Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "mathematical analysis" but does not use terms like AI, ML, deep learning, or neural networks. The performance studies focus on comparison to a predicate device and clinical trial results, not on training or validation of an AI/ML model.

Therapeutic

No.
The device is a monitor that detects and records heart rhythms, providing an indication of atrial fibrillation. It does not actively treat or intervene to alleviate the condition; its stated purpose is for self-testing and monitoring.

Diagnostic

Yes

The device is designed to monitor and record heart rhythms, process physiological data, and present an indicative result of the patient's likelihood of suffering from atrial fibrillation or other heart irregularity, which fits the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of hardware components: the Atrial Fibrillation Monitor, Finger Sensor, and Power Supply. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Melys Atrial Fibrillation Monitor is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Melys Device Function: The Melys Atrial Fibrillation Monitor works by receiving physiological data relating to heart rhythm directly from a finger sensor attached to the patient. It analyzes this data to provide an indication of the likelihood of atrial fibrillation. It does not analyze samples taken from the body.

Therefore, the Melys Atrial Fibrillation Monitor falls under the category of a non-IVD medical device that measures physiological signals directly from the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Melys Atrial Fibrillation Monitor is indicated for self-testing by patients, who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

Product codes

DXH

Device Description

The Melys Atrial Fibrillation Monitor is a lightweight portable device for measuring and displaying heart irregularity and pulse rate. The device consists of the following - 1) Atrial Fibrillation Monitor, 2) Finger Sensor (K101692), 3) Power Supply and 4) Instruction Manual.

The Melys Atrial Fibrillation Monitor device receives physiological data relating to heart rhythm from a finger sensor (K101692) attached to the patient's finger. The device captures, processes and records this data. Once sufficient data has been captured the device will run a mathematical analysis on the data and presents an indicative result of the patient's likelihood of suffering from atrial fibrillation or other heart irregularity.

The monitor contains a rechargeable battery, and a power supply is provided with the monitor for charging the monitor's battery. The finger sensor is connected to the monitor and with the pressing of the start button is ready to deliver trace measurements within 10 seconds. Each measurement is shown in a large display with a light and a number (the Arrhythmia Index Result). A history results bar at the bottom of the monitor will show the results of the previous 8 analyses with each light indicating each separate result by a green, amber, or red light. In the upper right corner of the display is an indication of the input signal strength and the level of battery charge.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Finger

Indicated Patient Age Range

Adult

Intended User / Care Setting

Self-testing by patients, home use

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)

Non-Clinical Performance Data:
Safety Testing: The Melys Atrial Fibrillation Monitor is compliant to the safety standards. IEC 60601-1 (1988), 200 Edition, Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(91) + A2(95)
Comparative Test: A comparative test was conducted between the subject and predicate device. The Melys Atrial Fibrillation Monitor matched the predicate device in all tests, giving the same heart rate measurements and the same indications towards atrial fibrillation in all but Tests 9 and 10, where the Melys Atrial Fibrillation Monitor correctly indicated that no atrial fibrillation was present.
Human Factor Study: A Human Factor Study was performed with 20 volunteers to evaluate ease of use and label comprehension. There was a 100% agreement that the device was easy to use and the instructions were clear and understandable.

Clinical Performance Data:
Two clinical trials were conducted for verification of Melys Atrial Fibrillation Monitor, safely and effectively identifying as having an arrhythmia those patients identified by EKG examination as having atrial fibrillation.
The Clinical Trial results show the EKG diagnosis compared with the Melys Atrial Fibrillation Monitor predictions.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K052767

Reference Device(s)

K101692

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).

Summary

0

AAR 1 9 2014

510(k) Summary 807.92(c)

SPONSOR		807.92(a)(1)
Company Name:	Advanced Fluidics, LLC
Company Address	8860 Columbia 100 Parkway, Suite 204
Columbia, MD 21045
Telephone:	(443) 864-5295
Contact Person:	Surya Raghu, Ph.D.
Summary Preparation Date: June 28, 2013

Summary Preparation Date: June 28, 2013

DEVICE NAME

Trade Name: Common/Usual N Classification Nar Regulation Numb Product Code: Device Class:

807.92(a)(2)

	Melys Atrial Fibrillation Monitor
Name:	Atrial Fibrillation Monitor
	Telephone electrocardiograph transmitter and receiver
	21 CFR 870.2920
	DXH
	Class II

PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device

K Number	Device	Manufacturer
K052767	AfibAlert Atrial Fibrillation Detector	Technologies Research, LLC

DEVICE DESCRIPTION

807.92(a)(4)

The Melys Atrial Fibrillation Monitor is a lightweight portable device for measuring and displaying heart irregularity and pulse rate. The device consists of the following - 1) Atrial Fibrillation Monitor, 2) Finger Sensor (K101692), 3) Power Supply and 4) Instruction Manual.

