The MHM200 Monitor is intended for in-context monitoring of adult patients where symptoms occur infrequently or where resting ECG monitoring is unlikely to capture symptomatic or asymptomatic abnormal rhythm events.

Its use includes assessing symptoms (including palpitations, dizzy spells, paroxysmal light-headedness, and pounding of the heart) that may relate to disturbances of the heart.

Where it is clinically appropriate, the MHM200 Monitor can assist in ongoing monitoring of the frequency of abnormal rhythm events in patients receiving antiarrhythmic medication or rehabilitation therapy.

Device Description

The Medick MHM200 is an ECG testing device that monitors heart on a beat by beat basis to detect any irregularities. It does this over a period of up to 8 hours and reports a person's heart rhythm. It is small, light weight, portable, single channel ECG ambulatory monitor equipped with an LCD that is used to set-up the monitor and display cardiac information. The monitor is powered by two (2) standard AAA alkaline batteries. The MHM200 can communicate with a computer over a standard USB connection to store and print a person's cardiac information. For safety reasons, the MHM200 uses proprietary patient and USB cables. The cables share a common input connector. The patient cable must be removed before the monitor can be connected to a computer through the USB cable.

AI/ML Overview

The provided text describes performance testing against various standards rather than a specific study detailing acceptance criteria and device performance in terms of clinical accuracy or diagnostic capabilities. The submission focuses on device safety, electrical compatibility, and conformity to general medical device standards. It states that the "ECG channel and arrhythmia analysis algorithm are the same" as the predicate device (C.Net 2100) and that the MHM200 is "as safe and effective as the predicate devices," implying that the predicate's performance is assumed to be met.

Therefore, many of the requested details about a study proving device adherence to acceptance criteria in a clinical or diagnostic context cannot be extracted from this document. The document lists "Cardiac Rhythm: AAMI/ANSI EC57-98 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment measurement Algorithms" as a standard the device conforms to, which is the most relevant in terms of performance, but it does not provide the actual results of such a test.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) or numerical results. Instead, it lists standards to which the device conforms. Therefore, the "acceptance criteria" are compliance with these listed standards, and the reported performance is simply that it conforms.

Item	Standard / Acceptance Criteria	Reported Device Performance
Safety	IEC/EN 60601-1 Medical Electrical Equipment - Part 1 General Requirements for Safety	Conforms to IEC/EN 60601-1, Amendment 1 & Amendment 2
EMC (Electromagnetic Compatibility)	EN 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety; Electrometric Compatibility - Requirements and Tests	Conforms to IEC/EN 60601-1-2
Patient Cables	21 CFR 898 Performance Standard for Electrode Lead Wires and Patient Cables	Conforms to 21 CFR 898
Disposable ECG electrodes	AAMI/ANSI EC 12:2000	Conforms to AAMI/ANSI EC 12:2000
ECG	AAMI/ANSI EC38:1998 Ambulatory Electrocardiographs	Conforms to AAMI/ANSI EC38:1998
Cardiac Rhythm & ST-Segment Measurement Algorithms	AAMI/ANSI EC57-98 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment measurement Algorithms	Conforms to AAMI/ANSI EC57-98

The critical statement regarding performance is that the "ECG channel and arrhythmia analysis algorithm are the same" as the predicate device (C.Net 2100). The submission posits that the MHM200 is "as safe and effective as the predicate devices when used according to the instructions," without providing new performance data for the MHM200's algorithm.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details about a specific test set, its sample size, or data provenance for proving the performance of the arrhythmia analysis algorithm. The listed standards are general compliance standards, not specific clinical performance studies that would typically involve a "test set" in the context of AI/algorithm validation with patients. The performance of the arrhythmia algorithm is stated to be derived from its substantial equivalence to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The document does not describe a clinical study involving a test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a clinical study with a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission relies on substantial equivalence to the predicate device.

6. Standalone Performance Study

No standalone (algorithm only without human-in-the-loop performance) study results are provided for the MHM200 itself. The performance of the algorithm is inherited from the predicate device by virtue of being the "same."

7. Type of Ground Truth Used

Not applicable, as no new clinical study validating the algorithm's performance with a ground truth is described for this device. The underlying algorithm's performance would have been verified when the predicate device was originally cleared, likely using expert consensus ECG interpretations or other established methods.

