(235 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ECG monitoring technology and communication.
No
The device is a monitor used for diagnosis and assessment, not for treatment. Its intended use includes monitoring symptoms related to heart disturbances and assisting in ongoing monitoring of abnormal rhythm events in patients receiving medication or therapy.
Yes
Explanation: The device is intended for "in-context monitoring... where symptoms occur infrequently or where resting ECG monitoring is unlikely to capture symptomatic or asymptomatic abnormal rhythm events" and "its use includes assessing symptoms... that may relate to disturbances of the heart." This indicates its purpose is to identify or assess the presence of a medical condition.
No
The device description explicitly states it is an "ECG testing device" that is "small, light weight, portable, single channel ECG ambulatory monitor equipped with an LCD" and is "powered by two (2) standard AAA alkaline batteries." This indicates it is a physical hardware device, not software only.
Based on the provided information, the Medick MHM200 Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The MHM200 Monitor directly monitors the electrical activity of the heart in vivo (within the living body) through electrodes placed on the skin.
- The intended use and device description clearly state that it is an ECG testing device that monitors the heart rhythm of adult patients. This is a physiological measurement taken directly from the patient, not an analysis of a biological specimen.
- The standards it conforms to are related to medical electrical equipment, patient cables, electrodes, and ambulatory electrocardiographs. These are all consistent with a device that measures physiological signals directly from the body.
Therefore, the MHM200 Monitor falls under the category of a medical device that performs physiological monitoring, not an IVD device.
N/A
Intended Use / Indications for Use
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.
Product codes
MLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Medick MHM200 has been tested and conforms to the appropriate sections of the following standards:
- Safety: IEC/EN 60601-1 Medical Electrical Equipment - Part 1 General Requirements for Safety
- Safety: IEC/EN 60601-1 Medical Electrical Equipment - Part 1 General Requirements for Safety, 1988:Amendment 1, 1991-11, Amendment 2, 1995
- EMC: EN 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety; Electrometric Compatibility - Requirements and Tests
- Patient Cables: 21 CFR 898 Performance Standard for Electrode Lead Wires and Patient Cables
- Disposable ECG electrodes: AAMI/ANSI EC 12:2000
- ECG: AAMI/ANSI EC38:1998 Ambulatory Electrocardiographs
- Cardiac Rhythm: AAMI/ANSI EC57-98 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment measurement Algorithms
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
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.
Indications for use:
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 mythm events.
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.
1
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:Amendment | ||
| 1, 1991-11, Amendment 2, 1995 | IEC/EN 60601-1 | |
| Amendment 1 & | ||
| Amendment 2 | ||
| 3 | EMC: EN 60601-1-2 Medical Electrical Equipment - Part 1- | |
| 2: General Requirements for Safety; Electrometric | ||
| Compatibility - Requirements and Tests | IEC/EN 60601-1-2 | |
| 4 | Patient Cables: 21 CFR 898 Performance Standard for | |
| Electrode Lead Wires and Patient Cables | 21 CFR 898 | |
| 5 | Disposable ECG electrodes | AAMI/ANSI |
| EC 12:2000 | ||
| 6 | ECG: AAMI/ANSI EC38:1998 Ambulatory | |
| Electrocardiographs | AAMI/ANSI | |
| EC38:1998 | ||
| 7 | Cardiac Rhythm: AAMI/ANSI EC57-98 Testing and | |
| Reporting Performance Results of Cardiac Rhythm and ST- | ||
| Segment measurement Algorithms | AAMI/ANSI | |
| EC57-98 |
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.
2
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.
3
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
4
Page 1 of 1
INDICATIONS FOR USE
510(k) Number: K063339
Device Name: Medick MHM200 Personal Heart Monitor
Indication for Use:
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.
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