The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult population. The device is not intended for home use. The device is not designated for intracardial use.

Device Description

As an electrocardiograph with 12-channel, CARDIOTOUCH-3000 does not only provide parameters and diagnose a patient automatically for patient's electrocardiogram, but also it improves chart management by printing information on an operator as well as on the patient. Furthermore, for the convenience of operators, it is designed so that an operator needs to press a button once to let the machine measure and record patient's electrocardiogram, apply a filter, extract parameters, diagnose a patient automatically then print out a result on an A-4- size report. In addition, the built-in battery helps an operator carry and use CARDIOTOUCH-3000 easily and conveniently for a hospital on wheel and an emergency.

AI/ML Overview

Acceptance Criteria and Device Performance for CARDIOTOUCH-3000

This submission for the CARDIOTOUCH-3000 is a "SPECIAL type" 510(k), claiming substantial equivalence to the predicate device, Bionet's EKG-2000 Cardio Care (K011328). The submission focuses on comparing technological characteristics rather than presenting new clinical study data with specific acceptance criteria. Therefore, the "acceptance criteria" are implicitly met by demonstrating identical or similar performance to the legally marketed predicate device.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, it relies on demonstrating technological equivalence to the predicate device. The "acceptance criteria" are therefore qualitative statements of similarity or identicality to the predicate device across various features and performance aspects.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (CARDIOTOUCH-3000)
Indications for Use: Identical to predicate device: detecting and measuring parameters to help doctors in determining patient's vital condition, including accurate heart rate, electrocardiograph wave, and printing current ECG waves and related numeric values.	Identical: "Both CardioCare-2000 and CardioTouch-3000 are detecting and measuring as below parameters to provide and help doctors for making figure out the patient's vital condition. • Accurate Heart Rate • Electrocardiograph wave • Printing the current ECG wave and related numeric values"
Target Population: Identical to predicate device: used by cardiologists and sports experts for monitoring heart patients.	Identical: "Predicate device and this device are used by cardiologist and sports expert etc. for watching heart patient condition."
Performance (Technical Specifications): Identical to predicate device for key ECG recording parameters.	Identical: • ECG leads: Standard 12 leads • Sensitivity: 5,10,20, Auto • Input circuit: floating input, isolated and defibrillation protected. • Input impedance: ≥ 10MΩ • Input circuit current: ≤ ± 5mV • Calibration Voltage: 1mV±2% • Time Constant: 100dB or better • Frequency response: 0.05~150Hz within -3dB
Design: Similar to predicate device, with variations in display type (e.g., LCD).	Similar: "CardioCare-2000 have 2line 16character LCD and CardioTouch-3000 have 320 X 200 dot with back lit LCD."
Materials: Identical to predicate device (ABS materials).	Identical: "CardioCare-2000 and CardioTouch-3000 are made of ABS materials."
Biocompatibility: Satisfied through use of disposable electrodes, identical to predicate device.	Identical: "Both of them are satisfied Biocompatibility through using disposable electrode."
Mechanical Safety: Identical to predicate device; coarse surfaces and sharp corners removed/covered to prevent patient damage.	Identical: "A coarse surface and a sharp corners of a device which has cause of patient damage of device are removed and covered."
Energy used and/or delivered: Identical to predicate device (rechargeable battery, 100V~240Vac 50/60 Hz).	Identical: "Both of them use the rechargeable battery (100V~240Vac 50/60 Hz and Built-in)."
Compatibility with environment and other devices: Identical to predicate device; suitable for EMI and EMC testing.	"CardioCare-2000 and CardioTouch-3000 are suitable for EMI and EMC test."
Where used: Identical to predicate device (Private Check, ER, Hospitals).	Identical: "Private Check, ER, Hospitals."
Standards met: Identical to predicate device.	Identical
Electrical safety: Identical to predicate device.	Identical
Thermal safety: Identical to predicate device.	Identical
Radiation safety: Identical to predicate device.	Identical
Automatic Diagnosis: Provides 25 diagnoses, an enhancement compared to the predicate's description but still within the scope of ECG analysis. (This is a feature rather than a direct comparison of diagnostic accuracy).	Available: "Twenty-five diagnoses are available through auto diagnosis"

