(266 days)
Not Found
No
The description mentions an "internal AF algorithm" but does not use terms like AI, ML, deep learning, or neural networks. The focus is on a pre-programmed algorithm for analysis.
No
The device is described as a cardiac event recorder used for monitoring and recording heart rhythms, specifically for detecting the presence or absence of atrial fibrillation. It does not actively treat or directly manage a disease but rather provides diagnostic information.
Yes
The device diagnoses atrial fibrillation using an internal AF algorithm and indicates its presence or absence via an LED.
No
The device description explicitly mentions hardware components such as solid-state non-volatile memory, thumb electrodes, chest placement, wrist electrodes, and LEDs, and the performance studies include electrical and mechanical testing in addition to software testing.
Based on the provided information, the AfibAlert™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- AfibAlert™ Function: The AfibAlert™ directly measures electrical signals from the patient's heart (ECG data) through electrodes placed on the skin. This is a form of in vivo (within the living body) measurement, not in vitro testing of a specimen.
- Intended Use: The intended use is for self-testing by patients to monitor their heart rhythms, which involves direct interaction with the patient's body.
Therefore, the AfibAlert™ falls under the category of a medical device that performs physiological measurements, but it is not an IVD.
N/A
Intended Use / Indications for Use
The AfibAlert™ is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
Product codes
DXH
Device Description
The AfibAlert™ is a cardiac event recorder capable of storing five 45-second events in solid-state non-volatile memory. AfibAlert™ allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.
The device can record a single channel of ECG data in three ways: (1) via the two thumb electrodes, (2) by placement on the chest, or (3) by applying wrist electrodes. In each case, the patient initiates the recording. The recording takes approximately 45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm. The appropriate LED (light emitting diode) is illuminated to indicate the presence or absence of AF.
If AF is indicated, or concerning symptoms are present, the patient makes a telephone call to a service provider as specified by their physician and transmits the ECG data to the receiving personnel. Data can also be transferred by using a computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ECG data
Anatomical Site
Heart rhythms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Self-testing by patients
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)
Electrical, mechanical, and software testing was conducted and data was collected in accordance with applicable standards to ensure that the device performs according to specifications and to verify that the device is suitable for home use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
JUN 2 3 2006
SECTION 5: 510(k) Summary
ر.ق. ت
| Submitter: | Lechnologies Research, Inc. |
|---|---|
| Contact Person: | Tim Lohman, President |
| Date Prepared: | September 29, 2005 |
| Trade Name: | The AfibAlert™ Atrial Fibrillation Detector |
| Classification: | Class II |
| 21 CFR 870.2920 - Telephone electrocardiograph transmitter and receiver | |
| Product Code: | DXH |
| Predicate | |
| Device(s): | The subject device is equivalent to the following devices: |
| • The King of Hearts Express AF (K020825), manufactured by Instromedix | |
| • The CG-2211 SelfCheck ECG Transmitter (K012223), manufactured by | |
| Card Guard Scientific Survival Ltd. | |
| • The HeartCard (K010945), manufactured by Instromedix | |
| Device Description: | The AfibAlert™ is a cardiac event recorder capable of storing five 45-second |
| events in solid-state non-volatile memory. AfibAlert™ allows patients who have | |
| been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to | |
| take periodic readings with a computerized rhythm monitor. The system was | |
| developed for the patient that has been previously diagnosed with AF, has a | |
| history of heart bypass, ablation, or other cardiac abnormality, or is on heart | |
| (anti-arrhythmic) medication. In these cases, detecting and determining AF early | |
| can potentially reduce the risk of heart attack and stroke. |
The device can record a single channel of ECG data in three ways: (1) via the
two thumb electrodes, (2) by placement on the chest, or (3) by applying wrist
electrodes. In each case, the patient initiates the recording. The recording takes
approximately 45 seconds. Immediately following data acquisition, an internal
AF algorithm is used to analyze the patient's rhythm. The appropriate LED
(light emitting diode) is illuminated to indicate the presence or absence of AF.
If AF is indicated, or concerning symptoms are present, the patient makes a
telephone call to a service provider as specified by their physician and transmits
the ECG data to the receiving personnel. Data can also be transferred by using a
computer. |
| Intended Use: | The AfibAlert™ is indicated for self-testing by patients who have been
diagnosed with, or are susceptible to developing atrial fibrillation and who would
like to monitor and record their heart rhythms on an intermittent basis. |
| Functional and
Safety Testing: | Electrical, mechanical, and software testing was conducted and data was
collected in accordance with applicable standards to ensure that the device
performs according to specifications and to verify that the device is suitable for
home use. |
| Conclusion: | Lechnologies Research Inc. considers the AfibAlert™ Atrial Fibrillation
Detector to be equivalent to the predicate devices listed above. This conclusion
is based upon the devices` similarities in functional design, method of use for
self-monitoring, and indications for use. |
1 echnologies Research, Inc.
AfibAlert™ 510(k) Premarket Notitication
September 29, 2005 Park 1-1
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a wavy line representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2006
Lechnologies c/o Ms. Stephanie King Senior Regulatory Consultant 450 Olsen Memorial Highway Minneapolis, MN 55422
Re: K052767
Trade Name: Afibalert Atrial Fibrillation Detector Regulation Number: 21 CFR 870-2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: II (two) Product Code: DXH Dated: May 25, 2006 Received: May 26, 2006
Dear Ms. King
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. Iisting of devices, good manufacturing practice. Iabeling, 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 such 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.
2
Page 2 - Ms. Stephanie King
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); 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. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
B. Harmonia, for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4: Indications for Use Statement
Device Name: AfibAlert™M
The AfibAlert™ is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODF)
Dhimma
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Resper : 010 Questions : 11 124 - 3
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