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.

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 cluc 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 and a Bluetooth 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 or Bluetooth to an IrDa or Bluetooth capable local PC or printer. If the receiving device is not IrDa or Bluetooth 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 a Bluetooth capable cell phone directly to the Telovital server for storage.

The device requires that a user is mentally and physically capable of reading and understanding the Patient Operating Instructions. The patient must also be physically capable of pressing the record button and holding the device to his/her chest for an adequate reading.

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 transmission to a local PC or printer. The purpose of this Special 510(k) is to modify the method of wireless data transmission for both the clue medical and clue medical BASIC to include Bluetooth technology.

AI/ML Overview

This 510(k) submission (K083630) is for a modification to an already cleared device, the Telovital clue medical and clue medical BASIC. The modification specifically concerns the addition of Bluetooth technology for wireless data transmission. As such, the submission focuses on demonstrating that this change does not affect the device's fundamental safety, effectiveness, or intended use compared to the previously cleared version (K082013).

Therefore, this document does not contain specific acceptance criteria for diagnostic performance or a detailed study proving the device meets new acceptance criteria for diagnostic accuracy. Instead, the "study" demonstrating acceptance is the testing performed against established safety and performance standards, asserting that the modification does not negatively impact these.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission is for a modification to an existing device, there are no specific diagnostic performance acceptance criteria or corresponding reported performance data for parameters like sensitivity, specificity, or AUC related to diagnostic accuracy. The acceptance criteria referenced are compliance with widely recognized medical device safety and performance standards. The reported "performance" for this submission is that the device continues to meet these standards after the modification.

Acceptance Criteria (Standards)	Reported Device Performance (Compliance)
IEC 60601-1: General Requirements for Safety	Compliant
IEC 60601-1-1: Safety Requirements for Medical Electrical Systems	Compliant (Previously, reaffirmed)
IEC 60601-1-2: Electromagnetic compatibility - Requirements and tests	Compliant
IEC 60601-2-25: Particular Requirements for the Safety of Electrocardiographs	Compliant
IEC 60601-2-47: Particular requirements for safety, including performance, for ambulatory electrocardiographic systems	Compliant
IEC 60601-1, subclause 56.3(c): Electrode leadwires (for K082013)	Compliant

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

Not applicable for diagnostic performance as this submission is for a modification of an already cleared device, not a new diagnostic claim or performance study. The testing referenced relates to engineering and safety standards. Details on sample sizes for these engineering tests are not provided. The data provenance is implied to be from laboratory testing performed by the manufacturer to ensure compliance with the listed standards.

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

Not applicable. Ground truth as typically understood for diagnostic device evaluation (e.g., expert labels for medical images) is not relevant here. The ground truth for the engineering standards is the specifications and requirements defined within those standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

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

No. An MRMC study or any study involving human readers comparing AI-assisted vs. non-AI-assisted performance was not conducted or reported in this submission. The device is an ECG recorder, not an AI-driven interpretation system.

6. Standalone (Algorithm Only) Performance Study

No. This device is a hardware ECG recorder. While it captures ECG data, it doesn't perform automated diagnostic interpretation or rely on a standalone algorithm in the sense of an AI diagnostic tool.

7. Type of Ground Truth Used

The "ground truth" for this submission is conformity to established international medical device safety and performance standards (IEC 60601 series). These standards define technical requirements, electromagnetic compatibility, and safety criteria for medical electrical equipment, specifically for electrocardiographs.

8. Sample Size for the Training Set

Not applicable. This device is a hardware ECG recorder and does not describe an AI training set.

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

Not applicable.

Summary

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K0f3630

Section 6: 510(k) Summary

APR 2 3 2009

510(k) Summary

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 / Manufacturer:	Telovital GmbH TelemedizinOffice Park I / Top 4A-1300 - Vienna - AirportAustria
Contact:	Cherita JamesM Squared Associates901 King St. Suite 200Alexandria, VA 22314Ph: 703-562-9800 x257Fax: 703-562-9797Email: CJames@MSquaredAssociates.com
Date Prepared:	December 8, 2008
Proposed Class:	II
Proprietary Name:	clue medical and clue medical BASIC
Common Name:	Electrocardiograph
Classification Name:	Electrocardiograph
Regulation Number:	21 CFR 870.2340, 21 CFR 870.2920
Product Codes:	DPS, DXH
Predicate Device:
	Device Name	Procode	Common Name	Class
K082013	clue medical and cluemedical BASIC	DPS, DXH	Electrocardiograph	Class II

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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 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 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

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phone directly to the Telovital server, it is only capable of transmission to a local PC or printer. The purpose of this Special 510(k) is to modify the method of wireless data transmission for both the clue medical and clue medical BASIC to include Bluetooth technology.

Performance Testing

The clue medical and clue medical BASIC were tested to meet the following standards for its previous clearance in K082013:

. 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 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility -Requirements and tests "
. 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).

For the purpose of this device modification the device was again tested to meet:

. IEC 60601-1, "Medical Electrical Equipment, General Requirements for Safety
. IEC 60601-1-2, " Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility -Requirements and tests "
. 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"

Summary of Technological Characteristics:

The only modification to the clue medical and clue medical BASIC since its previous clearance in K082013 is to enhance the method of wireless data transmission.

Substantial Equivalence Discussion:

The change to the method of wireless data transfer to include Bluetooth does not change the intended use or performance characteristics of the clue medical and clue medical BASIC as

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previously cleared in K082013.

Conclusion:

The modified clue medical and clue medical BASIC have the following similarities to the devices previously cleared in K082013:

4/4

has the exact same indication for use, .
uses the same operating principle, .
incorporates the same basic device design, ●
incorporates the same materials. .

Therefore the modification to the clue medical and clue medical BASIC can be found substantially equivalent to the same devices as cleared in K082013.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2009

Telovital GmbH Telemedizin c/o Ms. Cherita James M Squared Associates 901 King St., Suite 200 Alexandria, VA 22314

Re: K083630

Trade/Device Name: clue medical and clue medical BASIC Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (Two) Product Code: DXH and DPS Dated: March 26, 2009 Received: March 27, 2009

Dear Ms. James:

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 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.

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Page 2 - Ms. Cherita James

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

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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Section 5: Indications for Use Statement

Indications for Use

510(k) Number:

KO 83630

Device Name: clue medical and clue medical BASIC

Indications for Use:

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.

Prescription Use

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	AtthBte for B Zuckerman

1122/09 (Division Sign-Off) Division of Cardiovascular Devices

Page 1 of 1

510(k) Number K082630

Telovital GmbH December 2008

Page 15 of 33

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).