The vicardio is indicated for the recording of resting electrocardiograms (ECG), and for making measurements on the electrocardiograms, by a physician or under the direction of a physician.

Device Description

The vicardio is a digital, PC-based electrocardiograph with a special isolation amplifier between the patient and the computer.

AI/ML Overview

The provided documentation for the 'vicardio 12b' electrocardiograph does not include specific acceptance criteria or a detailed study proving the device meets performance criteria beyond non-clinical testing. It states that clinical tests were not required.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Non-clinical tests: The device will have passed AAMI/ANSI EC11 tests.	The software has been extensively validated and tested. The device will have passed AAMI/ANSI EC11 tests.
Clinical tests: (Not explicitly stated, but the submission implies basic functionality and safety for intended use based on predicate device equivalence).	Clinical tests were not required.
Safety and Efficacy: Equivalent to legally marketed predicate devices.	The vicardio is equivalent in safety and efficacy to the legally marketed predicate devices.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable. No clinical test set or data from a clinical study is mentioned for evaluating performance against acceptance criteria.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set or ground truth establishment by experts is described.

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

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

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

No. An MRMC comparative effectiveness study was not done. The device is a digital electrocardiograph for recording and measuring ECGs, not an AI-assisted diagnostic tool for human readers.

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

The document implies that the device (vicardio 12b) itself is a standalone electrocardiograph without human-in-the-loop AI assistance for diagnostic interpretation. Its performance is related to its ability to accurately record and measure ECGs, for which non-clinical tests (AAMI/ANSI EC11) suffice. The concept of "algorithm only" or "standalone" performance for an AI model doesn't directly apply here, as it's a hardware/software system for data acquisition and basic measurement, not an AI-driven interpretive algorithm with a diagnostic output.

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

For the non-clinical tests (AAMI/ANSI EC11), the ground truth would be established by the technical standards themselves, measured against known electrical signals and predefined performance benchmarks for ECG recording equipment. This is a technical, rather than a clinical or diagnostic, ground truth.

8. The sample size for the training set

Not applicable. The document does not describe the development of an AI model that would require a "training set" in the context of machine learning. The "software ... extensively validated and tested" likely refers to traditional software engineering validation and verification processes.

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

Not applicable, as no training set for an AI model is described.

Summary

{0}------------------------------------------------

Form Approved: OMB No. 0910-0120; Expiration Date: xx/xx/xx

K082380
page 1/2

Energy-Lab Technologies GmbH Vicardio Electrocardiograph 510(k) Submission

510(k) Summary

(1) Submitter Information Name: Energy-Lab Technologies GmbH Address: Energy-Lab Technologies GmbH Burchardstraße 21 20095 Hamburg / Germany

Tel .: +49-(0)40 - 30 37 23 30 Fax: +49-(0)40 - 30 37 23 50

info@vicardio.com

Contact Person: Dr. George Myers Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703 Fax 201-727-1708 Email medsyscons@yahoo.com Date Prepared: July 8, 2008

(2) Name of Device: Trade Name: vicardio 12b Common Name: Electrocardiograph
Classification Name: Electrocardiograph
(3) Equivalent legally-marketed devices: Spacelabs CardioDirect K024283 Spacelabs CardioCollect K013367
(4) Description The vicardio is a digital, PC-based electrocardiograph with a special isolation amplifier between the patient and the computer.

DEC 03 2008

{1}------------------------------------------------

K082380
page 2/2

(5) Intended Use
The vicardio is indicated for the recording of resting electrocardiograms (ECG), and for making measurements on the electrocardiograms, by a physician or under the direction of a physician.

(6) Technological characteristics

The vicardio is a digital electrocardiograph to be used with the purchaser's own PC. (b) Performance data

(1) Non-clinical tests The software has been extensively validated and tested. The device will have passed AAMI/ANSI EC11 tests.
(2) Clinical tests Clinical tests were not required.
(3) Conclusions

The vicardio is equivalent in safety and efficacy to the legally marketed predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle-like symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the circular seal.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2008

Energy-Lab Technologies, GmbH c/o Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462

Re: K082380

Trade/Device Name: Vicardio 12B Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (special controls) Product Code: DPS Dated: November 14, 2008 Received: November 17, 2008

Dear Mr. Mosenkis:

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

{3}------------------------------------------------

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. 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.

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): _KOR2380

Device Name:

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The vicardio12b is indicated for the recording of resting electrocardiograms (ECG), and for making measurements on the electrocardiograms, by a physician or under the direction of a physician.

Prescription Use	X (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 OF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

for B Zuckerman

Division of Cardiovascular Devices	12/2/08
510(k) Number	K082380
	Page 1 of 1

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).