Zio Monitor

K202359 · iRhythm Technologies, Inc. · DSH · May 21, 2021 · Cardiovascular

Device Facts

• Record ID: K202359
• Device Name: Zio Monitor
• Applicant: iRhythm Technologies, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: May 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The Zio monitor is a prescription-only, single-patient-use, ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue or anxiety.

Device Story

Zio Monitor is a single-patient-use, long-term ambulatory ECG monitor; adhered to patient's left pectoral region in modified Lead II orientation. Device records continuous ECG data for up to 14 days; activated by patient at home or clinic. Features include a patient-operated button to mark symptoms and an LED indicator (green for active, orange for error/loss of skin contact). Device provides continuous, uninterrupted ECG recording into internal memory. Physicians use the recorded data to initiate long-term monitoring; output aids in clinical decision-making regarding cardiac rhythm assessment. Benefits include patient-compliant, long-term monitoring in an ambulatory setting.

Clinical Evidence

No clinical testing was performed in support of this premarket notification. Substantial equivalence is supported by nonclinical bench testing, including mechanical verification, biocompatibility, firmware verification, and electrical safety/EMC testing in accordance with recognized consensus standards.

Technological Characteristics

Ambulatory ECG monitor; modified Lead II orientation. Adheres to left pectoral region. Features patient-activated event button and LED status indicator. Connectivity: internal memory storage. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, ISO 10993-1/5/10, IEC 62304. Packaging standards: ASTM D7386-16, ASTM D4332-14. Single-patient-use, non-sterile.

Indications for Use

Indicated for non-pediatric, non-critical care patients, asymptomatic or experiencing transient symptoms including palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, or anxiety.

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

• iRhythm Technologies, Inc. Zio® XT Patch (K121319)

Reference Devices

• iRhythm Technologies, Inc. Zio® AT Patch (K181502)

Submission Summary (Full Text)

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May 21, 2021

iRhythm Technologies, Inc. Rev Jacinto Sr. Manager, Regulatory Affairs 699 8th Street San Francisco, California 94103

Re: K202359

Trade/Device Name: Zio Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH, MWJ Dated: May 20, 2021 Received: May 21, 2021

Dear Rey Jacinto:

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.

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

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer Shih Kozen Assistant Director 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) K202359

Device Name Zio® Monitor

#### Indications for Use (Describe)

The Zio Monitor is a prescription-only, single-patient-use, ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue or anxiety.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|--|
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |

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Section 5 510(k) Summary

## 510(k) Notification K202359

#### l. General Information

### Applicant:

iRhythm Technologies, Inc.

699 8th Street, Suite 600

San Francisco, CA 94103 USA

Phone: [phone]

Fax: [phone]

### Contact Person:

Rey Jacinto Sr. Manager, Regulatory Affairs Phone: [phone] Email: [e-mail] Date Prepared: August 17, 2021

#### ll. Device Information

Trade Name:

Zio® monitor

### Generic/Common Name:

Medical magnetic tape recorder

### Classification Names:

Medical magnetic tape recorder [21CFR§870.2800]

### Regulatory Class:

Class II

### Product Codes:

DSH, Recorder, Magnetic Tape, Medical

MWJ, Electrocardiograph, Ambulatory (Without Analysis)

#### III. Predicate Devices

The following predicate device has been selected:

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iRhythm Technologies, Inc. Zio® XT Patch [K121319]

The following reference device has been selected:

- l iRhythm Technologies, Inc. Zio® AT Patch [K181502]
#### IV. Indications for Use

The Indications for Use statement for the Zio monitor is as follows:

The Zio monitor is a prescription-only, single-patient-use ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue or anxiety.

#### V. Device Description

The Zio monitor is a non-sterile, single-patient-use, long-term ambulatory ECG monitor that is adhered to a patient's left pectoral region in a modified Lead II orientation. The goal of the Zio monitor is to help physicians initiate long-term, patient-compliant ECG monitoring utilizing proprietary technology.

The Zio monitor is applied and activated by the patient at home or at a clinic. Once activated, the device provides continuous, uninterrupted ECG recording into memory with minimal patient interaction. There is a button on the surface of the Zio monitor, which serves to activate the device and may be pressed by the patient during wear to indicate when he or she is experiencing a symptom. Additionally, there is a surface LED light that blinks green to confirm proper activation or that the device is working, and orange to indicate loss of connection with the skin or the presence of error conditions.

#### VI. Comparison of Technological Characteristics with Predicate Devices (Substantial Equivalence)

The Indications for Use statement for the Zio monitor are substantially equivalent to the cleared Indications for Use statement of the predicate device. Differences in the phrasing of the proposed Indications for Use statement from the predicate device are not critical to the intended use of the device, nor do they affect the substantial equivalence of the subject device relative to the predicate device (Section 12.3.2). Therefore, the subject device can be considered substantially equivalent to the predicate device.

