(124 days)
The M5 Recorder is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.
The M5 Recorder is intended for use by adults and all pediatric subgroups (weighing more than 10 Kg).
The M5 Recorder is a small, lightweight ambulatory electrocardiograph (ECG) recorder that records ECG continuously. The M5 records 1 or 3 channels of ECG up to 21 days. The battery duration of the M5 is dependent on the configured settings of sample rate and channel selection. The device is composed of the ECG recorder that can be utilized with a patch electrode or with a patient cable lead set using off the shelf electrodes intended for long-term monitoring. The device snaps onto the patch electrode or patient cable lead set and automatically begins recording. The recording will continue until either the M5 completes the programmed monitoring session, is removed from the Patch Electrode or patient cable, or the battery is depleted.
At the end of the recording, the device can be plugged into a PC via the M5 USB cable. The ECG recording can be transferred to a PC where processing software can transfer the data to a format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. The M5 recorder acquires ECG data and does not perform any data processing or arrhythmia analysis of the ECG data. Only the M5 Recorder is part of this 510K application.
During the recording period the patient wears the M5 Recorder with the patch electrode on the upper chest near the sternum. If using the M5 Recorder with the patient cable, the patient will wear off the shelf electrodes (2 - 5) positioned on the torso. The M5 Recorder can be worn continuously up to 14 days with the same patch electrode and up to 4 days with the patient cable and same set of off the shelf electrodes.
The M5 Recorder consists of a microprocessor, measuring circuit, memory, data storage, light emitting diode (LED), and contacts to the electrode. In addition to that, the M5 Recorder contains firmware to control the collection of the ECG data and allows transfer to the processing software. The M5 Recorder has an internal Bluetooth radio that may be utilized with a host ambulatory ECG analysis system (such as the Global Instrumentation M12A application) to allow the qualified health care provider a view of the patient's ECG immediately following hook-up. The LED on the M5 Recorder will flash. This provides visual confirmation to the professional that the recorder is actively collecting data.
The M5 recorder also has a button on the recorder. The primary function of the button is to provide an event feature where the patient presses the button on the recorder when they feel a symptom. The LED will flash to provide feedback to the patient that the event marking has occurred. The button also allows for a battery status check.
The associated spare parts that are part of the M5 Recorder system are the M5 Patch Electrode, M5 Patient Cable, M5 USB Cable, and GI Wall Charger.
The M5 Recorder is an ambulatory ECG recorder. It records 1 or 3 channels of ECG for up to 21 days for the purpose of detecting transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, chest pain, and/or anxiety in adult and pediatric patients (weighing >10 kg).
Here’s a summary of the M5 Recorder's acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative clinical acceptance criteria for the M5 Recorder's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia detection), as the device itself does not perform arrhythmia analysis. Instead, the performance data focuses on technical compliance with established standards and usability. The acceptance criteria essentially revolves around demonstrating substantial equivalence to predicate devices and meeting relevant safety and performance standards.
