3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM

K092853 · Galix Biomedical Instrumentation, Inc. · MLO · Jul 9, 2010 · Cardiovascular

Device Facts

• Record ID: K092853
• Device Name: 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
• Applicant: Galix Biomedical Instrumentation, Inc.
• Product Code: MLO · Cardiovascular
• Decision Date: Jul 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The primary use of ambulatory monitoring are listed below. 1 Evaluation of suspected of known cardiac rhythm disorders. 2 Evaluation of symptoms suggestive of an arrhythmia disorder. 3 Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death. 4 Patients who have suspected pacemaker malfunction may also require long term monitoring to document an intermittent episode of failure to capture or failures to sense. 5 Evaluation of chest pain. 6 Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment. 7 The Galix GBI-3SM Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record 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

GBI-3SM is a 3-channel digital ambulatory Holter recorder; captures ECG signals for up to 24 hours; features high-resolution recording at 1000 samples/second. Device used in clinical settings or patient home environments; operated by healthcare professionals or patients under physician guidance. Recorded data transferred to external system for analysis via Late Potential Software. Physician reviews output to identify arrhythmias, evaluate pacemaker function, or assess drug efficacy. Enables long-term cardiac monitoring to document intermittent events; supports clinical decision-making regarding treatment adjustments or diagnostic interventions.

Clinical Evidence

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

Technological Characteristics

3-channel digital ambulatory ECG recorder; sampling rate 1000 samples/second; supports high-resolution ECG recording; includes Late Potential Software for data analysis. Class II device (21 CFR 870.2800).

Indications for Use

Indicated for patients requiring ambulatory ECG monitoring for evaluation of suspected or known cardiac rhythm disorders, arrhythmia-related symptoms, screening for sudden death risk, suspected pacemaker malfunction (failure to capture/sense), chest pain, and assessment of antiarrhythmic drug efficacy.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL - 9 2010

Galix Biomedical Instruments, Inc. c/o Mr. Yoel Palomino Technical Manager 2555 Collins Ave., C-5 Miami Beach, FL 33140

Re: K092853

> Trade/Device Name: 3 Channel Digital Ambulatory ECG Recorder, GBI - 3SM Regulatory Number: 21 CFR 870.2800 Regulation Name: Ambulatory Electrocardiograph with Analysis Option Regulatory Class: II (two) Product Code: 74 MLO Dated: June 2, 2010 Received: June 4, 2010

Dear Mr. Palomino:

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 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. Yoel Palomino

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

<http://www.fda.gov/MedicalDevices/ResourcestoYour/Industry/default.htm>.

Sincerely yours,

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]

## Indications for Use

510(k) Number: (092853/5/

Device Name: 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER GBI - 3SM

Indications For Use: The primary use of ambulatory monitoring are listed below.

- 1 Evaluation of suspected of known cardiac rhythm disorders.
- 2 Evaluation of symptoms suggestive of an arrhythmia disorder.
- 3 Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death.
- 4 Patients who have suspected pacemaker malfunction may also require long term monitoring to document an intermittent episode of failure to capture or failures to sense.
- 5 Evaluation of chest pain.
- 6 Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment.
- 7 The Galix GBI-3SM Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record 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.

| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
|----------------------------------------------|-------------------|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | _________________ |

Concurrence of ODRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

| 510(k) Number | K092853 |
|---------------|-------------------|
| Page 1 of | _________________ |

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