The myPatch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, presyncope, syncope, fatigue, chest pain and/or anxiety.

Device Description

The myPatch ambulatory electrocardiograph(ECG) recorder is a small, lightweight monitor that records ECG continuously. The unit records 2 channel of ECG data up to 3 days. The device is composed of a large ECG electrode and ECG recorder. The ECG recorder clips onto the electrode and records until the recorder is removed from the electrode. At the end of the recorder can be plugged into a PC via the USB connection. The ECG recording can be transferred in an available file that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers.

The myPatch records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders.

During the recording the patient wears the myPatch connected to an electrode on the sternym. The myPatch consists of a plastic casing containing a battery and electronics consisting of a microprocessor, measuring circult, memory, data storage, light-emitting dlode (transilluminates the plastic casing), and contact to the electrode. In addition to that, myPatch contains firmware to control the collection of the ECG-data and software to transfer to processing software.

The battery is a rechargeable lithium polymer battery with a built-in protection circuit. The charging of the myPatch is by use of a USB cable, which can only be connected to myPatch when it is not connected to the electrode. At the bottom of myPatch is an electrical and click-on connection for the electrode. myPatch must be connected to the electrode to turn on and to acquire data. myPatch has a serial number to secure the traceability of the equipment and the data during and after the investigation. myPatch is reusable.

The electrode ( accessory to myPatch, ) is the passive part. The electrode consists of one layer of onesided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the sternum. The electrode gel is placed on the underneath side of the adhesive tape. Through this electrode gel, the ECG of the patient is measured. The top side of the electrode has an electrical and click-on connection to myPatch. The conductor paths are printed on the adhesive tape. These conductor paths make the connection between the electrode gel on the underside and the connection to myPatch on the top side of the electrode.

Release liners are placed on the underside and on the top side of the electrode. These release liners cover the adhesive tape and the electrode gel and are torn off when placing the myPatch on the sternum. The electrode has to be connected to myPatch to have any practical use. The electrode is a single- use device and is disposed of after one single use.

AI/ML Overview

This document is a 510(k) summary for the myPatch Ambulatory ECG Recorder (Model #: Amors1000). It outlines the device's description, indications for use, and a list of standards it meets, which are typically used to demonstrate substantial equivalence to predicate devices. However, this document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document does not explicitly define specific performance-based acceptance criteria (e.g., sensitivity, specificity for arrhythmia detection). Instead, the acceptance criteria are demonstrated by compliance with various international standards for medical electrical equipment.

Reported Device Performance: Clinical performance data is not provided in this 510(k) summary. The document states that "All testing demonstrated acceptable results" for various electrical and safety standards, but no quantitative performance metrics for ECG recording accuracy or diagnostic capabilities are presented.

Acceptance Criterion (standard compliance)	Reported Device Performance
IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) / IEC 60601-1/A11:2011 (General requirements for basic safety and essential performance)	"All testing demonstrated acceptable results"
EN 60601-1-11: 2010 (Home healthcare environment requirements)	"All testing demonstrated acceptable results"
IEC 60601-2-47: 2012 (Particular requirements for ambulatory electrocardiographic systems, equivalent to ANSI/AAMI EC38)	"All testing demonstrated acceptable results" and "myPatch has met the design verification testing standards as set forth in IEC 60601-2-47"
EN 60601-1-2:2007 (Electromagnetic compatibility)	"All testing demonstrated acceptable results"
EN 62366:2008 (Application of usability engineering to medical devices)	"All testing demonstrated acceptable results"
EN 1041:2009 (Information supplied by the manufacturer)	"All testing demonstrated acceptable results"
EN 980:2008 / EN 980 Bil.1:2008 (Symbols for use in labeling)	"All testing demonstrated acceptable results"
ISO 15223-1:2012 (Medical devices - Symbols for labels)	"All testing demonstrated acceptable results"
CE Marking (EU guidelines for medical devices)	"The myPatch ECG Recorder has the CE Marking (CE 1008). The CE Mark is a statement that the myPatch ECG Recorder fulfills the guidelines established by the EU for medical devices."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document refers to "testing" but does not detail sample sizes for any performance evaluation beyond compliance with engineering standards.
Data Provenance: Not specified. Given the nature of the testing mentioned (compliance with standards), it likely refers to laboratory-based engineering and electrical testing rather than clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document focuses on compliance with technical standards, not on clinical performance evaluated against expert-established ground truth.

4. Adjudication method for the test set

This information is not provided. As clinical performance evaluation is not detailed, adjudication methods are not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done or reported. The device is an ECG recorder, not an AI-assisted interpretation system. There is no mention of AI in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable in the context of an "algorithm only" performance. The device is a data acquisition tool. Its standalone performance is in recording ECG data, which is confirmed by compliance with relevant standards (e.g., IEC 60601-2-47). The document affirms that the device records "in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the engineering and safety tests would be the specifications and requirements defined within the cited IEC/EN/ISO standards. For example, for "Electromagnetic compatibility," the ground truth would be the permissible emission and immunity levels defined in EN 60601-1-2. There is no clinical ground truth discussed.

