(169 days)
No reference devices were used in this submission.
Unknown
The document mentions an "arrhythmia auto-detection capabilities" and a "ZEUS detection algorithm" but does not explicitly state whether these utilize AI or ML. The description of the QA process involving manual review by CCTs suggests a traditional algorithmic approach, but it doesn't rule out the possibility of an underlying AI/ML component in the initial detection.
No.
This device is designed for monitoring and diagnostic purposes, capturing and reporting cardiac events and ECG information, but it does not provide any treatment or therapy.
Yes
The device captures, analyzes, and reports cardiac events and continuous ECG information with the explicit purpose of generating reports for a clinician to review and render a diagnosis. The text states: "The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience." This clearly defines it as a diagnostic device.
No
The device description clearly outlines three key hardware components: the Zio QX Patch Recorder, the Zio QX Wireless Gateway, and the Zio ECG Utilization Service (ZEUS) System. While the ZEUS System includes software for data analysis, the overall system relies on physical hardware for data acquisition and transmission.
Based on the provided information, the Zio QX ECG Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, or tissue.
- Zio QX Function: The Zio QX system directly monitors and records electrical activity of the heart (ECG) from the patient's body. It does not analyze biological specimens.
- Intended Use: The intended use is to capture, analyze, and report cardiac events and continuous ECG information for long-term monitoring. The reports are for review by a clinician to render a diagnosis based on clinical judgment. This is a direct physiological measurement and analysis, not an in vitro test.
Therefore, the Zio QX ECG Monitoring System falls under the category of a medical device that performs physiological monitoring and analysis, but it is not an IVD.
N/A
Intended Use / Indications for Use
The Zio QX ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on beat-to-beat information from the entire ECG recording. It is indicated for use on 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, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.
Product codes (comma separated list FDA assigned to the subject device)
QYX, DSH, DQK, DXH, DSI
Device Description
The Zio® QX ECG Monitoring System consists of three key device components: (1) Zio QX Patch Recorder with Bluetooth technology, (2) Zio QX Wireless Gateway with both Bluetooth and cellular technology, and (3) the Zio ECG Utilization Service (ZEUS) System for data analysis and reporting.
The Zio® QX Patch is a non-sterile, single-patient-use ECG monitor that provides a continuous, single-channel recording in addition to asymptomatic and symptomatic data transmission for up to 14 days. The Zio® QX Patch is applied and activated by the patient. Once activated, the Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. The Zio® QX Patch, in conjunction with the Wireless Gateway and the ZEUS System, has arrhythmia auto-detection capabilities. Additionally, patients have the option of pressing a convenient trigger button which marks the continuous record and initiates the wireless transfer of a 90-second ECG strip. The wireless transfer of data is enabled by the Zio® QX Gateway, which requires Bluetooth proximity to the Patch and cellular network reception but no patient interaction to transmit to the monitoring center. The patient is encouraged to document symptomatic events in either the provided booklet, mobile medical app (iOS 9+, Android 4.4+) or via a patient website, which will support symptom-rhythm correlation in the Zio QX Report.
At the conclusion of the wear period (up to 14 days), the patient removes the Zio® QX Patch and returns it by mail to an iRhythm data processing center.
Upon receipt of both symptomatic/asymptomatic transmissions (during wear) and downloaded continuous ECG data (post wear) at iRhythm's Clinical Center (iCC), the data is processed through the ZEUS detection algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm's Certified Cardiographic Technicians (CCTs) for accuracy. iRhythm employed and trained Patch in-take and CCT personnel follow internal procedures for processing and are made aware of performance limitations and anomalies with both the detection algorithms and software workflow tools. All anomalies are visible to and, where appropriate, are manually corrected by iRhythm Technologies CCTs during the QA review and/or Patch Report edits. The CCT generates a final report (Zio QX Report) of the ECG findings contained within the data, thereby providing 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. Alternatively, such periods are also available for inclusion in the final report, where the entire ECG recording is available for review and selective inclusion based on clinical relevance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
"The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients."
