(124 days)
Not Found
No
The device description explicitly states that the M5 recorder "acquires ECG data and does not perform any data processing or arrhythmia analysis of the ECG data." This indicates that the device's function is solely data acquisition and transfer, without any AI/ML-based analysis.
No
The device records ECG data, which is used for diagnosis, not for treating existing conditions or restoring function.
Yes
Explanation: The device is indicated for use on patients who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, etc., and records ECG continuously. This data can then be transferred to software for analysis by healthcare providers to help diagnose the underlying cause of these symptoms.
No
The device description explicitly states the M5 Recorder is a "small, lightweight ambulatory electrocardiograph (ECG) recorder" and details its hardware components (microprocessor, measuring circuit, memory, data storage, LED, contacts, internal Bluetooth radio, button). It also mentions associated spare parts like the patch electrode, patient cable, and USB cable. While it includes firmware and interacts with processing software, the core device is a physical hardware recorder.
Based on the provided information, the M5 Recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- M5 Recorder Function: The M5 Recorder is an ambulatory electrocardiograph (ECG) recorder. It records electrical activity of the heart directly from the patient's body using electrodes. It does not analyze or process biological specimens.
- Intended Use: The intended use is to record ECG data from patients experiencing or potentially experiencing cardiac symptoms. This is a direct measurement from the body, not an analysis of a specimen.
- Device Description: The description details the components and function of an ECG recorder, which is a device that interacts directly with the patient's body to acquire physiological signals.
- Lack of Specimen Handling: There is no mention of collecting or analyzing any biological specimens.
Therefore, the M5 Recorder falls under the category of a medical device that performs a direct physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / 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).
Product codes
DSH, DXH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper chest near the sternum / torso
Indicated Patient Age Range
Adult and pediatric subgroups (weighing more than 10 Kg).
Intended User / Care Setting
Professionals to acquire ECG data from a patient in a clinical, point of care or at a patient setting.
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)
The M5 Recorder was designed and tested for compliance with the applicable clauses of several standards related to medical electrical equipment, including basic safety, essential performance, electromagnetic disturbances, usability, and software life cycle processes. Biocompatibility testing was conducted following FDA GLP Regulations and ISO 10993 standards for cytotoxicity, irritation, and skin sensitization. Software verification and validation testing were conducted as per FDA guidance. Mechanical testing, including power input, humidity preconditioning, leakage current, and impact tests, was successfully performed according to IEC 60601-1. Usability testing involved 64 volunteer subjects and clinical users over 455 days, spanning five independent studies (U1-U5) that covered all components of the M5 System. The usability testing successfully validated the clinical and patient usability based on established goals and criteria. No clinical or animal studies were performed as appropriate verification and validation were achieved through bench and usability testing and compliance with predicate device acceptance criteria. Risk management was performed according to ISO 14971.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
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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3
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.
4
IV. Secondary Predicate Device
| 510(k) Number: | K143513 |
|---|---|
| Trade Name: | Zio Skyrunner (SR) Electrocardiogram (ECG) Monitoring |
| Service (Zio SR Patch Recorder with Bluetooth | |
| 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. |
| 650 Townsend Street, Ste 380 | |
| 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
5
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
6
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.
7
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
Equivalence | M5 Recorder
Subject Device | myPatchsl
Primary Predicate Device | Zio SR Patch Recorder
Secondary Predicate Device | Similarities/Differences |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of ECG
Recorder | Patch & attachable external lead
option | Patch & attachable external lead
option | Patch | (Primary) Similar. The predicate
device provides an attachable
external lead option for 3 channel
recordings. The M5 provides
attachable external lead options for
2 and 3 channel recordings. There is
no change to the safety and
effectiveness of the device.
(Secondary) Similar. Supports patch
but no external lead option. |
| 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). | myPatchsl 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 myPatchsl is intended for
use by adult and pediatric
subgroups. | The ZIO® SR ECG Monitoring
Service is intended to capture,
analyze, and report
symptomatic and/or
continuous electrocardiogram
(ECG) information for long-term
monitoring (up to 14 days). It is
indicated for use on adult
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 reported ECG metrics
include single-lead analysis on a | (Primary) Similar. The M5 Recorder
indications for use includes a weight
minimum for the pediatric
subgroup.
