(57 days)
Not Found
No
The description focuses on traditional time and frequency domain analysis of R-R intervals, and there is no mention of AI, ML, or related concepts. The performance studies also do not suggest the use of AI/ML.
No
This device analyzes the basic rhythms of R-R intervals in electrocardiograms and provides numerical analysis, but it explicitly states that it does not make diagnoses. Therefore, it is a diagnostic tool, not a therapeutic one.
No
The device description explicitly states, "It only provides numerical analyses of the input electrocardiogram - the program does not make diagnoses."
Yes
The device description explicitly states "HRV Tools is a software product (supplied on a CD)". The performance studies focus on non-clinical tests related to algorithms and data analysis, further supporting its software nature.
Based on the provided information, it is highly likely that this device is not an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use clearly states that the device "only provides numerical analyses of the input electrocardiogram - the program does not make diagnoses." IVDs are typically used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device analyzes in vivo data (ECG signals from a patient).
- Device Description: The description confirms it analyzes "RR intervals in electrocardiograms," which are electrical signals from the heart, not biological specimens.
- Lack of Mention of Specimens: There is no mention of analyzing any type of biological specimen.
- Focus on ECG Analysis: The entire description revolves around analyzing ECG data.
While the device provides analytical results, the crucial distinction is that it analyzes in vivo physiological signals rather than in vitro biological specimens. This places it outside the typical definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HRV Tools is indicated when it is desired to analyze the basic rhythms of the R-R intervals in electrocardiograms. It only provides numerical analyses of the input electrocardiogram - the program does not make diagnoses.
Product codes
DPS
Device Description
HRV Tools is a software product (supplied on a CD) that analyzes the basic rhythms of the RR intervals in electrocardiograms, both in the time domain (analysis of time intervals) and in the frequency domain (spectral analysis).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
electrocardiograms
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical tests:
- Tests with input data from the MIT database
- Validation tests
- Tests to check the operation of the algorithms
- Accuracy tests
Clinical tests are not necessary since IIRV Tools uses the same technology as the predicate devices.
Conclusions:
HRV Tools is equivalent in safety and efficacy to the legally marketed predicate devices.
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
§ 870.2340 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
Summary
K040313
page 1 of 2
| APR - 6 2004 | 510(k) Summary |
|---|---|
| HRV Tools |
January 12, 2004
1. Submitter Information
Name: Del Mar Reynolds Medical Ltd.
Address:
1 Harforde Court John Tate Road Hertford, Herts SG13 7NW ENGLAND
Telephone Number: 44-1992-507700
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: January 12, 2004
2. Name of Device
Trade Name: HRV Tools Common Name: Heart Rate Variability Analysis Program Classification name: Computers and Software, Medical
3. Equivalent legally-marketed devices.
- Marquette Mars Unity workstation with heart rate variability, K991786 (includes frequency-domain)
- Medical Predictive Science Corporation HERO, K021230 ם
4. Description
1