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:
- System performance testing
- Mechanical verification testing
- Software verification testing
- Firmware verification testing
- Electrical safety and EMC testing
Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements.
No clinical testing was performed in support of this premarket notification.
The results confirm by examination and provision of objective evidence that the design output met the design input requirements. The results of the nonclinical testing performed demonstrate that the Zio® QX ECG Monitoring System 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.)
"The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements."
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.
iRhythm Technologies, Inc. Zio® SR ECG Monitoring System [K143513], Medtronic, Inc. SEEQ™ Mobile Cardiac Telemetry (MCT) System [K133701]
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.
No reference devices were used in this submission.
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image contains 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.
November 15, 2023
iRhythm Technologies, Inc. Rich Laguna Director Qa/ra 650 Townsend Street Suite 380 San Francisco, California 94103
Re: K163512
Trade/Device Name: Zio AT ECG Monitoring System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: QYX, DSH, DQK, DXH, DSI
Dear Rich Laguna:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 2, 2017. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Kozen, OHT2: Office of Cardiovascular Devices, 301-796-5813, jennifer.kozen@fda.hhs.gov.
Sincerely.
Jennifer W. Shih -S
Jennifer 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
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, with a stylized design above them that resembles an eagle or bird in flight. The overall design is simple and professional.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2017
iRhythm Technologies, Inc. Rich Laguna Director of Quality & Regulatory Affairs 650 Townsend Street Suite 380 San Francisco, CA 94103
Re: K163512
Trade/Device Name: Zio QX ECG Monitoring System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH, DQK, DXH, DSI Dated: May 2, 2017 Received: May 3, 2017
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
2
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 Industry and Consumer Education 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. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
M.A. Hilleman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K163512
Device Name Zio® QX ECG Monitoring System
Indications for Use (Describe)
The Zio QX ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on beat-to-beat information from the entire ECG recording. It is indicated for use on 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, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Notification K163512
l. GENERAL INFORMATION [21CFR807.92(a)(1)]
Applicant:
iRhythm Technologies, Inc. 650 Townsend Street, Suite 500 San Francisco, CA 94103 U.S.A. Phone: 415-632-5700 Fax: 415-632-5701
Contact Person:
Rich Laguna Director Quality & Regulatory Affairs Phone: 415-632-5749 Email: rlaguna@irhythmtech.com
Date Prepared: May 2, 2017
ll. DEVICE INFORMATION [21CFR708.92(a)(2)]
Trade Name: Zio® QX ECG Monitoring System
Generic/Common Name:
Medical magnetic tape recorder
Classification Names:
Medical magnetic tape recorder [21 CFR§870.2800] Programmable diagnostic computer [21CFR§870.1425] Telephone electrocardiograph transmitter and receiver [21CFR§870.2920] Arrhythmia detector and alarm (including ST-segment measurement and alarm) [21 CFR§870.1025]
Regulatory Class:
Class II (special controls)
Product Codes:
DSH, Recorder, Magnetic Tape, Medical DQK, Computer, Diagnostic, Programmable DXH, Transmitters And Receivers, Electrocardiograph, Telephone DSI, Detector And Alarm, Arrhythmia
5
iRhythm Technologies, Inc.
510(k) SUMMARY
III. PREDICATE DEVICES [21CFR708.92(a)(3)]
The following predicate devices have been selected:
- iRhythm Technologies, Inc. Zio® SR ECG Monitoring System [K143513] (primary)
- Medtronic, Inc. SEEQ™ Mobile Cardiac Telemetry (MCT) System [K133701] -
No reference devices were used in this submission.
DEVICE DESCRIPTION [21CFR708.92(a)(4)] IV.
The Zio® QX ECG Monitoring System consists of three key device components: (1) Zio QX Patch Recorder with Bluetooth technology, (2) Zio QX Wireless Gateway with both Bluetooth and cellular technology, and (3) the Zio ECG Utilization Service (ZEUS) System for data analysis and reporting.
