BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM

K081444 · Braemar, Inc. · DSI · Jul 31, 2008 · Cardiovascular

Device Facts

• Record ID: K081444
• Device Name: BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
• Applicant: Braemar, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Jul 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The device is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an alarm triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.

Device Story

Fusion Wireless Ambulatory ECG Arrhythmia Monitor System provides continuous cardiac monitoring for patients with transient symptoms. Device captures ECG signals; utilizes internal arrhythmia detection algorithm to trigger alarms; allows patient-initiated manual event recording. System automatically transmits recorded cardiac data to remote location for physician review. Used in ambulatory settings; operated by patients. Healthcare providers use transmitted ECG data to evaluate cardiac rhythm, identify arrhythmias, and inform clinical management decisions. Benefits include timely detection of transient cardiac events outside clinical environment.

Clinical Evidence

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

Technological Characteristics

Ambulatory ECG monitor; wireless transmission capability; arrhythmia detection algorithm; patient-activated event recording. Device operates as a Class II arrhythmia detector and alarm system (21 CFR 870.1025).

Indications for Use

Indicated for patients experiencing transient symptoms suggestive of cardiac arrhythmia. Contraindicated for patients with potentially life-threatening arrhythmias requiring inpatient monitoring or those requiring hospitalization.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 31 2008

Braemar, Inc. c/o Mr. Darren Dershem Director of Quality Assurance 1285 Corporate Center Drive, Suite 150 Eagan, MN 55121

## Re: K081444

Trade/Device Name: Fusion Wireless Ambulatory ECG Arrhythmia Monitor System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST -segment measurement and alarm) Regulatory Class: Class II Product Code: DSI, DRG Dated: May 9, 2008 Received: May 22, 2008

Dear Mr. Dershem:

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. Darren Dershem

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please nate the regulation entitled, "Misbranding by reference to premarket notifications of Summer of Sunditions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket surveillance,
Surveillance at 240-776, 3474 - East weet Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

ellmee

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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## Indications for Use

510(k) Number (if known): ΚΟΣΙΨΨΥ

Device Name: Braemar Fusion Wireless - Ambulatory ECG Arrhythmia Monitoring System

Indications For Use:

The device is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an alarm triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.

Contraindications:

- 1. Patients with potentially life-threatening arrhythmia who require inpatient monitoring.
- 2. Patients who the attending physician thinks should be hospitalized.

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)

eemel

diovascular Devices

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KOS1444 510(k) Number