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | M5 Recorder Performance (Reported) |
|---|---|---|
| Safety & Essential Performance | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance) | Compliance shown through design verification. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 Edition 4.0 2014-02 (Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) | Compliance shown through design verification. |
| Usability | IEC 60601-1-6 Edition 3.1 2010-01 (Medical electrical equipment - part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability) and IEC/EN 62366-1 Edition 1.0 2015-02 (Medical devices Application of usability engineering to medical devices) | Successful in validating clinical and patient usability based on established usability goals and pass/fail criteria from 5 independent usability tests (U1-U5). |
| Home Healthcare Environment | IEC 60601-1-11 Edition 2.0 2015-01 (Medical electrical equipment – part 1-6: 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) | Compliance shown through design verification. |
| Ambulatory ECG Systems Performance | IEC/EN 60601-2-47 Edition 2.0 2012-02 (Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems) | Compliance shown through design verification. |
| Software Life Cycle Processes | IEC 62304:2006/A1:2016 (Medical device software Software life cycle processes) | Software verification and validation testing conducted; documentation provided. |
| Risk Management | ISO 14971:2007-03-01 (Medical devices Application of risk management to medical devices) | Risk management process performed according to the standard. |
| ECG Trunk Cables & Patient Leadwires | ANSI AAMI EC53:2013 | Compliance shown through design verification. |
| Disposable ECG Electrodes | ANSI/AAMI EC12:2000/(R) 2015 | Compliance shown through design verification. |
| Electrocardiograph Electrodes Special Controls | U.S. FDA Class II Special Controls Guidance Document: Electrocardiograph Electrodes (July, 2011) | Manufacturing follows recommendations of this guidance. |
| Biocompatibility | ISO 10993: Biological Evaluation of Medical Devices, Part 5, 10, 12, and FDA GLP Regulations, 21 CFR Part 58 | Biocompatibility evaluation conducted in compliance. Case material (Valox 357U polycarbonate) has ISO 10993 certification. |
| Mechanical Testing | IEC 60601-1 (various specific tests listed) | All listed tests successfully performed. |
| Recording Duration | Sustained recording for up to 14 days (comparable to predicates, though M5 can run up to 21 days with electrode/battery changes). | Battery runs up to 19.9 days, rated down 20% to guarantee minimum of 14 days of recording throughout life. |
| Frequency Response | Meets IEC 60601-2-47 requirement for >= 0.05-40Hz. | 0.05 Hz – 60Hz @ 200sps; 0.05 Hz – 100Hz @ 250sps; 0.05 Hz – 175 Hz @ 500sps (all meet or exceed requirement) |
| Input Impedance | >10 Ohms (comparable to predicates) | >10 Ohms |
| Resolution | Performance equivalent to IEC 60601-2-47 (comparable to predicates) | 16 bits (higher than predicates: 12 bits and 10 bits) |
2. Sample size used for the test set and the data provenance
The document states that no clinical studies were performed. The "test set" for the M5 Recorder primarily relates to usability testing and bench testing for compliance with standards.
- Usability Testing Test Set:
- Sample Size: 64 volunteer subjects.
- Data Provenance: Not explicitly stated regarding country of origin, but implied to be associated with Global Instrumentation LLC (Manlius, NY, USA), so likely U.S. based. The studies were prospective as they were conducted specifically for the M5 Recorder (May 7, 2019, through March 10, 2020).
- Bench Testing: No specific "sample size" of patients/data is applicable here, as these are technical performance tests on the device hardware and software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Usability Testing: The document mentions "Clinical users participated in the U5 Usability Test. The clinical user group comprised a cross section of experience in using ambulatory ECG recorders and clinical positions representative of the intended M5 Recorder user base." It does not specify a precise number of experts or their exact qualifications (e.g., "radiologist with 10 years of experience"). However, the implication is that qualified healthcare professionals who would typically use such devices were involved. The ground truth here is successful interaction with the device and its components, as assessed by these clinical users and observation by Global Instrumentation LLC personnel.
- Bench Testing: For compliance with technical standards, the "ground truth" is adherence to the specifications of those standards. This is established through engineering and quality assurance processes, not by external experts adjudicating clinical outcomes.
4. Adjudication method for the test set
- Usability Testing: The text indicates that the usability testing was "implemented and overseen by Global Instrumentation LLC personnel." It states, "The testing was successful in validating the clinical and patient usability of the M5 System based on the usability goals and pass/fail criteria established in each study." This implies an internal adjudication process based on predefined criteria, rather than an expert consensus method like 2+1 or 3+1 that is common in clinical diagnostic accuracy studies.
- Bench Testing: Adjudication is internal, based on meeting the requirements of each standard.
5. 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
No, an MRMC comparative effectiveness study was not done. The M5 Recorder is a data acquisition device (records ECG data) and does not perform any data processing or arrhythmia analysis. Therefore, there is no AI component in the device itself that would assist human readers, and such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The M5 Recorder is explicitly stated to "acquire ECG data and does not perform any data processing or arrhythmia analysis of the ECG data." It is a hardware recorder, not an analytical algorithm.
7. The type of ground truth used
- For biocompatibility and mechanical testing, the ground truth is adherence to the specified international and national standards (e.g., ISO 10993, IEC 60601-1).
- For software validation, the ground truth is successful execution against specified requirements, as guided by FDA's guidance for software in medical devices and IEC 62304.