The Zio® QX Patch is a non-sterile, single-patient-use ECG monitor that provides a continuous, single-channel recording in addition to asymptomatic and symptomatic data transmission for up to 14 days. The Zio® QX Patch is applied and activated by the patient. Once activated, the Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. The Zio® QX Patch, in conjunction with the Wireless Gateway and the ZEUS System, has arrhythmia auto-detection capabilities. Additionally, patients have the option of pressing a convenient trigger button which marks the continuous record and initiates the wireless transfer of a 90-second ECG strip. The wireless transfer of data is enabled by the Zio® QX Gateway, which requires Bluetooth proximity to the Patch and cellular network reception but no patient interaction to transmit to the monitoring center. The patient is encouraged to document symptomatic events in either the provided booklet, mobile medical app (iOS 9+, Android 4.4+) or via a patient website, which will support symptom-rhythm correlation in the Zio QX Report.
At the conclusion of the wear period (up to 14 days), the patient removes the Zio® QX Patch and returns it by mail to an iRhythm data processing center.
Upon receipt of both symptomatic/asymptomatic transmissions (during wear) and downloaded continuous ECG data (post wear) at iRhythm's Clinical Center (iCC), the data is processed through the ZEUS detection algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm's Certified Cardiographic Technicians (CCTs) for accuracy. iRhythm employed and trained Patch in-take and CCT personnel follow internal procedures for processing and are made aware of performance limitations and anomalies with both the detection algorithms and software workflow tools. All anomalies are visible to and, where appropriate, are manually corrected by iRhythm Technologies CCTs during the QA review and/or Patch Report edits. The CCT generates a final report (Zio QX Report) of the ECG findings contained within the data, thereby providing 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
6
retrieved during the wear period. Alternatively, such periods are also available for inclusion in the final report, where the entire ECG recording is available for review and selective inclusion based on clinical relevance.
V. INDICATIONS FOR USE [21CFR708.92(a)(5)]
The Indications for Use statement for the Zio® QX ECG Monitoring System is as follows:
The Zio QX ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on beatto-beat information from the entire ECG recording. It is indicated for use on 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 reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.
The Indications for Use statement for the Zio® QX ECG Monitoring System differs slightly from that of the primary predicate device to address automatically detected events during wear; however, these differences do not alter the intended use of the device. Collectively, the subject device has the same intended use in cardiac arrhythmia diagnostics as the two predicate devices. Differences in the proposed Indications for Use statement are not critical to the intended use of the device, nor do they affect the safety and effectiveness of the subject device relative to the predicate devices. Therefore, the subject device can be considered substantially equivalent to the predicate devices.
7
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES VI. [21CFR708.92(a)(6)]
The proposed indications for use statement for the Zio® QX ECG Monitoring System reflect the same intended use as represented in the cleared Indications for Use statements for the predicate devices. The performance testing results demonstrate that the differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness, demonstrating that the subject device is as safe and as effective as the predicate devices. Therefore, the Zio® QX ECG Monitoring System is determined to be substantially equivalent to the predicate devices. A comparison table outlining the differences and similarities between the subject device, the Zio® QX ECG Monitoring System, and the predicate devices is provided in Table 1.