8. The sample size for the training set

Not applicable. This device is an ECG recorder, and the document does not mention any machine learning or AI components that would require a training set.

9. How the ground truth for the training set was established

Not applicable. As no training set for an algorithm is mentioned, the method for establishing its ground truth is irrelevant.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through compliance with international safety and electrical performance standards for medical devices. It does not present clinical performance data, diagnostic accuracy metrics, or AI algorithm validation studies that would involve a test set, ground truth established by experts, or training sets.

Summary

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2800 Neilson Wy Sto 1 Santa Monica, CA 90405 ph: {775} 315-0660 fax: (B00] 441-3437

OCT 2 9 2013

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tervice.com

K131190 pg 1 of 3

510(k) Summary

March 26, 2013

Contact Person: Lynda Cole, Manager, Icole@dms-service.com,

ph: (775) 315-0660 fax: (800) 441-3437

Submitter: dms-service IIc, 2800 Neilson Way, Ste. 1, Santa Monica, CA 90405 Trade

Name: myPatch

Model #: Amors1000

Common Name: Ambulatory ECG Recorder

Classification: 21 CFR 870.2800, Medical Magnetic Tape Recorder, Cardiovascular Panel

Device Class: II

Product Code: DSH

Substantially Equivalent Devices

Manufacturer	Substantiallyequivalent devices	510(k)
iRhythm	Zio Patch	K113862
Cardiac Science Corp.	mySense Heart	K113176
Scole Engineering Co. Inc.	Scole 300	K923664

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Device Description:

The myPatch records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders.

During the recording the patient wears the myPatch connected to an electrode on the sternym. The

myPatch consists of a plastic casing containing a battery and electronics consisting of a microprocessor, measuring circult, memory, data storage, light-emitting dlode (transilluminates the plastic casing), and contact to the electrode. In addition to that, myPatch contains firmware to control the collection of the ECG-data and software to transfer to processing software.

Indications for Use:

Technological Characteristics/Substantial Equivalence:

myPatch has the same technological characteristics as the ZioPatch, mySense Heart and Scole 300 ambulatory monitors. myPatch, mySense and ZioPatch are all patch based monitors. The Scole 300 and myPatch can both continuously record 2 channels of ECG data. All monitors are powered by a battery, the frequency response will not degrade the system performance and all monitors can record a minimum of 24 hours. myPatch will record up to 3 days and Zio Patch will record up to 14 days of continuous ECG.

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K131190 pg 3 of 3

All of the above mentioned devices are intended for the same use, recording continuous ECG signals. Any differences in the hardware design of the monitors and myPatch does not affect the safety or the effectiveness of the myPatch monitor. myPatch has met the design verification testing standards as set forth in IEC 60601-2-47, which is equivalent to ANSI/AAMI EC38.

Testing:

The myPatch ECG Recorder has undergone extensive testing, including testing listed below. All testing demonstrated acceptable results:

IEC 60601 1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-1/A11:2011 Medical electrical

equipment - Part 1: General requirements for basic safety and essential performance same as

IEC 60601-1:2012 ed 3.1 Consol. with am1

EN 60601-1-11: 2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential perfor-mance - 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

EN 60601-1-2:2007 Collateral standard: Electromagnetic compatibility - Requirements and tests

EN 62366:2008 Application of usability engineering to medical devices

EN 1041:2009 Information supplied by the manufacturer of medical devices

EN 980:2008 Symbols for use in the labeling of medical devices

EN 980 Bil.1:2008 CD-ROM Graphical symbols for use in the labeling of medical devices – Fact Sheet 1: Graphical symbols in electronic format

ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements

The myPatch ECG Recorder has the CE Marking (CE 1008). The CE Mark is a statement that the myPatch ECG Recorder fulfills the guidelines established by the EU for medical devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 29, 2013

DMS-Service LLC C/O Lynda Cole 2800 Neilson Way, Ste. 1 Santa Monica, CA 90405 US

Re: K131190

Trade/Device Name: MyPatch Amores 1000 Ambulatory ECG Regulation Number: 21 CFR 870.2800 Regulation Name: Ambulatory Electrocardiograph (ECG) Recorder Regulatory Class: Class II Product Code: DSH Dated: September 26, 2013 Received: September 27, 2013

Dear Ms. Cole:

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.

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

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Page 2 - Lynda Cole

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Owen注册_aris -S

for

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

Enclosure

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Indications for Use Statement

510(k)

Number:K131190

Device Name: myPatch

Indications For Use:

Prescription Use _ _ X

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(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)

Image /page/5/Figure/13 description: The image shows a digital signature. The signature includes the text "Digitally signed by Owen P. Faris -S Date: 2013.10.29 13:00:42-04'00'". The signature also includes a stylized design to the left of the text.

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).