(44 days)
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.
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.
The Philips ST80i Stress Test System is a PC-based diagnostic tool designed to acquire, process, and store ECG data during stress exercise testing. It records ECG, heart rate, and ST data, generates summary tables, trends, and reports for cardiac data indices. The system's arrhythmia detection offers convenience but does not provide alarms. It is intended to assist trained medical personnel in evaluating cardiovascular conditions, diagnosing coronary artery disease (CAD), and assessing physiological conditions during stress exercise testing for patients 10 years or older. It is not intended as a physiological monitor.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ST80i Stress Test System are largely demonstrated through its equivalence to the predicate devices, CASE V6.6 and CS V6.6 Cardiac Testing Systems. The provided documentation presents a comparison of specifications and features rather than explicit acceptance criteria with numerical targets. The "Comparison" column indicates whether the ST80i's performance is "Same," "Similar," or "Different" to the predicate.
| Specification/Feature | ST80i Stress Test System Reported Performance | Predicate Device (CASE V6.6 and CS V6.6 Cardiac Testing Systems) | Comparison (Acceptance Status) |
|---|---|---|---|
| Indications for Use | PC-based diagnostic tool for acquiring, processing, storing ECG data during stress exercise testing. Assists in CAD diagnosis and cardiovascular condition evaluation by trained medical personnel. Arrhythmia detection for convenience, no alarms. | Similar intended use, operating environment, and diagnostic assistance features. Does not offer diagnostic opinion. | Similar |
| Healthcare Facilities | Used in hospital or facilities providing exercise & stress testing, ECG, spirometry, ABP testing. | Similar | Similar |
| Sampling Rate | 1000 samples per second | 500 samples per second | Different |
| Bandwidth | 0.050 - 150 Hz | 0.050 - 150 Hz | Same |
| Input Signal Resolution | 5µV/LSB at 1000 Hz | 4.88µV/LSB at 500 Hz | Similar |
| Notch Filter | Yes, configurable | Yes, Configurable | Same |
| Baseline Correction | Cubic Spline Algorithm | Cubic Spline Algorithm | Same |
| Artifact/Baseline Correction | No (did not implement FRF due to potential distortion) | Finite Residual Filter (FRF) Analysis | Different |
| ST Measurements | 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 |
| Heart Rate | Automatic Arrhythmia detection, documentation and annotation | Automatic Arrhythmia detection, documentation and annotation | Same |
| QRS detection and selection | Configurable | Configurable | Same |
| Full-disclosure | Automatic or manual lead selection | Automatic or manual lead selection | Same |
| Real-time ECG/TTL output | Real-time ECG/TTL or analog synchronization output | Real-time ECG/QRS beep/TTL synchronization output | Similar |
| Beat-to-beat ECG storage | Beat-to-beat ECG storage and event review | Beat-to-beat ECG storage and event review | Same |
| Post J-Point measurements | Post-test medians measurements from J point selections | Post-test medians measurements from E, J and post-J point selections | Similar |
| ECG interpretation | Philips ECG Algorithm (resting) (for adults and pediatrics) | (Optional) Marquette 12SL resting ECG analysis program for adults | Similar |
| Dynamic Range | 300 mV | 320 mV ± 10 mV signal superimposed on ± 150mV DC offset | Similar |
| Noise | < 20 uV peak-to-peak noise over 0.02 to 300 Hz (-3 dB) bandwidth | < 15 uV peak-to-peak noise over 0.01 to 150 Hz (-3 dB) bandwidth | Similar |
| Frequency Response | -3dB display and writer | -3dB display and writer | Same |