(Secondary) Similar. Symptom
indications for use are the same.
The secondary predicate includes an
analysis and reporting service in
addition to the Zio Patch Recorder. |
| | | | measurement and rhythm
analysis. The report does not
contain diagnostic
interpretation; the reported
analysis is provided for review
by the intended user to render
a diagnosis based on clinical
judgment and experience. | |
| Target
Population | Adult and pediatric subgroups
(weighing more than 10 Kg) | Adult and pediatric subgroups | Adult patients 18 years or older | (Primary) Similar. The primary
predicate does not set a minimum
weight level
(Secondary). Different. The
secondary predicate restricts use to
18 years or older. |
| Environment
of Use | Clinical site/facility, point of care or
at a patient setting. | Clinical site/facility, patient point
of care or at a patient setting. | Clinical site/facility, point of
care or at a patient setting. | (Primary & Secondary) Same |
| Number of
ECG Channels | 1, 2, 3 | 1, 2 or 3 | 1 | (Primary) Same
(Secondary) Similar. Provides a
single channel recording only. |
| Arrhythmia
Detection | None | None | None | (Primary & Secondary) Same.
neither device provides arrhythmia
detection functionality on the
recorder. |
| Alarm Systems | None | None | None | (Primary & Secondary) Same.
Neither device provides alarm
functionality and the 60601-1-8 is
not applicable. |
| Patient Event
Marking | Yes, by button press | Yes, by taping twice on the
recorder housing | Yes, by button press | (Primary) Similar. There is no change
to the safety and effectiveness of
the device. |
| | | | | (Secondary) Same |
| Continuous
Wear Time | Up to 14 Days | Up to 14 Days | Up to 14 Days | (Primary & Secondary) Same.
The battery in the M5 Recorder has
been tested and runs up to 19.9
days. If we rate it down 20%
(standard battery wear and tear),
we can expect to get a minimum of
14 days of recording throughout the
life of the M5 Recorder. We are
comfortable in quoting a 14 day
recording period. |
| Recording
Format | Continuous | Continuous | Continuous | (Primary & Secondary) Same |
| Power
Requirement | Rechargeable Lithium Polymer
battery; 3.7v 500 mAh with USB
charging | Rechargeable Lithium Polymer
battery; 3.7v 600 mAh with USB
charging | 2 Lithium Manganese
Dioxide Coin Cells; single-use | (Primary) Similar. The battery is still
a rechargeable 3.7v Lithium
Polymer. There is no change to the
safety and effectiveness of the
device.
(Secondary) Different. The
secondary predicate uses a non-
rechargeable, single-use battery.
There is no change to the safety and
effectiveness of the device. |
| Battery Life
(on single
charge) | Up to 14 Days | Up to 14 Days | Up to 14 Days | (Primary & Secondary) Same.
The battery in the M5 Recorder has
been tested and runs up to 19.9
days. If we rate it down 20%
(standard battery wear and tear),
we can expect to get a minimum of
14 days of recording throughout the
life of the M5 Recorder. Thus we are |
| | | | | comfortable in quoting a 14
day recording period. |
| Storage
Medium | 8GB internal storage | 8GB internal storage | Internal Storage | (Primary & Secondary) Same |
| External Data
Interface | USB cable
Bluetooth | USB cable | USB cable
Bluetooth | (Primary) Similar
(Secondary) Same |
| Recorder
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
to the safety and effectiveness of
the device.
(Secondary) Similar |
| Recorder
Weight | 26 grams | 25 grams | 25 grams | (Primary & Secondary) Same |
| Calibration | Calibration not required | Calibration not required | Calibration not required | (Primary & Secondary) Same |
| Frequency
Response | 0.05 Hz – 60Hz @ 200sps
0.05 Hz – 100Hz @ 250sps
0.05 Hz – 175 Hz @ 500sps | 0.05 –20 Hz @ 128 sps
0.05 – 40Hz @ 256 sps
0.05-55 Hz @ 512 sps
0.05Hz-175Hz @ 1024 sps | 0.5 to 30Hz @ 200 sps | (Primary) Similar. There is no change
to the safety and effectiveness of
the device. The IEC 60601-2-47
standard requires a minimum
frequency response of .05-40Hz.