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific test set, sample size, or data provenance for evaluating the CARDIOTOUCH-3000's performance against clinical acceptance criteria. The submission relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and shared intended use. This type of 510(k) (Special 510(k)) often focuses on design control changes and verification/validation activities to ensure the new device meets its own specifications, which are aligned with the predicate. There is no mention of a clinical performance study using patient data to prove diagnostic accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As no specific test set or clinical performance study for diagnostic accuracy is described, there is no information regarding experts, ground truth establishment, or their qualifications.

4. Adjudication Method for the Test Set

Since no specific test set or clinical performance study is described, there is no information regarding an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or at least not described in the provided summary. The submission focuses purely on demonstrating technological equivalence to a predicate device, not on comparing human reader performance with or without AI assistance. The device is a standalone ECG analysis system, not an AI-assisted interpretation tool for human readers in the context of this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself includes "automatic diagnosis" as a feature ("Twenty-five diagnoses are available through auto diagnosis"). However, the document does not describe a standalone performance study for this automatic diagnosis algorithm with explicit metrics (e.g., sensitivity, specificity, accuracy against a reference standard). The performance claims are limited to the technical specifications of ECG signal acquisition and analysis, stating they are "Identical" to the predicate.

7. The Type of Ground Truth Used

As no specific clinical performance study for diagnostic accuracy is described, there is no mention of the type of ground truth used. The "ground truth" for the submission is effectively the established performance and safety profile of the predicate device.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. ECG analysis algorithms can be developed using large datasets, but this information is not part of this 510(k) summary, which focuses on hardware and basic functionality equivalence.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth was established.

Summary

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NOV 1 4 2002

510(k) Summary As Required by 21 section 807.92 ( c )

KO23034 p. L/3

1-Submitter Name: BIONET Co., LTD

2-Address: #501. KICOX Venture Center. 188-5. Guro-Dong, Guro-Gu
- Seoul, South Korea
+82 2 6300 6419 / +82 2 6300 6418 3-Phone:
4-Fax: +82 2 6300 6425

5-Contact Person: Dong-Joo Kang, CEO

6-Date summary prepared: September 6th, 2002

7- Official Correspondent: Mansour Consulting LLC

1308 Morningside Park Dr 8- Address:
- Alpharetta, GA 30022 USA
9- Phone: (678) 908-8180 (425) 795-9341
10- Fax:
11- Contact person: Jay Mansour, president
12-Device Trade or Proprietary Name: CARDIOTOUCH-3000

13-Device Common or usual name: ECG

14-Device Classification Name: System, ECG Analysis

15-Substantial Equivalency is claimed against the following device: Bionet's EKG-2000 Cardio Care, 510k #K011328 (refer to Appendix 2 for FDA website printout) This notification for CARDIOTOUCH-3000 is of the

SPECIAL type

16-Description of the Device: (as per User Manual pages17 and 18) As an electrocardiograph with 12-channel, CARDIOTOUCH-3000 does not only provide parameters and diagnose a patient automatically for patient's electrocardiogram, but also it improves chart management by printing information on an operator as well as on the patient. Furthermore, for the convenience of operators, it is designed so that an operator needs to press a button once to let the machine measure and record patient's electrocardiogram, apply a filter, extract parameters, diagnose a patient automatically then print out a result on an A-4- size report. In addition, the built-in battery helps an operator carry and use CARDIOTOUCH-3000 easily and conveniently for a hospital on wheel and an emergency.

Product features:

It prints out 12-channel ECG waveforms on an A-4 size report in . various channel forms including 3ch+1rhy, 6ch+1rhy, and 12ch rhy.
It records 1ch rhy for 60 seconds and prints it on an A4-size report -
It displays 12ch rhy simultaneously and continuously in real-time. -
-It automatically calculates heart rate, PR interval, QRS interval, QT interval, QTc, and P-R-T axis for diagnosis and displays all of them with electrocardiogram on the report.
Twenty-five diagnoses are available through auto diagnosis ・
It helps a diagnosis with the changing once-recorded electrocardiogram in a filter setup, signal size, printing speed, channel form and rhythm form and then printing them.
With a built-in battery, it is easy to carry. -
Managing a chart is easy and improved because it prints information on a patient and operator at the same time.

