(114 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the algorithm's functions without using AI/ML terminology.
No
The device is described as an "ECG analysis algorithm" that "analyzes ECG waveforms to find and classify heart beats to calculate heart rate, detect arrhythmias and calculate ST deviation and ST slope." It is used for diagnosis and treatment decisions, but it does not directly provide therapy.
Yes
Explanation: The "Intended Use" states that the device produces measurements and calculations for "review by a trained physician or clinician in determining a diagnosis." The "Indications for Use" also mentions its use "as part of decisions regarding possible diagnosis." This indicates its role in aiding in the diagnostic process.
Yes
The device description explicitly states that the CAlg-STR Exercise ECG Analysis Algorithm is a "software module" and that it "may be integrated into a stress exercise system." It takes ECG waveforms as input and provides analysis and measurements, without mentioning any associated hardware components that are part of the device itself. The performance studies also focus on the algorithm's performance according to software standards.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The CAIg-STR Exercise ECG Analysis Algorithm analyzes ECG waveforms, which are electrical signals from the heart, not specimens derived from the body.
- Intended Use: The intended use is to analyze ECG waveforms acquired from a patient to produce measurements for review by a physician in determining a diagnosis. This is analysis of a physiological signal, not a biological specimen.
Therefore, the device falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
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.
Product codes
DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
10 years or older
Intended User / Care Setting
Used in hospital and clinical settings, by qualified medical personnel trained in stress exercise testing.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
K112959 pg 1 of 5
(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 or | ||
| Trade Name: | CAlg-STR Exercise | |
| ECG Analysis | ||
| Algorithm | Case Cardiac Testing | |
| Sytem/CS Cardiac | ||
| Testing System | ||
| Common | ||
| Name: | ECG Analysis System | ECG Analysis Computer |
| Device Class: | II | II |
| Device | ||
| ProCodes: | DPS | DQK |
| Device CFR: | 870.2340 | 870.1245 |
| Classification | ||
| Panel: | 74 Cardiovascular | 74 Cardiovascular |
| Classification | ||
| Name: | ECG Analysis System | Programmable |
| diagnostic computer |
Page 53 of 57
1
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.
2
Product Comparison:
| Specification/
Feature | CAlg-STR Exercise
ECG Analysis
Algorithm | CASE Cardiac Testing System/CS Cardiac
Testing System | Comparison |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Intended Use:
The intended use of
the CAlg-STR
exercise ECG analysis
algorithm is to
analyze mult-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. | Intended Use:
CASE Cardiac Testing System and the CS
Cardiac Testing System are intended to be used by
trained operators under direct supervision of a
licensed health care practitioner on adult and
pediatric patients. The CASE Cardiac Testing
System and the CS Cardiac Testing System are
designed to acquire, process, record, archive,
analyze and output (12 and 15 lead) ECG data
during a period of physiologic stress or during a
resting ECG test, acquire data from ancillary
devices (such as Spirometery and Ambulatory
Blood Pressure), provide median morphology
recordings and record ECG in real-time with and
without arrhythmia detection. The arrhythmia
detection portion of CASE Care provided to the
user for the convenience of automatic detection
of arrhythmias but does not provide alarms.
CASE Cardiac Testing System and the CS Cardiac
Testing System provide the control of external
devices (typically treadmill or Ergometer) and
communicate with centralized electronic/digital
storage system via network. CASE Cardiac
Testing System and the CS Cardiac Testing
System provide a user selectable option for
printouts of prognostic scores on select reports.
Vector loops are also available.
Case Cardiac Testing System and the CS
Cardiac Testing System can be configured in a
network environment for multiple CASE or CS
stations allowing the user to create a central
database of patient demographics and collected
patient physiological data. CASE Cardiac
Testing System and the CS Cardiac Testing
System are intended to be used primarily in the
hospital but can be used in clinics, physician
offices, outreach centers or wherever exercise,
stress testing ECG, Spirometry or ambulatory
blood pressure testing is performed.
CASE Cardiac Testing System and the CS
Cardiac Testing System offer no diagnostic
opinion to the user. Instead it provides
interpretive statements of morphology, rhythm,
and conduction for with the physician renders
his/her own medical opinion. CASE/CS Cardiac
Testing System is not intended to be used as a
transport device or for home use. CASE Cardiac
Testing System and the CS Cardiac Testing
System are not interceded for the use as a vital
signs physiological monitor or for intracardiac
use. | Similar for
algorithm and
use
environment. |
| Indications for
Use | Indications for Use:
The analysis
algorithm is indicated
for use in those
situations 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 | | |
| Target
Population | Adult and Pediatric | Adult and Pediatric | Same |
| Specification/
Feature | CAlg-STR Exercise
ECG Analysis
Algorithm | CASE Cardiac Testing System/CS Cardiac
Testing System | Comparison |
| Where Used | Used in hospital and
clinical settings, by
qualified medical
personnel trained in
stress exercise testing. | Used primarily in the hospital but can be
used in clinics, physician offices, outreach
centers or wherever exercise, stress testing
ECG, Spirometry or ambulatory blood
pressure testing is performed. | Similar |
| Display | Displayed on host
device | Displayed on host device. | Same |
| Number of ECG
Signal Leads | Up to 16 leads | Up to 16 leads | Same |
| Sampling Rate | 1000 samples per
second | 500 samples per second | Different |
| Bandwidth | .050 - 150 Hz | .050 - 150 Hz | Similar |
| Input Signal
Resolution | 5µV/LSB at 1000 Hz | 4.88µV/LSB at 500 Hz | Similar, Hz
difference is
due to sampling
rate |
| Notch Filter | Yes, configurable | Yes, Configurable | Same |
| Baseline
Correction | Cubic Spline
Algorithm | Cubic Spline Algorithm | Same |
| Artifact/Baseline
Correction | No | Finite Residual Filter (FRF) Analysis | Different, did
not implement
FRF due to
potential
distortion of ST
segment |
| ST
Measurements
and Calculations | ST amplitude, ST
Slope | ST amplitude, ST Slope, integral, index,
ST/HR slope, ST/HR loops, ST/HR index up
to 15 leads | Similar, only
ST amplitude
and ST slope
are calculated
other
measurements
are provided by
the host device |
| Heart Rate | Automatic
Arrhythmia detection,
documentation and
annotation | Automatic Arrhythmia detection,
documentation and annotation | Similar |
| Post J-Point
selection | 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
Page 55 of 57
3
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
4
K112959 pg 5 of 5
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.
5
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.
6
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
7
K112959 pg 1 of 1
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 |