(44 days)
No
The document describes standard ECG processing and analysis, with no mention of AI, ML, or related concepts. The "automatic detection of arrhythmias" is a common feature in ECG systems and doesn't necessarily imply AI/ML.
No
The device is described as a "diagnostic tool" intended to acquire, process, and store ECG data to assist in the evaluation and diagnosis of a patient's cardiovascular condition. It explicitly states it is "not intended to be used as a physiological monitor" and its purpose is related to "diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms," rather than direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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." It further mentions its use for "possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms of cardiovascular disease." The "Device Description" also refers to it as a "PC-based diagnostic tool" and states that the data 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)".
No
The device description explicitly states that the system includes an "ECG data acquisition module" and can be offered as a "complete turnkey system which includes an ECG data acquisition module, trolley with a PC loaded with the application software and optional thermal printer". This indicates the device is not solely software but includes hardware components for data acquisition and potentially printing.
Based on the provided information, the Philips ST80i Stress Test System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ST80i Function: The ST80i Stress Test System acquires, processes, and stores ECG data directly from the patient's body during stress exercise testing. It analyzes electrical signals from the heart, not specimens taken from the body.
- Intended Use: The intended use clearly states it's a "PC-based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing." This involves direct patient interaction and physiological measurement, not laboratory analysis of specimens.
Therefore, the Philips ST80i Stress Test System falls under the category of a physiological monitoring and diagnostic device, not an IVD.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
74 DQK
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.
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
Trained medical personnel; Used in a hospital or facilities providing exercise, stress testing, ECG, spirometry or ambulatory blood pressure 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 ST80i Stress Test System meets the design specifications of the system. The Philips CAlg-STR Exercise ECG Analysis Algorithm which has been incorporated into the ST80i Stress Test System has been previously approved for market under K112959. The Philips ECG Algorithm which has been incorporated into the ST80i Stress Test System has been previously approved for market under K073376.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
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/
Feature | ST80i Stress Test
System
Intended Use: | CASE V6.6 and CS V6.6 Cardiac
Testing Systems
Intended Use: | Comparison |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | The Philips ST80i Stress
Exercise 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 for diagnostic
purposes by trained
medical personnel to
assist in the diagnosis of
CAD 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 | 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 spirometryand
Ambulatory Blood Pressure), provide
median morphology recordings and record
ECG in real-time with and without
arrhythmia detection. The arrhythmia
detection portion of CASE Cardiac
Testing System and the CS Cardiac Testing
System are 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 a 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,
spirometryor ambulatory blood pressure
testing is performed. CASE Cardiac
Testing System and CS Cardiac Testing
System offer no diagnostic opinion to the
user. Instead it provides interpretive
statements of morphology, rhythm and
conductions for which the physician renders
his/her own medical opinion. CASE
Cardiac Testing System and CS Cardiac
Testing System are not intended to be used
as a transport device or for home use.
CASE Cardiac Testing System and CS
Cardiac Testing System are not intended for the use as a vital signs physiological | Similar |
| | | | K121638 |
| | | | p4/7 |
| ST80i Stress Test
System | CASE V6.6 and CS V6.6 Cardiac
Testing Systems | Comparison | |
| Healthcare facilities | Used in a hospital or facilities
providing exercise, stress testing,
ECG, spirometryor ambulatory
blood pressure testing. | Similar | |
| 1000 samples per
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
difference is
due to
sampling rate | |
| Yes, configurable | Yes, Configurable | Same | |
| Cubic Spline
Algorithm | Cubic Spline Algorithm | Same | |
| No | Finite Residual Filter (FRF)
Analysis | Different, did
not
implement
FRF due to
potential
distortion of
ST segment | |
| ST amplitude, ST
Slope, index, ST/HR
index | ST amplitude, ST Slope, integral,
index, ST/HR slope, ST/HR loops,
ST/HR index up to 15 leads | Similar | |
| Automatic Arrhythmia
detection,
documentation and
annotation | Automatic Arrhythmia detection,
documentation and annotation | Same | |
| Configurable | Configurable | Same | |
| Automatic or manual
lead selection | Automatic or manual lead selection | Same | |
| Real-time ECG/TTL
or analog
synchronization output | Real-time ECG//QRS beep/TTL
synchronization output | Similar | |
| Beat-to-beat ECG
storage and event
review | Beat-to-beat ECG storage and
event review | Same | |
| Post-test medians
measurements from J
point selections | Post-test medians measurements
from E, J and post-J point
selections | Similar | |
| Philips ECG
Algorithm (resting | (Optional) Marquette 12SL resting
ECG analysis program for adults | Similar | |
| Specification /
Feature | ST80i Stress Test
System | CASE V6.6 and CS V6.6 Cardiac
Testing Systems | Comparison |
| Dynamic Range | 300 mV | 320 mV ± 10 mV signal
superimposed on ± 150mV DC
offset | Similar |
| Noise | 118dB (110dB with
AC filter disabled) | >140 dB (123 dB with AC filter
disabled | Similar |
| Input Impedance | >=2.5M
ohms@10Hz, | .10 M Ohms @10 Hz, defibrillator
protected | Similar |
| Patient Leakage |