- For usability testing, the ground truth was the ability to meet "usability goals and pass/fail criteria established in each study," validated by participant interaction and observation by personnel.
8. The sample size for the training set
Not applicable. The M5 Recorder is a data acquisition device and does not contain artificial intelligence or machine learning algorithms that would require a "training set."
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no training set for this device.
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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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
December 29, 2020
Global Instrumentation LLC % Rafael Aguila Responsible Third Party Official Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, Florida 33155
Re: K202456
Trade/Device Name: M5 Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: DSH, DXH Dated: December 23, 2020 Received: December 23, 2020
Dear Rafael Aguila:
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 medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202456
Device Name
M5 Recorder
Indications for Use (Describe)
The M5 Recorder is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety.
The M5 Recorder is intended for use by adults and all pediatric subgroups (weighing 10 kg or more).
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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I. Submitter
| Submitted by: | Global Instrumentation LLC. |
|---|---|
| 8104 Cazenovia Road | |
| Manlius, NY 13104 USA | |
| Contact Person: | Jason DeMaso |
| Quality Assurance Manager | |
| Tel: (315) 682-0272 Ext 116 | |
| Fax: (315) 682-0278 | |
| e-mail: demasoj@gi-med.com | |
| Date Prepared: | December 17th, 2020 |
| II. Device | |
| 510(k) Number: | K202456 |
| Trade Name: | M5 Recorder |
| Model Number: | M5 |
| Regulation Number: | 21 CFR 870.2800 |
| Review Panel: | Cardiovascular |
| Regulation Name: | Medical Magnetic Tape Recorder |
| Regulatory Class: | II (Two) |
| Product Code: | DSH, DXH |
| Manufacturer: | Global Instrumentation, LLC 8104 |
| Cazenovia Rd. | |
| Manlius, NY 13104 | |
| III. Predicate Device | |
| 510(k) Number: | K163535 |
| Trade Name: | myPatch®sl |
| Model Number: | 3000sl |
| Regulation Number: | 21 CFR 870.2800 |
| Review Panel: | Cardiovascular |
| Regulation Name: | Medical Magnetic Tape Recorder |
| Regulatory Class: | II (Two) |
| Product Code: | DSH |
| Manufacturer: | dms-service, llc |
| 11845 W. Olympic Blvd, Ste | |
| 880W Los Angeles, CA 90064 | |
NOTE: This predicate has not been subject to a design-related recall.
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IV. Secondary Predicate Device
| 510(k) Number: | K143513 |
|---|---|
| Trade Name: | Zio Skyrunner (SR) Electrocardiogram (ECG) MonitoringService (Zio SR Patch Recorder with BluetoothTechnology) |
| Model Number: | Zio SR |
| Regulation Number: | 21 CFR 870.2800 |
| Review Panel: | Cardiovascular |
| Regulation Name: | Medical Magnetic Tape Recorder |
| Regulatory Class: | II (Two) |
| Product Code: | DSH, DQK, DXH |
| Manufacturer: | iRhythm Technologies, Inc.650 Townsend Street, Ste 380San Francisco, CA 94103 |
V. Description of the Device
The M5 Recorder is a small, lightweight ambulatory electrocardiograph (ECG) recorder that records ECG continuously. The M5 records 1 or 3 channels of ECG up to 21 days. The battery duration of the M5 is dependent on the configured settings of sample rate and channel selection. The device is composed of the ECG recorder that can be utilized with a patch electrode or with a patient cable lead set using off the shelf electrodes intended for long-term monitoring. The device snaps onto the patch electrode or patient cable lead set and automatically begins recording. The recording will continue until either the M5 completes the programmed monitoring session, is removed from the Patch Electrode or patient cable, or the battery is depleted.
At the end of the recording, the device can be plugged into a PC via the M5 USB cable. The ECG recording can be transferred to a PC where processing software can transfer the data to a format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. The M5 recorder acquires ECG data and does not perform any data processing or arrhythmia analysis of the ECG data. Only the M5 Recorder is part of this 510K application.
