M5 Recorder

K202456 · Global Instrumentation, LLC · DSH · Dec 29, 2020 · Cardiovascular

Device Facts

• Record ID: K202456
• Device Name: M5 Recorder
• Applicant: Global Instrumentation, LLC
• Product Code: DSH · Cardiovascular
• Decision Date: Dec 29, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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.

Device Story

M5 Recorder is a small, lightweight ambulatory ECG recorder; captures 1 or 3 channels of continuous ECG data for up to 21 days. Device snaps onto a patch electrode or connects to a patient cable with off-the-shelf electrodes. Input: ECG signals from patient torso. Operation: Microprocessor-based recording to internal non-volatile memory; no onboard arrhythmia analysis. Output: Proprietary ECG data files transferred via USB to PC-based analysis software for physician review. Features: LED status indicator; patient-activated event button; internal Bluetooth for immediate ECG viewing via host system. Used in clinical, point-of-care, or home settings by healthcare professionals and patients. Benefits: Enables long-term cardiac monitoring to detect transient arrhythmias; aids clinical diagnosis of symptomatic patients.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing, mechanical testing, and usability testing. Usability testing involved 64 subjects over 455 days of wear to validate clinical and patient usability across five independent studies (U1-U5). Device performance was verified against IEC 60601-2-47 standards for ambulatory ECG systems.

Technological Characteristics

Valox 357U polycarbonate (PBT) housing (ISO 10993 compliant). Rechargeable 3.7V 500 mAh lithium polymer battery. 8GB internal non-volatile storage. Connectivity: USB cable for data transfer/charging; internal Bluetooth for real-time viewing. Dimensions: 14 x 32 x 54 mm; weight: 26g. Standards: IEC 60601-1, IEC 60601-2-47, IEC 60601-1-11, ANSI/AAMI EC53, ANSI/AAMI EC12.

Indications for Use

Indicated for patients who may be asymptomatic or suffer from transient symptoms including palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain, and/or anxiety. Intended for use by adults and pediatric subgroups weighing 10 kg or more.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• myPatch®sl (K163535)
• Zio Skyrunner (SR) Electrocardiogram (ECG) Monitoring Service (K143513)

Reference Devices

• Faros Mobile (K182030)

Submission Summary (Full Text)

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

Sincerely,

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### 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: [phone] Ext 116 |
| | Fax: [phone] |
| | e-mail: [e-mail] |
| 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) Monitoring<br>Service (Zio SR Patch Recorder with Bluetooth<br>Technology) |
| 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.<br>650 Townsend Street, Ste 380<br>San 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.