| High Pass Filter | 0.02, 0.05, 0.15 (selectable) | 0.01 (or 0.05 Hz, special use) with DC offset control | Similar |
| Low Pass Filter | 40, 100, 150, 300 (selectable) | 20, 40, 100, 150 (selectable) | Similar |
| Common Mode Rejection | >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 | <10uA | <10 uA | Same |
| Pace detect | 2mV@100us | Orthogonal LA, LL and V6; 750 uV @ 50us | Similar |
| Display Type | LCD (flat panel display) | LCD (flat panel display) | Same |
| Display resolution | LCD- 1280 x 1024 or 1920 x 1020 | LCD - 1280 x 1024 | Similar |
| Display size | 19- to 24-inch LCD | 17- or 19-inch LCD | Similar |
| Monitored Leads | 3, 6 or 12 | 3, 6, 12 or 15 | Similar |
| Displayed Leads | Number on screen 3, 6, 12, 6x2 | Number on screen 3, 6, 12, 15 | Similar |
| Display format | 3 rhythm, 6 rhythm, 6 x 2, 12 rhythm | 3 rhythm, 3 rhythm + medians, 3 rhythm + trends, 6 rhythm, 4 x 2.5 + 1 rhythm, 2 X 6 | Similar |
| Display sensitivity/gain | 2.5, 5, 10, 20 mm/mV | 2.5, 5, 10, 20 mm/mV | Same |
| Displayed vital signs | Heart rate, Target heart rate, blood pressure, exercise clock, stage clock, protocol, speed, grade, Watts, METS, RPE, DP, STI and SpO2 | Heart rate, Target heart rate, blood pressure, exercise clock, stage clock, phase clock, protocol, speed, grade, Watts, METS, RRP and SpO2 | Similar |
| Displayed data | Zoomed ST, event notification, 3-12 lead waveform, lead map, ST Map, trends report, tabular report, summary report, event report, stored ECG strips, interpretation, time-of-day clock, wireless signal, battery status, patient id/name/DOB, watermark warning | ST scan/median complexes, arrhythmias, ventricular ectopic/min counter, 3 to 12 lead waveforms, lead check torso and 12 leads, waterfall display, trends, tabular summary, stored ECG strips, interpretation, time-of-day clock, patient name, warning messages and prompts | Similar |
| Printer technology | "Instant" load, thermal dot array | "Instant" load, thermal dot array | Same |
| Printer leads | 1-12 leads (standard, Cabrera, configurable) | 3, 6, 12 or 15 leads (standard, NEHB, Cabrera, configurable) | Similar |
| Printer Speeds | 5, 10, 25 and 50mm/s (+/- 2%) | 5, 12.5, 25, and 50 mm/sec (+ 2%) | Similar |
| Printer sensitivity/gain | 2.5, 5, 10 or 20mm/mV (+/- 5%) | 2.5, 5, 10 or 20 mm/mV (+5%) | Same |
| Paper type/size | Thermal, perforated, Z-folded in A size or A4 size | Thermal, perforated, fan folded in A size or A4 size | Similar |
| Interfaces included | Advanced interface module and Patient interface module; Keyboard/Mouse: USB or wireless; Treadmill or ergometer: USB/RS232; NiBP/SpO2:USB/RS232; 2 analog and 1 TTL output; RJ-45 Ethernet; CD drive | Acquisition module; keyboard (PS/2); dedicated stress keypad (USB); Mouse (PS/2); 100 Mbps Ethernet; 6 serial ports; 4 analog and 1 TTL (trigger) output; Diskette drive; CD-R/W drive | Similar |
| Communication/Storage types | Network, Local Storage, PDF export of final reports, removable media such USB sticks | Network, Local Storage, PDF export of final reports, XML export of specified data | Similar |
| Operating System | Windows 7 | Windows 2000 Server, Windows 2003 Server | Similar |
| Power Supply | AC operation only | AC operation only | Same |
| Operating Voltage Range | 120± 10% VAC 50-60 Hz; 240± 10% VAC 50-60 Hz | 110-120 VAC 50-60 Hz; 200-240 VAC 50-60 Hz | Similar |
| Biocompatibility | Patient leads, electrodes | Patient leads, electrodes | Same |
| Sterility | Not applicable | Not applicable | Same |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly detail a specific "test set" or its sample size for evaluating the ST80i Stress Test System's performance for this 510(k) submission. Instead, the document states: "The performance data demonstrated that the ST80i Stress Test System meets the design specifications of the system."
