The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. This device is intended for self-testing by adult users who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks.

ECG acquisition and transmission can be voluntarily and mutually activated by the adult users for the purpose of healthcare management and reference for healthcare professionals.

The user is normally not required to apply electrode on body. Two electrodes integrated within the device are provided. The user has to press his/her thumbs on the electrodes in order to record the ECG signal. The users may also record the signals optionally through auxiliary external electrode provided separately if thumb pressing is not convenient for reason. The recorded data can be downloaded to Personal Computer via USB interface port.

Device Description

The InstantCheck RTD-ECG monitor is a new model of handheld ECG monitors series of DailyCare BioMedical Inc. InstantCheck RTD-ECG is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions and displays the data in a clear and precise waveform for daily health check. It takes ECG signals of users by thumbs pressing gently on electrodes which are integrated on the device. InstantCheck RTD-ECG can record real-time display the user's ECG data for about 30 seconds, and automatically store the last 15 seconds signals into the build-in memory. While three parameters were measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, will be displayed on LCD display of the device.

User may also record ECG data optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in InstantCheck RTD-ECG can be printed for analysis, and for long-term tracking. InstantCheck RTD-ECG is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.

InstantCheck RTD-ECG is not intended for use as a substitution of precise diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device.

AI/ML Overview

This document is a 510(k) Premarket Notification for the InstantCheck RTD-ECG monitor. It focuses on demonstrating substantial equivalence to a predicate device and adherence to relevant safety and performance standards, rather than providing a detailed study proving the device meets specific acceptance criteria based on complex clinical outcomes or AI performance.

Therefore, many of the requested categories regarding clinical studies, AI performance, ground truth, and expert adjudication are not applicable as described for an AI/ML device.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (Non-Clinical)

The document does not explicitly state "acceptance criteria" in terms of clinical accuracy metrics (like sensitivity, specificity, or AUC) as one would expect for an AI/ML diagnostic device with a clinical endpoint. Instead, the "acceptance criteria" are implied by adherence to recognized electrical safety, EMC, and performance standards. The "reported device performance" refers to its compliance with these standards and its functional specifications.

Acceptance Criteria (Implied by Standards)	Reported Device Performance (Compliance)
Electrical Safety (IEC 60601-2-25 & IEC 60601-1)	Conforms to applicable standards
EMC Requirements (IEC 60601-1-2)	Conforms to applicable standards
Performance Tests (IEC 60601-2-47 and IEC 60601-2-51)	Conforms to applicable standards. The performance is also tested with MIT-IBH database and simulators. Measures Heart Rate (HR), ST segment, and QRS interval.
Environment Tests	Complies with safety requirements

Study Details (Based on the provided document)

Sample size used for the test set and the data provenance:
- The document mentions "MIT-IBH database and simulators" for performance tests. The specific sample size (number of ECGs or patients) from the MIT-IBH database used for testing is not specified.
- Data Provenance: The MIT-IBH database is a publicly available database from MIT, often used for algorithm development and testing in cardiology. The geographical origin of the patients in the database is not specified in this document. The data is retrospective as it's a pre-existing database.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as described for an AI/ML diagnostic device. The MIT-IBH database contains expert-annotated ECGs, but this document does not detail how the ground truth for this specific study was established (e.g., number of cardiologists for review). It assumes the inherent ground truth of the database.
Adjudication method for the test set:
- Not applicable as described for an AI/ML diagnostic device. The document does not describe a process of expert adjudication for this specific device's performance against a test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not conducted or reported in this document. This device is a monitor, and the premarket notification focuses on its functionality and safety, not on improving human reader performance with AI assistance. It states the monitor is for "healthcare management and reference for healthcare professionals" but is "not intended for use as a substitution of precise diagnostic tool."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in a way. The performance tests against the MIT-IBH database and simulators represent a standalone evaluation of the device's ability to measure ECG parameters (HR, ST segment, QRS interval) against established references, which is an "algorithm only" type of test for the device's signal processing capabilities.
The type of ground truth used:
- Expert Consensus/Reference Standards: For the MIT-IBH database tests, the ground truth is derived from the established and validated annotations within that database, which are typically based on expert cardiologists' interpretations and reference recordings. For the functional parameters (HR, ST, QRS), the ground truth would be the known, reference values in the database or from simulators.
The sample size for the training set:
- Not specified. The document states that the InstantCheck RTD-ECG monitor has "the same fundamental scientific technology as the original cleared device, ReadMyHeart." It doesn't describe an AI model that would typically have a separate training set. The underlying technology (signal processing to derive HR, ST, QRS) would be developed and validated rather than "trained" on a dataset in the modern AI sense.
How the ground truth for the training set was established:
- Not applicable. As no distinct "training set" for an AI algorithm is described, the method for establishing its ground truth is not relevant here. The device's core functionality relies on established signal processing principles for ECG analysis.

