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.
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 without known arrhythmias to obtain a correlation of rhythm with symptoms.
Patients who require monitoring of the 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 arrial 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.

Contraindications:

The PocketECG IV is not intended to be used by:

Patients who have been diagnosed with life-threatening arrhythmias and require hospitalization.
Patients who require inpatient monitoring using a life-saving device.

Device Description

The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV, type P4TR-AA-ADS 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Unified Arrhythmia Diagnostic System PocketECG IV, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission references compliance with the IEC 60601-2-47:2012 standard for arrhythmia detection algorithms. The text explicitly states: "Test results were considered to be in complaint with standard requirements." However, concrete numerical acceptance criteria and specific performance metrics (e.g., sensitivity, specificity, accuracy for various arrhythmia types) from this standard are not detailed in the provided document. The document implies that the device meets the standard but doesn't provide the standard's exact requirements or the device's specific results against those requirements.

Similarly, for wireless transmission, the document states: "Wireless transmission performance has been tested according to Verizon Open Development (based on CTIA) requirements for LTE data transmissions." Again, the specific numerical acceptance criteria and detailed performance results are not provided.

Therefore, I can only create a table that states the areas tested and the general conclusion of compliance, not a detailed comparison of specific numerical acceptance criteria versus reported performance.

Test Area	Acceptance Criteria (Implied)	Reported Device Performance
Arrhythmia Detection	Compliance with IEC 60601-2-47:2012	In compliance with standard requirements
Wireless Transmission	Compliance with Verizon Open Development (based on CTIA) for LTE	Tested according to requirements; implicitly in compliance
Electrical Safety & EMC	Compliance with US electrical safety and EMC standards	Fully complying with US electrical safety and EMC standards
General Product Performance	Meets requirements of various IEC and AAMI standards (listed in document)	Performance data not specified, but general compliance claimed

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "performance testing according to IEC 60601-2-47:2012" but doesn't provide any details about the dataset used for this testing, including the number of patients, recordings, or specific arrhythmias.
Data Provenance: Not explicitly stated. There is no mention of the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated. The document does not describe how ground truth was established for the performance testing, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The document does not describe any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No indication of an MRMC comparative effectiveness study being performed or reported in the provided text. The submission focuses on device performance against standards, not on human-AI collaboration or improvement metrics.

6. Standalone Performance Study (Algorithm Only)

Standalone Performance: Yes, a standalone performance study was implicitly done for the arrhythmia detection algorithms. The text states: "Arrhythmia detection algorithms implemented in PocketECG IV have been subject for performance testing according to IEC 60601-2-47:2012 (AAMI / ANSI / IEC 60601-2-47:2012)." This refers to the algorithm's performance in detecting arrhythmias against established standards, without human intervention as part of the testing methodology described. While the overall system involves human review, the specific performance testing mentioned here would be for the automated algorithm's accuracy.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. While performance testing against IEC 60601-2-47:2012 implies a comparison to a known, verified "true" state of cardiac rhythms, the method by which this ground truth was established (e.g., expert consensus, pathology, other validated methods) is not detailed in the document.

8. Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated. The document makes no mention of a training set or its size, which is common for submissions primarily focused on verification and validation of a developed product rather than describing the entire development process of an AI model from scratch.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not explicitly stated. Since a training set isn't mentioned, the method for establishing its ground truth is also not provided.

Summary

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April 9, 2020

Medicalgorithmics S.A. % Przemyslaw Tadla Strategy Director Medicalgorithmics US Holding Corporation Corporation Service Company 251 Little Falls Drive Wilmington, Delaware 19808

Re: K193104

Trade/Device Name: Unified Arrhythmia Diagnostic System PocketECG IV Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: DSI Dated: March 6, 2020 Received: March 11, 2020

Dear Przemyslaw Tadla:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193104

Device Name

Unified Arrhythmia Diagnostic System PocketECG IV

Indications for Use (Describe)

The PocketECG IV is intended to be used by:

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.
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 without known arrhythmias to obtain a correlation of rhythm with symptoms.
Patients who require monitoring of the 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 arrial 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.

Contraindications:

The PocketECG IV is not intended to be used by:

Patients who have been diagnosed with life-threatening arrhythmias and require hospitalization.
Patients who require inpatient monitoring using a life-saving device.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Medical Algorithms. The logo has the word "MEDICAL" in gray and the word "Algorithms" in red. Below the words is the phrase "Innovative Solutions in Medicine".

