(208 days)
Not Found
No
The description mentions an "algorithm" based on a "physical-mathematical description," but there is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No
This device is described as a "measuring tool" for analyzing prerecorded ECG data and presenting Heart Rate Variability (HRV) for clinician review. It does not provide any treatment or therapy.
Yes
The device is described as software for "analysis, summary and reporting of pre-recorded ambulatory ECG data" to present Heart Rate Variability (HRV) for "qualified clinician review, edit and assessment." This functionality, particularly the analysis and reporting of physiological data for clinical assessment, indicates its use in diagnosing or aiding in the diagnosis of medical conditions related to heart rate variability.
Yes
The device description explicitly states "The HeartTrends™ software is employed as a measuring tool" and "The HeartTrends™ software is based on an algorithm". There is no mention of any accompanying hardware component being part of the device itself. The input is "prerecorded ambulatory ECG data", implying the software processes data acquired by a separate device.
Based on the provided information, the HeartTrends™ software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- HeartTrends™ Function: The HeartTrends™ software analyzes prerecorded ambulatory ECG data. ECG data is a measurement of electrical activity of the heart, not a sample taken from the body for laboratory analysis.
- Intended Use: The intended use is for the analysis, summary, and reporting of ECG data for clinician review and assessment of Heart Rate Variability (HRV). This is a diagnostic aid based on physiological signals, not a test performed on a biological sample.
Therefore, the HeartTrends™ software falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HeartTrends™ software is intended for the analysis, summary and reporting of up to 3 channels of prerecorded ambulatory ECG data. reporting of up to 5 chainters of the MPW (Multipole Paramater Weighted) HRV.
Product codes
DQK
Device Description
The HeartTrends™ software is employed as a measuring tool to present Heart Rate Variability (HRV) to qualified clinician review, edit and assessment. It provides measurements of the MPW (Multipole Paramater Weighted) HRV. The HeartTrends™ software is based on an algorithm, which is constructed The HeartTronos - sorvice, based on a physical-mathematical description of complex time series.
The multipole method generates several parameters, multipoles, where every single one describes the HRV.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
prerecorded ambulatory ECG data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified clinician review
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a drawing of a heart with an electrocardiogram (ECG) line running through it. The heart is drawn in a simple, slightly rough style, and the ECG line is jagged and uneven. The drawing is done in black on a white background, giving it a stark, graphic look. The overall impression is one of love and health, or perhaps a reminder of the importance of heart health.
510(k) Summary Lev-El, Ltd.'s HeartTrends™ 510(k) Number K012825
MAR 1 9 2002
Applicant's Name:
Lev-El, Ltd. P.O.B 3 Ariel Israel 44837
Contact Person:
Avner Ben-Harush Lev-El, Ltd. P.O.B 3 Ariel Israel 44837 Telephone: 972-3-9367489 Fax: 972-3-9060472
Date Prepared:
15 August 2001
Trade Name:
HeartTrends™
Classification Name:
Programmable Diagnostic Computer
Classification:
The FDA has classified Programmable Diagnostic Computer devices as class II device (product code DQK) and it is reviewed by the Cardiovascular Advisory Committee.
1
Predicate Devices:
The HeartTrends™ is substantially equivalent to the Biosensor The Treason Ambulatory (Holter) Recording System cleared under K950944.
Performance Standards:
The HeartTrends ™ complies with the following standards and regulations: cGMP/QSR, MDD 93/42 EEC (1993), ISO 9001 (1994), EN 46002 (1996), EN 60601-1-4 (1997), EN 1441 (1998).
Indication for Use:
The HeartTrends™ software is intended for the analysis, summary and reporting of up to 3 channels of prerecorded ambulatory ECG data. reporting of up to 5 chainters of the MPW (Multipole Paramater Weighted) HRV.
Device Description:
The HeartTrends™ software is employed as a measuring tool to present Heart Rate Variability (HRV) to qualified clinician review, edit and assessment. It provides measurements of the MPW (Multipole Paramater Weighted) HRV. The HeartTrends™ software is based on an algorithm, which is constructed The HeartTronos - sorvice, based on a physical-mathematical description of complex time series.
The multipole method generates several parameters, multipoles, where every single one describes the HRV.
Substantial Equivalence:
Lev-El Ltd. believes that the HeartTrends™ is substantially equivalent to the Biosensor Corporation Ambulatory (Holter) Recording System cleared under K950944 in respect to intended use, technological characteristics, performance, and labeling.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2002
Lev-El, Ltd. c/o Ms. Einat Shammai Arazy Group Mizpe Aviv Industrial Park 13 M.P. Misgav, 20187 ISRAEL
Re: K012825
Trade Name: HeartTrends™ Software, Version 1.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: December 16, 2001 Received: December 19, 2001
Dear Ms. Shammai:
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 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.
3
Page 2 - Ms. Einat Shammai
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I DT has made a active manufactions administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 comply with an all aller of 21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607); adoning (21 OFF regulation (21 CFR Part 820); and if applicable, the electronic rord in and quality by some (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) I mis lotter will and w your to by finding of substantial equivalence of your device to a legally marketed predicated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of I Crain 6646. Additionally, for questions on the promotion and advertising of Compinates at (301) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entired, "Thisocialism" responsibilities under the Act may be obtained from the Ourision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
ha. Dertteth
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
K012825 510(k) Number:
HeartTrends™ Device Name:
Indications for Use:
The HeartTrends™ software is intended for the analysis, summary and reporting of up The Ficart Fredesto 3 channels of prerecorded ambulatory ECG data.
to 3 channels of prevecorded antouratory DOC caref the MPW (Multipole Paramater Weighted) HRV.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use ﮐﮯ (Per 21 CFR 801.109)
OR
Over the Counter Use_
Division of Cardiovascular & Respiratory Devices
510(k) Number K012885
12