The clue medical and clue medical BASIC are handheld, battery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm. The clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals.

Specifically, the clue medical and clue medical BASIC are intended for patients that are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm:

Skipped beats Pounding heart (palpitations)

History of arrhythmia

The clue medical and clue medical BASIC ECG data is intended to be used by a licensed health care practitioner. These measurements are not intended for any specific clinical diagnosis. The clinical significance must be determined by the physician.

Device Description

The clue medical is an handheld battery operated single-channel ECG recorder featuring four fixed electrodes on the back of the device, an ECG lead connector, an IrDA interface and one single button to record and store up to ten ECG recordings with 30 seconds or two minutes duration. The stored ECG tests are processed into a printable Portable Document Format (pdf) that can be transmitted two ways. The pdf can be transmitted via IrDA to an IrDA capable local PC or printer. If the receiving device is not IrDA capable, an optional IrDA USB stick is provided with the clue medical. The pdf file can then be saved, sent, displayed or printed. Alternatively, the pdf can be transmitted via an IrDA capable cell phone directly to the Telovital server for storage.

The clue medical BASIC is identical to the clue medical in design. The only difference is that the clue medical BASIC does not provide the added capability of sending the ECG data via cell phone directly to the Telovital server, it is only capable of IrDA transmission to a local PC or printer.

AI/ML Overview

The provided text describes the "clue medical and clue medical BASIC Telemedical Systems" and states that "Performance Testing" was conducted to meet several IEC standards. However, it does not provide detailed acceptance criteria with specific thresholds or reported device performance metrics in a quantitative manner that would allow for the creation of a table.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the devices "have been tested to meet all of the following standards," implying that compliance with these standards represents the acceptance criteria. However, it does not provide any quantitative performance results from these tests. Therefore, a table with specific performance metrics cannot be generated from the given text.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
IEC 60601-1: General Requirements for Safety	Compliant (Stated)
IEC 60601-1-1: Safety Requirements for Medical Electrical Systems	Compliant (Stated)
IEC 60601-1-2: General Requirements for Safety	Compliant (Stated)
IEC 60601-2-25: Particular Requirements for the Safety of Electrocardiographs	Compliant (Stated)
IEC 60601-2-47: Particular requirements for safety, including performance, for ambulatory electrocardiographic systems	Compliant (Stated)
IEC 60601-1, subclause 56.3(c) for electrode leadwires	Compliant (Stated)

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

The document mentions "Performance Testing" but does not specify any sample size for a test set (e.g., number of patients, number of ECG recordings). There is also no information regarding data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention the use of experts to establish ground truth for any test set or the qualifications of such experts. The study described focuses on compliance with electrical and safety standards, not on clinical performance evaluated by human experts against a ground truth.

4. Adjudication Method for the Test Set:

Since there is no mention of a test set being evaluated by experts or any clinical outcome, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or mentioned. The submission describes compliance with technical standards for an electrocardiograph and its electrical safety, not a study evaluating human reader performance with or without AI assistance. The device is a "single channel electrocardiograph intended for recording and transmitting ECG data," not an AI-powered interpretation system.

6. Standalone (Algorithm Only) Performance Study:

No standalone (algorithm only) performance study was conducted or described in the provided text. The device itself is hardware for recording ECG data; it doesn't appear to have an independent algorithm for interpretation (beyond potentially saving it as a PDF for healthcare professionals). The output is intended to be used by a "licensed health care practitioner" for determination of clinical significance.

7. Type of Ground Truth Used:

The study referenced is focused on compliance with electrical safety and performance standards (e.g., IEC 60601 series), not clinical diagnostic accuracy. Therefore, the "ground truth" for this "study" would be the specifications and requirements outlined in those standards, rather than expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

No training set is mentioned or implied as the device is not described as utilizing machine learning or artificial intelligence that would require a training set.

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

Since there is no training set, this question is not applicable.

Summary

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NOV 10 2008

K082013
Pg 1 of 3

Class II

Section 5: 510(k) Summary

and the same

. . . . . .

Monitor, Omron Healthcare

The following information is provided as required by 21 CFR § 807.87 for Telovital's 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the clue medical and clue medical BASIC is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).

