ST80I STRESS TEST SYSTEM
Device Facts
| Record ID | K121638 |
|---|---|
| Device Name | ST80I STRESS TEST SYSTEM |
| Applicant | Philips Health Care |
| Product Code | DQK · Cardiovascular |
| Decision Date | Jul 18, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1425 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Philips ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The cardiac data provided by the Stress system is intended to be reviewed, confirmed, and used by trained medical personnel to assist in the evaluation of the patient's cardiovascular condition and the patient's physiological condition during stress exercise testing. The arrhythmia detection portion of the ST80i Stress Exercise System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.
Device Story
PC-based diagnostic system for stress exercise testing; acquires, processes, and stores ECG, heart rate, and ST data. Inputs include ECG signals and ancillary data (SpO2, ambulatory blood pressure). System comprises ECG acquisition module, PC with application software, and optional thermal printer. Operated by trained medical personnel in clinical settings. Software performs automatic arrhythmia detection (no alarms) and generates summary tables, trends, and cardiac indices reports. Healthcare providers review and confirm automated outputs to assist in diagnosing coronary artery disease and assessing physiological condition during exercise. Benefits include streamlined data collection and analysis for cardiac stress testing.
Clinical Evidence
Bench testing only. Performance data confirmed the system meets design specifications. The device incorporates previously cleared Philips ECG analysis algorithms (K073376) and CAlg-STR Exercise ECG Analysis Algorithm (K112959).
Technological Characteristics
PC-based system; Windows 7 OS. ECG acquisition module; 1000 samples/sec; 0.050-150 Hz bandwidth. Connectivity via USB, Ethernet, wireless. Thermal dot array printer. Cubic Spline algorithm for baseline correction. Software-based arrhythmia detection. Biocompatible patient leads/electrodes. AC power operation.
Indications for Use
Indicated for exercise ECG testing in patients 10 years or older to evaluate electrocardiograms for diagnosis, treatment planning, treatment effectiveness, or ruling out cardiovascular disease symptoms. Not for use as a physiological monitor.
Regulatory Classification
Identification
A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.
Predicate Devices
Submission Summary (Full Text)
{0}------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Summary
JUL 18 2012
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
### ST80i Stress Test System
#### Submitter's Name and Address
Submitter's Name: Division: Address: City, State, and Zip: Contact Name: Telephone / Fax:
Philips Healthcare Diagnostic ECG 1525 Rancho Conejo Boulevard Suite 100 Thousand Oaks, CA 91320 Gretel Lumley/Quality and Regulatory Engineer ( 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 CASE V6.6 and CS V6.6 ST80i Stress Test System Proprietary or Cardiac Testing System Trade Name: ECG Analysis Computer ECG Analysis Computer Common Name: II Device Class: II DOK Device DOK ProCodes: 870.1425 Device CFR: 870.1425 Classification 74 Cardiovascular 74 Cardiovascular Panel: Programmable diagnostic Programmable diagnostic Classification computer Name: computer
Philips Medical Systems K121638 ST80i Stress Test System
Page S of 11
{1}------------------------------------------------
K.121638
p2/7
#### Intended Use
The Philips ST80i Stress Test System is a PC-based diagnostic tool intended to acquire. process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The cardiac data provided by the Stress system is intended to be reviewed, confirmed, and used by trained medical personnel to assist in the evaluation of the patient's cardiovascular condition and the patient's physiological condition during stress exercise testing. The arrhythmia detection portion of the ST80i Stress Exercise System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.
#### Indications for Use:
The Philips ST80i Stress Test System 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 of cardiovascular disease. The Philips ST80i Stress Test System is not intended to be used as a physiological monitor.
#### Device Description
The ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data (resting and physiologic) of patients undergoing stress exercise testing and acquire data from ancillary devices (such as SpO2 and Ambulatory Blood Pressure). The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The arrhythmia detection portion of ST80i Stress Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. The cardiac data provided by the stress system is intended to be reviewed, confirmed and used for diagnostic purposes by trained medical personnel to assist in the diagnosis of coronary artery disease (CAD) and the patient's physiological condition during stress exercise testing. The ST80i Stress Test System will be offered in two versions which are a complete turnkey system which includes an ECG data acquisition module, trolley with a PC loaded with the application software and optional thermal printer or a minimal system with the application software and data acquisition module only.
