MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM

K112921 · Medicalgorithmics S.A. · DSI · May 16, 2012 · Cardiovascular

Device Facts

• Record ID: K112921
• Device Name: MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
• Applicant: Medicalgorithmics S.A.
• Product Code: DSI · Cardiovascular
• Decision Date: May 16, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The indications for use for the PocketECG v2 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.

Device Story

Ambulatory ECG monitor; captures electrographic signals via patient-worn transmitter; streams data via Bluetooth to Windows Mobile or Android PDA. PDA runs proprietary software to classify heart beats, generate QRS annotations, and manage data transmission. Entire ECG signal and classification results transmitted via cellular network to remote server; reviewed by trained medical staff at Monitoring Center. Enables correlation of rhythm with symptoms; supports long-term monitoring (30+ days). Benefits include remote diagnostic capability for outpatient arrhythmia evaluation; assists clinical decision-making regarding drug efficacy and cardiac event etiology.

Clinical Evidence

Bench testing only. Device performance validated against AAMI/ANSI EC38 (ambulatory ECG systems) and AAMI/ANSI EC57 (cardiac rhythm and ST-segment measurement algorithms) standards. No clinical trial data provided.

Technological Characteristics

Ambulatory ECG monitor; patient-worn transmitter with Bluetooth connectivity to PDA; cellular network transmission to remote server. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), AAMI/ANSI EC38, and AAMI/ANSI EC57. Quality management per ISO 9001 and ISO 13485. Software performs real-time ECG analysis, QRS annotation, and morphology classification.

Indications for Use

Indicated for patients requiring cardiac arrhythmia monitoring, including those with supraventricular tachycardias, ventricular ectopy, bradyarrhythmias, bundle branch block, or symptoms like dizziness, syncope, dyspnea, and palpitations. Also for post-cardiac surgery, sleep-disordered breathing, and stroke/TIA etiology evaluation. Contraindicated for patients with life-threatening arrhythmias requiring inpatient monitoring or those requiring hospitalization.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CardioNet's Ambulatory ECG Monitor (K072558)
• Universal Medical's Heartrak Smart AF (K071130)
• GE's SEER Light Extend Compact Digital Holter System (K050731)

Submission Summary (Full Text)

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## Medicalgorithmics 510(k) Premarket Notification

#### May 7, 2012 510(k) Summary

| 1. Submitter Name and Address | |
|-------------------------------|--------------------------------------------------------------------------|
| Medicalgorithmics LLC | 245 West 107th St., Suite 11A<br>New York, NY 10025, USA |
| Contact Person | Martin Jasinski, phone [phone],<br>fax [phone] |
| 2. Device | |
| Trade name: | PocketECG v2 - Medicalgorithmics Unified<br>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:

- 1. CardioNet's Ambulatory ECG Monitor, K072558 (Reg. no. 870.1025)
- 2. Universal Medical's Heartrak Smart AF, K071130, (Reg. No. 870.2920)
- 3. GE's SEER Light Extend Compact Digital Holter System, K050731 (Reg. no. 870.2800)

#### 4. Device Description

PocketECG v2 - 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.

The patient worn transmitter streams via Bluetooth link the ECG signal to a Windows Mobile or Android OS operated PDA (Personal Digital Assistant) device with mobile phone capabilities. The PDA runs Medicalgorithmics proprietary software which produces QRS annotations and manages the data transmission. The PDA device transmits and stores the entire ECG on its storage card.

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## 5. Indications for Use and contradictions

K112921

The indications for use for the PocketECG v2 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 bradyarhythmias 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 annea (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 OT interval. The device is not intended to sound any alarms for OT interval changes.

## Contradictions:

- 1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
- 2. Patients who the attending physician thinks should be hospitalized.

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#### 6. Technological comparison to predicate devices

K112921

# To K072558 - Mobile Cardiovascular Outpatient Telemetry

- Similarities:
- o The subject device and the predicate device analyze the ECG signal in real time

30%

- o The subject device and the predicate device allow for storing 30 or more days of data
- o The subject device and the predicate device utilize a patient-worn sensor and a monitor that communicate with each other wirelessly
- Differences:
- o The subject device produces and sends beat labels for each ORS complex. 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:
- o 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:

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- 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
- o The subject devices analyzes the ECG signal before transmission and 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

#### 7. Referenced standards

K112921

The Medicalgorithmics Unified Arrhythmia Diagnostic System, PocketECG v2 meets the requirements of following performance standards in accordance with FDA Class Il Special Controls Guidance Document: Arrhythmia Detector and Alarm.

- . IEC 60601-1:1999 "Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995"
- IEC 60601-1-2:2001/A1:2004 "Medical Electrical Equipment Part 1-2: . General Requirements for Safety; Electromagnetic Compatibility --Requirements and Tests" Class B
- 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

Quality management system - Medical devices is in conformance with the standards: PN-EN ISO 9001:2001 and PN-EN ISO 13485:2005.

## 8. Substantial Equivalence Conclusion

Medicalgorithmics Unified Arrhythmia Diagnostic System, PocketECG v2 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 of off-the-shelf, certified devices and components fully complying with the US safety and EMC standards.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY-1 622012

Medicalgorithmics LLC. c/o Mr. Martin Jasinski 245 West 107th street, Suite 11A New York, NY 10025

Re: K112921

K 112921
Trade Name: PocketECG v2 – Medicalgorithmics unified arrhythmia diagnostic system
Trade Name: Pocket Process 1995 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector Alarm Regulatory Class: Class II (two) Product Codes: DSI Dated: May 11, 2012 Received: May 11, 2012

Dear Mr. Jasinski:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) prematics is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally manced to the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Rederal Food. Drug. commerce prior to May 28, 1976, the enactinent and of the Federal Food. Drug, devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval on the Act. The and Cosmetic Act (Act) that do not require approvation a provisions of the Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject on the general or annual registration, listing of
general controls provisions of the Act include requirements for annual regis general controls provisions of the Accurity, and prohibitions against misbranding and devices, good manufacturing practice, laocmation related to contract liability.
adulteration. Please note: CDRH does not evaluate information related to adulteration. Please note: CDKH does not evaluate information of misleading.
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
and be If your device is classified (see above) micr ciass it (epicas affecting your device can be
may be subject to additional controls. Existing major regulation FDA may may be subject to additional controls. Existing fitle 21, Parts 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a found in the Code of Federal Regulations, Trille 20, 2

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### Page 2 -Mr. Jasinski

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112921 pg lof2

# Indications for Use

510(k) Number (if known): K112921 Device Name: PocketECG -v2 Medicalgorithmics Unified Arrhythmia Diagnostic System

#### Indications For Use:

The indications for use for the PocketECG v2 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.

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)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K112921

Page 5-1

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- K112921
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.