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LifeWatch King of Hearts
®King of Hearts® Express + AF Monitor or TBD
2002.03.14 2002.04.05 510(k) No. K020825
Recorder, Magnetic Tape, Medical
DSH Class II – Special Controls
Special 510(k) Substantially Equivalent (SE) Predicate 1. King of Hearts® Express Monitor (K920984)
2. King of Hearts® Express II Monitor (K983626)
* (looping recorder)
(1) Two wire single channel lead sensor (2)
(Atrial Fibrillation) (Tachycardia ) (Bradycardia)
(3) looping memory
FDA
(1) (Dizziness) (2) (Palpitation) (3) (Syncope) (4) (Chest Pain)
FDA
‧
LifeWatch TM2005
TM2005 PERSONAL MEDICAL PHONE CENTER
2002.12.31 2003.01.15 510(k) No. K024365
Transmitters And Receivers, Electrocardiograph, Telephone
DXH Class II – Special Controls
Special 510(k) Substantially Equivalent (SE)
Predicate Telemedicine 2000 Reciving Center (K992164)
TM 2005 Telemedicine 2000 DB Serve web server
(1) (2)
(3) -
FDA 1 performance standard2 TM2005
1. EN 1441: ‘Medical Device – Risk Analysis’, 1997 2. IEC 1025: ‘Fault tree analysis (FTA)’, 1990
3. IEC/TR 513: ‘Fundamental aspects of safety standards for medical electrical equipment’, 1994
4. IEC 601-1: ‘Medical Electrical Equipment, General Requirement for Safety’, 1996 5. IEC 601-1-1: ‘Safety Requirements for Medical Electrical Systems’, 1996
6. IEC 601-1-4: ‘Part 1-4, Programmable Electrical Medical Systems’, 1996 7. IEC 812: ‘Analysis techniques for system reliability – Procedure for failure mode
and effects analysis (FMEA)
8. IEC 300-3-9: “Dependability management, Part 3: Application guide, Section 9, Risk analysis of technological systems
9. Reviewer Guidance for Computer Controlled Medical Devices, FDA Aug 29, 1991 10. ISO/IEC Guide 51: ‘Guidelines for the inclusion of safety aspects in standards’,
1990
11. ISO 9002 guidelines 12. EN-46002
13. IEEE Standard for Software Quality Assurance Plan
14. FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 29,1998
15. FDA’s New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial equivalence in Premarket Notifications – Final Guidance, CDHR, March 29, 1998.
/
3
1. Design control procedure requirements specified in 21 CFR Part 20.61
2. Quality System Regulation in 21 CRF 820.30 Subpart C Design Controls of the Quality System Regulation
FDA
1 Telephone ECG and Spirometric transmitter devices
2 Section 514 of the Federal Food, Drug and Cosmetic Act
3 Design Control Quality System
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LifeWatch CG-6180
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
2008.05.02 2008.05.29 510(k) No. K081257
Detector And Alarm, Arrhythmia
DSI Class II – Special Controls
Special 510(k) Substantially Equivalent (SE)
Predicate 1. Card Guard’s CG-6108 Continuous ECG Monitor And Arrhythmia Detector (K071995) – as the parent model
2. Card Guard’s CG-6550 Personal ECG Transmitter (K990478) – 3 leads design
remote Monitoring Center
(1) A chest-worn ECG sensor:
(2) A handheld device: PDA
SmartPhone PC
(3) A proprietary application: (2)
(1) Sensor handheld
device
(2) Proprietary application
memory loop memory loop
(3) Handheld device Monitoring Center
1. ANSI/AAMI EC38: ‘Ambulatory electrocardiographs’, 1998
2. ANSI/AAMI EC57: ‘Testing and reporting performance results of cardiac rhythm and ST segment algorithms’, 1998
3. ‘Arrhythmia Detector and Alarm Guidance’ for industry and FDA Staff Class II Special Controls Guidance
4. IEC 60601-2 Medical electrical equipment – Part 2: ‘Particular requirements for the safety of electrocardiographic monitoring equipment’, 2005
5. EN 475: ‘Medical device – Electrically-generated alarm signals’, 1995 6. EN 980: ‘Graphical symbols for use in the labeling of medical devices’, 2003 7. EN 104-1: ‘Terminology, Symbols and information provided with Medical Devices;
Information supplied by the manufacturer with medical devices’, 1998 8. EN ISO 9001: ‘Quality management systems – Requirements’, 2000 9. EN ISO 13485: ‘Quality systems – Medical devices’, 2000
10. EN ISO 14971: ‘Medical devices – application of risk management to medical devices’, 2001
11. EN ISO 10993: ‘Biological evaluation of medical devices Part 1: Evaluation and testing’ 1997
12. EN 60601-1: ‘Medical electrical equipment; Part 1: General requirements for safety’, 2002
13. EN 60601-1-2: ‘Medical electrical equipment; Part 1: 2. Collateral Std: EMC;
requirement and tests’, 2007
14. EN 60601-1-4+A1 2000: ‘Medical electrical equipment; Part 1: 4. Collateral Std:
Programmable electric medical systems’,
‧
1. CardioNet Ambulatory ECG Monitor
2000.12.01 2001.05.16 510(k) No. K003707
Electrocardiograph, Ambulatory (Without Analysis)
MWJ Class II – Special Controls
Traditional 510(k) Substantially Equivalent (SE) Predicate 1. DigiTrackPlus (Medical Magnetic Tape Recorder), K993617
2. Reynolds cLifeCard CF (Medical Magnetic Tape Recorder), K001025
3. Reynolds CardioCall (Telephone Electrocardiograph Transmitter and Receiver), K972649
4. Cordigital Examiner (Telephone Electrocardiograph Transmitter and Receiver), K994009
3 channels Holter Monitor, looping event Recorder.