Any upper frequency response of
40Hz, or higher, meets the
frequency response performance
required by all applicable standards,
including IEC 60601-2-47 "Particular
requirements for the basic safety
and essential performance of
ambulatory electrocardiographic
systems". The devices provide
equivalent performance as they
both provide upper frequency
response limits >= 40 Hz. So |
| Input
Impedance | >10 Ohms | >10 Ohms | >10 Ohms | performance is equivalent as all
devices have been tested meet IEC
60601-2-47 required performance
requirements.
(Secondary) Similar |
| Resolution | 16 bits | 12 bits | 10 bits | (Primary & Secondary) Similar.
There is no change to the safety and
effectiveness of the device.
Performance is equivalent to IEC
60601-2-47 for all devices. |
| Performance
Standard | Design Verification IEC 60601-2-47 | Design Verification IEC 60601-2-
47 | Design Verification IEC 60601-
2-47 | (Primary & Secondary) Same |
| Safety | | | | |
| ISO, IEC, or
ANSI/AAMI
Standards Met | IEC 60601-1 Basic Safety & Essential
Performance
IEC 60601-2-47
IEC 60601-1-11 | IEC 60601-1 Basic Safety &
Essential Performance
IEC 60601-2-47
IEC 60601-1-11 | IEC 60601-1 Basic Safety &
Essential Performance
IEC 60601-2-47
IEC 60601-1-11 | (Primary & Secondary) Same |
| Biological Equivalence | | | | |
| Medicinal
Substances | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Tissue | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Blood
Products | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Body Fluids
Contacted by
Device | N/A | N/A | N/A | (Primary & Secondary) Same. |
| | | | | |
| Type of
Contact to
Skin | Non-invasive | Non-invasive | Non-invasive | (Primary & Secondary) Same. |
| Mucosal
Membrane
Contact | N/A | N/A | N/A | (Primary & Secondary) Same. |
| Duration of
Skin 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 All
devices are non-sterile. |
| Biological
Compatibility | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | (Primary & Secondary) Same |
| Clinical Equivalence | | | | |
| Medical
Purpose | Ambulatory ECG | Ambulatory ECG | Ambulatory ECG | (Primary & Secondary) Same |
| Single Use
Patch
Electrode | Single Use Patch Electrode (single
channel) | Single Use Patch Electrode (2
channel) | Recorder, Single Use Patch
Electrode (single channel) | (Primary) Similar The myPatchsl has
3 electrodes integrated in the patch
to provide a 2 channel recording.
The M5 has 2 electrodes integrated
in the patch to provide a single
channel recording. There are no
technological characteristics that
would raise different questions of
safety and effectiveness.
(Secondary) Similar. The secondary
predicate device utilizes single use
batteries. |
| Single Use
Standard
Electrode | Attachable external lead option
used with single use standard
electrode | Attachable external lead option
used with single use standard
electrode | No attachable lead option | (Primary) Same
(Secondary) Different. No additional
lead option for use with standard
electrode. |
| Recording
Standard | Holter | Holter | Holter | (Primary & Secondary) Same
Standard is IEC 60601-2-47 |
| Patch
Electrode
Placement
(Anatomical
Site) | Left Sternum
or Center Vertical Sternum | Left Sternum or Center Vertical
Sternum | Left Sternum | (Primary) Same.
(Secondary) Similar. The secondary
predicate only indicates left sternum
placement. |
| Lead Set
Electrode
Placement | Additional attachable external lead
option for 3 channel recording. | Additional attachable external
lead option for 3 channel
recording. | No additional lead option
offered. | (Primary) Same.
(Secondary) Different. Additional
lead option not offered. |
| Recording
Period | Up to 21 Days | Up to 14 Days | Up to 14 Days | (Primary & Secondary) Different:
more and more practitioners and
researchers are requesting longer
recording times from ambulatory
ECG recorders with clinical data
confirming the increased value of
longer-term recordings in detecting
cardiac arrythmias. This is an
improvement to the device. There
are no technological characteristics
that would raise different questions
of safety and effectiveness. (Note:
Electrode replacement and
recharging of the recorder battery
may be needed to achieve the full
duration of recording) |
Table 1: Technological Comparison of M5 Recorder with Predicate Device
8
9
10
11
12
13
14
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
15
- 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.