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.

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.

AI/ML Overview

The provided text, K131572, describes a 510(k) submission for the Dimetek Micro Ambulatory ECG Recorder (DiCare m1CP). However, it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or detailed performance data beyond a general statement of "Performance - same" when compared to predicate devices.

The document focuses on establishing substantial equivalence to predicate devices (Omron HCG-801 Portable ECG Monitor and TaiDoc V-TRUST TD-2202 Portable ECG Recorder) based on similar intended use, operational principles, patient population, technical parameters, and safety characteristics.

Therefore, many of the requested details for a study proving acceptance criteria cannot be extracted from this specific 510(k) summary.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

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

Acceptance Criteria (Implied)	Reported Device Performance
Similar Intended Use: Intended for ECG detecting, recording and playback by adult patients in clinics and home care.	"Similar" to predicate devices. The device's intended use matches this criterion.
Similar Operational Principle: Records and stores ECG data.	"Same" as predicate devices. The device records ECG data.
Similar Patient Population: Adult patients concerned about their heart rhythm.	"Same" as predicate devices. The device is for adult patients.
Similar Technical Parameters: Resolution, sampling frequency, storage, display.	"Similar" to predicate devices. The device has a resolution of 24-bits with sampling frequencies of 100, 200, or 400 SPS, and stores un-compressed data on a TF card.
Similar / Same Performance (General): Expected to perform comparably to predicate devices in recording and displaying ECG.	"Same" as predicate devices. This is a general statement made in the comparison table, but specific performance metrics are not provided.
Mechanical Safety: Meets relevant safety standards.	"Same" as predicate devices. Compliance with IEC 60601-1 and ANSI/AAMI EC38 is noted.
Electrical Safety: Meets relevant safety standards.	"Same" as predicate devices. Compliance with IEC 60601-1 and IEC 60601-1-2 is noted.
Biocompatibility: Materials in contact with the patient are biocompatible.	"Same" as predicate devices. Compliance with ISO 10993-1, -5, and -10 is noted.
EMC: Electromagnetic compatibility is maintained.	"Same" as predicate devices. Compliance with IEC 60601-1-2 is noted.
Function: ECG recording, real-time display, data storage, and playback.	"Similar" to predicate devices. The device performs these functions.

Note: The acceptance criteria are largely implied by the declaration of "substantial equivalence" to predicate devices across various characteristics. The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity, or error rates) for clinical performance. The "reported device performance" is primarily a statement of similarity or sameness to predicate devices rather than independent quantitative results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance (Country of Origin): Not specified.
Retrospective or Prospective: Not specified.

The submission generally references compliance with various standards (e.g., IEC, ANSI/AAMI, ISO) but does not describe a performance study with a specific test set, patient data, or clinical evaluation. The statement "The following practices were followed and monitored for development of the DiCare m1CP ECG Recorder" refers to adherence to regulatory standards for design and safety, not a clinical performance study as typically understood for an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

The device is not intended for medical diagnosis, but for "playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia." This implies that human review is part of the intended use, but there's no mention of expert ground truth establishment for a test set within this submission.

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

Adjudication Method: Not specified, as no specific test set or clinical performance study is described.

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

MRMC Study: No. This device is a basic ECG recorder and not described as having AI assistance for interpretation.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable in the context of an algorithm's diagnostic performance. The device records ECG data for human analysis rather than providing automated diagnosis. Its standalone performance relates to its ability to accurately acquire and store ECG signals, which is generally covered by compliance with standards like ANSI/AAMI EC38 for ambulatory electrocardiographic systems. No specific data on this "standalone" signal acquisition performance is detailed beyond meeting standards.

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

Type of Ground Truth: Not specified, as no specific performance study requiring ground truth is detailed. The device records raw ECG data for a physician to interpret.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is an ECG recorder, not an AI/ML algorithm that requires a training set.

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

Ground Truth Establishment for Training Set: Not applicable. This device is an ECG recorder, not an AI/ML algorithm that requires a training set.

Summary

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K131572

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

Micro Ambulatory ECG Recorder - 510(k) submission

Page 1 of 3

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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

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

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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.

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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

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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

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Section 4 Indications for Use

510(k) Number: __

Device Name: Micro Ambulatory ECG Recorder

Model: DiCare m1CP

Indications for Use

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

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).