It further indicates that key algorithms incorporated into the ST80i Stress Test System—the Philips CAlg-STR Exercise ECG Analysis Algorithm and the Philips ECG Algorithm—were previously approved for market under separate 510(k) submissions (K112959 and K073376, respectively). The performance data related to these algorithms would have been established during their individual approval processes.
Therefore, for the ST80i system itself, the primary "test" was likely a verification against its own design specifications and a comparison to the predicate device, rather than a new clinical study with a distinct test set for de novo performance evaluation.
No information is provided regarding the country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given 510(k) summary for the ST80i Stress Test System. The document does not describe the establishment of a new ground truth for a test set for this specific submission, but rather relies on the performance of previously approved algorithms and substantial equivalence to a predicate device.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary. Given the reliance on previously approved algorithms and substantial equivalence, a specific adjudication method for a new clinical test set is not described for the ST80i Stress Test System in this document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being performed for the ST80i Stress Test System in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device and notes the prior approval of its constituent algorithms.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
While a standalone performance evaluation wasn't explicitly conducted for the entire ST80i system for this submission, the document states that the Philips CAlg-STR Exercise ECG Analysis Algorithm and the Philips ECG Algorithm have been previously approved for market under K112959 and K073376, respectively. This implies that these core algorithms would have undergone standalone performance evaluations during their individual 510(k) approval processes. The current submission leverages these prior approvals.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
The 510(k) submission for the ST80i Stress Test System mainly relies on demonstrating "substantial equivalence" to a predicate device (CASE V6.6 and CS V6.6 Cardiac Testing Systems) and the previous approvals of its incorporated algorithms (Philips CAlg-STR Exercise ECG Analysis Algorithm and Philips ECG Algorithm).
For the individual algorithms (K112959 and K073376), it is typical for ground truth in ECG analysis algorithms to be established by:
- Expert Consensus: Review by multiple cardiologists or electrophysiologists.
- Manual measurements: Detailed manual measurements of ECG waveforms by trained experts.
- Correlation with clinical diagnoses or outcomes: Although not explicitly stated, this is often a component in such evaluations.
However, the specific type of ground truth used for those previous approvals is not detailed within this particular 510(k) summary.
8. The Sample Size for the Training Set
The 510(k) summary does not provide information about the sample size used for the training set of the ST80i Stress Test System or its incorporated algorithms (Philips CAlg-STR Exercise ECG Analysis Algorithm and Philips ECG Algorithm). This level of detail regarding algorithm training data is typically found in the original 510(k) submissions for those algorithms (K112959 and K073376) rather than in a subsequent submission for a system integrating them.
9. How the Ground Truth for the Training Set Was Established
The 510(k) summary does not provide information on how the ground truth for the training set was established for the ST80i Stress Test System or its incorporated algorithms. Similar to the training set size, this information would generally be found in the details of the original 510(k) submissions (K112959 and K073376) for the algorithms themselves.
