The device is for prescription use only.
The device is intended to be used in a clinic or hospital.
The device is intended for use by the physician (or his/her representative), not by the patient, although one intended use is to record the patient's 12-lead ECG.
The device is intended for use as a : Fully functional ECG/heart rate monitoring system for clinical use. Pacemaker Detection and measurement. A TTM (trans-telephonic) Receiving Station.
In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It is not intended to be used with wireless networks.

Device Description

Cygnus 12 Lead/TTM ECG module is a fully functional ECG and Pacemaker monitoring system that is powered through a PC USB (Universal Serial Bus) port.
Four general parts could be distinguished in the Cygnus 12 Lead/TTM ECG module:

An analog front end.
Digital Signal Processing USB Interface Unit.
TTM Interface for analog phone lines.
TTM Interface for digital phones.
The module measures the 12 standard ECG leads on the isolated input, and is capable of acting as an ECG Receiving Station over the phone line for ECG and pacemaker encoded signal with Frequency Modulation (FM).

AI/ML Overview

The provided document is a 510(k) summary for the Cygnus 12 Lead/TTM ECG Module. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain explicit acceptance criteria or a detailed study report that would typically prove a device meets specific performance metrics.

Instead, the summary states:

"The device was tested in accordance with applicable sections of AAMI/ANSI EC 11: 1991, Diagnostic Electrocardiographic Devices and AAMI/ANSI EC 38: 1998, Ambulatory Electrocardiographs."

This indicates that the device's performance was evaluated against the standards outlined in these AAMI/ANSI documents, which would inherently contain performance requirements and testing methodologies for ECG devices. The "Summary of testing" section broadly states this, and the "Conclusion" relies on functional similarities with the predicate device (K915632) to establish substantial equivalence.

Without access to the actual test reports or the specific sections of the AAMI/ANSI standards that Cygnus LLC applied and measured against, a detailed table of acceptance criteria and reported device performance cannot be generated from this document alone.

Therefore, many of your requested points cannot be extracted directly from this 510(k) summary. I will answer what is available and indicate when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit acceptance criteria and corresponding reported performance are not detailed in this 510(k) summary. The document states compliance with AAMI/ANSI EC 11: 1991 and AAMI/ANSI EC 38: 1998. These standards would contain the acceptance criteria for diagnostic and ambulatory ECG devices, respectively. Without access to these standards and Cygnus's specific test reports, a detailed table cannot be created.

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

This information is not provided in the 510(k) summary. The document only mentions that the device was "tested in accordance with applicable sections" of the AAMI/ANSI standards, but provides no specifics about the test set, sample size, or data provenance.

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)

This information is not provided in the 510(k) summary, as it does not detail the specific testing methodology for establishing ground truth or the involvement of experts in that process.

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

This information is not provided in the 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not described or referenced in this 510(k) summary. This device is a measurement and monitoring system, not an AI-assisted diagnostic tool in the typical sense that would necessitate such a study (i.e., it's not performing diagnostic interpretation that would then be compared to human readers).

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

The 510(k) summary describes a "fully functional ECG and Pacemaker monitoring system." The testing mentioned (AAMI/ANSI EC 11 and EC 38) would evaluate the standalone performance of the device's measurement capabilities (e.g., accuracy of ECG waveform acquisition, heart rate measurement, pacemaker pulse detection). While not explicitly stated as "standalone algorithm performance," the nature of these standards implies testing the device's technical specifications and measurements without a human interpreting the device's output to influence the device's function or measurement.

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

The document does not explicitly state the "type of ground truth used." For a device measuring ECG signals and detecting pacemaker activity, the ground truth would typically be established through:

Reference standard equipment: Comparison to known, calibrated, and highly accurate ECG and pacemaker simulators or other established reference devices.
Physiological recordings: In some cases, recordings from human subjects or animal models where true physiological events are simultaneously measured by gold-standard methods, although the AAMI/ANSI standards primarily focus on technical performance.

Given the nature of the device and the standards cited, the ground truth would likely involve a combination of precise electrical signals, simulated ECGs, pacemaker pulses, and potentially recordings validated against professional interpretation or other highly accurate monitoring equipment.

8. The sample size for the training set

This device is not presented as an AI/machine learning model requiring a "training set" in the conventional sense. Therefore, this information is not applicable and not provided. The device's performance would be based on its engineering design, hardware, and algorithms for signal acquisition and processing, evaluated against technical standards.

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

As the device is not an AI/machine learning model with a "training set," this question is not applicable.

