(111 days)
Not Found
No
The summary describes a device that records and transmits ECG data for interpretation by medical professionals. There is no mention of automated analysis, algorithms, or any technology that would suggest AI or ML is used for interpretation or diagnosis.
No.
The document states that the device is not intended for use as a conventional diagnostic tool. Instead, it is a patient evaluation tool that provides recorded ECG data to a medical practitioner for evaluation, helping to detect and analyze heart events. It records cardiac rhythm but does not provide therapy.
No
The device description explicitly states: "This device is not intended for use as a conventional diagnostic tool, but is to be used as a healthcare patient evaluation tool which can provide a doctor with the recorded ECG data as a reference to help detect and analyze heart events that a patient may experience at any time or any place."
No
The device description explicitly states that the device is a "handheld, personal electrocardiograph unit" with "two (2) built-in finger electrode sensors" and the option for a "2-leadwire cable with 2 electrodes pasted on body" for acquiring ECG signals. This indicates the presence of hardware components for signal acquisition, making it a hardware device with accompanying software.
Based on the provided text, the REKA E100 ECG Event Recorder (Cardiac Rhythm Monitor) is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to record the patient's ECG on demand when they feel symptoms indicative of a potential heart event. This recorded ECG data is then transmitted to a monitoring center for evaluation by medical practitioners. While the device itself isn't a conventional diagnostic tool, the data it collects is used for diagnostic purposes by healthcare professionals.
- Data Analysis: The text explicitly states that the monitoring center provides the ECG data to the medical practitioner for evaluation and that the device provides a doctor with recorded ECG data as a reference to help detect and analyze heart events. This process of analyzing biological data (ECG signals) to aid in diagnosis is a key characteristic of IVDs.
- Predicate Devices: The listed predicate devices (K052303, K060766, K963811, K093872) are all ECG event recorders or cardiac rhythm monitors, which are typically classified as IVDs because they collect and provide data used for diagnosing cardiac conditions.
While the device itself is a piece of hardware that collects the data, its intended use and the subsequent analysis of the collected data by medical professionals for diagnostic purposes firmly place it within the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The REKA E100 ECG Event Recorder (Cardiac Rhythm Monitor) is intended for use by patients who may experience transient symptoms that could suggest cardiac arrhythmia. The device records the patients ECG on demand at any time the patient feels any physical symptom indicative of a potential heart event. A 30 second single channel ECG is recorded and transmitted to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation. The Indications for Use are the same as the predicate devices.
The REKA E100 is designed for self-recording an ECG by out-hospital patients and for analysis by medical professionals at a remote monitoring center or a cardiologist or a physician. The E100 ECG is intended for use by patients who may experience transient symptoms that could suggest cardiac arrhythmia. The device is intended for non-lethal long term monitoring. The intended use is the same as the predicate devices.
It is suitable for adult users, who suffer from cardio-vascular diseases, are considered at high risk for potential cardiovascular events or other adult people who are concerned about their heart function and rhythm as they more about during their daily life. This device is not intended for use as a conventional diagnostic tool, but is to be used as a healthcare patient evaluation tool which can provide a doctor with the recorded ECG data as a reference to help detect and analyze heart events that a patient may experience at any time or any place.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The REKA E100 ECG Event Recorder (Cardiac Rhythm Monitor) is designed for on-demand, self-recording of a single channel ECG by patients at almost any place and any time. The recording takes 30 seconds and is transmitted to backend website for analysis and interpretation by medical professionals of the remote Monitoring Center. ECG signals are acquired by the two (2) built-in finger electrode sensors on the device. As an alternative, a better quality ECG can be recorded using the 2-leadwire cable with 2 electrodes pasted on body. The acquired signals are recorded in a build-in NAND flash memory and E100 can store up to 4000 ECG records.
