(52 days)
Not Found
No
The summary describes a device for recording and storing ECG data for later analysis by a physician. There is no mention of automated analysis, pattern recognition, or any technology that would typically involve AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
Explanation: The device is designed for ECG detection, recording, and playback for analysis by healthcare professionals, but it explicitly states that it is "NOT designed or intended for medical diagnosis" and is used for "self-testing before diagnosis." This indicates it's a diagnostic or monitoring tool, not a therapeutic one that provides treatment.
No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state: "The device is NOT designed or intended for medical diagnosis." It is intended for recording ECG data for later analysis by a physician.
No
The device description clearly outlines a physical, handhold, battery-operated physiological device with touch pads and the ability to use leadwires and disposable electrodes for ECG recording. While it includes software for viewing the data, the core medical device is hardware.
Based on the provided information, the Dimetek Micro Ambulatory ECG Recorder is not an In Vitro Diagnostic (IVD) device.
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 provide information for diagnosis, monitoring, or screening.
- Device Function: The Dimetek Micro Ambulatory ECG Recorder records electrical activity of the heart (ECG) directly from the patient's body through skin contact or electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use is for ECG detection, recording, and playback for adult patients concerned about their heart rhythm. While the data can be analyzed by a physician for potential diagnosis, the device itself is explicitly stated as NOT designed or intended for medical diagnosis.
- Device Description: The description reinforces that it's a physiological device for recording ECG data from the patient.
Therefore, the device falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Dimetek Micro Ambulatory ECG Recorder is intended for ECG detecting, recording and playback by adult patients who are concerned about their heart rhythm. It is used both in the clinics and home care environment.
User can choose the monitor mode and event mode to record the ECG data when feeling any heart condition occur. The device allows user to record their ECG data in TF card and playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia.
The ECG data in TF card can be downloaded to PC, and be read by ECG viewer software.
The device is NOT designed or intended for medical diagnosis.
Product codes
DPS
Device Description
The recorder is a handhold, light weight, battery-operated physiological device designed for recording ECG data. For its small size, it may be used in a clinical or non-clinical setting to record physiological signal waveforms while the patient is unattended; the device provides Real-time display function.
The device has a resolution of 24-bits with a fundamental sampling frequency of 100, 200, or 400 SPS and is stored un-compressed on a removable TF card. The sampling rate, display rate, display amplitude could be defined through control interface; meanwhile, heart rate would also be measured.
The Micro Ambulatory ECG Recorder is used for self-testing before diagnosis and is not recommended for users with implanted pacemakers or defibrillators. It works with a single lead, and has 4 testing modes:
- a) Hand contact mode, place your left and right index fingers are touching the touc pads integrated on the device.
- b) Leg contact mode, place your index finger on one electrode of the device and place your leg on the other electrode.
- c) Chest contact mode, place your right index finger on the right touch pad of and place left touch pad on your chest.
- d) Leadwire mode, using leadwires and two disposable electrodes. Paste the disposable electrodes on your body and connect them to the device through the lead wire cable.
The measurement data can be stored in the TF card, and then you can download to PC, and read the ECG by ECG Viewer software.
The device is NOT designed or intended for medical diagnosis.
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 patients
Intended User / Care Setting
Used both in the clinics and home care environment.
Data analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia.
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)
The following practices were followed and monitored for development of the DiCare m1CP ECG Recorder:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988+A1:1991+A2:1995
- . IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007
- . ANSI/AAMI EC38, Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems, 2007
- ANSI/AAMI EC53:1995/(R)2008 ECG cables and leadwires .
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and . testing, 2009
- . ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for . irritation and delayed-type hypersensitivity, 2010
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
510(k) Summary Section 5
L 2 2 2013
Date: April 10, 2013
Submitter Information
Name: Dimetek Digital Medical Technologies, LTD. Address: 3/F-A2, Unit 8, Xing Hua Building, 6th Industrial Road, Shekou, Shenzhen, China Tel: 86 755 88855978 Fax: 86 755 86199249 Contact person: Jimmy Guan E-mail: jimmy.quan@dimetek.net
Name of Device
Trade name: Micro Ambulatory ECG Recorder (DiCare m1CP) Common name: ECG Monitor Classification name: Electrocardiograph Production regulation: 21 CFR 870.2340 Product code: DPS
Predicate Device
HCG-801 Portable ECG Monitor (K060766, DPS, Omron Healthcare Co., Ltd.) V-TRUST TD-2202 Portable ECG Recorder (K101569, DPS, TaiDoc Technology Corporation)
Description
The recorder is a handhold, light weight, battery-operated physiological device designed for recording ECG data. For its small size, it may be used in a clinical or non-clinical setting to record physiological signal waveforms while the patient is unattended; the device provides Real-time display function.