(1) Sensor
(2) Monitor Unit (1) LCD
QT interval ST changes
ANSI/AAMI EC38: ‘Ambulatory electrocardiographs’, 1998
1. ANSI/AAMI EC13: ‘Cardiac Monitors, Heart rate meters and alarms’, 1992 2. ANSI/AAMI EC11: ‘Diagnostic Electrocardiographic device’, 1991 3. ANSI/AAMI EC53: ‘ECG cable and Lead wires’, 1995
4. ISO 10993 ‘FDA modified Biocompatibility’ (for skin contact >30 days) 5. UL2601 (Medical Electronic Equipment, )
6. ANSI/AAMI EC1: ‘Safe Current Limits for electromechanical Apparatus’ 1993 FCC part 15, subpart C (for intentional radiators of the Monitor)
2. CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL
2001.07.17 2002.02.01 510(k) No. K012241
Detector And Alarm, Arrhythmia
DSI Class II – Special Controls
Traditional 510(k) Substantially Equivalent (SE) Predicate 1. CardioNet Ambulatory ECG Monitor (Medical Magnetic Tape Recorder)
(Electrocardiograph, Ambulatory [Without analysis]), K003707
2. Cardiac Telecom Cardiac TeleCom HeartLink II EGG Arrhythmia detector and Alarm System (ECG Arrhythmia detector and alarm), K982803
K003707
(1) A patient-worn sensor
monitor AAA
(2) A monitor LCD
Quinton Q-tel Mortara ( QT interval ST segments)
CardioNet
(3) A charging base monitor RS232 monitor
‧
1. ANSI/AAMI EC38: ‘Ambulatory electrocardiographs’, 1998
2. ANSI/AAMI EC57: ‘Testing and reporting performance results of cardiac rhythm and ST segment algorithms’, 1998
1. ANSI/AAMI EC13: ‘Cardiac Monitors, Heart rate meters and alarms’, 1992 2. ANSI/AAMI EC11: ‘Diagnostic Electrocardiographic device’, 1991 3. ANSI/AAMI EC53: ‘ECG cable and Lead wires’, 1995
4. ISO 10993 ‘FDA modified Biocompatibility’ (for skin contact >30 days) 5. UL2601 (Medical Electronic Equipment, )
6. ANSI/AAMI EC1: ‘Safe Current Limits for electromechanical Apparatus’ 1993 FCC part 15, subpart C (for intentional radiators of the Monitor)
3. CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002
2005.08.07 2005.10.19 510(k) No. K052240
Detector And Alarm, Arrhythmia
DSI Class II – Special Controls
Abbreviated 510(k) Substantially Equivalent (SE) Predicate CardoNet Ambulatory ECG Monitor, K012241
K12241 K12241
1. ANSI/AAMI EC38: ‘Ambulatory electrocardiographs’, 1998
2. ANSI/AAMI EC57: ‘Testing and reporting performance results of cardiac rhythm and ST segment algorithms’, 1998
3. International Electrotechnical Commission (IEC) 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety
4. CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
2005.11.12 2005.04.25 510(k) No. K053263
Detector And Alarm, Arrhythmia
DSI Class II – Special
Abbreviated 510(k) Substantially Equivalent (SE) Predicate 1. CardoNet Ambulatory ECG Monitor, K052240
2. Century SeriesTM Holter Scanner System, Model C3000/C2000/C1000 (Medical Magnetic Tape Recorder), K024323
CardioNet 1002
1. ANSI/AAMI EC38: ‘Ambulatory electrocardiographs’, 1998
2. ANSI/AAMI EC57: ‘Testing and reporting performance results of cardiac rhythm and ST segment algorithms’, 1998
3. International Electrotechnical Commission (IEC) 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety
5. CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
2006.10.25 2006.11.14 510(k) No. K063222
Detector And Alarm, Arrhythmia
DSI Class II – Special Controls
Speical 510(k) Substantially Equivalent (SE)
‧
Predicate 1. CardoNet Ambulatory ECG Monitor, K052240 2. CardoNet Ambulatory ECG Monitor, K012241
CardioNet 1003
(1) A patient-worn sensor 2 channels
Sensor monitor
monitor (2) A monitor Sensor
Cellular RF charging base
Monitoring Services Application
(3) A charging base 1003
1. ANSI/AAMI EC38: ‘Ambulatory electrocardiographs’, 1998
2. ANSI/AAMI EC57: ‘Testing and reporting performance results of cardiac rhythm and ST segment algorithms’, 1998
3. International Electrotechnical Commission (IEC) 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety
6. CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
2007.09.11 2007.12.05 510(k) No. K072558
Detector And Alarm, Arrhythmia
DSI Class II – Special Controls
Abbreviated 510(k) Substantially Equivalent (SE) Predicate 1. CardoNet Ambulatory ECG Monitor, K063222
2. CardoNet Ambulatory ECG Monitor, K012241
CardioNet 1004
(1) monitor monitor
(2) CardioNet Mortara
1. ANSI/AAMI EC38: ‘Ambulatory electrocardiographs’, 1998
2. ANSI/AAMI EC57: ‘Testing and reporting performance results of cardiac rhythm and ST segment algorithms’, 1998
3. International Electrotechnical Commission (IEC) 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety
FDA