During the recording period the patient wears the M5 Recorder with the patch electrode on the upper chest near the sternum. If using the M5 Recorder with the patient cable, the patient will wear off the shelf electrodes (2 - 5) positioned on the torso. The M5 Recorder can be worn continuously up to 14 days with the same patch electrode and up to 4 days with the patient cable and same set of off the shelf electrodes.
The M5 Recorder consists of a microprocessor, measuring circuit, memory, data storage, light emitting diode (LED), and contacts to the electrode. In addition to that, the M5 Recorder contains firmware to control the collection of the ECG data and allows transfer to the processing software. The M5 Recorder has an internal Bluetooth radio that may be utilized with a host ambulatory ECG analysis system (such as the Global Instrumentation M12A application) to allow the qualified health care provider a view of the patient's ECG immediately following hook-up. The LED on the M5 Recorder will flash. This provides visual confirmation to the professional that the recorder is actively collecting data.
The M5 recorder also has a button on the recorder. The primary function of the button is to
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provide an event feature where the patient presses the button on the recorder when they feel a symptom. The LED will flash to provide feedback to the patient that the event marking has occurred. The button also allows for a battery status check.
The associated spare parts that are part of the M5 Recorder system are the M5 Patch Electrode, M5 Patient Cable, M5 USB Cable, and GI Wall Charger.
Components, Spare parts and Collateral Devices - Overview
M5 Recorder
The M5 Recorder has interfaces to a compatible M5 Patch Electrode, M5 Patient Cable, and M5 USB Cable. The Recorder is reusable and rechargeable. The battery is a rechargeable lithium polymer battery with built-in protection circuit. Charging the M5 Recorder battery is done by use of the M5 USB cable with a proprietary connector which can only be connected to the M5 Recorder when it is not connected to the M5 Patch Electrode or M5 Patient Cable. The Recorder contains internal non-volatile storage that stores ECG data until uploaded to host system. The M5 Recorder also contains firmware for recording ECG, storing ECG, and user interface. When the recorder is connected to the host system through the M5 USB Cable, the recorded ECG files are accessible via a proprietary communication protocol. All M5 Recorder data files are in a proprietary file format. All communication to the M5 Recorder requires proprietary encrypted authentication.
The recorder has a serial number and product number in a GS-128 bar code format to secure the traceability of the equipment and the data during and after recordings.
The case of the M5 Recorder is a Valox 357U polycarbonate (PBT) for medical device applications and has ISO 10993 certification.
M5 Patch Electrode
The electrode is non-sterile and disposed of after a single use. The patch electrode (spare part to M5 Recorder) is a passive part. The electrode consists of one layer of one-sided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the upper sternum. The electrode gel is located on the underneath side of the adhesive tape. Through this electrode gel the ECG of the patient is recorded. The M5 Patch Electrode provides a single channel ECG recording. The top side of the electrode has a plastic cradle that holds the M5 Recorder in place and provides an electrical connection to the patch electrode conductor path. The conductor paths are flex strips that run between the cradle and the electrode gel. A release liner is placed on the underside of the electrode. The release liner covers the adhesive tape and the electrode gel. This liner is peeled off when placing the M5 Patch Electrode on the upper sternum. The electrode must be connected to the M5 Recorder to have any practical use.
Per the U.S. FDA Class II Special Controls Guidance Document: Electrocardiograph Electrodes, issued on July 21, 2011 "the FDA has determined that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of this generic type of device if the manufacturer follows the recommendations in this special controls guidance to address the issues identified in this guidance." The scope of the guidance includes "bare ECG electrodes or ECG electrodes that incorporate as part of their design, a conductive gel, an adhesive system or a lead wire". Per this guidance, we have the device specifications, composition, formulation, component specifications, engineering drawings with dimensions & composition, written description, description of how the M5 Patch Electrode connects to the M5 Recorder and a list of features and specifications in tabular format.
M5 Patient Cable (lead set)
The M5 Patient Cable (spare part to M5 Recorder) is a reusable lead set option for collecting ECG recordings in single or three channel modes. The patient cable is available in 2 lead, 3 lead, 4 lead and 5 lead options and uses off the shelf electrodes suited for ambulatory ECG
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monitoring. The patient cable features a custom connector that attaches to the M5 Recorder. The placement of the electrodes are left arm (LA), right arm (RA), left leg (LL), right leg (RL), and V. The V lead electrode may be positioned in any of the precordial (V1 - V6) placements based on physician preference.