| Subject device: | Primary predicate: | Predicate: | |
|---|---|---|---|
| iRhythm Technologies | iRhythm Technologies | Medtronic, Inc. | |
| Zio® QX ECG Monitoring | |||
| System | Zio® SR ECG Monitoring | ||
| System | SEEQ™ MCT System | ||
| Feature | [K163512] | [K143513] | [K133701] |
| General Characteristics | |||
| Classification | Class II | Class II | Class II |
| Classification | |||
| Regulation(s) | 21CFR§870.2800 | ||
| 21CFR§870.1425 | |||
| 21CFR§870.2920 | |||
| 21CFR§870.1025 | 21CFR§870.2800 | ||
| 21CFR§870.1425 | |||
| 21CFR§870.2920 | 21CFR§870.1025 | ||
| Product Code(s) | DSH, DQK, DXH, DSI | DSH, DQK, DXH | DSI |
| Patient | |||
| Environment | Ambulatory | Same | Same |
| Patient | |||
| Population | Non-pediatric, non-critical care patients | Same | Non-critical care |
| patients | |||
| Technological Characteristics | |||
| Key System | |||
| Components | 1) Zio® QX Patch | ||
| (wearable sensor) |
- Zio® QX Gateway
(transmitter) - ZEUS System
(software) | 1) Zio® SR Patch
(wearable sensor) - Zio® SR Gateway
(transmitter) - ZEUS System
(software) | 1) SEEQ™ MCT
Wearable Sensor - SEEQ™ MCT
Transmitter - Software |
| Event Trigger | Manually by patient or
automatically by
arrhythmia detection
algorithm | Manually by patient | Manually by patient
or automatically by
arrhythmia detection
algorithm |
8
VII. PERFORMANCE DATA [21CFR708.92(b)]
There are no required FDA performance standards for the Zio® QX ECG Monitoring System. All necessary performance testing was conducted on the Zio® QX ECG Monitoring System to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate devices.
[21CFR708.92(b)(1)]:
Nonclinical testing included:
- System performance testing
- Mechanical verification testing
- Software verification testing
- o Firmware verification testing
- Electrical safety and EMC testing
Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements.
The scope of the nonclinical testing summarized in Table 2 demonstrates that the Zio® QX ECG Monitoring System is in conformance with FDA-recognized consensus standards and FDA guidance documents.
| FDA # | Body | Number / Version | Title |
|---|---|---|---|
| 5-70 | AAMI | ||
| ANSI ISO | 14971:2007/(R)2010 | ||
| (Corrected 4 October 2007) | Medical Devices - Applications Of Risk Management To | ||
| Medical Devices | |||
| 19-4 | AAMI | ||
| ANSI | ES60601-1:2005/(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) | |||
| 19-12 | 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 | |||
| 19-1 | IEC | 60601-1-2 | |
| Edition 3: 2007-03 | Medical Electrical Equipment - Part 1-2: General | ||
| Requirements For Basic Safety And Essential | |||
| Performance - Collateral Standard: Electromagnetic | |||
| Compatibility - 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 |
| Table 2: FDA-Recognized Consensus Standards & Guidance Document Summary | ||
|---|---|---|
9
| FDA # | Body | Number / Version | Title |
|---|---|---|---|
| Systems | |||
| 3-52 | AAMI | ||
| ANSI | EC12:2000/(R)2010 | Disposable ECG Electrodes | |
| 3-118 | AAMI | ||
| ANSI | EC57:2012 | Testing And Reporting Performance Results Of Cardiac | |
| Rhythm And ST-Segment Measurement Algorithms | |||
| N/A | U.S. FDA | October 28, 2003 | Guidance for Industry and FDA Staff - Class II Special |
| Controls Guidance Document: Arrhythmia Detector and | |||
| Alarm | |||
| N/A | U.S. FDA | October 2, 2014 | Guidance for Industry and FDA Staff – Content of |
| Premarket Submissions for Management of | |||
| Cybersecurity in Medical Devices |
| Table 2: FDA-Recognized Consensus Standards & Guidance Document Summary | |
|---|---|
| ------------------------------------------------------------------------- | -- |
[21CFR708.92(b)(2)]:
No clinical testing was performed in support of this premarket notification.
[21CFR708.92(b)(3)]:
The results confirm by examination and provision of objective evidence that the design output met the design input requirements. The results of the nonclinical testing performed demonstrate that the Zio® QX ECG Monitoring System 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.
VIII. CONCLUSION
The Zio® QX ECG Monitoring System is substantially equivalent to the predicate devices.