3/1

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Basic configuration and accessories:

1- CARDIOTOUCH-3000 body
2- Patient cable (1 EA)
3- User Manual (1 VOL.)
4- ECG Paper (2 EA)
5- Power cable (1 EA)

Options:

1- Battery (built-in type)
2- Protective Ground wire (1 EA)
3- Electrode (10 EA)
4- ECG cream (1 EA)
5- Hanger (1 EA)
6- Cart (1 EA)

17-Intended use of the device: (Indications for use typed on a separate FDA form) The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult population. The device is not intended for home use. The device is not designated for intracardial use.

18-Safety and effectiveness of the device:

This device is safe and effective as the predicate device, being a deviation from the previously cleared Bionet's product EKG-2000 Cardio Care.

This is better expressed in the tabulated comparison (Paragraph 19 below) 19-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that CARDIOTOUCH-3000 is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency detailed chart path is attached.

FDA file reference number	510k #K011328
Attachments insidenotification submission file	510k summary print out
TECHNOLOGICALCHARACTERISTICS	Comparison result
Indications for use	Identical:Both CardioCare-2000 and CardioTouch-3000are detecting and measuring as below parametersto provide and help doctors for making figure outthe patient's vital condition.• Accurate Heart Rate• Electrocardiograph wave• Printing the current ECG wave and relatednumeric values
Target population	Identical:Predicate device and this device are used bycardiologist and sports expert etc. for watchingheart patient condition.
	K023034p.313
Design	Similar:CardioCare-2000 have 2line 16character LCDand CardioTouch-3000 have 320 X 200 dot withback lit LCD.
Materials	Identical:CardioCare-2000 and CardioTouch-3000 aremade of ABS materials.
Performance	Identical:ECG leads : Standard 12 leadsSensitivity : 5,10,20, AutoInput circuit : floting input, isolated anddefibrillation protected.Input impedence : $\geq$ 10MΩInput circuit current : $\leq \pm$ 5mVCalibration Voltage : 1mV±2%Time Constant : 100dB or betterFrequency response : 0.05~150Hz within -3dB
Sterility	Not applicable
Biocompatibility	Identical:Both of them are satisfied Biocompatibilitythrough using disposable electrode.
Mechanical safety	Identical:A coarse surface and a sharp corners of a devicewhich has cause of patient damage of device areremoved and covered.
Chemical safety	Not applicable
Anatomical sites	Not applicable
Human factors	Not applicable
Energy used and/or delivered	Identical:Both of them use the rechargeable battery(100V~240Vac 50/60 Hz and Built-in).
Compatibility withenvironment and otherdevices	CardioCare-2000 and CardioTouch-3000 aresuitable for EMI and EMC test.
Where used	Identical: Private Check, ER, Hospitals.
Standards met	Identical
Electrical safety	Identical
Thermal safety	Identical
Radiation safety	Identical

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3/3

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bionet Company Ltd. c/o Mr. Jay Mansour President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022

Re: K023034

Trade Name: CARDIOTOUCH-3000 Regulation Number: Unclassified Regulation Name: ECG Analysis System Product Code: LOS Dated: October 8, 2002 Received: October 21, 2002

Dear Mr. Mansour:

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.

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 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.

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Page 2 - Mr. Jay Mansour

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Elias Mallis

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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510(k) Number (if known): KO23034

Device Name: CARDIOTOUCH-3000

Indications for Use:

The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardio information from adult population. The device is not intended for home use. The device is not designated for intracardial use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ----------------------------------------------------

Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Format 3-10-98)

Dias Malli

Division of Cardiovascular & Respiratory Devices

510(k) Number K023034

Prescription Use
(Per 21 C.

Regulation Number and Section

N/A