The M5 Patient Cable is used with standard electrodes intended for longer duration ambulatory ECG recording. The off the shelf electrodes feature a snap which provides connection to the leads of the M5 Patient Cable.
M5 USB Cable
The M5 USB Cable (spare part to M5 Recorder) is used to recharge the M5 Recorder and to upload the stored ECG data from the recorder to a host system. The M5 USB Cable features a proprietary connector design to match to the M5 Recorder. The opposite end of the cable uses a standard USB Type A male connector.
GI Wall Charger
GI Wall Charger is a 60601-1 compliant medical grade power supply with integral USB jack used with the M5 USB Cable for charging the M5 Recorder.
VI. Indications For Use
M5 Recorder - Indications for Use
The M5 Recorder is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.
The M5 Recorder is intended for use by adults and all pediatric subgroups (weighing more than 10 Kg).
M5 Recorder - Intended Use
The M5 Recorder is a small digital ambulatory ECG recorder intended for use by professionals to acquire ECG data from a patient in a clinical, point of care or at a patient setting.
The M5 Recorder uses a rechargeable lithium polymer battery and can record ECG up to 21 days (3 channels) on the torso of a patient through a M5 Patch ECG electrode or M5 lead set and standard electrodes (length or recording time is based on the sample rate and channel selection). The patient's ECG is recorded to the M5 Recorder and then transferred via the M5 USB cable to a PC-based ambulatory ECG analysis system (such as the Global Instrumentation M12A application) for review by physicians or other qualified personnel.
Due to the continual wearing of an ambulatory ECG monitor, this is a medical device that is used both in professional healthcare facilities and outside those facilities. This description meets the definition of a home use device. The M5 Recorder is intended for use by adults and pediatric sub-groups (weighing more than 10 Kg). The intended use, expected service life and conditions for transport and storage were taken into consideration for selection and treatment of materials used in the construction of the M5 Recorder.
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VII. Comparison of Technological & Performance Characteristics with the Predicate Devices
The M5 Recorder is substantially equivalent in hardware, software and performany predicate DMS-Service myPatchsl (K163535) and the Faros Mobile (K182030) Secondary Predicate. Table 1 shows a comparative analysis of characteristics between the predicate and subject devices.
| TechnicalEquivalence | M5 RecorderSubject Device | myPatchslPrimary Predicate Device | Zio SR Patch RecorderSecondary Predicate Device | Similarities/Differences |
|---|---|---|---|---|
| Type of ECGRecorder | Patch & attachable external leadoption | Patch & attachable external leadoption | Patch | (Primary) Similar. The predicatedevice provides an attachableexternal lead option for 3 channelrecordings. The M5 providesattachable external lead options for2 and 3 channel recordings. There isno change to the safety andeffectiveness of the device.(Secondary) Similar. Supports patchbut no external lead option. |
| Indications forUse | The M5 Recorder is indicated foruse on patients who may beasymptomatic or who may sufferfrom transient symptoms such aspalpitations, shortness of breath,dizziness, light headedness, pre-syncope, syncope, fatigue, chestpain and/or anxiety.The M5 Recorder is intended foruse by adults and all pediatricsubgroups (weighing more than 10Kg). | myPatchsl is indicated for use onpatients who may beasymptomatic or who may sufferfrom transient symptoms such aspalpitations, shortness of breath,dizziness, light headedness, pre-syncope, syncope, fatigue, chestpain and/or anxiety.The myPatchsl is intended foruse by adult and pediatricsubgroups. | The ZIO® SR ECG MonitoringService is intended to capture,analyze, and reportsymptomatic and/orcontinuous electrocardiogram(ECG) information for long-termmonitoring (up to 14 days). It isindicated for use on adultpatients 18 years or older whomay be asymptomatic or whomay suffer from transientsymptoms such as palpitations,shortness of breath, dizziness,light-headedness, pre-syncope,syncope, fatigue, or anxiety.The reported ECG metricsinclude single-lead analysis on a | (Primary) Similar. The M5 Recorderindications for use includes a weightminimum for the pediatricsubgroup.(Secondary) Similar. Symptomindications for use are the same.The secondary predicate includes ananalysis and reporting service inaddition to the Zio Patch Recorder. |