Summary

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K072950

Image /page/0/Picture/1 description: The image shows the word "CYGNUS" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The word appears to be a title or heading, possibly related to astronomy or a company name.

Image /page/0/Picture/3 description: The image shows the ISO 9001:2000 certification logo. The logo includes a globe with lines representing latitude and longitude. Below the globe, the word "CERTIFICATION" is written in a curved manner. The Intertek logo is at the bottom of the image.

Technology as

510 East 41* Street, Paterson, NJ 07504

AUG 2 2 2008

Certificate no. US-3238

Phone: 973 523-0668 Fax: 973 523-0375 Email: info@cygnusnj.com Web: www.cygnusnj.com

510(k) Summary [As required by 21 CFR 807.92(c)]

1. Submitter Information:

Name:	Cygnus LLC
Address:	510 East 41st Street, Paterson, NJ 07504
Telephone:	973-523-0668
Fax:	973-523-0375
Email:	info@cygnusnj.com
Contact Person:	Narcis Naydenov
Date Prepared:	September 26, 2007

2. Device:

Proprietary Name:	Cygnus 12 Lead/TTM ECG Module
Common Name:	Analyzer, Pacemaker Generator Function, Indirect
Classification Name:	Class II (21 CFR 870.3640, Product code KRE)

3. Description:

Cygnus 12 Lead/TTM ECG module is a fully functional ECG and Pacemaker monitoring system that is powered through a PC USB (Universal Serial Bus) port.

Four general parts could be distinguished in the Cygnus 12 Lead/TTM ECG module:

An analog front end. .

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Digital Signal Processing USB Interface Unit. �
TTM Interface for analog phone lines. .
TTM Interface for digital phones. t

1 we module measures the 12 standard ECG leads on the isolated input, and is capable of acting as an ECG Receiving Station over the phonc line for ECG and pacemaker encoded signal with Frequency Modulation (FM).

4. Intended Use:

The device is for prescription use only. .
The device is intended to be used in a clinic or hospital. .
The device is intended for use by the physician (or his/her representative), not by the patient, although one t intended use is to record the patient's 12-lead ECG.
. The device is intended for use as a : Fully functional ECG/heart rate monitoring system for clinical use. Pacemaker Detection and measurement. A TTM (trans-telephonic) Receiving Station.
In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It . is not intended to be used with wireless networks.

5. Substantially equivalent devices:

Cygnus LLC considers the legally marketed PACEART CPTS-86/12 (K915632) cardiac receiving station to be substantially equivalent to Cygnus 12 Lead/TTM ECG Module, with a number of features shared.

6. Jummary of testing:

The device was tested in accordance with applicable sections of AAMI/ANSI EC 11: 1991, Diagnostic Electrocardiographic Devices and AAMI/ANSI EC 38: 1998, Ambulatory Electrocardiographs.

7. Conclusion:

Based on the information presented in this application, and namely the functional similarities with K915632, Cygnus LLC considers the Cygnus 12 Lead/TTM ECG Module to be substantially equivalent to a legally marketed predicate device.

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Image /page/2/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 22 2008

Cygnus, LLC c/o Mr. Narcis Naydenov Member of Board 510 East 41st Street Paterson, NJ 07504

Rc: K072950

Trade/Device Name: Cygnus 12 Lead/TTM ECG Module Regulation Number: 21 CFR 870.3640 Regulation Name: Indirect pacemaker generator function analyzer Regulatory Class: Class II (Two) Product Code: KRE Dated: August 18, 2008 Received: August 19, 2008

Dear Mr. Naydenov:

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. Narcis Naydenov

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. This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1egally 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 (240) 276-0120. Also, please note the regulation ontitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Swall Manufacturers, International and Consumer Assistance at its toll-free number (800) 631-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

ell Mall

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 1

Indications for Use Statement

.(k) Number (if known):K072950

Device Name: Cygnus 12 Lead/TTM ECG module

Indication for Use:

The device is for prescription use only. .
. The device is intended to be used in a clinic or hospital.
The device is intended for use by the physician (or his/her representative), not by the patient, although one . intended use is to record the patient's 12-lead ECG.
. The device is intended for use as a : Fully functional ECG/heart rate monitoring system for clinical use. Paccmaker Detection and measurement. A TTM (trans-telephonic) Receiving Station.
In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It ● is not intended to be used with wireless networks.

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)

ecmre

(Division Sign-Off)
Division of Cardiovascular Devices

K672950 510(k) Number_

Regulation Number and Section

§ 870.3640 Indirect pacemaker generator function analyzer.

(a)
Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin.(b)
Classification. Class II (performance standards).