The Handheld ECG Monitor MD100 is intended for use in non-invasive recording and displaying ECG waveform by adult patients. It addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events. suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This ECG monitor allows the patient to record their ECG data into the device memory for display by healtheare professional during office visits.

The product is not a conventional diagnostic tool.

Device Description

The applicant device of Handheld ECG Monitor MD100 is a handheld device, which can records cardiac event data and displays the data in a clear and precise waveform.

The ECG Monitor is made up of signal input unit, signal amplify unit, CPU, Display unit, power unit and storage chip. They are all in one PCB that is designed and made by our company.

The MD100 Handheld ECG Monitor is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and are later shown to physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring, the utilization of MD100 has the feature of recording this real time data that is normally difficult to capture.

The applicant device has "data upload" function which controlled by hardware, it can transmit the data measured by the device to computer via the USB port. The software attached with the device named " Keep-it-easy" in CD ROM, which is use for store and playback the data collected by MD100 ECG monitor. The "Keep-it-Easy" software needs to install in the computer by user. The "Keep-it-Easy" software CD ROM is the accessory of the applicant device.

The applicant device has low battery voltage indication function. The power of the monitor works supplied by 2*AAA batteries.

AI/ML Overview

The provided text appears to be a 510(k) summary for a medical device submission, focusing on establishing substantial equivalence rather than a detailed performance study as would be seen in a clinical trial report. As such, it does not contain the specific study design details like sample sizes, ground truth establishment, expert qualifications, or MRMC study results that you requested.

However, based on the provided text, I can infer and extract some information regarding acceptance criteria and performance as presented for the 510(k) submission.

Here's a breakdown of the requested information based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document focuses on establishing substantial equivalence to a predicate device (Omron HCG-801) rather than setting and reporting against specific numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity). The "acceptance criteria" here are implied by meeting recognized standards and demonstrating similar capabilities to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance (MD100)
Intended Use	Same as predicate: non-invasive recording and display of ECG waveform by adult patients, manually record transient cardiac events.
Prescription Use	Yes, prescription use.
Display of waveform	Display real-time ECG waveform.
Type of Transmission	USB Transmission. (Different from predicate, but deemed equivalent in safety/effectiveness)
Lead Placement	Palm and Chest Placement. (Similar to predicate's chest placement, with an additional option)
Multiple Event Recording	Yes.
Base-line stabilization	Yes.
Battery Life Indicator	Yes.
Adherence to Standards	IEC 60601-1, IEC 60601-1-2, AAMI EC38, ISO 10993 (Biological Evaluation). "Performance Testing" demonstrates safety and effectiveness.
Safety and Effectiveness	Determined to be substantially equivalent to predicate, no new questions of safety and effectiveness, no adverse health effects or safety risks.

2. Sample sizes used for the test set and the data provenance

The document references "Performance Testing" and "bench testing" but does not specify any sample sizes for test sets (e.g., number of patients, number of ECGs). It does not mention clinical data or its provenance (country of origin, retrospective/prospective). The testing described is primarily bench testing for electrical safety and electromagnetic compatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable based on the provided text. The submission focuses on substantial equivalence through engineering and safety standards, not clinical performance against expert-derived ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set data requiring adjudication is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ECG monitor, not an AI-assisted diagnostic tool for interpretation by human readers, and no MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable for diagnostic performance as an algorithm. The device records and displays ECG waveforms; it is not presented as automatically interpreting them diagnostically. Its "performance" is based on its ability to accurately capture and present the ECG data and meet safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "Performance Testing" mentioned, the ground truth would be against the defined parameters of the relevant standards (e.g., correct voltage readings, stable baseline, accurate heart rate measurement against a known signal, electromagnetic compatibility limits). There's no mention of clinical ground truth (like pathology or outcomes data) because no clinical performance study for diagnostic accuracy is described.

8. The sample size for the training set

Not applicable. The device is not described as utilizing a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable (as above).

Summary

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Kofo933

SEP 2 6 2008

Appendix II 510(K) Summary

Non-Confidential Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance the requirements of 21 CFR 807.92

Beijing Choice Electronic Technology Co.,LTd. East Building 3F, No.5 Shixing Street, Badachu Hi-tech Zone Shijingshan District, Beijing Tel: 0086-10-88790480 China 100041 Fax:0086-10-88798860 Official Contact: Lei Chen Manager Email: chenlei@choicemmed.com Proprietary or Trade Name: MD100 Handheld ECG Monitor Common/Usual Name: Handheld, ECG Monitor Classification: Class II Device: MD100 Handheld ECG Monitor Predicate Devices: Omron HCG-801 Portable ECG Monitor K060766

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Device Description:

The applicant device of Handheld ECG Monitor MD100 is a handheld device, which can records cardiac event data and displays the data in a clear and precise waveform.

The ECG Monitor is made up of signal input unit, signal amplify unit, CPU, Display unit, power unit and storage chip. They are all in one PCB that is designed and made by our company.

The applicant device has "data upload" function which controlled by hardware, it can transmit the data measured by the device to computer via the USB port. The software attached with the device named " Keep-it-easy" in CD ROM, which is use for store and playback the data collected by MD100 ECG monitor. The "Keep-it-easy" software needs to install in the computer by user. The "Keep-it-Easy" software CD ROM is the accessory of the applicant device.

The applicant device has low battery voltage indication function. The power of the monitor works supplied by 2*AAA batteries.