| measurement and rhythmanalysis. The report does notcontain diagnosticinterpretation; the reportedanalysis is provided for reviewby the intended user to rendera diagnosis based on clinicaljudgment and experience. | ||||
| TargetPopulation | Adult and pediatric subgroups(weighing more than 10 Kg) | Adult and pediatric subgroups | Adult patients 18 years or older | (Primary) Similar. The primarypredicate does not set a minimumweight level(Secondary). Different. Thesecondary predicate restricts use to18 years or older. |
| Environmentof Use | Clinical site/facility, point of care orat a patient setting. | Clinical site/facility, patient pointof care or at a patient setting. | Clinical site/facility, point ofcare or at a patient setting. | (Primary & Secondary) Same |
| Number ofECG Channels | 1, 2, 3 | 1, 2 or 3 | 1 | (Primary) Same(Secondary) Similar. Provides asingle channel recording only. |
| ArrhythmiaDetection | None | None | None | (Primary & Secondary) Same.neither device provides arrhythmiadetection functionality on therecorder. |
| Alarm Systems | None | None | None | (Primary & Secondary) Same.Neither device provides alarmfunctionality and the 60601-1-8 isnot applicable. |
| Patient EventMarking | Yes, by button press | Yes, by taping twice on therecorder housing | Yes, by button press | (Primary) Similar. There is no changeto the safety and effectiveness ofthe device. |
| (Secondary) Same | ||||
| ContinuousWear Time | Up to 14 Days | Up to 14 Days | Up to 14 Days | (Primary & Secondary) Same.The battery in the M5 Recorder hasbeen tested and runs up to 19.9days. If we rate it down 20%(standard battery wear and tear),we can expect to get a minimum of14 days of recording throughout thelife of the M5 Recorder. We arecomfortable in quoting a 14 dayrecording period. |
| RecordingFormat | Continuous | Continuous | Continuous | (Primary & Secondary) Same |
| PowerRequirement | Rechargeable Lithium Polymerbattery; 3.7v 500 mAh with USBcharging | Rechargeable Lithium Polymerbattery; 3.7v 600 mAh with USBcharging | 2 Lithium ManganeseDioxide Coin Cells; single-use | (Primary) Similar. The battery is stilla rechargeable 3.7v LithiumPolymer. There is no change to thesafety and effectiveness of thedevice.(Secondary) Different. Thesecondary predicate uses a non-rechargeable, single-use battery.There is no change to the safety andeffectiveness of the device. |
| Battery Life(on singlecharge) | Up to 14 Days | Up to 14 Days | Up to 14 Days | (Primary & Secondary) Same.The battery in the M5 Recorder hasbeen tested and runs up to 19.9days. If we rate it down 20%(standard battery wear and tear),we can expect to get a minimum of14 days of recording throughout thelife of the M5 Recorder. Thus we are |
| comfortable in quoting a 14day recording period. | ||||
| StorageMedium | 8GB internal storage | 8GB internal storage | Internal Storage | (Primary & Secondary) Same |
| External DataInterface | USB cableBluetooth | USB cable | USB cableBluetooth | (Primary) Similar(Secondary) Same |
| RecorderDimensions | 14 x 32 x 54 mm | 10 x 40 x 49 mm | 12.7 x 37 x 51 mm | (Primary) Similar. There is no changeto the safety and effectiveness ofthe device.(Secondary) Similar |
| RecorderWeight | 26 grams | 25 grams | 25 grams | (Primary & Secondary) Same |
| Calibration | Calibration not required | Calibration not required | Calibration not required | (Primary & Secondary) Same |
| FrequencyResponse | 0.05 Hz – 60Hz @ 200sps0.05 Hz – 100Hz @ 250sps0.05 Hz – 175 Hz @ 500sps | 0.05 –20 Hz @ 128 sps0.05 – 40Hz @ 256 sps0.05-55 Hz @ 512 sps0.05Hz-175Hz @ 1024 sps | 0.5 to 30Hz @ 200 sps | (Primary) Similar. There is no changeto the safety and effectiveness ofthe device. The IEC 60601-2-47standard requires a minimumfrequency response of .05-40Hz.Any upper frequency response of40Hz, or higher, meets thefrequency response performancerequired by all applicable standards,including IEC 60601-2-47 "Particularrequirements for the basic safetyand essential performance ofambulatory electrocardiographicsystems". The devices provideequivalent performance as theyboth provide upper frequencyresponse limits >= 40 Hz. So |
| InputImpedance | >10 Ohms | >10 Ohms | >10 Ohms | performance is equivalent as alldevices have been tested meet IEC60601-2-47 required performancerequirements.(Secondary) Similar |
