GALIX GBI -3S-LP

K992706 · Galix Biomedical Instrumentation, Inc. · MLO · Mar 15, 2001 · Cardiovascular

Device Facts

• Record ID: K992706
• Device Name: GALIX GBI -3S-LP
• Applicant: Galix Biomedical Instrumentation, Inc.
• Product Code: MLO · Cardiovascular
• Decision Date: Mar 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The Galix GBI-3S-LP Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record up to 10 minutes of Very High Resolution ECG, at a sampling rate of 1000 samples per second. The ECG data stored is then analyzed with the Late Potential Software,

Device Story

Galix GBI-3S-LP is a digital Holter recorder; captures 24-hour ambulatory ECG signals; provides optional 10-minute high-resolution ECG recording at 1000 samples/second. Device stores data for subsequent analysis using integrated Late Potential Software. Used in clinical settings; operated by healthcare professionals. Output consists of ECG data and late potential measurements; reviewed by physicians to assist in cardiac diagnostic decision-making. Benefits include extended cardiac rhythm monitoring and detection of late potentials for clinical evaluation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital Holter recorder; 1000 samples/second sampling rate for high-resolution mode; 24-hour recording capacity; includes Late Potential Software for signal analysis.

Indications for Use

Indicated for patients requiring 24-hour ambulatory ECG monitoring and high-resolution ECG recording for the assessment of late potentials. Clinical significance of findings must be determined by a qualified physician.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2001

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

K992706 Re: GALIX GBI -- 3S - LP Regulatory Class: II (two) Product Code: 74 MLO Dated: February 12, 2001 Received: February 20, 2001

Dear Mr. Gavrielides:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave and we have determined the device is substantially equivalent (for the indications for use above and we nave acteriment of the marketed predicate devices marketed in interstate commerce stated in the enoroute, to regarly and date of the Medical Device Amendments, or to devices that prove to may 20, 1977, 10, 1977, 19, 1977, 1997, 1999, 1999, 1999, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosments of the Act. The general controls provisions of the Act include requirements for annual provisions of the Fea. "The generood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( remarket rippt vary will be of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A subscribury Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Four and Diam may result in regulatory action. In addition, FDA may publish

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## Page 2 - Mr. Jordan Gavrielides

further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

A. Htip Rhodes

James E. Dillard III Director Division of Cardiovascular and Respiratory 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 Boach, FL 33140 U,S.A. Phone Nº [phone] Fax Nº [phone]

## 510 (k) Nº K992706

Device Name: GALIX GBI - 3S - LP

Indications For Use:

The Galix GBI-3S-LP Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record up to 10 minutes of Very High Resolution ECG, at a sampling rate of 1000 samples per second.

The ECG data stored is then analyzed with the Late Potential Software,

Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.

T. Garrido

Jordan Gavrielides

President

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K992706