Summary

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Image /page/0/Picture/1 description: The image contains a logo for "DailyCare BioMedical". The logo features a stylized letter "D" with two figures above it, one larger and one smaller. To the right of the "D" is the word "DailyCare" in a sans-serif font, with "BioMedical" in a smaller font below it. The overall design is simple and modern.

Premarket Notification of InstantCheck RTD-ECG monitor

8 2007 FEB

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

	1.0 Submitter's Indentification:
	Submitter's Name:	DailyCare BioMedical Inc.
	Address:	8F, 25-3, Ji-Lin Road, Chungli 320, Taiwan
	TEL:	+886-3-2621688
	FAX:	+886-3-2617688
	Contact:	Mr. Daniel J. H. Chang

Device Name: 2.0

Trade Name:	InstantCheck RTD-ECG Monitor
Common Name:	Handheld ECG monitor
Classification Name:	Electrocardiograph (per 21 CFR 870.2340)

Class II 3.0 Classification:
ReadMyHeart (RMH2.0) (K042814) 4.0 Predicate Device: Omron HCG-801 Portable ECG Monitor (K060766)

5.0 Intended Use:

The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor which the ECG acquisition and transmission can be voluntarily and mutually activated by the adult users for the purpose of healthcare management and reference for healthcare professionals.

The user presses his/her thumbs on the electrodes in order to record the ECG signal. The users may also record the signals optionally through auxiliary external electrode provided separately if thumb pressing is not convenient for reason.

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Premarket Notification of InstantCheck RTD-ECG monitor

6.0 Indications for Use:

ECG acquisition and transmission can be voluntarily and mutually activated by the adult users for the purpose of healthcare management and reference for healthcare professionals.

7.0 Device Description:

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Premarket Notification of InstantCheck RTD-ECG monitor

GUI software provided separately, data stored in InstantCheck RTD-ECG can be printed for analysis, and for long-term tracking. InstantCheck RTD-ECG is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.

8.0 Non-Clinical Performance Summary:

In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards including

Electrical Safety test according to IEC 60601-2-25 & IEC 60601-1,
EMC tests according to IEC 60601-1-2
Performance tests according to IEC 60601-2-47 and IEC 60601-2-51.
Environment tests are tested to comply with the safety requirements.

*The performance is also tested with MIT-IBH database and simulators.

Discussion of Clinical Test performed: 9.0

InstantCheck RTD-ECG has the same fundamental scientific technology as the original cleared device, ReadMyHeart. Clinical validation for ECG parameters is not required.

10.0 Conclusions:

In order to benefit the public health and healthcare professionals, the InstantCheck RTD-ECG has simple, friendly software user interface. It has similar technological characteristics as previously cleared ReadMyHeart. The InstantCheck RTD-ECG demonstrates essential safety and effective to the users.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEE 8 2007

DailyCare BioMedical Inc. c/o Mr. Daniel J.H. Chang 8F, 25-3, Ji-Lin Road Chungli 320, Taiwan

Re: K062894

Trade Name: InstantCheck RTD-ECG Monitor, Model RMH4.0 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: September 27, 2006 Received: January 9, 2007

Dear Mr. Chang:

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 misburnelijng and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA 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 if the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Chang

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

B.F. Zimmerman for

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

Enclosure

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Indications for Use

K062894 510(k) Number (if known):

Device Name: __InstantCheck RTD-ECG monitor (DailyCare BioMedical Inc.)

Indications for Use:

ECG acquisition and transmission can be voluntarily and mutually activated by the adult users for the purpose of healthcare management and reference for healthcare professionals.

Over-The-Counter Use _ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Hamamoto

Page 1 of 1

ERNETRE

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).