| Resolution | 16 bits | 12 bits | 10 bits | (Primary & Secondary) Similar.There is no change to the safety andeffectiveness of the device.Performance is equivalent to IEC60601-2-47 for all devices. |
| PerformanceStandard | Design Verification IEC 60601-2-47 | Design Verification IEC 60601-2-47 | Design Verification IEC 60601-2-47 | (Primary & Secondary) Same |
| Safety | ||||
| ISO, IEC, orANSI/AAMIStandards Met | IEC 60601-1 Basic Safety & EssentialPerformanceIEC 60601-2-47IEC 60601-1-11 | IEC 60601-1 Basic Safety &Essential PerformanceIEC 60601-2-47IEC 60601-1-11 | IEC 60601-1 Basic Safety &Essential PerformanceIEC 60601-2-47IEC 60601-1-11 | (Primary & Secondary) Same |
| Biological Equivalence | ||||
| MedicinalSubstances | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Tissue | N/A | N/A | N/A | (Primary & Secondary) Same. |
| BloodProducts | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Body FluidsContacted byDevice | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Type ofContact toSkin | Non-invasive | Non-invasive | Non-invasive | (Primary & Secondary) Same. |
| MucosalMembraneContact | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Duration ofSkin Contact | Up to 14 Days | Up to 14 Days | Up to 14 Days | (Primary & Secondary) Same. |
| Sterile vs Non-Sterile | N/A | N/A | N/A | (Primary & Secondary) Same Alldevices are non-sterile. |
| BiologicalCompatibility | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | (Primary & Secondary) Same |
| Clinical Equivalence | ||||
| MedicalPurpose | Ambulatory ECG | Ambulatory ECG | Ambulatory ECG | (Primary & Secondary) Same |
| Single UsePatchElectrode | Single Use Patch Electrode (singlechannel) | Single Use Patch Electrode (2channel) | Recorder, Single Use PatchElectrode (single channel) | (Primary) Similar The myPatchsl has3 electrodes integrated in the patchto provide a 2 channel recording.The M5 has 2 electrodes integratedin the patch to provide a singlechannel recording. There are notechnological characteristics thatwould raise different questions ofsafety and effectiveness.(Secondary) Similar. The secondarypredicate device utilizes single usebatteries. |
| Single UseStandardElectrode | Attachable external lead optionused with single use standardelectrode | Attachable external lead optionused with single use standardelectrode | No attachable lead option | (Primary) Same(Secondary) Different. No additionallead option for use with standardelectrode. |
| RecordingStandard | Holter | Holter | Holter | (Primary & Secondary) SameStandard is IEC 60601-2-47 |
| PatchElectrodePlacement(AnatomicalSite) | Left Sternumor Center Vertical Sternum | Left Sternum or Center VerticalSternum | Left Sternum | (Primary) Same.(Secondary) Similar. The secondarypredicate only indicates left sternumplacement. |
| Lead SetElectrodePlacement | Additional attachable external leadoption for 3 channel recording. | Additional attachable externallead option for 3 channelrecording. | No additional lead optionoffered. | (Primary) Same.(Secondary) Different. Additionallead option not offered. |
| RecordingPeriod | Up to 21 Days | Up to 14 Days | Up to 14 Days | (Primary & Secondary) Different:more and more practitioners andresearchers are requesting longerrecording times from ambulatoryECG recorders with clinical dataconfirming the increased value oflonger-term recordings in detectingcardiac arrythmias. This is animprovement to the device. Thereare no technological characteristicsthat would raise different questionsof safety and effectiveness. (Note:Electrode replacement andrecharging of the recorder batterymay be needed to achieve the fullduration of recording) |
Table 1: Technological Comparison of M5 Recorder with Predicate Device
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VIII. Performance Data
The M5 Recorder was designed and tested for compliance with the applicable clauses of the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical Electrical Equipment -● Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.0 2014-02 - Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6 Edition 3.1 2010-01 - Medical electrical equipment - part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- . IEC 60601-1-11 Edition 2.0 2015-01 - Medical electrical equipment – part 1-6: 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/EN 60601-2-47 Edition 2.0 2012-02 - Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- IEC 62304:2006/A1:2016 Medical device software Software life cycle processes .
