CYGNUS 12 LEAD ECG MODULE

K072950 · Cygnus, LLC · KRE · Aug 22, 2008 · Cardiovascular

Device Facts

• Record ID: K072950
• Device Name: CYGNUS 12 LEAD ECG MODULE
• Applicant: Cygnus, LLC
• Product Code: KRE · Cardiovascular
• Decision Date: Aug 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3640
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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 Story

Cygnus 12 Lead/TTM ECG Module is a PC-based ECG and pacemaker monitoring system; connects via USB. System components: analog front end; digital signal processing USB interface; TTM interface for analog/digital phone lines. Operates in clinic/hospital; used by physicians or representatives. Inputs: 12-lead ECG signals; encoded pacemaker signals via phone line (FM). Outputs: ECG/heart rate monitoring data; pacemaker detection/measurement metrics. Functions as TTM receiving station for remote signal transmission. Enables clinical assessment of cardiac rhythm and pacemaker function; supports remote monitoring workflows via landline telephony.

Clinical Evidence

Bench testing only. The device was tested for compliance with AAMI/ANSI EC 11:1991 (Diagnostic Electrocardiographic Devices) and AAMI/ANSI EC 38:1998 (Ambulatory Electrocardiographs). No clinical data provided.

Technological Characteristics

PC-powered via USB. Components: analog front end, digital signal processing unit, TTM interface for analog/digital phone lines. Supports 12-lead ECG acquisition and FM-encoded pacemaker signal reception. Standards: AAMI/ANSI EC 11:1991, AAMI/ANSI EC 38:1998.

Indications for Use

Indicated for clinical use in hospital or clinic settings for 12-lead ECG recording, heart rate monitoring, pacemaker detection/measurement, and as a trans-telephonic (TTM) receiving station for ECG and pacemaker signals via landline analog or digital PBX telephone systems. Not for patient self-use or wireless network use.

Regulatory Classification

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.

Predicate Devices

• PACEART CPTS-86/12 (K915632)

Submission Summary (Full Text)

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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.

2

#### Technology as

510 East 41* Street, Paterson, NJ 07504

AUG 2 2 2008

Certificate no. US-3238

Phone: [phone] Fax: [phone] Email: [e-mail] 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: | [e-mail] |
| 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 [phone]. 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 [phone] or [phone] 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_