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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
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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
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| Specification/Feature | ST80i Stress TestSystemIntended Use: | CASE V6.6 and CS V6.6 CardiacTesting SystemsIntended Use: | Comparison |
|---|---|---|---|
| Indications for Use | The Philips ST80i StressExercise System is a PC-based diagnostic toolintended to acquire,process, and store ECGdata of patientsundergoing stressexercise testing. Thesoftware records ECG,heart rate, and ST data,creates summary tables,trends, and produces afinal report regarding avariety of cardiac dataindices. The cardiac dataprovided by the Stresssystem is intended to bereviewed, confirmed, andused for diagnosticpurposes by trainedmedical personnel toassist in the diagnosis ofCAD and the patient'sphysiological conditionduring stress exercisetesting. The arrhythmiadetection portion of theST80i Stress ExerciseSystem is provided to theuser for the convenienceof automatic detection ofarrhythmias but does notprovide alarms | CASE Cardiac Testing System and the CSCardiac Testing System are intended to beused by trained operators under directsupervision of a licensed health carepractitioner on adult and pediatric patients.The CASE Cardiac Testing System and theCS Cardiac Testing System are designed toacquire, process, record, archive, analyzeand output (12 and 15 lead) ECG dataduring a period of physiologic stress orduring a resting ECG test, acquire data fromancillary devices (such as spirometryandAmbulatory Blood Pressure), providemedian morphology recordings and recordECG in real-time with and withoutarrhythmia detection. The arrhythmiadetection portion of CASE CardiacTesting System and the CS Cardiac TestingSystem are provided to the user for theconvenience of automatic detection ofarrhythmias but does not provide alarms.CASE Cardiac Testing System and the CSCardiac Testing System provide the controlof external devices typically a treadmill orErgometer) and communicate withcentralized electronic/digital storage systemvia network. CASE Cardiac TestingSystem and the CS Cardiac Testing Systemprovide a user selectable option forprintouts of prognostic scores on selectreports. Vector loops are also available.CASE Cardiac Testing System and the CSCardiac Testing System can be configuredin a network environment for multipleCASE or CS stations allowing the user tocreate a central database of patientdemographics and collected patientphysiological data. CASE Cardiac TestingSystem and the CS Cardiac Testing Systemare intended to be used primarily in thehospital but can be used in clinics,physician offices, outreach centers orwherever exercise, stress testing, ECG,spirometryor ambulatory blood pressuretesting is performed. CASE CardiacTesting System and CS Cardiac TestingSystem offer no diagnostic opinion to theuser. Instead it provides interpretivestatements of morphology, rhythm andconductions for which the physician rendershis/her own medical opinion. CASECardiac Testing System and CS CardiacTesting System are not intended to be usedas a transport device or for home use.CASE Cardiac Testing System and CSCardiac Testing System are not intended for the use as a vital signs physiological | Similar |
| K121638 | |||
| p4/7 | |||
| ST80i Stress TestSystem | CASE V6.6 and CS V6.6 CardiacTesting Systems | Comparison | |
| Healthcare facilities | Used in a hospital or facilitiesproviding exercise, stress testing,ECG, spirometryor ambulatoryblood pressure testing. | Similar | |
| 1000 samples persecond | 500 samples per second | Different | |
| .050 - 150 Hz | .050 - 150 Hz | Same | |
| 5µV/LSB at 1000 Hz | 4.88µV/LSB at 500 Hz | Similar, Hzdifference isdue tosampling rate | |
| Yes, configurable | Yes, Configurable | Same | |
| Cubic SplineAlgorithm | Cubic Spline Algorithm | Same | |
| No | Finite Residual Filter (FRF)Analysis | Different, didnotimplementFRF due topotentialdistortion ofST segment | |
