(52 days)
No
The description mentions analysis and classification of heartbeats and rhythm abnormalities but does not explicitly state the use of AI or ML. The "Mentions AI, DNN, or ML" field is marked as "Not Found".
No.
The "Intended Use / Indications for Use" and "Device Description" sections describe the device as a monitor that analyzes ECG signals and recognizes rhythm abnormalities for diagnostic purposes and monitoring, not for providing therapy or treatment.
Yes.
The device is described as an "ambulatory ECG monitor which analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities." Its intended use includes monitoring for various arrhythmias, evaluating the etiology of symptoms like dizziness or syncope, and assessing the effect of drugs, all of which fall under the scope of diagnosis. It is explicitly called a "Unified Arrhythmia Diagnostic System."
No
The device description explicitly states it is an "ambulatory ECG monitor which analyzes electrographic signal". This indicates the device includes hardware to acquire the ECG signal, making it more than just software.
Based on the provided information, the PocketECG v3 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- PocketECG v3 Function: The PocketECG v3 is an ambulatory ECG monitor. It directly measures electrical activity of the heart from the body surface (in vivo) using electrodes. It analyzes this signal to detect and classify heart beats and rhythm abnormalities.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient.
Therefore, the PocketECG v3 falls under the category of a medical device that performs physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use for the PocketECG v3 monitor are as follows:
- 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
- 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)
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
- Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring
- Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
- 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:
- Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
- Patients who the attending physician thinks should be hospitalized.
Product codes
DSI
Device Description
PocketECG v3 - Medicalgorithmics Unified Arrhythmia Diagnostic System 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.
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
Not Found
Intended User / Care Setting
Monitoring Center for reviewing by trained medical staff.
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)
Medicalgorithmics Unified Arrhythmia Diagnostic System, PocketECG v3 is safe, effective and substantially equivalent to the predicate devices as supported by the descriptive information and the performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072558, K071130, K050731, K112921
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
K124060 page 1 of 5
510(k) Summary
Medicalgorithmics 510(k) Premarket Notification
510(k) Summary
November 21, 2012
| 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 | |
| 2. Device | |
| Trade name: | PocketECG v3 - Medicalgorithmics Unified |
| Arrhythmia Diagnostic System | |
| Classification name: | Arrhythmia Detector and Alarm |
| Product code: | DSI |
| Regulation no: | 870.1025 |
| Class: | Class II, Special Controls |
3. Substantial Equivalence
The selected predicate devices are:
-
- CardioNet's Ambulatory ECG Monitor, K072558 (Reg. no. 870.1025)
-
- Universal Medical's Heartrak Smart AF, K071130, (Reg. No. 870.2920)
-
- GE's SEER Light Extend Compact Digital Holter System, K050731 (Reg. no. 870.2800)
-
- Medicalgorithmics PocketECG v2 Unified Arrhythmia Diagnostic System, K112921 (Reg. no. 870.1025)
4. Device Description
PocketECG v3 - Medicalgorithmics Unified Arrhythmia Diagnostic System 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.
1
510(k) Summary
5. Indications for Use and contradictions
The indications for use for the PocketECG v3 monitor are as follows:
-
- 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
-
- 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)
-
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
-
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
-
- Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring
-
- Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
-
- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
-
- 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 OT interval changes.
Contradictions:
-
- Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
-
- Patients who the attending physician thinks should be hospitalized.
2
510(k) Summary
6. Technological comparison to predicate devices
To K072558 - Mobile Cardiovascular Outpatient Telemetry
- Similarities:
- o The subject device and the predicate device analyze the ECG signal in real time
- The subject device and the predicate device allow for storing 30 or more O days of data
- The subject device and the predicate device utilize a patient-worn sensor o and a monitor that communicate with each other wirelessly
- Differences:
- The subject device produces and sends beat labels for each QRS complex, o while the predicate device transmits ECG strips with more generalized description
- o The subject device transmits the entire ECG signal for each day, while the predicate device sends only preselected ECG strips
To K071130 - Heartrak Smart AF: Cardiac Event Recorder With Atrial Fibrillation Auto-Capture
- Similarities: .