Non-Confidential Summary of Safety and Effectiveness

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Indications for Use:

The product is not a conventional diagnostic tool.

Non-Confidential Summary of Safety and Effectiveness

Environment of Use - Prescription

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4/7

.....

Device Attributes:

Features	MD100
Environment of use	Prescription use for self testing anywhere and anytime.
Patient Population	Adult
Type of waveform	Real time ECG Waveform display.
Heart Rate Range	30-240 beats/min
Software driven	Yes
Materials in patientcontact	ABS, Metal
Standard met	IEC 60601-1, IEC 60601-1-2, AAMI EC38
Measurement Rate	30 Seconds
Components	2 AAA Batteries, Hanging rope, Dustproof cover, Operation manual, USB Cable(Optional )
Operatingconditions	5°C~40 °C
Storage conditions	-20℃~40℃≤RH80%
Dimensions(mm)	136mm(W)×84mm(H)×21mm(D)
Weight(kg)withoutbattery	100 g

Non-Confidential Summary of Safety and Effectiveness

Differences Between Other Legally Marketed Predicate Devices

. 11:

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The MD100 Handheld ECG Monitor is viewed as substantially equivalent to predicate device: Omron HCG-801 portable ECG Monitor. (K060766)

The OnIron HCG-801 portable ECG Monitor features real-time display of waveform and ECG recording.

BASIC COMPARISONS BETWEEN MD100 and HCG-801,

	MD100	HCG-801
SUBSTANTIALEQUIVALENCECOMPARISONS	K060766
Intended Use	Same	Same
Prescription/Overthe Counter	Prescription	Prescription
Display of waveform	Display real-time ECGwaveform	Display real-time ECGwaveform
Type of Transmission	USB Transmission	Non-USB Transmission
Transmission Tool	USB	Standard compact memorycard
Lead placement on body	Palm and Chest Placement	Chest Placement
Multiple Event Recording	Yes	Yes
Base-line stabilization	Yes	Yes
Battery Life Indicator	Yes	Yes
Lead Cable	No	No
Pacemaker Detection	No	No

Non-Confidential Summary of Safety and Effectiveness

In summary, the MD100 Handheld ECG Monitor is substantially equivalent to Omron HCG-801 portable ECG Monitor in the following ways:

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MD100 Handheld ECG Monitor is schematically similar to Omron HCG-801 portable ECG Monitor.

Both devices are handheld, portable, personal type ECG monitor. MD100 Handheld ECG Monitor does provide the data transmission option which is not an option the Omron HCG-801 ECG offers. Both devices are prescription devices intended for self-testing by patients under doctors' supervision. In both devices, user can place device on his/her chest and hold it steadily to test although the MD100 Handheld ECG Monitor provides another method that test by the centre of the palm. In both devices the user is not required to apply external electrodes to the body. Both devices have the capability to record real time heart rhythm waveform and heart beat and store data that can be displayed and downloaded.

The MD100 Handheld ECG Monitor constitutes a safe, accurate, and reliable means for recording of ECG data. When this device is used as intended it is as safe and effective as the predicate device. As shown, MD100 device has generally the same technological characteristics and intended use as Omron HCG-801 portable ECG Monitor but more advantageous and practical in terms of ease of use and reliability.

Validation testing contained in the submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety and effectiveness. When the device is used as it is intended it poses no adverse health effects of safety risks to users.

Performance Testing:

We performed the following bench testing to demonstrate safety and effectiveness and equivalency to the predicate device:

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety; Amendment 1, 1991-11,Amendment 2,1995-03. Version 1995

EMC tests according to IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility Requirements and Tests. Version 2001

AAMI EC38 Ambulatory Electrocardiographs ISO 10993, Biological Evaluation of Medical Devices

Non-Confidential Summary of Safety and Effectiveness

Conclusion

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Based upon the performance testing and comparison to legally marketed predicate device ( for indications for use, technology, and performance ) we have demonstrated that the MD100 Handheld ECG Monitor is substantially equivalent in safety and effectiveness to the predicate device.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

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Image /page/7/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle-like symbol with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Beijing Choice Electronic Technology Co., Ltd. c/o Ms. Diana Hong Shanghai Midlink Business Consulting Co., Ltd. Suite 8D, Zhongxin Zhongshan Mansion, No. 19, Lanc 999, Zhong Shan Nan Er Rd. Shanghai 200030, CHINA

Re: K080933

Trade/Device Name: Handheld ECG Monitor MD 100 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: September 18, 2008 Received: September 19, 2008

Dear Ms. Hong:

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 individe for use stated in the enclosure) to legally marketed predicate devices marked 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, Drig 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, inte Act. 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 Province

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Page 2 - Mr. Mark Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 seting forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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,

Duna R. Vachner

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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Appendix I Indications for Use Form

510(k) Number: K080993

Device Name: Handheld ECG Monitor MD100

Indications for Use:

The Handheld ECG Monitor MD100 is intended for use in non-invasive recording and displaying ECG waveform by adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This ECG monitor allows the patient to record their ECG data into the device memory for display by healthcare professional during office visits.

The product is not a conventional diagnostic tool.

Prescription Use

Over-The-Counter Use

AND/OR

( Part 21 CFR 801 Subpart D)

( Part 21 CFR 801 Subpart C)

( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Duma D. Vahine

Division Sign-Off)
Division of Cardiovascular Devices

Page 1 of _1

510(k) Number K800733

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).