| ST amplitude, STSlope, index, ST/HRindex | ST amplitude, ST Slope, integral,index, ST/HR slope, ST/HR loops,ST/HR index up to 15 leads | Similar | |
| Automatic Arrhythmiadetection,documentation andannotation | Automatic Arrhythmia detection,documentation and annotation | Same | |
| Configurable | Configurable | Same | |
| Automatic or manuallead selection | Automatic or manual lead selection | Same | |
| Real-time ECG/TTLor analogsynchronization output | Real-time ECG//QRS beep/TTLsynchronization output | Similar | |
| Beat-to-beat ECGstorage and eventreview | Beat-to-beat ECG storage andevent review | Same | |
| Post-test mediansmeasurements from Jpoint selections | Post-test medians measurementsfrom E, J and post-J pointselections | Similar | |
| Philips ECGAlgorithm (resting | (Optional) Marquette 12SL restingECG analysis program for adults | Similar | |
| Specification /Feature | ST80i Stress TestSystem | CASE V6.6 and CS V6.6 CardiacTesting Systems | Comparison |
| Dynamic Range | 300 mV | 320 mV ± 10 mV signalsuperimposed on ± 150mV DCoffset | Similar |
| Noise | < 20 uV peak-to-peaknoise over 0.02.to 300Hz (-3 dB) bandwidth | < 15 uV peak-to-peak noise over0.01 to 150 Hz (-3 dB) bandwidth | Similar |
| FrequencyResponse | -3dB display andwriter | -3dB display and writer | Same |
| High Pass Filter | 0.02, 0.05, 0.15(selectable) | 0.01(or 0.05 Hz, special use) withDC offset control | Similar |
| Low Pass Filter | 40,100,150,300(selectable) | 20, 40, 100, 150 (selectable) | Similar |
| Common ModeRejection | >118dB (110dB withAC filter disabled) | >140 dB (123 dB with AC filterdisabled | Similar |
| Input Impedance | >=2.5Mohms@10Hz, | .10 M Ohms @10 Hz, defibrillatorprotected | Similar |
| Patient Leakage | <10uA | <10 uA | Same |
| Pace detect | 2mV@100us | Orthogonal LA, LL and V6; 750uV @ 50us | Similar |
| Display Type | LCD (flat paneldisplay) | LCD (flat panel display) | Same |
| Display resolution | LCD- 1280 x 1024 or1920 x 1020 | LCD - 1280 x 1024 | Similar |
| Display size | 19- to 24-inch LCD | 17- or 19-inch LCD | Similar |
| Monitored Leads | 3, 6 or 12 | 3, 6, 12 or 15 | Similar |
| Displayed Leads | Number on screen 3,6, 12, 6x2 | Number on screen 3, 6, 12, 15 | Similar |
| Display format | 3 rhythm, 6 rhythm, 6x 2, 12 rhythm | 3 rhythm, 3 rhythm + medians, 3rhythm + trends, 6 rhythm, 4 x 2.5+ 1 rhythm, 2 X 6 | Similar |
| Display sensitivity/gain | 2.5, 5, 10, 20 mm/mV | 2.5, 5, 10, 20 mm/mV | Same |
| Displayed vitalsigns(configurable) | Heart rate, Targetheart rate, bloodpressure, exerciseclock, stage clock,protocol, speed, grade,Watts, METS, RPE,DP, STI and SpO2 | Heart rate, Target heart rate, bloodpressure, exercise clock, stageclock, phase clock, protocol, speed,grade, Watts, METS, RRP andSpO2 | Similar |
| Displayed data | Zoomed ST, eventnotification, 3-12 leadwaveform, lead map,ST Map, trends report,tabular report,summary report, eventreport, stored ECGstrips, interpretation,time-of-day closck,wireless signal, batterystatus, patientid/name/DOB,watermark warning | ST scan/median complexes,arrhythmias, ventricularectopic/min counter, 3 to 12 leadwaveforms, lead check torso and12 leads, waterfall display, trends,tabular summary, stored ECGstrips, interpretation, time-of-dayclock, patient name, warningmessages and prompts | Similar |
| Specification /Feature | ST80i Stress TestSystem | CASE V6.6 and CS V6.6 CardiacTesting Systems | Comparison |
| Printer technology | "Instant" load,thermal dot array | "Instant" load, thermal dot array | Same |
| Printer leads | 1-12 leads(standard, Cabrera,configurable) | 3, 6, 12 or 15 leads (standard,NEHB, Cabrera, configurable) | Similar |
| Printer Speeds | 5, 10, 25 and 50mm/s(+/- 2%) | 5, 12.5, 25, and 50 mm/sec (+ 2%) | Similar |
| Printersensitivity/gain | 2.5, 5, 10 or20mm/mV(+/- 5%) | 2.5, 5, 10 or 20 mm/mV (+5%) | Same |
| Paper type/size | Thermal, perforated,Z-folded in A size orA4 size | Thermal, perforated, fan folded inA size or A4 size | Similar |
