(177 days)
Not Found
No
The summary describes a basic handheld ECG monitor that records and displays data. There is no mention of any analytical capabilities beyond simple data capture and storage, nor any terms associated with AI/ML.
No
The device is described as a monitor that records and displays ECG waveforms, providing data on cardiac rhythm. It is not intended for diagnosis or treatment, and the statement "The product is not a conventional diagnostic tool" further supports its non-therapeutic function.
No
The "Intended Use" section explicitly states, "The product is not a conventional diagnostic tool."
No
The device description explicitly states it is a "handheld device" and lists hardware components like a signal input unit, signal amplify unit, CPU, Display unit, power unit, and storage chip, all on a PCB. While it includes accompanying software, the core medical device is a physical piece of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The Handheld ECG Monitor MD100 records and displays ECG waveforms by being placed on the patient's body (palm and chest). This is a non-invasive method of measuring electrical activity of the heart within the body.
- Intended Use: The intended use clearly states it's for "non-invasive recording and displaying ECG waveform by adult patients." It also mentions providing data on cardiac rhythm to physicians. None of these activities involve testing samples taken from the body.
- Device Description: The description details the internal components and how it records data from the user's body. There is no mention of handling or analyzing biological samples.
- Explicit Statement: The intended use section explicitly states, "The product is not a conventional diagnostic tool." While this doesn't directly say it's not an IVD, it reinforces that its function is different from typical diagnostic tests that often involve laboratory analysis of samples.
Therefore, the Handheld ECG Monitor MD100 is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
patient and professional use, in hospital patients, for self testing anywhere and anytime.
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
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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.
Non-Confidential Summary of Safety and Effectiveness
2
Indications for Use:
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.
Non-Confidential Summary of Safety and Effectiveness
Environment of Use - Prescription
3
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 patient | |
| contact | 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 ) |
| Operating | |
| conditions | 5°C~40 °C |
| Storage conditions | -20℃~40℃ |
| ≤RH80% | |
| Dimensions(mm) | 136mm(W)×84mm(H)×21mm(D) |
| Weight(kg) | |
| without | |
| battery | 100 g |
Non-Confidential Summary of Safety and Effectiveness
Differences Between Other Legally Marketed Predicate Devices
. 11:
4
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 | |
|---|---|---|
| SUBSTANTIAL | ||
| EQUIVALENCE | ||
| COMPARISONS | K060766 | |
| Intended Use | Same | Same |
| Prescription/Over | ||
| the Counter | Prescription | Prescription |
| Display of waveform | Display real-time ECG | |
| waveform | Display real-time ECG | |
| waveform | ||
| Type of Transmission | USB Transmission | Non-USB Transmission |
| Transmission Tool | USB | Standard compact memory |
| card | ||
| 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:
5
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
6
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.
7
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
8
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
9
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