Sponsor:		Telovital GmbH TelemedizinOffice Park I / Top 4A-1300 - Vienna - Airport
Contact:		Calley HerzogM Squared Associates901 King St. Suite 200Alexandria, VA 22314Ph: 703-562-9800 x261Fax: 703-562-9797Email: cherzog@msquaredassociates.com
Date Prepared:		October 10, 2008
Proposed Class:		II
Proprietary Name:		clue medical and clue medical BASIC TelemedicalSystems
Common Name:		Electrocardiograph
Classification Name:		Electrocardiograph
Regulation Number:		21 CFR 870.2340, 21 CFR 870.2920
Product Codes:		DPS, DXH
Predicate Device(s):
	Device Name	Procode	Common Name	Class
K072353	Portable ECScope,DyAnsis Corp.	DPS	Electrocardiograph	Class II
K060766	HCG Portable ECG	DPS	Electrocardiograph	Class II

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K082213
pg 2 of 3

K050670 Sensor mobile SM 100 DXH VITAPHONE

transmitters and receivers, electrocardiograph, telephone

Class II

Indication for Use

The clue medical and clue medical BASIC are handheld battery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm. The clue medical and clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals.

Skipped beats Pounding heart (palpitations) History of arrhythmia

Device Description

The clue medical is an handheld battery operated single-channel ECG recorder featuring four fixed electrodes on the back of the device, an ECG lead connector, an IrDA1 interface and one single button to record and store up to ten ECG recordings with 30 seconds or two minutes duration. The stored ECG tests are processed into a printable Portable Document Format (pdf) that can be transmitted two ways. The pdf can be transmitted via IrDA to an IrDA capable local PC or printer. If the receiving device is not IrDA capable, an optional IrDA USB stick is provided with the clue medical. The pdf file can then be saved, sent, displayed or printed. Alternatively, the pdf can be transmitted via an IrDA capable cell phone directly to the Telovital server for storage.

IIDA refers to Infrared Data Association, a standard for communication between devices (such as computers, PDAs and mobile phones) over short distances using infrared Data Association (IrDA) defines physical specifications communications protocol standards for the short-range exchange of data over infrared light.

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K082013

pg 3 of 3

Performance Testing

The clue medical and clue medical BASIC have been tested to mcct all of the following standards:

IEC 60601-1, "Medical Electrical Equipment, General Requirements for Safety" �
IEC 60601-1-1, "Safety Requirements for Medical Electrical Systems" .
IEC 60601-1-2, "Part 1, General Requirements for Safety" .
IEC 60601-2-25, "Medical Electrical Equipment Part 2: Particular Requirements for . the Safety of Electrocardiographs"
IEC 60601-2-47, "Medical Electrical Equipment, Particular requirements for safety, . including performance, for ambulatory electrocardiographic systems"

Electrode leadwires were found to be compliant to IEC 60601-1, subclause 56.3(c),

Technological Characteristics and Substantial Equivalence

The clue medical and clue medical BASIC are substantially equivalent to one or more of the predicate devices in design, measurement capability intended use and output format.

Their design, measurement capability and output are equivalent to the previously cleared Sensor Mobile device (K050670) and Portable EC Scope (K072353). Their intended use is equivalent to the Omron HCG-801 Portable ECG Monitor (K060766). This premarket notification has described the characteristics of the clue medical and clue medical BASIC in sufficient detail to assure substantial equivalence.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Telovital GmbII Telemedizin c/o Ms. Calley Herzog M Squared Associates 901 King St. Suite 200 Alexandria, VA 22314

NOV 1 0 2008

Re: K082013

Trade Name: clue medical and clue medical BASIC Telemedical Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Codes: DPS, DXH Dated: October 9, 2008 Received: October 10, 2008

Dear Ms. Herzog:

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.

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 (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.

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Page 2 - Ms. Calley Herzog

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Onna R. bo dines

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

Enclosures

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Section 4: Indications for Use Statement

K082013 510(k) Number:

Device Name: clue medical and clue medical BASIC

Indications for Use:

Skipped beats Pounding heart (palpitations)

History of arrhythmia

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

er R. vi hines

of Cardiovascular Devices

KOBZOIB 510(k) Number ...

Page 1 of

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).