| Technical<br>Equivalence | M5 Recorder<br>Subject Device | myPatchsl<br>Primary Predicate Device | Zio SR Patch Recorder<br>Secondary Predicate Device | Similarities/Differences |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of ECG<br>Recorder | Patch & attachable external lead<br>option | Patch & attachable external lead<br>option | Patch | (Primary) Similar. The predicate<br>device provides an attachable<br>external lead option for 3 channel<br>recordings. The M5 provides<br>attachable external lead options for<br>2 and 3 channel recordings. There is<br>no change to the safety and<br>effectiveness of the device.<br>(Secondary) Similar. Supports patch<br>but no external lead option. |
| Indications for<br>Use | The M5 Recorder is indicated for<br>use on patients who may be<br>asymptomatic or who may suffer<br>from transient symptoms such as<br>palpitations, shortness of breath,<br>dizziness, light headedness, pre-<br>syncope, syncope, fatigue, chest<br>pain and/or anxiety.<br>The M5 Recorder is intended for<br>use by adults and all pediatric<br>subgroups (weighing more than 10<br>Kg). | myPatchsl is indicated for use on<br>patients who may be<br>asymptomatic or who may suffer<br>from transient symptoms such as<br>palpitations, shortness of breath,<br>dizziness, light headedness, pre-<br>syncope, syncope, fatigue, chest<br>pain and/or anxiety.<br>The myPatchsl is intended for<br>use by adult and pediatric<br>subgroups. | The ZIO® SR ECG Monitoring<br>Service is intended to capture,<br>analyze, and report<br>symptomatic and/or<br>continuous electrocardiogram<br>(ECG) information for long-term<br>monitoring (up to 14 days). It is<br>indicated for use on adult<br>patients 18 years or older who<br>may be asymptomatic or who<br>may suffer from transient<br>symptoms such as palpitations,<br>shortness of breath, dizziness,<br>light-headedness, pre-syncope,<br>syncope, fatigue, or anxiety.<br>The reported ECG metrics<br>include single-lead analysis on a | (Primary) Similar. The M5 Recorder<br>indications for use includes a weight<br>minimum for the pediatric<br>subgroup.<br>(Secondary) Similar. Symptom<br>indications for use are the same.<br>The secondary predicate includes an<br>analysis and reporting service in<br>addition to the Zio Patch Recorder. |
| | | | measurement and rhythm<br>analysis. The report does not<br>contain diagnostic<br>interpretation; the reported<br>analysis is provided for review<br>by the intended user to render<br>a diagnosis based on clinical<br>judgment and experience. | |
| Target<br>Population | Adult and pediatric subgroups<br>(weighing more than 10 Kg) | Adult and pediatric subgroups | Adult patients 18 years or older | (Primary) Similar. The primary<br>predicate does not set a minimum<br>weight level<br>(Secondary). Different. The<br>secondary predicate restricts use to<br>18 years or older. |
| Environment<br>of Use | Clinical site/facility, point of care or<br>at a patient setting. | Clinical site/facility, patient point<br>of care or at a patient setting. | Clinical site/facility, point of<br>care or at a patient setting. | (Primary & Secondary) Same |
| Number of<br>ECG Channels | 1, 2, 3 | 1, 2 or 3 | 1 | (Primary) Same<br>(Secondary) Similar. Provides a<br>single channel recording only. |
| Arrhythmia<br>Detection | None | None | None | (Primary & Secondary) Same.<br>neither device provides arrhythmia<br>detection functionality on the<br>recorder. |
| Alarm Systems | None | None | None | (Primary & Secondary) Same.<br>Neither device provides alarm<br>functionality and the 60601-1-8 is<br>not applicable. |
| Patient Event<br>Marking | Yes, by button press | Yes, by taping twice on the<br>recorder housing | Yes, by button press | (Primary) Similar. There is no change<br>to the safety and effectiveness of<br>the device. |
| | | | | (Secondary) Same |
| Continuous<br>Wear Time | Up to 14 Days | Up to 14 Days | Up to 14 Days | (Primary & Secondary) Same.<br>The battery in the M5 Recorder has<br>been tested and runs up to 19.9<br>days. If we rate it down 20%<br>(standard battery wear and tear),<br>we can expect to get a minimum of<br>14 days of recording throughout the<br>life of the M5 Recorder. We are<br>comfortable in quoting a 14 day<br>recording period. |
| Recording<br>Format | Continuous | Continuous | Continuous | (Primary & Secondary) Same |
| Power<br>Requirement | Rechargeable Lithium Polymer<br>battery; 3.7v 500 mAh with USB<br>charging | Rechargeable Lithium Polymer<br>battery; 3.7v 600 mAh with USB<br>charging | 2 Lithium Manganese<br>Dioxide Coin Cells; single-use | (Primary) Similar. The battery is still<br>a rechargeable 3.7v Lithium<br>Polymer. There is no change to the<br>safety and effectiveness of the<br>device.<br>(Secondary) Different. The<br>secondary predicate uses a non-<br>rechargeable, single-use battery.<br>There is no change to the safety and<br>effectiveness of the device. |
| Battery Life<br>(on single<br>charge) | Up to 14 Days | Up to 14 Days | Up to 14 Days | (Primary & Secondary) Same.<br>The battery in the M5 Recorder has<br>been tested and runs up to 19.9<br>days. If we rate it down 20%<br>(standard battery wear and tear),<br>we can expect to get a minimum of<br>14 days of recording throughout the<br>life of the M5 Recorder. Thus we are |
| | | | | comfortable in quoting a 14<br>day recording period. |
| Storage<br>Medium | 8GB internal storage | 8GB internal storage | Internal Storage | (Primary & Secondary) Same |
| External Data<br>Interface | USB cable<br>Bluetooth | USB cable | USB cable<br>Bluetooth | (Primary) Similar<br>(Secondary) Same |
| Recorder<br>Dimensions | 14 x 32 x 54 mm | 10 x 40 x 49 mm | 12.7 x 37 x 51 mm | (Primary) Similar. There is no change<br>to the safety and effectiveness of<br>the device.<br>(Secondary) Similar |
| Recorder<br>Weight | 26 grams | 25 grams | 25 grams | (Primary & Secondary) Same |
| Calibration | Calibration not required | Calibration not required | Calibration not required | (Primary & Secondary) Same |
| Frequency<br>Response | 0.05 Hz – 60Hz @ 200sps<br>0.05 Hz – 100Hz @ 250sps<br>0.05 Hz – 175 Hz @ 500sps | 0.05 –20 Hz @ 128 sps<br>0.05 – 40Hz @ 256 sps<br>0.05-55 Hz @ 512 sps<br>0.05Hz-175Hz @ 1024 sps | 0.5 to 30Hz @ 200 sps | (Primary) Similar. There is no change<br>to the safety and effectiveness of<br>the device. The IEC 60601-2-47<br>standard requires a minimum<br>frequency response of .05-40Hz.<br>Any upper frequency response of<br>40Hz, or higher, meets the<br>frequency response performance<br>required by all applicable standards,<br>including IEC 60601-2-47 "Particular<br>requirements for the basic safety<br>and essential performance of<br>ambulatory electrocardiographic<br>systems". The devices provide<br>equivalent performance as they<br>both provide upper frequency<br>response limits >= 40 Hz. So |
| Input<br>Impedance | >10 Ohms | >10 Ohms | >10 Ohms | performance is equivalent as all<br>devices have been tested meet IEC<br>60601-2-47 required performance<br>requirements.<br>(Secondary) Similar |
| Resolution | 16 bits | 12 bits | 10 bits | (Primary & Secondary) Similar.<br>There is no change to the safety and<br>effectiveness of the device.<br>Performance is equivalent to IEC<br>60601-2-47 for all devices. |
| Performance<br>Standard | Design Verification IEC 60601-2-47 | Design Verification IEC 60601-2-<br>47 | Design Verification IEC 60601-<br>2-47 | (Primary & Secondary) Same |
| Safety | | | | |
| ISO, IEC, or<br>ANSI/AAMI<br>Standards Met | IEC 60601-1 Basic Safety & Essential<br>Performance<br>IEC 60601-2-47<br>IEC 60601-1-11 | IEC 60601-1 Basic Safety &<br>Essential Performance<br>IEC 60601-2-47<br>IEC 60601-1-11 | IEC 60601-1 Basic Safety &<br>Essential Performance<br>IEC 60601-2-47<br>IEC 60601-1-11 | (Primary & Secondary) Same |
| Biological Equivalence | | | | |
| Medicinal<br>Substances | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Tissue | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Blood<br>Products | N/A…