510(k) Summary

l. Submitter's name and address:

Medicalgorithmics S.A.	Aleje Jerozolimskie 81,
	02-001 Warsaw, Poland
Contact Person:	Przemysław Tadla
	Phone: (+1) 302 2615184
	Email: p.tadla@medicalgorithmics.com
Date Prepared:	2019-10-28

II. Device

Trade name:	Unified Arrhythmia Diagnostic System PocketECG IV
Type:	P4TR-AA-ADS
Regulation number:	870.1025
Classification name:	Arrhythmia detector and alarm (including ST-segmentmeasurement and alarm)
Regulatory Class:	Class II, Special Controls
Classification:	Detector And Alarm, Arrhythmia; DSI

.............................................................................................................................................................................. Substantial Equivalence

The selected predicate device is:

1. Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III, type PECGT-IIIV K152550 (Predicate Device)

IV. Device description

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Image /page/4/Picture/1 description: The image is a logo for Medical Algorithms. The word "MEDICAL" is in dark gray, and the word "Algorithms" is in red. Below the words is the phrase "Innovative Solutions in Medicine" in a smaller, gray font.

V. Indications for use

The PocketECG IV is intended to be used by:

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.
1. 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).
1. Patients with palpitations with or without known arrhythmias to obtain a correlation of rhvthm with symptoms.
1. Patients who require monitoring of the effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
1. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
1. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias.
1. 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.

Contraindications:

The PocketECG IV is not intended to be used by:

1. Patients who have been diagnosed with life-threatening arrhythmias and require hospitalization.
1. Patients who require inpatient monitoring using a life-saving device.

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Image /page/5/Picture/1 description: The image shows the logo for Medical Algorithms. The logo has the word "MEDICAL" in gray and the word "Algorithms" in red. Below the words is the phrase "Innovative Solutions in Medicine" in gray.

Technological comparison to predicate device VI.

Predicate Device (K152550):

Similarities: -
- The subject device and the predicate device have the same fundamental O 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.
- The subject device and the predicate device send all detection results, о 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 Code Division Multiple Access protocol (CDMA), whereas the subject device uses Verizon Wireless Long-Term Evolution (LTE) for data transmission to a remote server.

VII. Guidance documents

The following guidance documents have been taken into account during preparation of this submission:

-Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, October 28, 2003;
Guidance for the Content of Premarket Submissions for Software Contained in -Medical Devices, May 11, 2005;
-Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and FDA Staff, August 14, 2013;
Content of Premarket Submissions for Management of Cybersecurity in -Medical Devices, Guidance for Industry and Food and Drug Administration Staff, October 2, 2014;
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, June 16, 2016.

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Image /page/6/Picture/1 description: The image shows the logo for Medical Algorithms. The logo has the word "MEDICAL" in gray and the word "Algorithms" in red. Below the words is the phrase "Innovative Solutions in Medicine" in gray.

Referenced standards VIII.

Medicalgorithmics Arrhythmia Diagnostic System PocketECG IV, type The P4TR-AA-ADS meets the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document Arrhythmia Detector and Alarm.

AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And ● A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod);
IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment Part 1-6: ● General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability;
AAMI / ANSI / IEC 62366:2007/(R)2013, Medical Devices Application Of . Usability Engineering To Medical Devices;
AAMI / ANSI HA60601-1-11:2015, Medical Electrical Equipment -- Part 1-11: . General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment (IEC 60601-1-11:2015 Mod);
AAMI / ANSI / IEC 60601-2-47:2012, Medical Electrical Equipment -- Part 2-47: ● Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems;
ANSI/AAMI/IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: ● General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 4).

Medicalgorithmics has assessed the PocketECG IV for wireless coexistence in accordance with the FDA quidance document Radio Frequency Wireless Technology in Medical Devices (August 14, 2013). This include FCC & Verizon Open Development performance testing.

Performance data IX.

Arrhythmia detection algorithms implemented in PocketECG IV have been subject for performance testing according to to IEC 60601-2-47:2012 (AAMI / ANSI / IEC 60601-2-47:2012) Test results were considered to be in complaint with standard requirements.

Wireless transmission performance has been tested according to Verizon Open Development (based on CTIA) requirements for LTE data transmissions.

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Image /page/7/Picture/1 description: The image shows the logo for Medical Algorithms. The word "MEDICAL" is in dark gray, and the word "Algorithms" is in red. Below the words is the phrase "Innovative Solutions in Medicine" in a smaller, gray font.

Substantial Equivalence Conclusion X.

The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV, type P4TR-AA-ADS is 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 US electrical safety and EMC standards.

Regulation Number and Section

§ 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.