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Page 2 Martin Jasinski, 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. contact the Division of Industry and Consumer Education at its toll free number 800 638 2041. or 301 796 7100 or at its Internet address, http www fda gov MedicalDevices ResourcesforYou Industry default htm Also please note. the regulation entitled Misbranding by reference to premarket notification 21 CFR 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 Industry and Consumer Education at its toll free number 800 638 2041 or 301. 796 7100 or at its Internet address, http www fda gov MedicalDevices ResourcesforYou Industry default htm. Sincerely yours,Kenneth J Cavanaugh S,for Bram D Zuckerman M D.
Division of Cardiovascular Devices,Office of Device Evaluation. Center for Devices and Radiological Health,Page 1 of 1. Indications for Use, 510 k Number if known K152550 Device Name PocketECG III. Medicalgorithmics Unified Arrhythmia Diagnostic System type PECGT IIIV. Indications For Use, The indications for use for the PocketECG III monitor are as follows. 1 Patients who have a demonstrated need for cardiac monitoring These may include. but are not limited to patients who require monitoring for a non life threatening. arrhythmias such as supraventricular tachycardias e g atrial fibrillation atrial flutter. PACs PSVT and ventricular ectopy b evaluation of bradyarrhythmias and. intermittent bundle branch block including after cardiovascular surgery and. myocardial infarction and c arrhythmias associated with co morbid conditions such. as hyperthyroidism or chronic lung disease, 2 Patients with symptoms that may be due to cardiac arrhythmias These may include.
but are not limited to symptoms such as a dizziness or lightheadedness b syncope. of unknown etiology in which arrhythmias are suspected or need to be excluded and. c dyspnea shortness of breath, 3 Patients with palpitations with or without known arrhythmias to obtain correlation of. rhythm with symptoms, 4 Patients who require monitoring of effect of drugs to control ventricular rate in. various atrial arrhythmias e g atrial fibrillation. 5 Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia. monitoring, 6 Patients with diagnosed sleep disordered breathing including sleep apnea obstructive. central to evaluate possible nocturnal arrhythmias. 7 Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral. ischemia possibly secondary to atrial fibrillation or atrial flutter. 8 Data from the device may be used by another device to analyze measure or report QT. interval The device is not intended to sound any alarms for QT interval changes. Contradictions, 1 Patients with potentially life threatening arrhythmias who require inpatient. monitoring, 2 Patients who the attending physician thinks should be hospitalized.
Prescription Use X AND OR Over The Counter Use,Part 21 CFR 801 Subpart D 21 CFR 801 Subpart C. CONTINUE ON A SEPARATE PAGE IF NEEDED, Concurrence of CDRH Office of Device Evaluation ODE. K152550 Page 1 of 3,510 k Summary Medicalgorithmics 510 k Special. 510 k Summary August 4 2015,1 Submitter Name and Address. Medicalgorithmics LLC 245 West 107th St Suite 11A,New York NY 10025 USA.
Contact Person Martin Jasinski phone 917 9419581,fax 817 5829527. Trade name PocketECG III Medicalgorithmics Unified Arrhythmia. Diagnostic System,Type PECGT IIIV,Classification name Arrhythmia Detector and Alarm. Product code DSI,Regulation no 870 1025,Class Class II Special Controls. 3 Substantial Equivalence, The PocketECG III Medicalgorithmics Unified Arrhythmia Diagnostic System type. PECGT IIIV is a modification of a legally marked Medicalgorithmics predicate device. PocketECG v3 Medicalgorithmics Unified Arrhythmia Diagnostic System type. PECGT III K124060 Reg no 870 1025, Note For commercial reasons Medicalgorithmics S A launched the medical device.
