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 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.

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.

AI/ML Overview

The provided document describes the Exelys MH1 MicroHolter Recorder, a device intended for ambulatory ECG recording, and details its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any statistical performance metrics typically associated with AI/algorithm-driven medical devices.

Instead, the document focuses on:

Applicant Information: Contact details for Exelys LLC and their correspondent.
Device Name and Classification: Proprietary and classification names, regulatory information, and product codes.
Predicate Device: Identification of the Braemar, Inc. DL900 Series Holter Recorder (K071733) as the predicate device, emphasizing substantial equivalence in indications for use, performance, and technological characteristics.
Device Description: Explanation of the MH1 MicroHolter Recorder's components (Recorder, Base Station, Base Software) and how it operates to record and transfer ECG data. It mentions the conversion of analog inputs to 10-bit digital values stored in internal FLASH memory and a low-frequency carrier signal for electrode placement verification.
Intended Use/Indications for Use: A list of clinical scenarios where the device is intended to be used, such as evaluation of symptoms, therapeutic interventions, ST segment changes, patient response after activities, research studies, pacemaker evaluation, and heart rate variability/QT interval assessment.
Summary of Technical Characteristics: Highlights the device's 3-channel recording capability, small size, lightweight design, and the use of the Base Station for data interface and contact-less signal monitoring.
Testing: A general statement that "EXELYS LLC has conducted extensive validation testing... as a cardiovascular monitoring device that is capable of accurately recording and transmitting ECG data." It further states that all components "have been tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively."
Safety and Effectiveness Conclusions: Concludes substantial equivalence to the predicate device and states that the MH1 MicroHolter Recorder "raises no new safety or effectiveness issues."
FDA Communication: An FDA letter granting 510(k) clearance based on substantial equivalence to the predicate device.

Therefore, based on the provided text, the following information cannot be extracted:

A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed. The document relies on substantial equivalence to a predicate device.
Sample size used for the test set and the data provenance: No test set details are provided. The "extensive validation testing" is mentioned, but without specifics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no specific test set or ground truth establishment process is described beyond general validation.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is an ECG recorder, not an AI analysis tool for human interpretation.
Standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device records ECG data; it does not perform automated analysis that would require a "standalone" performance study in the context of an AI algorithm. Its function is data acquisition for subsequent analysis by other systems or human readers.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the document serves as a 510(k) premarket notification for a medical device (an ECG recorder) using the substantial equivalence pathway. It does not describe an AI/algorithm-based device and thus does not contain the types of performance study details requested in the prompt, which are typically associated with such technologies.

Summary

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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: (818) 385-0824
	Fax: (818) 385-0803
	e-mail: ron@exelys.com
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: (512) 327-9997
	Fax: (512) 327-9998
	e-mail: neal@emergogroup.com
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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K101969 pg 2 of 3

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

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

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 (800) 638-2041 or (301) 796-7100 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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Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
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.(b)
Classification. Class II (performance standards).