ZIO SR ECG Monitoring Service

K143513 · iRhythm Technologies, Inc. · DSH · Jun 19, 2015 · Cardiovascular

Device Facts

• Record ID: K143513
• Device Name: ZIO SR ECG Monitoring Service
• Applicant: iRhythm Technologies, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Jun 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The ZIO® SR ECG Monitoring Service is intended to capture, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

Device Story

ZIO SR ECG Monitoring Service captures continuous single-lead ECG data for up to 14 days. System includes a wearable patch recorder with Bluetooth, a wireless gateway, and a central processing service. Patient wears patch; patch records ECG continuously and allows patient-triggered 90-second ECG strip transmission via gateway. Data uploaded to iRhythm Clinical Center (iCC) post-wear or via wireless transfer. Algorithms process ECG data to generate metrics (beat-by-beat analysis, heart rate, rhythm). Certified Cardiographic Technicians (CCTs) review and edit algorithm outputs using a QA tool. Final report provided to clinicians for diagnostic decision-making. Benefits include improved patient compliance and symptom-rhythm correlation for cardiac event detection.

Clinical Evidence

Bench testing only. Performance testing confirmed design outputs met requirements per consensus standards (ISO 14971, IEC 60601 series, ISO 10993-1, EC12). Automated ECG analysis performance quantified; sensitivity and positive predictivity levels met requirements.

Technological Characteristics

Single-lead ambulatory ECG monitor; Bluetooth connectivity; wireless gateway; disposable electrodes (EC12:2000). Complies with IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-47. Biocompatible materials (ISO 10993-1). Software-based analysis with manual technician review.

Indications for Use

Indicated for adult patients 18+ years, asymptomatic or experiencing transient symptoms (palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, anxiety) requiring long-term ECG monitoring up to 14 days.

Regulatory Classification

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.

Predicate Devices

• ZEUS (ZIO ECG Utilization Services) System (K142681)
• ZIO PATCH (K121319)
• EPI MINI (K121628)

Submission Summary (Full Text)

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Public Health Service

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

June 19, 2015

iRhythm Technologies, Inc. Rich Laguna Director QA/RA 650 Townsend Street, Ste 380 San Francisco, California 94103

Re: K143513

Trade/Device Name: ZIO® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH, DOK, DXH Dated: May 15, 2015 Received: May 18, 2015

Dear Rich Laguna:

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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mitchell Stein

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

Enclosure

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# SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K143513

Device Name: ZIO® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service

#### Indications for Use:

The ZIO® SR ECG Monitoring Service is intended to capture, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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# SECTION 5 510(k) SUMMARY

This summary of the 510(k) premarket notification for the ZEUS System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

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IRHYTHM TECHNOLOGIES, INC.

K143513

## SECTION 5 510(k) SUMMARY

510(k) Notification K

## GENERAL INFORMATION

## Applicant:

iRhythm Technologies, Inc. 650 Townsend Street, Suite 380 San Francisco, CA 94103 U.S.A Phone: [phone] Fax: [phone]

# Contact Person:

Rich Laguna Director Quality & Regulatory Affairs eMail: [e-mail] Phone: [phone] Fax: [phone]

Date Prepared: December 10, 2014

## DEVICE INFORMATION

## Classification:

Recorder, Magnetic Tape, Medical, 21 CFR§870.2800 Computer, diagnostic, programmable, 21CFR§870.1425 Transmitters and receivers, electrocardiograph, telephone, 21CFR§870.2920

#### Product Codes: DSH, DQK, DXH

Trade Name: ZIO®®

Generic/Common Name: Medical magnetic tape recorder

# PREDICATE DEVICE(S)

ZEUS (ZIO ECG Utilization Services) System [K142681] ZIO PATCH [K121319] EPI MINI [K121628]

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## SECTION 5 510(k) SUMMARY

## INDICATIONS FOR USE

The ZIO® SR ECG Monitoring Service is intended to capture, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

## PRODUCT DESCRIPTION

The ZIO® SR ECG Monitoring Service consists of three components: (1) ZIO SR Patch Recorder with Bluetooth technology, (2) ZIO SR Wireless Gateway, and (3) ZIO ECG Utilization Service System.

The ZIO® SR Patch is a single-patient-use ECG monitor that provides a continuous, singlechannel recording in addition to symptomatic data transmission for up to 14 days. The ZIO® SR Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. Patients have the option of pressing a convenient trigger button which marks the continuous record and initiates a wireless transfer of an ECG strip of 90-second duration. The wireless transfer of data is enabled by the ZIO® SR Gateway, which requires proximity and reception but no patient interaction. The patient is encouraged to fill out a log to document symptomatic events, which will support symptom-rhythm correlation in the ZIO SR Report. Alternatively, the patient can enter symptom logs and view received transmissions via an online patient portal.

At the conclusion of the wear period (up to 14 days), the patient removes the ZIO® SR Patch and returns it by mail to an iRhythm data processing center.

Upon receipt of symptomatic or continuous ECG data at iRhythm's Clinical Center (iCC) the ECG data is downloaded, the data is processed through the algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy. iRhythm employed and trained Patch in-take and CCT personnel follow internal procedures for processing and are of algorithm performance anomalies. Any software anomalies are visible to and manually corrected by iRhythm Technologies CCT's during the QA review and/or Patch Report edits. The CCT generates a final report of the ECG findings contained within the data; thereby enabling the provision of a complete ECG processing and analysis service.

Upon explicit request from a clinician responsible for the patient's healthcare, longer segments of ECG data from the continuous recording on the Patch can also be wirelessly retrieved during the wear period.

Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns.

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## SECTION 5 510(k) SUMMARY

# SUBSTANTIAL EQUIVALENCE

The indications for use for the ZIO® SR ECG Monitoring Service are substantially equivalent to the indications for use for the predicate devices. The performance testing results demonstrate that any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Therefore, the ZIO® SR ECG Monitoring Service is substantially equivalent to the predicate device.

## NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

There are no required FDA performance standards for the ZIO® SR ECG Monitoring Service. All necessary performance testing was conducted on the ZIO® SR ECG Monitoring Service to support determination of substantial equivalence to the predicate devices. The results confirm by examination and provision of objective evidence that the design output met the design input requirements in conformance with the following list of recognized consensus standards:

- . ISO 14971:2007/(R)2010 (Corrected 4 October 2007), medical devices - applications of risk management to medical devices
- IEC 60601-1:2005/(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 60601-1-2:2007, Medical electrical equipment part 1-2: general requirements for . basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests
- IEC 60601-1-11 Edition 1.0 2010-04, 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. (Cardiovascular)
- o EC12:2000/(R)2010, disposable ecg electrodes. (Cardiovascular)
- ISO 10993-1:2009/(R) 2013, biological evaluation of medical devices -- part 1: evaluation and testing within a risk management process. (Biocompatibility)

## CONCLUSION

The ZIO® SR ECG Monitoring Service is substantially equivalent to the predicate devices.