GALIX WINTER

K030145 · Galix Biomedical Instrumentation, Inc. · DQK · Sep 17, 2003 · Cardiovascular

Device Facts

• Record ID: K030145
• Device Name: GALIX WINTER
• Applicant: Galix Biomedical Instrumentation, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The GALIX WinTer ECG Holter Analysis system is intended for patients requiring 24hr ambulatory monitoring. It is indicated for use in: - the replay, analysis, display, editing and report generation of ambulatory ECG data - . the assessment of cardiac disturbance and myocardial ischemia

Device Story

GalixWinTer is an ECG Holter analysis system; processes 24-hour ambulatory ECG data. Device performs replay, analysis, display, editing, and report generation of cardiac signals. Used by clinicians in clinical settings to assess cardiac disturbances and myocardial ischemia. System aids healthcare providers in diagnostic decision-making by providing processed ECG reports, facilitating identification of arrhythmias or ischemic events. Benefits include improved diagnostic efficiency for ambulatory cardiac monitoring.

Technological Characteristics

Programmable diagnostic computer for ECG analysis. System functions as a software-based workstation for processing ambulatory ECG data. Class II device (21 CFR 870.1425).

Indications for Use

Indicated for patients requiring 24-hour ambulatory ECG monitoring for assessment of cardiac disturbance and myocardial ischemia. Prescription use only.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Submission Summary (Full Text)

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Public Health Service

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SEP 1 7 2003

ond and Drug Administra Rockville MD 20050

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

Re: K030145 Trade Name: GalixWinTer Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: July 24, 2003 Received: August 12, 2003

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, 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

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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]. Also, 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/dsma/dsmamain.html

Sincerely yours,

VeahtM

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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## GALIX BIOMEDICAL INSTRUMENTATION INC. 2555 Collins Avenue, Suite C-5 - Miami Beach, FL 33140, U.S.A.

Tel .: [phone] Fax : [phone]

## 510(K) GALIX WinTer ECG Holter Analyzer

## Indications for Use:

The GALIX WinTer ECG Holter Analysis system is intended for patients requiring 24hr ambulatory monitoring. It is indicated for use in:

- the replay, analysis, display, editing and report generation of ambulatory ECG data ●
- . the assessment of cardiac disturbance and myocardial ischemia

...

Prescription Use Only

Kala Th

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K030145