(60 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its functions does not mention any AI/ML capabilities.
No.
The device's intended use explicitly states it is "not intended for use as a conventional diagnostic tool" and is to be used as a "healthcare tool which can provide doctor the recorded data as references," rather than directly treating or mitigating a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "This device is not intended for use as a conventional diagnostic tool" and "The product is not a conventional diagnostic tool." It further clarifies its role as a "healthcare tool which can provide doctor the recorded data as references."
No
The device description explicitly states it is composed of a "host and USB cable" and is "powered by Built-in large capability rechargeable lithium battery," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures electrical activity of the heart (ECG signals) directly from the body surface. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for measuring electrical activities of the heart and providing ECG signals and heart rate. It explicitly states it's "not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references." This further reinforces that it's not performing in vitro diagnostic tests.
Therefore, this device falls under the category of a medical device that measures physiological signals directly from the body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.
It is suitable for the adult users, who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.
The product is not a conventional diagnostic tool.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.
The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, ORS interval and VEB measurement, print, etc.
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 users
Intended User / Care Setting
home health care use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2: 2014. Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
ISO 60601-2-47:2012, Medical Electrical Equipment -- Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems.
Clinical Test Conclusion: No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2017
Contec Medical Systems Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 CN
Re: K170954
Trade/Device Name: Portable ECG Monitor Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: March 22, 2017 Received: March 31, 2017
Dear Ms. Diana Hong:
This letter corrects our substantially equivalent letter of May 30, 2017.
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.
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
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
M. G. Willemann
for
$\scriptstyle{R}$
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170954
Device Name Portable ECG Monitor
Indications for Use (Describe)
The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.
It is suitable for the adult users, who suffers from cardiovascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.
The product is not a conventional diagnostic tool
| Type of Use (Select one or both, as applicable) |
|---|
| Residential Use (Part 21 CFR 601 Subpart D) |
| On-Site Septic System Use (State or Local Requirement) |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K170954
Page 1 of 4
Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: ___________
- Date of Preparation:03/24/2017
Sponsor Identification
Contec Medical Systems Co., Ltd
No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China.
Establishment Registration Number: 3006979678
Contact Person: Xueyong Li Position: Quality Manager Tel: 86 355 8015489 Fax: 86 355 8015490 Email: lxy1011@163.com
Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Cindy Wang (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
K170954 Page 2 of 4
Identification of Proposed Device
Trade Name: Portable ECG Monitor Common Name: Electrocardiograph Model: PM10
Regulatory Information Classification Name: Electrocardiograph Classification: Class II Product Code: DPS Regulation Number: 21 CFR870.2340 Review Panel: Cardiovascular
Indication for use
The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.
It is suitable for the adult users, who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.
The product is not a conventional diagnostic tool.
Device Description
The Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.
The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, ORS interval and VEB measurement, print, etc.
5
K170954 Page 3 of 4
510(k) Number: K093872 Product Name: Handheld ECG Monitor Model Name: MD100
Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2: 2014. Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
ISO 60601-2-47:2012, Medical Electrical Equipment -- Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems.
Clinical Test Conclusion
No clinical study is included in this submission.
Substantially Equivalent (SE) Comparison
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Product Code | DPS | Same |
| Regulation Number | 870.2340 | Same |
| Indication for use | The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart | Similar |
Table 1 Comparison of Technology Characteristics
6
| | rate message after ECG measurement. The
users can use it themselves to check their heart
condition.
It is suitable for the adult users, who suffers
from cardio-vascular diseases, or the adult
people who are caring about their heart
working conditions during their daily life.
This device is not intended for use as a
conventional diagnostic tool, but use as a
healthcare tool which can provide doctor the
recorded data as references.
The product is not a conventional diagnostic
tool. | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Lead | Lead I | Same |
| Recording mode | automatic | Same |
| Measurement
parameters | Heart rate, ECG waveform | Same |
| Display | LCD | Same |
| HR measurement
range | 30bpm~300bpm | Similar |
| HR measurement
accuracy | ±1bpm or 1% | Similar |
| Power supply | Battery | Same |
| Electrical safety | The proposed device was tested to
demonstrated to comply with IEC 60601-1 | Same |
| EMC | The proposed device was tested to
demonstrated to comply with IEC 60601-1-2 | Same |
| Patient Contact
Material | Metal electrode | Same |
Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.