Philips Medical Systems K121638 ST80i Stress Test System
Page 6 of 11
{2}------------------------------------------------
| Specification/<br>Feature | ST80i Stress Test<br>System<br>Intended Use: | CASE V6.6 and CS V6.6 Cardiac<br>Testing Systems<br>Intended Use: | Comparison |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | The Philips ST80i Stress<br>Exercise System is a PC-<br>based diagnostic tool<br>intended to acquire,<br>process, and store ECG<br>data of patients<br>undergoing stress<br>exercise testing. The<br>software records ECG,<br>heart rate, and ST data,<br>creates summary tables,<br>trends, and produces a<br>final report regarding a<br>variety of cardiac data<br>indices. The cardiac data<br>provided by the Stress<br>system is intended to be<br>reviewed, confirmed, and<br>used for diagnostic<br>purposes by trained<br>medical personnel to<br>assist in the diagnosis of<br>CAD and the patient's<br>physiological condition<br>during stress exercise<br>testing. The arrhythmia<br>detection portion of the<br>ST80i Stress Exercise<br>System is provided to the<br>user for the convenience<br>of automatic detection of<br>arrhythmias but does not<br>provide alarms | CASE Cardiac Testing System and the CS<br>Cardiac Testing System are intended to be<br>used by trained operators under direct<br>supervision of a licensed health care<br>practitioner on adult and pediatric patients.<br>The CASE Cardiac Testing System and the<br>CS Cardiac Testing System are designed to<br>acquire, process, record, archive, analyze<br>and output (12 and 15 lead) ECG data<br>during a period of physiologic stress or<br>during a resting ECG test, acquire data from<br>ancillary devices (such as spirometryand<br>Ambulatory Blood Pressure), provide<br>median morphology recordings and record<br>ECG in real-time with and without<br>arrhythmia detection. The arrhythmia<br>detection portion of CASE Cardiac<br>Testing System and the CS Cardiac Testing<br>System are provided to the user for the<br>convenience of automatic detection of<br>arrhythmias but does not provide alarms.<br>CASE Cardiac Testing System and the CS<br>Cardiac Testing System provide the control<br>of external devices typically a treadmill or<br>Ergometer) and communicate with<br>centralized electronic/digital storage system<br>via network. CASE Cardiac Testing<br>System and the CS Cardiac Testing System<br>provide a user selectable option for<br>printouts of prognostic scores on select<br>reports. Vector loops are also available.<br>CASE Cardiac Testing System and the CS<br>Cardiac Testing System can be configured<br>in a network environment for multiple<br>CASE or CS stations allowing the user to<br>create a central database of patient<br>demographics and collected patient<br>physiological data. CASE Cardiac Testing<br>System and the CS Cardiac Testing System<br>are intended to be used primarily in the<br>hospital but can be used in clinics,<br>physician offices, outreach centers or<br>wherever exercise, stress testing, ECG,<br>spirometryor ambulatory blood pressure<br>testing is performed. CASE Cardiac<br>Testing System and CS Cardiac Testing<br>System offer no diagnostic opinion to the<br>user. Instead it provides interpretive<br>statements of morphology, rhythm and<br>conductions for which the physician renders<br>his/her own medical opinion. CASE<br>Cardiac Testing System and CS Cardiac<br>Testing System are not intended to be used<br>as a transport device or for home use.<br>CASE Cardiac Testing System and CS<br>Cardiac Testing System are not intended for the use as a vital signs physiological | Similar |
| | | | K121638 |
| | | | p4/7 |
| ST80i Stress Test<br>System | CASE V6.6 and CS V6.6 Cardiac<br>Testing Systems | Comparison | |
| Healthcare facilities | Used in a hospital or facilities<br>providing exercise, stress testing,<br>ECG, spirometryor ambulatory<br>blood pressure testing. | Similar | |
| 1000 samples per<br>second | 500 samples per second | Different | |
| .050 - 150 Hz | .050 - 150 Hz | Same | |
| 5µV/LSB at 1000 Hz | 4.88µV/LSB at 500 Hz | Similar, Hz<br>difference is<br>due to<br>sampling rate | |
| Yes, configurable | Yes, Configurable | Same | |
| Cubic Spline<br>Algorithm | Cubic Spline Algorithm | Same | |
| No | Finite Residual Filter (FRF)<br>Analysis | Different, did<br>not<br>implement<br>FRF due to<br>potential<br>distortion of<br>ST segment | |
| ST amplitude, ST<br>Slope, index, ST/HR<br>index | ST amplitude, ST Slope, integral,<br>index, ST/HR slope, ST/HR loops,<br>ST/HR index up to 15 leads | Similar | |
| Automatic Arrhythmia<br>detection,<br>documentation and<br>annotation | Automatic Arrhythmia detection,<br>documentation and annotation | Same | |
| Configurable | Configurable | Same | |
| Automatic or manual<br>lead selection | Automatic or manual lead selection | Same | |
| Real-time ECG/TTL<br>or analog<br>synchronization output | Real-time ECG//QRS beep/TTL<br>synchronization output | Similar | |
| Beat-to-beat ECG<br>storage and event<br>review | Beat-to-beat ECG storage and<br>event review | Same | |
| Post-test medians<br>measurements from J<br>point selections | Post-test medians measurements<br>from E, J and post-J point<br>selections | Similar | |
| Philips ECG<br>Algorithm (resting | (Optional) Marquette 12SL resting<br>ECG analysis program for adults | Similar | |
| Specification /<br>Feature | ST80i Stress Test<br>System | CASE V6.6 and CS V6.6 Cardiac<br>Testing Systems | Comparison |
| Dynamic Range | 300 mV | 320 mV ± 10 mV signal<br>superimposed on ± 150mV DC<br>offset…