The recorded ECG data can be transferred to mobile phone using micro USB cable/ 30-pin cable provided. The ECG then can be transmitted via cellular link or WiFi to an Internet depository when the patient ECG records are filed. The Internet depositories compatible with E100 can be accessed via www.reka.net and www.rekahealth.com. The compatible smart cell/mobile phones that can upload ECG records from E100 include iPhone®, Blackberry®, Symbian® and smart phones running on Android™. These mobile phones will require to install E100 Uploader (Apps) developed by REKA, the user can easily download the Apps from App World, Android Market etc. and install it.
Alternatively, the ECG signals stored in E100 can be transmitted to backend website through PC or Laptop with Internet connection by plugging E100 to computer using USB cable. For computer with Windows® & Mac®, user can easily access to the corresponding Uploader apps pre-stored in the device to run it for installation at 1ª time use. After then the Uploader runs automatically once E100 is plugged in. For computer with Linux®, user can directly upload ECG data by clicking the apps, no installation required.
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
Intended User / Care Setting
Patients (self-recording), Medical professionals (remote monitoring center, cardiologist, physician)
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)
REKA E100 has been subjected to extensive verification & validation testing. Final testing of the system included various performance tests and software validation tests designed to ensure that the device meet all of its functional and performance requirements and is fit for its intended use. The following list summarizes the testing performed on the device;
- . Product Specification Verification
- . Software Verification and Validation according to IEC 60601-1-4 and IEC 62304,
including Firmware, Uploader, Backend, and the system level - . IEC 60601-1 Safety Test
- IEC 60601-1-2 EMC Test .
- . ISO 10993 Biocompatibility Test
- Functionality Test, including accuracy test, compatibility test .
- . Reliability Test, including drop test, environment test, connector test, button test, packaging test
- . Risk Management according to ISO 14971
- . Bench Test against predicate device
- . Performance Test voluntarily against AAMI EC38
The results of the bench tests (Please refer to Section 18) demonstrate that the REKA E100 is as safe and effective as compared to the currently marketed predicate device.
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.
K052303, K060766, K963811, K093872
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) Summarv
SEP 1 2 2011
K 111438
In accordance with 21 CFR 807.87(h), the following 510 (k) summary has been prepared per 21 CFR 807.92.
.
Electrocardiograph Recorder / ECG Monitor
Submitter: REKA Pte. Ltd 21 Science Park Road #03-10/11 The Aquarius Singapore Science Park Singapore 117 628
Tax I.D. # CRN 200202641G
Tel: +65 6777 1588 Fax: +65 6779 5677 Email: Kaevuan tan@rekapd.com Website: www.rekapd.com
Contact person: Larry Petersen Requlatory Affairs Specialist Phone: 303-489-2500 USA Email: Larrypetersen7@gmail.com Date summary prepared: July 29, 2011 Device trade name: REKA E100 Device common name: ECG Event Recorder (Cardiac Rhythm Monitor) Device classification: Handheld ECG Recorder /Monitor; Product Code: DPS 21 CFR 870-2340, Class II
Legally marketed Predicate devices to which this device is Substantially Equivalent:
Predicate Device #1 Daily Care Biomedical, Inc. Model: ReadMyHeart FDA 510(k): K052303 (2005)
Predicate Device #2 Omron Corp. Model: HCG- 801 FDA 510(k): K060766 (2006)
Predicate Device #3 Card Guard Scientific Survival, Ltd. Model: CG-6106 FDA 510(k): K963811 (1996)
Predicate Device #4 Beijing Choice Electronics Model: MD100 FDA 510(k): K093872 (2010)
1
Description of the Device:
Section 5
The REKA E100 device has the following characteristics:
Device Description
The REKA E100 ECG Event Recorder (Cardiac Rhythm Monitor) is designed for on-demand, self-recording of a single channel ECG by patients at almost any place and any time. The recording takes 30 seconds and is transmitted to backend website for analysis and interpretation by medical professionals of the remote Monitoring Center. ECG signals are acquired by the two (2) built-in finger electrode sensors on the device. As an alternative, a better quality ECG can be recorded using the 2-leadwire cable with 2 electrodes pasted on body. The acquired signals are recorded in a build-in NAND flash memory and E100 can store up to 4000 ECG records.
