydevices (such as Spirometery and AmbulatoryBlood Pressure), provide median morphologyrecordings and record ECG in real-time with andwithout arrhythmia detection. The arrhythmiadetection portion of CASE Care provided to theuser for the convenience of automatic detectionof arrhythmias but does not provide alarms.CASE Cardiac Testing System and the CS CardiacTesting System provide the control of externaldevices (typically treadmill or Ergometer) andcommunicate with centralized electronic/digitalstorage system via network. CASE CardiacTesting System and the CS Cardiac TestingSystem provide a user selectable option forprintouts of prognostic scores on select reports.Vector loops are also available.Case Cardiac Testing System and the CSCardiac Testing System can be configured in anetwork environment for multiple CASE or CSstations allowing the user to create a centraldatabase of patient demographics and collectedpatient physiological data. CASE CardiacTesting System and the CS Cardiac TestingSystem are intended to be used primarily in thehospital but can be used in clinics, physicianoffices, outreach centers or wherever exercise,stress testing ECG, Spirometry or ambulatoryblood pressure testing is performed.CASE Cardiac Testing System and the CSCardiac Testing System offer no diagnosticopinion to the user. Instead it providesinterpretive statements of morphology, rhythm,and conduction for with the physician rendershis/her own medical opinion. CASE/CS CardiacTesting System is not intended to be used as atransport device or for home use. CASE CardiacTesting System and the CS Cardiac TestingSystem are not interceded for the use as a vitalsigns physiological monitor or for intracardiacuse. | Similar foralgorithm anduseenvironment. |
| Indications forUse | Indications for Use:The analysisalgorithm is indicatedfor use in thosesituations where theclinician decides toevaluate theelectrocardiogram ofpatients at 10 years orolder, as part ofdecisions regardingpossible diagnosis,potential treatment,effectiveness oftreatment or to ruleout causes forsymptoms | ||
| TargetPopulation | Adult and Pediatric | Adult and Pediatric | Same |
| Specification/Feature | CAlg-STR ExerciseECG AnalysisAlgorithm | CASE Cardiac Testing System/CS CardiacTesting System | Comparison |
| Where Used | Used in hospital andclinical settings, byqualified medicalpersonnel trained instress exercise testing. | Used primarily in the hospital but can beused in clinics, physician offices, outreachcenters or wherever exercise, stress testingECG, Spirometry or ambulatory bloodpressure testing is performed. | Similar |
| Display | Displayed on hostdevice | Displayed on host device. | Same |
| Number of ECGSignal Leads | Up to 16 leads | Up to 16 leads | Same |
| Sampling Rate | 1000 samples persecond | 500 samples per second | Different |
| Bandwidth | .050 - 150 Hz | .050 - 150 Hz | Similar |
| Input SignalResolution | 5µV/LSB at 1000 Hz | 4.88µV/LSB at 500 Hz | Similar, Hzdifference isdue to samplingrate |
| Notch Filter | Yes, configurable | Yes, Configurable | Same |
| BaselineCorrection | Cubic SplineAlgorithm | Cubic Spline Algorithm | Same |
| Artifact/BaselineCorrection | No | Finite Residual Filter (FRF) Analysis | Different, didnot implementFRF due topotentialdistortion of STsegment |
| STMeasurementsand Calculations | ST amplitude, STSlope | ST amplitude, ST Slope, integral, index,ST/HR slope, ST/HR loops, ST/HR index upto 15 leads | Similar, onlyST amplitudeand ST slopeare calculatedothermeasurementsare provided bythe host device |
| Heart Rate | AutomaticArrhythmia detection,documentation andannotation | Automatic Arrhythmia detection,documentation and annotation | Similar |
| Post J-Pointselection | Configurable | Configurable | Same |
| Biocompatibility | Not applicable | Not applicable | Identical |
| Sterility | Not applicable | Not applicable | Identical |
Philips Medical Systems
K112959 CAIg-STR Exercise ECG Analysis Algorithm Response
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KII 2959 pg 4of 5
The CAIg-STR Exercise ECG Analysis Algorithm has same technological characteristics except for the sampling rate and Artifact/Baseline correction as shown in the table above. The difference between the predicate's sampling rate and the CAIg-STR Exercise ECG Analysis Algorithm is not significant because a higher sampling rate creates a better fidelity of the ECG signal that is analyzed. The predicate device chose to include Artifact/Baseline correction which is not included in the CAlg-STR Exercise ECG Analysis Algorithm. Philips Medical Systems chose not to include Artifact/Baseline Correction due to potential distortion of the ST segment which would have potentially
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caused decreased accuracy of the algorithm and additional design changes to the algorithm would have been necessary to address distortion of the ST segment.
Performance Data
The performance data demonstrated that the CAIg-STR Exercise ECG Analysis Algorithm meet with the design specifications of the algorithm. The CAIg-STR Exercise ECG Analysis Algorithm was tested to the requirements of ANSVAAMI/ISO EC57:1988/(R)2008: Testing and reporting performance results of cardiac rhythm and ST-sgement measurement algorithms. The performance results from this testing demonstrated that CAlg-STR Exercise ECG Analysis Algorithm performed consistentlyand meets the requirements of ANSI/AAMI/ISO EC57:1988/(R)2008: Testing and reporting performance results of cardiac rhythm and ST-sgement measurement algorithms.
Conclusions
In conclusion, the performance and non-clinical testing demonstrated that the CAIg-STR Exercise ECG Analysis Algorithm is as safe and effective as the analysis software of the predicate device. This is supported by the adherence to the FDA recognized consenus standard (ANSI/AAMI/ISO EC57:1988/(R) 2008: Testing and reporting performance results of cardiac rhythm and ST-sgement measurement algorithms) and comparison testing to other algorithms already approved for market.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 6 2012
Philips Healthcare c/o Ms. Gretel Lumley 1525 Rancho Conejo Blvd, Suite 100 Thousand Oaks, CA 91320
Re: K112959
Trade/Device Name: CAlg-STR Exercise ECG Analysis Algorithm Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 10, 2012 Received: January 11, 2012
Dear Ms. Lumley:
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. Gretel Lumley
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix H
Indications for Use Statement
510(k) Number: Device Name: Philips CAlg-STR Exercise Analysis Algorithm
Indications for Use:
Intended Use:
The intended use of the CAIg-STR exercise ECG analysis algorithm is to analyze multi-channel ECG waveforms acquired from a patient and produce measurements such as heart rate, detect ventricular arrhythmias, form representative beats, and calculate ST segment deviation (elevation or depression) and ST slope for review by a trained physician or clinician in determining a diagnosis. The measurements should not be used as a sole means for determining a patient's diagnosis.
Indications for Use:
The analysis algorithm is indicated for use in exercise ECG testing where the clinician decides to evaluate the electrocardiogram of patients at 10 years or older, as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms. The analysis algorithm is not intended to be used as a physiological monitor.
| Prescription Use (21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
Philips Medical Systems
K112959 CAlg-STR Exercise ECG Analysis Algorithm Response
(Division Sign-Off)
Division of Cardiovascular Devices
| Page | 52 of 57 |
|---|---|
| 510(k) Number | K112959 |
§ 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).