GALIX ECG PROFESSIONAL STATION

K051163 · Galix Biomedical Instrumentation, Inc. · DPS · Jan 31, 2006 · Cardiovascular

Device Facts

• Record ID: K051163
• Device Name: GALIX ECG PROFESSIONAL STATION
• Applicant: Galix Biomedical Instrumentation, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jan 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GALIX ECG Professional Station system is intended for 12 Channel ECG recording and monitoring (running the ECG-PS software module) and 12 channel cardiac stress testing (running the ERGO-PS software). It is indicated for use: - · with Male/Female Pediatric to Adult population - · in Hospital, Clinic and Physician´s office - · under prescription by a physician

Device Story

GALIX ECG Professional Station (Models ECG-PS and ERGO-PS) performs 12-channel ECG recording, monitoring, and cardiac stress testing. System captures cardiac electrical signals; processes data via software modules; displays ECG waveforms for physician review. Used in hospitals, clinics, and physician offices; operated by healthcare professionals. Output assists clinicians in cardiac assessment and diagnostic decision-making. Benefits include standardized cardiac monitoring and stress testing capabilities.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

12-channel ECG system; software-based modules (ECG-PS for monitoring, ERGO-PS for stress testing). Operates as a professional station for signal acquisition and display. Class II device (21 CFR 870.2340).

Indications for Use

Indicated for male and female pediatric to adult patients requiring 12-channel ECG recording, monitoring, or cardiac stress testing. For use in hospitals, clinics, and physician offices under physician prescription.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2006

Galix Biomedical Instrumentation, Inc. c/o Mr. Jordan Gavrielides President 2555 Collins Avenue Suite C-5 Miami Beach, FL 33140

Re: K051163

Trade Name: GALIX ECG Professional Station, Models ECG-PS and ERGO-PS, Regulation Number: 21 CFR 870,2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: November 28, 2005 Received: December 2, 2005

Dear Mr. Gavrielides:

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. Ilsting 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. Jordan Gavrielides

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 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 Office of Compliance at [phone]lso, please note the regulation entitled, "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 Small 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 yours,

Bfremmer for

Bram D. Zuckerman, M.D. Director Divison 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): k051163

GALIX ECG Professional Station Device Name:

Indications For Use:

The GALIX ECG Professional Station system is intended for 12 Channel ECG recording and monitoring (running the ECG-PS software module) and 12 channel cardiac stress testing (running the ERGO-PS software). It is indicated for use:

- · with Male/Female Pediatric to Adult population
- · in Hospital, Clinic and Physician´s office
- · under prescription by a physician

X 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)

Bhammuna

510(in Namber

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