- · The subject device and the predicate device automatically detect atrial fibrillation episodes
- o The subject device and the predicate device allow for patients to mark symptoms and activate transmission
- o The subject device and the predicate device utilize loop memory
- o The subject device and the predicate device send the ECG signal to remote location from patient's home
- Differences:
- o The subject device allows for storing in its loop memory data exceeding 30 days, while the predicate device stores 15 minutes of data
- o The subject device transmits ECG signal over mobile telephony network using file transfer protocol, while the predicate device sends the ECG signal trans-telephonically
To K050731 - SEER Light Extend Compact Digital Holter System
- Similarities:
- o The subject device and the predicate device store the entire ECG signal in memory
- o The subject device and the predicate device enable the use of the entire ECG waveform for calculating beat labels for each ORS complex with morphology classification
- The subject device and the predicate device allow for accessing and o printing the full disclosure ECG waveform
- Differences:
3
· -
510(k) Summary
- The subject device transmits the entire ECG waveform to a remote o location, while for the predicate device the ECG signal has to be downloaded directly onto a computer
- The subject devices analyzes the ECG signal before transmission and o transmits the waveform along with all classification results, while the predicate device is used for downloading the ECG signal only and the analysis is performed using an external computer
To K 112921- Medicalgorithmics PocketECG v2 Unified Arrhythmia Diagnostic System
Similarities:
.
- o The subject device and the predicate device analyze electrographic signal, classify all detected heart beats and recognize rhythm abnormalities
- The subject device and the predicate device send all detection results, o including annotations for every detected heart beat and the entire ECG signal via cellular telephony network to a remote server
- Differences: .
- o The predicate device uses a separate ECG sensor for acquiring the signal and a separate PDA device for transmitting the data to a remote server, while the subject device integrates the ECG sensor and the data transmission platform into a single device
7. Referenced standards
The Medicalgorithmics Unified Arrhythmia Diagnostic System, PocketECG v3 meets the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm.
- . IEC 60601-1:2005 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance"
- AAMI / ANSI EC38:2007 Medical electrical equipment Part 2-47: Particular . requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
- . AAMI / ANSI EC57:1998/(R)2003 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms.
- IEC 60601-1-2:2007 "Medical Electrical Equipment Part 1-2: General . requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility - Requirements and tests"
Quality management system - Medical devices is in conformance with the standards: PN-EN ISO 9001:2009 and PN-EN ISO 13485:2005.
8. Substantial Equivalence Conclusion
Medicalgorithmics Unified Arrhythmia Diagnostic System, PocketECG v3 is safe, effective and substantially equivalent to the predicate devices as supported by the descriptive information and the performance testing. The subject device is composed
4
510(k) Summary
:
005_Vol 001 Page 5
of off-the-shelf, certified devices and components fully complying with the US safety and EMC standards.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 21, 2013
Medicalgorithmics LLC. c/o Mr. Martin Jasinski 245 West 107th street, Suite 11A New York, NY 10025
Re: K124060
Trade Name: PocketECG v3 - Medicalgorithmics unified arrhythmia diagnostic system Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector Alarm Regulatory Class: Class II (two) Product Codes: DSI Dated: December 11, 2012 Received: December 31, 2012
Dear Mr. Jasinski:
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.
6
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 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.
Owen-Paris -S
for Bram D. Zuckerman, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K124060 pg 1 of 2
Indications for Use
510(k) Number (if known): K124060 PocketECG Device Name: -v3 Medicalgorithmics Unified Arrhythmia Diagnostic System
Indications For Use:
The indications for use for the PocketECG v3 monitor are as follows:
-
- 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 archythmias 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
-
- 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)
-
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OwenPFaris-S
004 Vol 001 Page 1
8
- Patients who require monitoring of effect of drugs to control ventricular rate in 4. various atrial arrhythmias (e.g. atrial fibrillation)
-
- Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring
- Patients with diagnosed sleep disordered breathing including sleep apnea 6. (obstructive, central) to evaluate possible nocturnal arrhythmias
-
- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
-
- Data from the device may be used by another device to analyze. measure or report OT 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.
Image /page/8/Picture/9 description: The image shows the text "Owen P. Faris -S". The text is written in a bold, sans-serif font. The letters "P. F" are stylized with a geometric design. The text is black and the background is white.
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