The device has a resolution of 24-bits with a fundamental sampling frequency of 100, 200, or 400 SPS and is stored un-compressed on a removable TF card. The sampling rate, display rate, display amplitude could be defined through control interface; meanwhile, heart rate would also be measured.
The Micro Ambulatory ECG Recorder is used for self-testing before diagnosis and is not recommended for users with implanted pacemakers or defibrillators. It works with a single lead, and has 4 testing modes:
Micro Ambulatory ECG Recorder - 510(k) submission
Page 1 of 3
1
- a) Hand contact mode, place your left and right index fingers are touching the touc pads integrated on the device.
- b) Leg contact mode, place your index finger on one electrode of the device and place your leg on the other electrode.
- c) Chest contact mode, place your right index finger on the right touch pad of and place left touch pad on your chest.
- d) Leadwire mode, using leadwires and two disposable electrodes. Paste the disposable electrodes on your body and connect them to the device through the lead wire cable.
The measurement data can be stored in the TF card, and then you can download to PC, and read the ECG by ECG Viewer software.
The device is NOT designed or intended for medical diagnosis.
Intended Use
Dimetek Micro Ambulatory ECG Recorder is intended for ECG detecting, recording and playback by adult patients who are concerned about their heart rhythm. It is used both in the clinics and home care environment.
User can choose the monitor mode and event mode to record the ECG data when feeling any heart condition occur. The device allows user to record their ECG data in TF card and playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia.
The ECG data in TF card can be downloaded to PC, and be read by ECG viewer software.
The device is NOT designed or intended for medical diagnosis.
Summary of technological characteristics of device compared to the predicate devices (K060766 and K101569)
The Dimetek Micro Ambulatory ECG Recorder (DiCare m1CP) and the predicate devices (Omron HCG-801 Monitor & TaiDoc V-TRUST TD-2202 Portable ECG Recorder) have the similar Intended Use & Indications for Use, and similar / same technological characteristics. See Table 1.
| Table 1 | |
|---|---|
| Technological Characteristics | Comparison Result |
| Intended Use & Indications for Use | similar |
2
| Operational Principle | same |
|---|---|
| Patient Population | same |
| Technical Parameter | similar |
| Performance | same |
| Mechanical Safety | same |
| Electrical Safety | same |
| Biocompatibility | same |
| EMC | same |
| Function | similar |
Performance Data
The following practices were followed and monitored for development of the DiCare m1CP ECG Recorder:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988+A1:1991+A2:1995
- . IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007
- . ANSI/AAMI EC38, Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems, 2007
- ANSI/AAMI EC53:1995/(R)2008 ECG cables and leadwires .
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and . testing, 2009
- . ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for . irritation and delayed-type hypersensitivity, 2010
Conclusion
The ECG Recorder in this 510(k) is substantially equivalent to the predicate devices.
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
July 22, 2013
Dimetek Digital Medical Technologies Ltd. c/o Mr. Ned Devine Underwriters Laboratories, Inc 333 Pfingsten Road Northbrook, IL 60062
Re: K131572 Trade/Device Name: Micro Ambulatory ECG Recorder Regulation Number: 21 CFR 870.2340 Regulation Name: ECG Monitor Regulatory Class: Class II Product Code: DPS Dated: May 27, 2013 Received: June 5, 2013
Dear Mr. Devine:
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 (reporting of medical device-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 Small Manufacturers, International and Consumer Assistance at its toll-free
Image /page/3/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
July 22, 2013
4
Page 2 - Mr. Ned Devine
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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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Section 4 Indications for Use
510(k) Number: __
Device Name: Micro Ambulatory ECG Recorder
Model: DiCare m1CP
Indications for Use
Dimetek Micro Ambulatory ECG Recorder is intended for ECG detecting, recording and playback by adult patients who are concerned about their heart rhythm. It is used both in the clinics and home care environment.
User can choose the monitor mode and event mode to record the ECG data when feeling any heart condition occur. The device allows user to record their ECG data in TF card and playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia.
The ECG data in TF card can be downloaded to PC, and be read by ECG viewer software.
The device is NOT designed or intended for medical diagnosis.
Prescription Use _ X (Part 21 CFR 801 Sub part D) Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by
Owen P. Faris -S
Date: 2013.07.22
15:46:22 -04'00'
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Micro Ambulatory ECG Recorder - 510(k) Submisslon