onto the U S market under the name of PocketECG III Medicalgorithmics Unified. Arrhythmia Diagnostic System and has continued to distribute the device under the. same name The modified device is the latest evolution of this predicate one. 4 Device Description, PocketECG III Medicalgorithmics Unified Arrhythmia Diagnostic System type. PECGT IIIV is an ambulatory ECG monitor which analyzes electrographic signal. classifies all detected heart beats and recognizes rhythm abnormalities All detection. results including annotations for every detected heart beat and the entire ECG signal are. transmitted via cellular telephony network to a remote server accessible by a Monitoring. Center for reviewing by trained medical staff,5 Indications for Use and contradictions. The indications for use for the PocketECG III type PECGT IIIV monitor are as follows. K152550 Page 2 of 3,510 k Summary Medicalgorithmics 510 k Special. 1 Patients who have a demonstrated need for cardiac monitoring These may include. but are not limited to patients who require monitoring for a non life threatening. arrhythmias such as supraventricular tachycardias e g atrial fibrillation atrial flutter. PACs PSVT and ventricular ectopy b evaluation of bradyarrhythmias and intermittent. bundle branch block including after cardiovascular surgery and myocardial infarction. and c arrhythmias associated with co morbid conditions such as hyperthyroidism or. chronic lung disease, 2 Patients with symptoms that may be due to cardiac arrhythmias These may include. but are not limited to symptoms such as a dizziness or lightheadedness b syncope. of unknown etiology in which arrhythmias are suspected or need to be excluded and. c dyspnea shortness of breath, 3 Patients with palpitations with or without known arrhythmias to obtain correlation of.
rhythm with symptoms, 4 Patients who require monitoring of effect of drugs to control ventricular rate in. various atrial arrhythmias e g atrial fibrillation. 5 Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia. monitoring, 6 Patients with diagnosed sleep disordered breathing including sleep apnea obstructive. central to evaluate possible nocturnal arrhythmias. 7 Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral. ischemia possibly secondary to atrial fibrillation or atrial flutter. 8 Data from the device may be used by another device to analyze measure or report QT. interval The device is not intended to sound any alarms for QT interval changes. Contradictions, 1 Patients with potentially life threatening arrhythmias who require inpatient. monitoring, 2 Patients who the attending physician thinks should be hospitalized. 6 Predicate Device Information, To K124060 PocketECG v3 Medicalgorithmics Unified Arrhythmia Diagnostic System type.
Similarities, o The subject device and the predicate device have the same fundamental. scientific technology and intended use, o The subject device and the predicate device have the same components. transmitter lithium ion rechargeable batteries AC plug in battery charger and. PC application, o The subject device and the predicate device analyze electrographic signal. classify all detected heart beats and recognize rhythm abnormalities. o The subject device and the predicate device send all detection results. including annotations for every detected heart beat and the entire ECG signal. via cellular telephony network to a remote server,Differences. K152550 Page 3 of 3,510 k Summary Medicalgorithmics 510 k Special.
o The predicate device uses a Global System for Mobile Communication GSM. protocol whereas the subject device uses Code Division Multiple Access. protocol CDMA for data transmission to a remote server. 7 Referenced standards, The PocketECG III Medicalgorithmics Unified Arrhythmia Diagnostic System type. PECGT IIIV meets the requirements of following performance standards in accordance. with FDA Class II Special Controls Guidance Document Arrhythmia Detector and. Alarm like the predicate device, IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 Medical electrical. equipment Part 1 General requirements for basic safety and essential. performance, with National Differences for United States US ANSI AAMI ES 60601. 1 2005 A2 2010 Medical electrical equipment Part 1 General requirements for. basic safety and essential performance, IEC 60601 1 2 2007 Medical electrical equipment Part 1 2 General. requirements for basic safety and essential performance Collateral Standard. Electromagnetic disturbances Requirements and tests. IEC 60601 1 11 2010 Medical electrical equipment Part 1 11 General. requirements for basic safety and essential performance Collateral Standard. Requirements for medical electrical equipment and medical electrical systems. used in the home healthcare environment, IEC 60601 2 47 2012 Medical electrical equipment Part 2 47 Particular.
requirements for the basic safety and essential performance of ambulatory. electrocardiographic systems, AAMI ANSI EC57 2012 Testing and Reporting Performance Results of Cardiac. Rhythm and ST Segment Measurement Algorithms, Quality management system Medical devices is in conformance with the standards EN. ISO 13485 2012 EN ISO 13485 2012 AC 2012 ISO 13485 2003 under CMDCAS and. EN ISO 9001 2008,8 Substantial Equivalence Conclusion. PocketECG III Medicalgorithmics Unified Arrhythmia Diagnostic System type. PECGT IIIV is safe effective and substantially equivalent to the predicate device as. supported by the descriptive information and the performance testing The subject device. is composed of off the shelf certified devices and components fully complying with the. classifies all detected heart beats and recognizes rhythm abnormalities All detection results including annotations for every detected heart beat and the entire ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff 5 Indications for Use and

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