The recorded EGG data can be transferred to mobile phone using micro USB cable/ 30-pin cable provided. The ECG then can be transmitted via cellular link or WiFi to an Internet depository when the patient ECG records are filed. The Internet depositories compatible with E100 can be accessed via www.reka.net and www.rekahealth.com. The compatible smart cell/mobile phones that can upload ECG records from E100 include iPhone®, Blackberry®, Symbian® and smart phones running on Android™. These mobile phones will require to install E100 Uploader (Apps) developed by REKA, the user can easily download the Apps from App World, Android Market etc. and install it.
Alternatively, the EGG signals stored in E100 can be transmitted to backend website through PC or Laptop with Internet connection by plugging E100 to computer using USB cable. For computer with Windows® & Mac®, user can easily access to the corresponding Uploader apps pre-stored in the device to run it for installation at 1ª time use. After then the Uploader runs automatically once E100 is plugged in. For computer with Linux®, user can directly upload ECG data by clicking the apps, no installation required.
Indications for Use:
The REKA E100 ECG Event Recorder (Cardiac Rhythm Monitor) is intended for use by patients who may experience transient symptoms that could suggest cardiac arrhythmia. The device records the patients EGG on demand at any time the patient feels any physical symptom indicative of a potential heart event. A 30 second single channel ECG is recorded and transmitted to a monitoring center. The monitoring center provides the EGG data to the medical practitioner for evaluation. The Indications for Use are the same as the predicate devices.
The REKA E100 is designed for self-recording an ECG by out-hospital patients and for analysis by medical professionals at a remote monitoring center or a cardiologist or a physician. The E100 EGG is intended for use by patients who may experience transient symptoms that could suggest cardiac arrhythmia. The device is intended for non-lethal long term monitoring. The intended use is the same as the predicate devices.
It is suitable for adult users, who suffer from cardio-vascular diseases, are considered at high risk for potential cardiovascular events or other adult people who are concerned about their heart function and rhythm as they more about during their daily life. This device is not intended for use as a conventional diagnostic tool, but is to be used as a healthcare patient evaluation
2
tool which can provide a doctor with the recorded ECG data as a reference to help detect and analyze heart events that a patient may experience at any time or any place.
Summary of Technological Characteristics & Principals of Operation
The technological characteristics and principles of operation of REKA E100 are the same as the predicate device. The two finger electrode sensors built in the REKA E100 are used for the ECG signal acquisition and the acquired signal is recorded in a build-in memory. Alternatively, patient can use the 2-leadwire cable provided and 2 electrodes pasted on body to capture better quality ECG signal. The ECG data stored in E100 will be transmitted to backend website through smart mobile phone or computer using cables provided. The ECG data uploaded on website will be as reference for analysis by medical professionals at a remote monitoring center or a cardiologist or a physician.
Non-Clinical Performance Tests and Data for the REKA E100:
REKA E100 has been subjected to extensive verification & validation testing. Final testing of the system included various performance tests and software validation tests designed to ensure that the device meet all of its functional and performance requirements and is fit for its intended use. The following list summarizes the testing performed on the device;
- . Product Specification Verification
- . Software Verification and Validation according to IEC 60601-1-4 and IEC 62304,
including Firmware, Uploader, Backend, and the system level
- . IEC 60601-1 Safety Test
- IEC 60601-1-2 EMC Test .
- . ISO 10993 Biocompatibility Test
- Functionality Test, including accuracy test, compatibility test .
