(315 days)
Not Found
No
The document explicitly states "It is not intend for automatic analysis or diagnostic ECG device" and there are no mentions of AI, DNN, or ML. The device focuses on recording and displaying basic ECG parameters.
No
A therapeutic device is used for treatment. This device monitors ECG signals and displays parameters, which is a diagnostic or monitoring function, not a therapeutic one.
No
The "Intended Use / Indications for Use" section explicitly states, "This device is not intended to substitute for a hospital diagnostic ECG device." and the "Device Description" section notes, "It is not intend for automatic analysis or diagnostic ECG device."
No
The device description explicitly states it is a "handheld, personalized use and affordable ECC Lead I recording device with metal electrode" and is "powered by internal battery source," indicating it is a physical hardware device, not software only.
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.
- Device Function: The description clearly states that the device "records and store Lead I ECG signals" and "records user's cardiac function for daily health check by palm." This involves directly measuring electrical activity from the body's surface, not analyzing samples taken from the body.
- Intended Use: The intended use is for "home health care use" to "record and store Lead I ECG signals" and "display three ECG parameters." This is a direct physiological measurement, not an in vitro test.
Therefore, the Handheld ECG Monitor OTC version falls under the category of a medical device that performs a physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
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 check by obtaining the measured parameters including heart rate, ST segment, and the QRS duration of users by the method of loading the measured parameters into 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.
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
adults above 20 years old.
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)
Bench tests were conducted to verify that the proposed device met all designs specifications as was initially planned. The bench tests consisted of the technical assessment 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.
IEC 60601-2-25: 1993 +A1: 1999, Medical Electrical Equipment - Part 2: Particular requirements for the safety of electrocardiographs.
IEC 60601-1-2: 2007, Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility -Requirements and tests.
IEC60601-2-47: 2001, Medical electrical equipment -- Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems.
ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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
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: +86-10-88798300 Fax: +86-10-88798860 Email: chenlei@choicemmed.com
-
- Submission Correspondent Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
-
- 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
1
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
2
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 .
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
3
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
4
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 (800) 638-2041 or (301) 796-7100 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
5
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)
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K112622
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