| Interfaces included | Advanced interfacemodule and Patientinterface module;Keyboard/Mouse:USB or wireless;Treadmill orergometer:USB/RS232;NiBP/SpO2:USB/RS232; 2 analog and 1TTL output interface;RJ-45 Ethernet;CD drive; | Acquisition module; keyboard(PS/2); dedicated stress keypad(USB); Mouse (PS/2); 100 MbpsEthernet; 6 serial ports: (COM 1-2,COM A-D), treadmill, BP,ergometer, SpO2; 4 analog and 1TTL (trigger) output analogergometer, camera sync, etc .;Diskette drive; CD-R/W drive | Similar |
| Communication/Storage types | Network, LocalStorage, PDF exportof final reports,removable media suchUSB sticks | Network, Local Storage, PDFexport of final reports, XMLexport of specified data | Similar |
| Operating System | Windows 7 | Windows 2000 ServerWindows 2003 Server | Similar |
| Power Supply | AC operation only | AC operation only | Same |
| Operating VoltageRange | 120± 10% VAC 50-60Hz;240± 10% VAC 50-60Hz | 110-120 VAC 50-60 Hz;200-240 VAC 50-60 Hz | Similar |
| Biocompatibility | Patient leads,electrodes | Patient leads, electrodes | Same |
| Sterility | Not applicable | Not applicable | Same |
Philips Medical Systems K121638 ST80i Stress Test System
·
:
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•
:
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CF. Philips Medical Systems K121638 ST80i Stress Test System
ECG analysis program
Battery powered 10-
channel acquisition module with built-in
lead-fail detection and
lead prep impedance
measurement. The applied part is type
for adults and pediatrics)
and pediatrics
measurement
Active, "Type BF' floating isolated
detection and lead prep impedance
powered 14-channel acquisition
module with built-in lead-fail
Specification / Feature :
Where Used
Sampling Rate
Bandwidth
Input Signal Resolution
Notch Filter
Baseline
Correction
Correction
Heart Rate
Post J-Point
QRS detection and
Full-disclosure
ECG interpretation
Reanalysis
Technology
selection
analysis ECG Output
ECG
Artifact/Baseline
ST Measurements
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Similar
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Philips Medical Systems
K121638 ST80i Stress Test System
.
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·
.
·
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ST80i Stress Test System overall has the same or similar basic technological characteristics to CASE V6.6 and CS V6.6 Cardiac Testing Systems as shown in the table above.
Performance Data
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.
Philips Medical Systems K121638 ST80i Stress Test System
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Conclusions
.
.
In conclusion, the performance and non-clinical testing demonstrates that ST80i Stress Test System is as safe and effective as the predicate device. The performance is substantially equivalent to the predicate device.
Philips Medical Systems K121638 ST80i Stress Test System
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Image /page/7/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 18 2012
Philips Healthcare c/o Ms. Gretel Lumley Quality and Regulatory Engineer 1525 Rancho Conejo Boulevard, Suite 100 Thousand Oaks, CA 91320
Re: K121638
Trade/Device Name: ST80i Stress Test System Regulatory Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: 74 DQK Dated: May 31, 2012 Received: June 4, 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
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Page 2 - Ms. Gretel Lumley
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.
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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
Appendix A
Indications for Use Statement
K121638 510(k) Number: Device Name: ST80i Stress Test System
Indications for Use:
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.
| Prescription Use(21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
|---|---|---|---|
| -------------------------------------------- | --- | -------- | ------------------------------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Philips Medical Systems
K121638 ST80i Stress Test System
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K121638 |
|---|---|
| --------------- | --------- |
Page 4 of 11
§ 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).