HANDHELD ECG MONITOR

K112622 · Beijing Choice Electronic Technololgy Co., Ltd. · DPS · Jul 19, 2012 · Cardiovascular

Device Facts

• Record ID: K112622
• Device Name: HANDHELD ECG MONITOR
• Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Jul 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Handheld ECG Monitor OTC version is intended to record and store Lead I ECG signals, and display three ECG parameters for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Handheld ECG Monitor OTC version has simple user interface without ECG trace viewing function.

Device Story

Handheld ECG Monitor (MD100A1-F) is a portable, battery-powered device for home health care. It uses metal electrodes to record Lead I ECG signals; stores up to 200 records. Device displays heart rate and other parameters; lacks ECG trace viewing function. Operated by adult users for daily health checks. No automatic analysis or diagnostic interpretation provided. Output is viewed directly on the device screen to assist users in monitoring cardiac function. Benefits include convenient, personalized access to heart rate data outside clinical settings.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified against IEC 60601-1 (safety), IEC 60601-2-25 (ECG safety), IEC 60601-1-2 (EMC), IEC 60601-2-47 (ambulatory ECG systems), and ISO 10993 (biocompatibility).

Technological Characteristics

Handheld form factor; metal electrodes; internal battery power. Complies with IEC 60601-1, IEC 60601-2-25, IEC 60601-1-2, IEC 60601-2-47, and ISO 10993-5/10. No wireless connectivity or cloud integration mentioned. Software is non-diagnostic, non-analytical.

Indications for Use

Indicated for adults >20 years old for home health care use to record/store Lead I ECG signals and display three ECG parameters. Contraindicated for users with implanted pacemakers. Not for use as a hospital diagnostic ECG device.

Regulatory Classification

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.

Predicate Devices

• ReadMyHeart (K052303)

Submission Summary (Full Text)

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dditional Information I K112622 - Attachment I 510(k) Summary

#### 1 9 2012 JUL

### Attachment I 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: ______________

Date of Submission: August 12,2011 1.

Sponsor 2.

> Beijing Choice Electronic Technology Co., Ltd. Bailangyuan Building B, Rm. 1126-1127, Fuxing Road A36, 100039 Beijing , P. R. China

Establishment Registration Number: 3005569927

Contact Person: Mr. Lei Chen Position: Quality Director Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]
- 4. Proposed Device Identification

Proposed Device Name: Handheld ECG Monitor Proposed Device Model: MD100A1-F

Classification: Class II Product Code: DPS Regulation Number: 21 CFR 870.2340 Review Panel: Cardiovascular

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# dditional Information I K112622 - Attachment I 510(k) Summary

## Intended Use Statement:

intended Use Statement:
The Handheld ECG Monitor OTC version is intended users are adults above 20 years display three ECG parameters for home health care use. The interded users are adults above 20 years
display three ECG parameters for home health account disagnesic ECC device display three ECG parameters for nome health car as hospital diagnostic ECG device. Users with old. This device is not intended to subsitions to use this device. The Handheld ECG Monitor OTC
implanted pacemaker are not recommended to use this device. The Handheld ECG M implanted pacchiator are not not conce without ECG trace viewing function.

Predicate Device Identification

510(k) Number: K052303 Product Name: ReadMyHeart Manufacturer: DailyCare BioMedical Inc.

#### Device Description 6.

న్న

Handheld ECG Monitor is a handheld, personalized use and affordable ECC Lead I recording device with metal electrode that records user's cardiac function for daily health chevice by valm. The device with metal electrode that records user 3 carelies were and prometers, including heart rate of users by the method or louding the measured parameters including heart rate will record user's ECG signal tor Suscentus, and the of the device. It is not intend for automatic analysis or ECG signals monitor.

The device can store 200 records. Handheld ECG Monitor is powered by internal battery source. And The device can store 200 records: Handlerd DOC nebulating date, time, ID number, backlight and Beep sound.

#### Non-Clinical Test Conclusion 7.

Bench tests were conducted to verify that the proposed device met all designs specifications as was
t the proposed on the consisted to the montal assesses demonstrated that t Bench tests were conducted to verly that the properties. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1: 1988 +A1:1991+A2:1995, Medical Electrical Equipment - Part 1: General requirements for safety.

requirements for safety.
IEC 60601-2-25: 1993 +A1: 1999, Medical Electrical Equipment - Part 2: Particular requirements for the safety of electrocardiographs.

for the safety of electrocardiographs.
IEC 60601-1-2: 2007, Medical Electrical Equipment – Part 1-2: General requirements for basic IEC 60601-1-2: 2007, Medical Electrical Standard: Electromagnetic compatibility -Requirements and tests.

Requirements and tests.
IEC60601-2-47: 2001, Medical electrical equipment -- Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems.
Safety, including essential performance, of ambulatory electronal 474 Perticular regi

safety, including essential performance, or anisetalisty of the equirements for the start of the

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Summary

safety, including essential performance, of ambulatory electrocardiographic systems.
The formance, Dialaciael avaluation of medical devices - Part 5: Tests for In Vi safety, including essential performance, of ambulatory electrocardions.
ISO 1099-5: 2009, Biological evaluation of medical devices - Part 3: Tests for in Vitro cyclosioily.
I safety, model o
ISO 1099-5: 2009, Biological evaluation of medical devices - Part 11: Tests for in The 19
ISO 10993-10: 2010, Biological evaluation of medical devices - Part sensitization.

Substantially Equivalent Conclusion .

8.

Substantialy of The proposed device, Handheld ECG Monitor, is determined to 30 common
the proposed device, ReadMyHeart (K052303), in respect of safety and effectiveness.
The predicate device

1-3

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Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is an abstract image of an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Beijing Choice Electronic Technology Co., Ltd. c/o Diana Hong Submission Correspondent, Mid-Link Consulting Co., Ltd P.O. Box 237-023 Shanghai, 200237, China

Re: K112622

Trade/Device Name: Handheld ECG Monitor MD100A1-F Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: July 2, 2012 Received: July 6, 2012

### 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 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.

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 mav 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

JUL 19 2012

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Page 2 – Ms. Diana Hong

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Bram D. Zuckerman, M.D.
Director

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment V Indications for Use

510(k) Number: Device Name: Handheld ECG Monitor

Indications for Use:

The Handheld ECG Monitor OTC version is intended to record and store Lead I ECG signals, and display three ECG parameters for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Handheld ECG Monitor OTC version has simple user interface without ECG trace viewing function.

□PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

### ZOVER-THE-COUNTER USE (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)

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K112622

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