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 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.

AI/ML Overview

Although the provided document is a 510(k) summary for the Zio Monitor, it explicitly states that no clinical testing was performed in support of this premarket notification. Therefore, the document does not contain information about acceptance criteria based on clinical performance, a study proving device performance against such criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or grand truth details for either test or training sets.

The document focuses on demonstrating substantial equivalence to a predicate device (Zio XT Patch) through nonclinical testing, changes in technological characteristics (reduced weight and power), and adherence to recognized consensus standards and guidance documents.

Here's an analysis of the provided information, noting the absence of the requested clinical performance details:

A table of acceptance criteria and the reported device performance
- The document states: "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."
- It lists several nonclinical tests (Mechanical verification, Biocompatibility, Firmware verification, Electrical safety and EMC, and packaging tests conforming to ASTM standards) and mentions conformance to various ISO/AAMI/IEC standards (Table 2).
- However, specific quantitative acceptance criteria and their corresponding reported device performance values from these nonclinical tests are not detailed in this summary. The summary only asserts that the device meets these standards and specifications.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No clinical test set was used as no clinical testing was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No clinical test set requiring expert ground truth was used.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical test set requiring adjudication was used.
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
- Not applicable / Not provided. No clinical testing, including MRMC studies, was performed. The device itself is an ECG monitor, not explicitly described as having AI assistance for human readers in this document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. No clinical or algorithm-only performance study was conducted or reported in this summary.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No clinical ground truth was established as no clinical testing was performed. For the engineering/nonclinical tests, the "ground truth" would be the specifications and standards themselves.
The sample size for the training set
- Not applicable / Not provided. No machine learning or AI algorithm requiring a training set is discussed or implied to have been evaluated clinically in this document.
How the ground truth for the training set was established
- Not applicable / Not provided. As no training set is mentioned, its ground truth establishment is also not applicable.

In summary, the provided 510(k) summary for the Zio Monitor focuses on demonstrating substantial equivalence through nonclinical conformity and engineering specifications rather than clinical performance data. Therefore, the requested information regarding acceptance criteria derived from clinical studies and their supporting evidence is not present in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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: 415-632-5700

Fax: 415-632-5701

Contact Person:

Rey Jacinto Sr. Manager, Regulatory Affairs Phone: 415-214-7440 Email: rey.jacinto@irhythmtech.com 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

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:Zio® monitor	Predicate Device:Zio® XT Patch
General Characteristics
Classification	Class II:21CFR870.2800	Same
Product Code	DSHMWJ	DSH
Patient Environment	Ambulatory	Same
Patient Population	Non-pediatric, non-criticalcare 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	AAMIANSI ISO	14971:2012(R)2010(Corrected 4 October 2017)	Medical Devices – Applications OfRisk Management To MedicalDevices
19-4	AAMIANSI	ES 60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012	Medical Electrical Equipment – Part1: General Requirements For BasicSafety And Essential Performance(IEC 60601-1:2005, MOD)
19-8	AAMIANSI IEC	60601-1-2:2014	Medical Electrical Equipment – Part1-2: General Requirements for BasicSafety And Essential Performance –Collateral Standard:Electromagnetic Disturbances –Requirements And Tests
19-6	IEC	60601-1-11Edition 1.0 2010-04[Including: TechnicalCorrigendum 1 (2011)]	Medical Electrical Equipment – Part1-11: General Requirements ForBasic Safety And EssentialPerformance - Collateral Standard:Requirements For Medical ElectricalEquipment And Medical ElectricalSystems Used In The HomeHealthcare Environment
3-127	AAMIANSI IEC	60601-2-47:2012	Medical Electrical Equipment – Part2-47: Particular Requirements ForThe Basic Safety And EssentialPerformance Of AmbulatoryElectrocardiographic Systems
2-220	ISO	10993-1:2009	Biological evaluation of medicaldevices – Part 1: Evaluation andtesting within a risk managementprocess
2-245	ISO	10993-5:2009	Biological evaluation of medicaldevices – Part 5: Tests for in vitrocytotoxicity
2-174	ISO	10993-10:2010	Biological evaluation of medicaldevices – Part 10: Tests for irritationand skin sensitization
13-79	IEC	62304 Edition 1.1 2015-06CONSOLIDATED VERSION	Medical device software - Softwarelife cycle processes
5-113	ASTM	D7386-16	Standard Practice for PerformanceTesting of Packages for Single DeliverySystems
5-99	ASTM	D4332-14	Standard Practice for ConditioningContainers, Packages, or PackagingComponents 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.

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).