(275 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on continuous ECG recording and basic patient interaction features.
No.
The device is an ECG monitor that records data for diagnostic purposes, not for treating a condition.
Yes
The device continuously records ECG data for patients who may be asymptomatic or suffering from transient symptoms, which is used to help physicians initiate long-term ECG monitoring. This data collection serves the purpose of identifying and analyzing cardiac conditions, thereby aiding in diagnosis.
No
The device description explicitly details hardware components (adhered patch, button, LED light) and the performance studies include mechanical, biocompatibility, and electrical safety testing, indicating it is a physical device with embedded software, not a software-only device.
Based on the provided information, the Zio Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro - "in glass"). This includes things like blood, urine, tissue, etc.
- The Zio Monitor records electrical signals from the body (in vivo - "in the living"). It's an external device that monitors physiological activity directly from the patient's skin.
The description clearly states it's an "ECG monitor" that records data from the "left pectoral region." This is a direct measurement of the heart's electrical activity, not an analysis of a sample taken from the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DSH, MWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left pectoral region in a modified Lead II orientation
Indicated Patient Age Range
Non-pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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:
4
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
5
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 | DSH
MWJ | DSH |
| Patient Environment | Ambulatory | Same |
| Patient Population | Non-pediatric, non-critical
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.
6
| Section 5 |
|---|
| 510(k) Summary |
| FDA# | Body | Number / Version | Title |
|---|---|---|---|
| 5-40 | AAMI | ||
| ANSI ISO | 14971:2012(R)2010 | ||
| (Corrected 4 October 2017) | Medical Devices – Applications Of | ||
| Risk Management To Medical | |||
| Devices | |||
| 19-4 | AAMI | ||
| ANSI | ES 60601-1:2005/(R)2012 | ||
| and A1:2012, | |||
| C1:2009/(R)2012 and | |||
| A2:2010/(R)2012 | Medical Electrical Equipment – Part | ||
| 1: General Requirements For Basic | |||
| Safety And Essential Performance | |||
| (IEC 60601-1:2005, MOD) | |||
| 19-8 | AAMI | ||
| ANSI IEC | 60601-1-2:2014 | Medical Electrical Equipment – Part | |
| 1-2: General Requirements for Basic | |||
| Safety And Essential Performance – | |||
| Collateral Standard: | |||
| Electromagnetic Disturbances – | |||
| Requirements And Tests | |||
| 19-6 | IEC | 60601-1-11 | |
| Edition 1.0 2010-04 | |||
| [Including: Technical | |||
| Corrigendum 1 (2011)] | 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 | |||
| 3-127 | 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 | |||
| 2-220 | ISO | 10993-1:2009 | Biological evaluation of medical |
| devices – Part 1: Evaluation and | |||
| testing within a risk management | |||
| process | |||
| 2-245 | ISO | 10993-5:2009 | Biological evaluation of medical |
| devices – Part 5: Tests for in vitro | |||
| cytotoxicity | |||
| 2-174 | ISO | 10993-10:2010 | Biological evaluation of medical |
| devices – Part 10: Tests for irritation | |||
| and skin sensitization | |||
| 13-79 | IEC | 62304 Edition 1.1 2015-06 | |
| CONSOLIDATED VERSION | Medical device software - Software | ||
| life cycle processes | |||
| 5-113 | ASTM | D7386-16 | Standard Practice for Performance |
| Testing of Packages for Single Delivery | |||
| Systems | |||
| 5-99 | ASTM | D4332-14 | Standard Practice for Conditioning |
| Containers, Packages, or Packaging | |||
| Components for Testing |
Table 2. FDA-Recognized Consensus Standards & Guidance Document Summary
7
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.