The Melys Atrial Fibrillation Monitor device receives physiological data relating to heart rhythm from a finger sensor (K101692) attached to the patient's finger. The device captures, processes and records this data. Once sufficient data has been captured the device will run a mathematical analysis on the data and presents an indicative result of the patient's likelihood of suffering from atrial fibrillation or other heart irregularity.

1

The monitor contains a rechargeable battery, and a power supply is provided with the monitor for charging the monitor's battery. The finger sensor is connected to the monitor and with the pressing of the start button is ready to deliver trace measurements within 10 seconds. Each measurement is shown in a large display with a light and a number (the Arrhythmia Index Result). A history results bar at the bottom of the monitor will show the results of the previous 8 analyses with each light indicating each separate result by a green, amber, or red light. In the upper right corner of the display is an indication of the input signal strength and the level of battery charge.

DEVICE INDICATIONS FOR USE

807.92(a){5)

The Melys Atrial Fibrillation Monitor is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a){6)

2

	Subject	Predicate
Parameters	Melys AFS Ltd.	Lechnologies Research, Inc.	Similarities and Differences
510(k) Number		K052767
Indications for Use	The Melys Atrial Fibrillation Monitor is
indicated for self-testing by patients, who
have been diagnosed with, or are
susceptible to developing, atrial fibrillation
and who would like to monitor and record
their heart rhythms on an intermittent
basis.	The AfibAlert™ is indicated for self-testing
by patients who have been diagnosed with,
or are susceptible to developing atrial
fibrillation and who would like to monitor
and record their heart rhythms on an
intermittent basis.	Same
Regulation Name	Telephone electrocardiograph transmitter
and receiver	Telephone electrocardiograph transmitter
and receiver	Same
Product Code	DXH	DXH	Same
intended User	Adult	Adult	Same
Prescription device for
home use	yes	yes	Same
Single Patient Use	yes	yes	Same
Monitors regularity of
heartbeat	yes	yes	Same
Alerts user to an
irregularity in their
pulse through a light
indicator.	yes	yes	Same
Principle of Operation	The monitor passes light through the
fingertip sensor and receives data from
which the waveform is directly created.
Displays regularity or irregularity with a
light indicator.	The monitor creates an electrocardiograph
reading from the data received from the
thumb, wrist or chest sensor from which a
waveform is derived.
Displays regularity or irregularity with a
light indicator.	The Melys monitor receives its
information from the finger rather
than the thumb, wrist or chest, using
a familiar, pulse oximeter style finger
sensor.
Device Design	Monitor obtains waveform via finger
sensor and displays waveform in real time
on the monitor with an arrhythmia index.	Cardiac event recorder with thumb, wrist,
or chest sensor that displays results by light
indicator (green, red), but no pulse	Different acquisition of waveform
but same result and light indicator
display of heart regularity or

3

page 4 of 6

| Functional Features | Light display (green, amber, or red) indicates heart regularity or irregularity.
Last 8 tests are stored on the display by light indicator not Arrhythmia Index number. | waveform.
Records, stores and transmits results over the telephone wire. | irregularity. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User programmable | No | No | Same |
| Recording length | 10 seconds
(Recommended four (4) consecutive measurement should show same indication (red, amber or green) before a conclusion is drawn) | 45 seconds | Melys Atrial Fibrillation Monitor
Instructions recommends four (4) consecutive measurement should show same indication (red, amber or green) before a conclusion is drawn |
| Low battery detection | Yes | Yes | Same |
| Heart rate accuracy | $\pm$ 1 BPM | $\pm$ 1 BPM (average for data collected, updated every three (3) seconds) | Same |
| Physical and Environmental | | | |
| Weight (w. Batteries) | 200g 7.05 oz. | 4.6 oz. | Slight difference does not affect safety & efficacy |
| Size | 4.52" x 4.13" x 1.37" | 5.88" x 2.75" x 1.11" | Slight difference does not affect safety & efficacy |
| Operational
Temperature | 20°C to 40° C | 0°C to +45° C (+32° F to 113°F) | Slight difference does not affect safety & efficacy |
| Storage & Transport | 0-20°C | -120°C to +60°C (-4°F to 140°F) | Slight difference does not affect safety & efficacy |
| Power | | | |
| Battery type | Lithium-ion Polymer Battery (Minamoto)
3.7 V | Two (2) AAA 1.5 V Eveready x -92 | Both use battery as power source |
| Battery Life | 40 days continuous | 90 days nominal used 1 x per day | Difference does not affect safety & efficacy |
| Differences | | | |
| Memory Capability | No | Yes | The subject device displays the last eight Indicator lights on the monitor face but not the arrhythmia Index. |
| Transmission of Data | No | Yes | The subject devices does not transmit data |