- IEC/EN 62366-1 Edition 1.0 2015-02 Medical devices Application of usability ● engineering to medical devices
- ISO 14971:2007-03-01 Medical devices Application of risk management to . medical devices
- ANSI AAMI EC53:2013 ECG trunk cables and patient leadwires ●
- ANSI/AAMI EC12:2000/(R) 2015 Disposable ECG Electrodes .
- U.S. FDA Class II Special Controls Guidance Document: Electrocardiograph . Electrodes (July, 2011)
Biocompatibility Testing:
The biocompatibility evaluation was conducted in compliance to the FDA GLP Regulations, 21 CFR Part 58 and ISO 10993: Biological Evaluation of Medical Devices, Part 5: Tests for in vitro cytotoxicity, Part 10: Tests for irritation and skin sensitization, and Part 12: sample preparation and reference materials.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
Mechanical Testing
The following tests were successfully performed in accordance with IEC 60601-1:
- Power input
- Humidity preconditioning treatment
- Accessible parts.
- Legibility of markings
- Durability of marking
- Leakage current test
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- Dielectric voltage withstand
- Ball pressure
- Defibrillation-proof applied parts-Measurement of hazardous electrical energies
- Defibrillation-Proof Applied Parts or Patient connection of Defibrillation
- Temperature test
- Ingress protection
- Cleaning
- Measurement of power
- Single fault conditions
- Push test
- Impact test
- Drop test
- Mold stress
- Simulated use testing
Usability Testing
The clinical usability testing was implemented and overseen by Global Instrumentation LLC personnel with volunteer subjects acting as surrogate patients during the testing. The usability studies started May 7, 2019 and continued through March 10, 2020. The Human Factors and Usability Engineering to Medical Devices guidance has been followed in tandem with IEC 62366-1:2016" Application of usability to medical devices" and IEC 60601-1-6 Edition 3.1 2015 "General requirements for basic safety and essential performance - Collateral standard: Usability".
There were a total of 64 subjects that wore the M5 Recorder and components during daily activities. Total days of wear involving the M5 Recorder and components was 455 days.
Clinical users participated in the U5 Usability Test. The clinical user group comprised a cross section of experience in using ambulatory ECG recorders and clinical positions representative of the intended M5 Recorder user base.
Testing consisted of 5 independent usability tests: U1, U2, U3, U4 and U5. The U5 study included clinical users working with the M5 System and volunteer subjects. The usability testing involved all aspects of the M5 System including the M5 Recorder, M5 Patch Electrode, and M5 Patient Cable.
The testing was successful in validating the clinical and patient usability of the M5 System based on the usability goals and pass/fail criteria established in each study.
Clinical Studies:
No clinical studies were performed as appropriate verification and validation for the subject device were achieved in accordance with the acceptance criteria for the predicate devices and from the results of the bench and usability testing.
Animal Study:
No animal studies were performed as appropriate verification and validation for the subject device were achieved in accordance with the acceptance criteria for the predicate devices and from the results of the bench and usability testing.
Risk Management
The Risk Management process was performed according to ISO 14971, 2nd ed.
IX. Conclusions
Based on the information presented in this 510(k) premarket notification, the M5 Recorder is considered substantially equivalent to the currently marketed predicate devices.
§ 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).