- . Reliability Test, including drop test, environment test, connector test, button test, packaging test
- . Risk Management according to ISO 14971
- . Bench Test against predicate device
- . Performance Test voluntarily against AAMI EC38
Performance Standards:
This 510(k) submission was written in accordance with the FDA Guidance document "Class II Special Controls Guidance Document: Arrhythmia Detector, October 28, 2003" and the device conforms to the applicable performance requirements contained in and referenced in this document. In addition, this submission was prepared in accordance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11 2005".
3
Below is the list of the specific recognized standards that Reka E100 conforms to.
-
- IEC 60601-1:1988/A1:1991/A2:1995 Medical electrical equipment Part 1: General requirements for safety
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- JEC 60601-1-2:2007 Medical electrical equipment, Part 1-2 General requirements for safety - Collateral Standard: Electromagnetic compatibility -Requirements and tests
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- ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
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- 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
-
- IEC 60601-1-4:1996/A1:1999 Medical electrical equipment; Part 1-4 General requirements for safety - Collateral Standard: Programmable electric medical systems
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- IEC 62304:2006 Medical device software Software life cycle processes
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- ISO 15223-1:2007 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
-
- ISO 14971:2009 Medical devices -- Application of risk management to medical devices
E100 is also tested voluntarily against the applicable clauses of:
- AAMI/ANSI EC38:2007 Medical electrical equipment Part 2-47: Particular requirements for . the safety, including essential performance, of ambulatory electrocardiographic systems
Substantial Equivalence:
The REKA E100 device is substantially equivalent with respect to the indications for use, technological characteristics and performance characteristics to the identified legally marketed predicate devices.
Assessment of non-clinical performance data:
The results of the bench tests (Please refer to Section 18) demonstrate that the REKA E100 is as safe and effective as compared to the currently marketed predicate device.
Summary:
The REKA E100 ECG Monitor has the same intended use as the predicate devices. Based on the assessment of non-clinical performance data to verify the intended use, and the technological characteristic comparison, the REKA E100 is substantially equivalent to the legally marketed predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three stylized lines that appear to be curved and connected, resembling a human figure or a stylized design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
REKA Pic, Ltd. c/o Mr. Larry Peiersen Regulatory Affairs Consultant 1001 Bear Island Road, Suite 136 Summerville, SC 29483
1 5 2011
રિટ: K111438 Trade/Device Name: REKA E100 Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: August 9, 2011 Received: August 11, 2011
Dear Mr. Petersen:
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 imerstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 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 may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Larry Petersen
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Bram D. Zuckerman, M.D. Director ! Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Image /page/6/Picture/1 description: The image shows the word "REKA" in a bold, sans-serif font. The letters are slightly stylized, with a textured or grainy appearance. The letters are arranged horizontally, with equal spacing between them. The word appears to be a title or heading, possibly indicating a name or a concept.
Indications for Use
Section 4
510(k) Number: K111438
Device Name: Reka E100
Indications for Use
The REKA E100 EGG Event Recorder (Cardiac Rhythm Monitor) is intended for use by patients who may be at risk for experiencing transient cardiac symptoms that could suggest cardiac arrhythmia. The device records the patients EGG on demand at any time the patient feels any physical symptoms indicative of a potential heart event. A 30 second single channel ECG is recorded and transmitted to a monitoring center. The monitoring center provides the EGG data to the medical practitioner for evaluation. The Indications for Use are the same as the predicate devices.
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, and which can record and store an ECG signal, and then transmit the ECG recording to a hospital or cardiology center for interpretation and review.
It is suitable for adult users, who suffer from cardio-vascular diseases, are considered at high risk for potential cardiovascular events or other adult people who are concerned about their heart function and rhythm as they move about during their daily life.
This device is not intended for use as a conventional diagnostic tool, but is to be used as a healthcare patient evaluation tool which can provide a doctor with the recorded ECG data as a reference to help detect and analyze heart events that a patient may experience at any time or any place.
Prescription Use: X
AND/OR
Over-The Counter Use: _
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
Please do not write below this line
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of
510(k) Number K 111438 Devices
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