The performance testing results demonstrate that the differences in the technological characteristics (i.e. reduced weight and power) between the devices do not raise any

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### Section 5 510(k) Summary

new issues of safety or efficacy as compared to the predicate. Therefore, the Zio monitor is determined to be substantially equivalent to the predicate device.

A comparison table outlining the differences and similarities between the subject device and the predicate device is provided in Table 1.

| Feature | Subject Device:<br>Zio® monitor | Predicate Device:<br>Zio® XT Patch |
|-------------------------------|----------------------------------------------|------------------------------------|
| General Characteristics | | |
| Classification | Class II:<br>21CFR870.2800 | Same |
| Product Code | DSH<br>MWJ | DSH |
| Patient Environment | Ambulatory | Same |
| Patient Population | Non-pediatric, non-critical<br>care patients | Same |
| Technological Characteristics | | |
| Event Trigger | Manually by patient | Same |
| Size | The Zio Monitor has a reduced form factor | |

## Table 1. Substantial Equivalence Summary Table

#### VII. Performance Data

There are no required FDA performance standards for the Zio monitor. All necessary performance testing was conducted on the Zio monitor to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate device.

Nonclinical testing included:

- Mechanical verification testing
- Biocompatibility testing
- Firmware verification testing
- Electrical safety and EMC testing

The scope of the nonclinical testing summarized in Table 2 demonstrates that the Zio monitor is in conformance with FDA recognized consensus standards and FDA guidance documents.

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| Section 5 |
|----------------|
| 510(k) Summary |

| FDA# | Body | Number / Version | Title |
|-------|------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5-40 | AAMI<br>ANSI ISO | 14971:2012(R)2010<br>(Corrected 4 October 2017) | Medical Devices – Applications Of<br>Risk Management To Medical<br>Devices |
| 19-4 | AAMI<br>ANSI | ES 60601-1:2005/(R)2012<br>and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 | Medical Electrical Equipment – Part<br>1: General Requirements For Basic<br>Safety And Essential Performance<br>(IEC 60601-1:2005, MOD) |
| 19-8 | AAMI<br>ANSI IEC | 60601-1-2:2014 | Medical Electrical Equipment – Part<br>1-2: General Requirements for Basic<br>Safety And Essential Performance –<br>Collateral Standard:<br>Electromagnetic Disturbances –<br>Requirements And Tests |
| 19-6 | IEC | 60601-1-11<br>Edition 1.0 2010-04<br>[Including: Technical<br>Corrigendum 1 (2011)] | Medical Electrical Equipment – Part<br>1-11: General Requirements For<br>Basic Safety And Essential<br>Performance - Collateral Standard:<br>Requirements For Medical Electrical<br>Equipment And Medical Electrical<br>Systems Used In The Home<br>Healthcare Environment |
| 3-127 | AAMI<br>ANSI IEC | 60601-2-47:2012 | Medical Electrical Equipment – Part<br>2-47: Particular Requirements For<br>The Basic Safety And Essential<br>Performance Of Ambulatory<br>Electrocardiographic Systems |
| 2-220 | ISO | 10993-1:2009 | Biological evaluation of medical<br>devices – Part 1: Evaluation and<br>testing within a risk management<br>process |
| 2-245 | ISO | 10993-5:2009 | Biological evaluation of medical<br>devices – Part 5: Tests for in vitro<br>cytotoxicity |
| 2-174 | ISO | 10993-10:2010 | Biological evaluation of medical<br>devices – Part 10: Tests for irritation<br>and skin sensitization |
| 13-79 | IEC | 62304 Edition 1.1 2015-06<br>CONSOLIDATED VERSION | Medical device software - Software<br>life cycle processes |
| 5-113 | ASTM | D7386-16 | Standard Practice for Performance<br>Testing of Packages for Single Delivery<br>Systems |
| 5-99 | ASTM | D4332-14 | Standard Practice for Conditioning<br>Containers, Packages, or Packaging<br>Components for Testing |

## Table 2. FDA-Recognized Consensus Standards & Guidance Document Summary

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#### VIII. Clinical Testing in Support of Substantial Equivalence Determination

No clinical testing was performed in support of this premarket notification.

#### IX. Conclusion

The results confirm by examination and provision of objective evidence that the design outputs met the design input requirements. The results of the nonclinical testing performed demonstrate that the Zio monitor meets the requirements of established conformance standards and performance specifications necessary for its intended use, and does not raise new questions of safety or effectiveness as compared to the predicate devices. The Zio monitor is substantially equivalent to the predicate device.