MH1 MICROHOLTER RECORDER

K101969 · Exelys, LLC · MWJ · Feb 4, 2011 · Cardiovascular

Device Facts

• Record ID: K101969
• Device Name: MH1 MICROHOLTER RECORDER
• Applicant: Exelys, LLC
• Product Code: MWJ · Cardiovascular
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The MH1 MicroHolter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the following indications: - Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. - Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. - Evaluation of patients for ST segment changes. - Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery). - Clinical and epidemiological research studies. - Evaluation of patients with pacemakers. - Indication of time and frequency domain heart rate variability. - Evaluation of patient for QT interval.

Device Story

MH1 MicroHolter Recorder is a 3-channel ambulatory ECG monitor. Device records ECG signals onto internal Flash memory; converts differential inputs into 10-bit digital values. Features a Base Station for data interface with a host computer and contact-less monitoring of signals via magnetic loop antenna for real-time electrode placement verification. After recording, device docks with Base Station connected to a PC via USB; data is uploaded via MH1 Base Software. Healthcare providers use the software to transfer data to a Computer Analysis System for clinical review. Used in clinical settings to assist physicians in diagnosing arrhythmias, ischemia, and evaluating cardiac interventions or patient recovery.

Clinical Evidence

Bench testing only. Validation testing conducted to ensure system components operate safely and effectively for recording and transmitting ECG data.

Technological Characteristics

3-channel ambulatory ECG recorder; 10-bit digital conversion; internal Flash memory storage; magnetic loop antenna for contact-less signal transmission/verification; USB interface to Base Station; compatible with Windows 98 or higher.

Indications for Use

Indicated for patients requiring ambulatory (Holter) monitoring for evaluation of arrhythmia, myocardial ischemia, ST segment changes, QT interval, heart rate variability, pacemaker function, therapeutic intervention efficacy, and post-cardiac event recovery.

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.

Predicate Devices

• DL900 Series Holter Recorder (K071733)

Submission Summary (Full Text)

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FEB - 4 2011

(in accordance with 21 CFR 807.92)

510(k) Number K |0 | 969

### I. Applicant Information

| Applicant: | EXELYS LLC |
|----------------------------|------------------------------------------|
| | 14457 Glorietta Drive |
| | Sherman Oaks, CA 91423 |
| | U.S.A. |
| Contact Person: | Ron Wilkerson |
| | President |
| | Tel: [phone] |
| | Fax: [phone] |
| | e-mail: [e-mail] |
| Application Correspondent: | EMERGO GROUP INC. |
| | 1705 S. Capital of Texas Hwy., Suite 500 |
| | Austin, TX 78746 |
| | U.S.A. |
| Contact Person: | Neal Kolber |
| | Project Manager |
| | Tel: [phone] |
| | Fax: [phone] |
| | e-mail: [e-mail] |
| Date Prepared: | June 7, 2010 |

#### II. Device Name and Classification

| Proprietary Name: | MH1 MicroHolter Recorder |
|-----------------------|---------------------------------------------------|
| Classification Name: | Electrocardiograph, Ambulatory (Without Analysis) |
| Common/Usual Name: | Cardiovascular Monitoring Device |
| Classification: | Class II |
| Regulation Number: | 870.2800 |
| Product Codes: | MWJ |
| Classification Panel: | Cardiovascular Devices |

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#### III. Predicate Device

The MH1 MicroHolter Recorder device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:

| 510(k) Number: | K071733 |
|----------------------|---------------------------------------------------|
| Trade Name: | DL900 Series Holter Recorder |
| Manufacturer: | Braemar, Inc. |
| Classification Name: | Electrocardiograph, Ambulatory (Without Analysis) |
| Common/Usual Name: | Cardiovascular Monitoring Device |
| Classification: | Class II |
| Regulation Number: | 870.2800 |
| Product Codes: | MWJ |

#### IV. Device Description

The MH1 MicroHolter Recorder is a Holter recorder for ambulatory electrocardiogram (ECG) recording. The system consists of three components: a Recorder, a Base Station (computer interface) and the Base Software. The system operates like a conventional ECG monitoring system where data is recorded on Flash memory installed within the MH1 Recorder.

The MH1 MicroHolter Recorder is worn by the patient during ECG monitoring whereas the Base Station is connected to a computer.

After the recording is complete, the MH1 MicroHolter Recorder docks with the Base Station, connected to a personal computer via USB. The Flash memory is then automatically uploaded to the computer via the MH1 Base Software for basic analysis. Data can then be transferred to a Computer Analysis System for further analysis of the recorded ECG data. The MH1, MH1B Base Station and MH1 Base Software are compatible with Windows 98 or higher.

#### V. Intended Use

The MH1 MicroHolter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the following indications:

- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. ●
- Evaluation of ECG documenting therapeutic interventions in individual . patients or groups of patients.
- . Evaluation of patients for ST segment changes.

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- Evaluation of a patient's response after resuming occupational or . recreational activities (e.g. after M.I. or cardiac surgery).
- . Clinical and epidemiological research studies.
- . Evaluation of patients with pacemakers.
- Indication of time and frequency domain heart rate variability. .
- . Evaluation of patient for OT interval.

#### VI. Summary of the Technical Characteristics

The MicroHolter Recorder system is primarily a 3 channel recorder designed to be as small and lightweight as possible, using a second hardware component, the Base Station, for data interface with a host computer and contact-less monitoring of the recorded signals for electrode placement purposes.

The recorder converts the three differential inputs into 10 bit digital values which are stored in an internal FLASH memory along with the condition of the annotate button and a parity check bit. Simultaneously, the data values are modulated onto a low frequency carrier signal which is applied to a magnetic loop antenna so that the signal may be picked up at a short distance and converted into a visible waveform on a host computer for verification of electrode lead function.

#### VII. Testing

EXELYS LLC has conducted extensive validation testing of the MH1 MicroHolter Recorder system, as a cardiovascular monitoring device that is capable of accurately recording and transmitting ECG data. All of the different components of the MH1 MicroHolter Recorder have been tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively.

### VIII. Safety and Effectiveness Conclusions

Based on the comparison of intended use and technological characteristics, the MH1 MicroHolter Recorder system is substantially equivalent to the DL900 Series Holter Recorder manufactured by Braemar, Inc. (K071733). The MH1 MicroHolter Recorder device raises no new safety or effectiveness issues.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Exelvs. LLC. c/o Ms. Caroline Tontini Project Manager Emergo Group, Inc. 1705 S. Capital of Texas Hwy., Suite 500 Austin, TX 78746

FEB - 4 201

Re: K101969

Trade/Device Name: Mh1 Microholter Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: January 5, 2011 Received: January 6, 2011

Dear Ms. Tontini:

·

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Ms. Caroline Tontini

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

6 Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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# 4. Indication for Use Statement

510(k) Number (if known):

Device Name:

# MH1 MicroHolter Recorder

### Indications for Use:

The MH1 MicroHolter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the following indications:

- . Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
- . Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
- . Evaluation of patients for ST segment changes.
- . Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery).
- . Clinical and epidemiological research studies.
- . Evaluation of patients with pacemakers.
- Indication of time and frequency domain heart rate variability. �
- · · Evaluation of patient for QT interval.

Prescription Use X (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)

| (Division Sign-Off) Division of Cardiovascular Devices |
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| 510(k) Number | K101969 |
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