4

page 5 of 6

| Patient Interface | Finger Sensor | Thumb, or wrist sensor, and direct chest
contact | Most users will have encountered a
fingertip sensor such as the Melys
AFS Ltd fingertip sensor and
therefore require little instruction on
how to correctly use it. The finger
sensor passes light through the
fingertip and creates a waveform
from this data. The Lechnologies
thumb, wrist and chest sensors
require user education to use
correctly. The chest sensor requires
that the patient removes clothing
and is therefore less convenient than
a fingertip sensor. |
|-------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Waveform display | Waveform shown in real time on the
monitor screen. | Waveform is not shown on the monitor,
but is available by a download-from the
Lechnologies Research, Inc's website. | While the waveform is available to
the user, the subject device is the
only device with the display in real
time.
|

5

page 6 of 6

NON-CLINICAL PERFORMANCE DATA

807.92(b)(1)

Safety Testing

The Melys Atrial Fibrillation Monitor is compliant to the safety standards. IEC 60601-1 (1988), 200 Edition, Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(91) + A2(95)

Comparative Test

A comparative test was conducted between the subject and predicate device. The Melys Atrial Fibrillation Monitor matched the predicate device in all tests, giving the same heart rate measurements and the same indications towards atrial fibrillation in all but Tests 9 and 10, where the Melys Atrial Fibrillation Monitor correctly indicated that no atrial fibrillation was present.

Human Factor Study

A Human Factor Study was performed with 20 volunteers to evaluate ease of use and label comprehension. There was a 100% agreement that the device was easy to use and the instructions were clear and understandable.

CLINICAL PERFORMANCE DATA

Two clinical trials were conducted for verification of Melys Atrial Fibrillation Monitor, safely and effectively identifying as having an arrhythmia those patients identified by EKG examination as having atrial fibrillation.

The Clinical Trial results show the EKG diagnosis compared with the Melys Atrial Fibrillation Monitor predictions.

CONCLUSION

807.92(b)(3)

807.92(b)(2)

Electrical, mechanical and software testing was conducted and data collected in accordance with applicable standards to ensure that the device performs in accordance with applicable standards to ensure that the device performs according to specification and to verify that the device is suitable for home use. A Human Factor Study was conducted to verify Ease of Use and Label Comprehension

Advanced Fluidics considers the Melys Atrial Fibrillation Monitor to be equivalent to the predicate device. This conclusion is based upon the devices' similarities in functional design, method of use for self-monitoring and indications for use.

6

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Cantrol Center - WO66-G609 Silver Spring, MD 20993-0002

Image /page/6/Picture/3 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

March 19, 2014

Advanced Fluidics, LLC c/o E J Smith 1468 Harwell Ave Crofton, MD 21114 US

Re: K132206 Trade/Device Name: Melys Atrial Fibrillation Monitor Regulation Number: 21 CFR 870.2920 Regulation Name: Atrial Fibrillation Detector Regulatory Class: Class II Product Code: DXH Dated: February 12, 2014 Received: February 14, 2014

Dear E J Smith,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free

7

number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

Image /page/7/Picture/4 description: The image shows a logo with the letters FDA. The letters are stylized and overlapping, with a geometric design. The logo is black and white and appears to be a vectorized image.

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

8

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) KI32206

Device Name Melys Atrial Fibrillation Monitor

Indications for Use (Describe)

The Melys Atrial Fibrillation Montor is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial florillation and who would like to monitor and record their heart thythms on an internitient basis.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concur

Date: 2014.03.19
15:24:12 -04'00'
for Bram Zuckerman

FORM FDA 3881 (1/14)	Page 1	PRC Publishing Services (301) 443-6740 EF
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