8. Sample Size for the Training Set

Not applicable. The document does not mention any new training of an algorithm for the MHM200. It explicitly states that the "ECG channel and arrhythmia analysis algorithm are the same" as the predicate device, C.Net 2100.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no new training is described for the MHM200. The original training and ground truth establishment for the algorithm implemented in the predicate device (C.Net 2100) are not discussed in this document.

Summary

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K063339

510(k) Summary of Safety and Effectiveness

JUN 2 9 , 007

Submitter Information:

Medick Healthcare Ltd. 4" Floor Exchange House 494 Midsummer Boulevard Central Milton Keynes Mk9 2EA United Kingdom

Phone: +44 (0) 1908 255945 FAX: +44 (0) 1908 255700

Contact: Graham Wilson, Chairman and CEO, Medick Healthcare Limited

USA Contact:

B. Harlow & Associates, LLC 803 NE Juanita Drive Kirkland, WA 98034 USA

Phone: 425 891-7347 FAX: 425 823-4469

Device Name:

Trade Name: Medick MHM200 Personal Heart Monitor Common Name: Event Recorder Classification Name: Electrocardiograph, Ambulatory,

with Analysis Algorithm

Predicate Device:

The Medick MHM200 Personal Heart Monitor is substantially equivalent to the C.Net 2100 Single Channel ECG Ambulatory Monitor cleared for market by the United States Food and Drug Administration under 510(k) number K010396.

Device Description:

Indications for use:

Its use includes assessing symptoms (including palpitations, dizzy spells, paroxysmal lightheadedness, and pounding of the heart) that may relate to disturbances of the heart.

Where it is clinically appropriate, the MHM200 Monitor can assist in ongoing monitoring of the frequency of abnormal rhythm events in patients receiving anti-arrhythmic medication or rehabilitation therapy.

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06:33339

Technology Characteristics:

Technology characteristics of the Medick MHM200 are substantially equivalent to the C.Net 2100, Both products were developed by Cardionetics Ltd. The ECG channel and annythmia analysis algorithm are the same. New software has been added to the MHM200 to drive the LCD display and the housing has been changed to accommodate the display. New directions for use were developed to describe the display and ensure that the operator can use the MHM200 safely and for the purpose for which it is intended.

Summary of Performance Testing:

Item	Title	Number
1	Safety: IEC/EN 60601-1 Medical Electrical Equipment -Part 1 General Requirements for Safety	IEC/EN 60601-1
2	Safety: IEC/EN 60601-1 Medical Electrical Equipment -Part 1 General Requirements for Safety, 1988:Amendment1, 1991-11, Amendment 2, 1995	IEC/EN 60601-1Amendment 1 &Amendment 2
3	EMC: EN 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety; ElectrometricCompatibility - Requirements and Tests	IEC/EN 60601-1-2
4	Patient Cables: 21 CFR 898 Performance Standard forElectrode Lead Wires and Patient Cables	21 CFR 898
5	Disposable ECG electrodes	AAMI/ANSIEC 12:2000
6	ECG: AAMI/ANSI EC38:1998 AmbulatoryElectrocardiographs	AAMI/ANSIEC38:1998
7	Cardiac Rhythm: AAMI/ANSI EC57-98 Testing andReporting Performance Results of Cardiac Rhythm and ST-Segment measurement Algorithms	AAMI/ANSIEC57-98

The Medick MHM200 has been tested and conforms to the appropriate sections of the above noted standards.

Conclusion:

The Medick MHM200 Personal Heart Monitor is as safe and effective as the predicate devices when used according to the instructions in the directions for use supplied with the monitor.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007

Medick Healthcare Ltd. c/o James W. Sandberg, P.E. B. Harlow & Associates 8303 N.E. Juanita Drive LLC Kirkland, WA 98034

Re: K063339

Trade Name: Medick MHM 200 Personal Heart Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: MLO Dated: June 26, 2007 Received: June 27, 2007

Dear Mr. Sandberg:

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. Ilsting 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. James W. Sandberg, P.E.

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 Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dvina R. Lechner

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: K063339

Device Name: Medick MHM200 Personal Heart Monitor

Indication for Use:

Its use includes assessing symptoms (including palpitations, dizzy spells, paroxysmal light-headedness, and pounding of the heart) that may relate to disturbances of the heart.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

uma R. hachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K063339

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).