The Vitaphone 100 BT device is single-channel cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system, such as REMOS ECG Receiving Software (510(k) K050670) or compatible ECG receivers.

The Vitaphone 100 BT device is intended for patient activated event recordings. It is battery driven and utilizes a Flash memory to store ECG data with an adjustable event time.

AI/ML Overview

This 510(k) submission for the Vitasystems GmbH Post-Event Recorder Vitaphone 100 BT focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way a novel AI algorithm would.

Therefore, many of the requested categories regarding acceptance criteria, study design, and performance metrics are not applicable or cannot be extracted directly from this document. This submission relies on proving the new device performs similarly to
already approved devices under established safety and performance standards.

Here's an breakdown of the available information based on your request, with an explanation of why some sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a specific table of acceptance criteria and reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, accuracy, F1 score) that would be relevant for an AI/CADe device. Instead, the "acceptance criteria" for this type of device are centered around meeting established safety and performance standards for electrophysiological equipment and demonstrating substantial equivalence to predicate devices.

Acceptance Criteria (Implied from the 510(k) and applicable standards):

Acceptance Criteria Category	Vitaphone 100 BT Performance/Evidence
Safety and Electrical Performance	Compliance with:EN 60601-1:2006 (General Requirements for Safety)EN 60601-1-2:2007 (Electromagnetic compatibility)E DIN IEC 60601-2-47:2008 (Safety and essential performance of ambulatory ECG systems)
Biological Compatibility	Compliance with:ISO 10993-1:2003 (Biological Evaluation of Medical Devices)
Risk Management	Compliance with:ISO 14971:2007 (Application of risk management to medical devices)
Quality Management System	Compliance with:ISO 13485:2007 (Quality management systems)
Functional Equivalence	"The operation of the Vitaphone 100 BT shows a safe and reliable means for recording and transmission of patient ECG parameters and no adverse health effect or safety risk to patients when used as intended." (This is a summary statement of functional equivalence to predicate devices for its intended use as a cardiac event recorder transmitting ECGs to compatible receiving systems.)
Intended Use	The device successfully performs its intended use: "single-channel cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system... intended for patient activated event recordings. It is battery driven and utilizes a Flash memory to store ECG data with an adjustable event time." This aligns with the capabilities of the predicate devices.
Substantial Equivalence	Demonstrated through comparison with Vitaphone 3100 BT (K053378) and PMP4 SelfCheck ECG (K042254), implying similar technological characteristics and performance in recording and transmitting ECG data.

2. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission is for a hardware device (cardiac event recorder) that records and transmits ECGs. It does not involve a "test set" of data for diagnostic performance evaluation of an algorithm in the way an AI/CADe device would. The evaluation is against engineering standards and comparison to predicate devices, not against a clinical dataset for diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As above, there is no "test set" requiring ground truth establishment by experts for diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set requiring adjudication in this context.

5. 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

Not Applicable. This is a standalone device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware device for recording and transmitting ECGs. While its function implicitly involves "sensing" and "recording," it is not an "algorithm only" device in the AI sense, nor does it perform automated diagnosis. Its "standalone performance" is related to its ability to accurately capture and transmit ECG signals, which is assessed through compliance with technical standards rather than an algorithmic evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. For a device of this nature, the "ground truth" would relate to the accuracy of its electrical measurements and data transmission properties, verified against calibrated equipment and engineering specifications, rather than clinical ground truth like pathology or expert consensus on a diagnosis.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established

Not Applicable. No training set exists for this type of device.

Summary

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Vitasystems GmbH 510(K) Submission 100 BT Sec. 5, 510(k) Summary

vitasvstem

APR 2 0 2010

510(k) Summary

Post-Event Recorder vitaphone 100 BT

Submitter:

Vitasystems GmbH Stadlerstraße 14 D-09126 Chemnitz, Germany Phone: +49 371 40081 0 Fax: +49 371 40081 22

Contact Person: Tilo Borchardt, CTO Phone: +49 371 40081 122 Fax: +49 371 40081 22 Email: tb@vitasystems-gmbh.com

Establishment Registration Number:	3005191294
Trade Name:	Vitaphone 100 BT
Common Name:	Tele ECG System, Cardiac Event Recorder, Post-Event Recorder
Classification Name:	Telephone electrocardiograph transmitter and receiver(per 21 CFR Section 870.2920, Product Code: DXH)

1. Predicate Devices

Device Type	Vitaphone 3100 BT	PMP4 SelfCheck ECG
Manufacturer	Vitasystems GmbH	Card Guard Ltd.
510(K) Number	K053378	K042254

Table 5-1

2. Intended Use

The Vitaphone 100 BT device is intended for patient activated event recordings. It is battery driven and utilizes a Flash memory to store ECG data with an adjustable event time.

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Vitasystems GmbH 510(K) Submission 100 BT Sec. 5, 510(k) Summary

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3. Device Classification

The system is classified as Class II medical device (21 CFR 870.2920).

4. Applicable Standards

EN 60601-1:2006, "Medical Electrical Equipment, General Requirements for Safety"
EN 60601-1-2:2007, "Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic compatibility - Requirements and tests"
E DIN IEC 60601-2-47:2008, "Medical Electrical Equipment, Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems"
ISO 10993-1:2003, "Biological Evaluation of Medical Devices, Evaluation and Testing"
ISO 14971:2007, "Medical devices Application of risk management to medical devices"
ISO 13485:2007, "Medical Devices Quality management systems Requirements for regulatory purposes"

5. Substantial Equivalence

Through the data and information presented, Vitasystems GmbH considers the Vitaphone 100 BT as substantially equivalent to the previously mentioned predicate devices. The operation of the Vitaphone 100 BT shows a safe and reliable means for recording and transmission of patient ECG parameters and no adverse health effect or safety risk to patients when used as intended.

Vitasystems GmbH Tilo Borchardt сто

Signature: ...

Date: ....................................................................................

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Vitasystems GmbH c/o Mr. Tilo Borchardt Chief Technical Officer (CTO) Stadlerstrasse 14 Chemnitz GERMANY 09126

APR 2 0 2010

Re: K100383

Trade/Device Name: Post-Event Recorder Vitaphone 100 BT Regulatory Number: 21 CFR 870.2920 Regulation Name: Transmitter and Receiver, Electrocardiograph, Telephone Regulatory Class: II (two) Product Code: 74 DXH Dated: February 14, 2010 Received: February 16, 2010

Dear Mr. Borchardt:

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 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. Tilo Borchardt

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

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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Indications for Use

510(k) Number (if known):

Device Name: Post-Event Recorder Vitaphone 100 BT

Indications for Use:

Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as:

– Dizziness

Heart race
Palpitations
Syncopes of unknown cause

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

__, and I'm here to help.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K100393

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).