(497 days)
Not Found
No
The summary mentions a "proprietary algorithm" for calculating HFVI, but there is no mention of AI, ML, deep learning, or any related concepts. The performance testing focuses on standard software, electrical safety, EMC, and bench testing, not on validation of an AI/ML model.
No.
The device is intended to acquire, display, and analyze electrocardiographic information and measure heart rate variability, which are diagnostic measurements, not therapeutic interventions. The text explicitly states, "These and other measurements are not intended for any specific clinical diagnosis." and "The clinical significance of HRV and other parameters must be determined by the physician." This indicates a monitoring and analysis function, not a treatment function.
No
The device acquires, displays, and analyzes electrocardiographic information and measures heart rate variability (HRV), but the "Intended Use / Indications for Use" explicitly states that "These and other measurements are not intended for any specific clinical diagnosis." It also notes that "The clinical significance of HRV and other parameters must be determined by the physician," indicating it provides data for interpretation rather than a diagnosis itself.
No
The device description explicitly mentions an "HFVI Sensor" which acquires ECG signals, indicating a hardware component is part of the system. The performance studies also include electrical safety and electromagnetic compatibility testing, which are typically performed on hardware devices.
Based on the provided information, the Mdoloris Medical Systems SAS HFVI Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is for acquiring, displaying, and analyzing electrocardiographic information and measuring heart rate variability. It also clearly states that "These and other measurements are not intended for any specific clinical diagnosis." IVD devices are specifically intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on acquiring and analyzing ECG signals from the patient's body, not on analyzing samples taken from the body.
- Lack of Mention of Specimens: There is no mention of the device being used with blood, urine, tissue, or any other type of biological specimen.
Therefore, the HFVI Monitor falls under the category of a medical device that measures physiological parameters directly from the patient, rather than an IVD device that analyzes samples.
N/A
Intended Use / Indications for Use
The Mdoloris Medical Systems SAS HFVI Monitor is intended to acquire, display, and analyze electrocardiographic information and to measure-heart rate variability (HRV). These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The Mdoloris Medical Systems SAS (Mdoloris) HFVI Monitor is a heart rate variability monitor intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use. The HFVI Sensor acquires electrocardiographic (ECG) signals from the patient, and the Mdoloris HFVI Monitor analyzes the ECG information using a proprietary algorithm that results in the calculation of the High Frequency Variability Index (HFVI). The HFVI is a measure of heart rate variability (HRV), and has a value between 0 and 100. It is intended for use on adult and pediatric patients.
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 and pediatric patients
Intended User / Care Setting
medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its 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)
Software: The Mdoloris HFVI Monitor software was designed and developed according to a robust software development process, and were rigorously verified and validated. Test results indicate that the Mdoloris HFVI Monitor complies with its predetermined specifications and the guidance documents.
Electrical Safety: The Mdoloris HFVI Monitor was tested for patient safety in accordance with IEC 60601-1: 2005. Test results indicated that the Mdoloris HFVI Monitor complies with the applicable Standards.
Electromagnetic Compatibility: The Mdoloris HFVI Monitor was tested for EMC in accordance with IEC 60601-1-2: 2007. Test results indicated that the Mdoloris HFVI Monitor complies with the applicable Standard.
Performance Testing – Bench: The Mdoloris HFVI Monitor was tested for performance in accordance with internal requirements and the following standard: AAMI EC12: 2000, IEC 62366: 2007, and ISTA Procedure 2A. Test results indicated that the Mdoloris HFVI Monitor complies with internal requirements and the applicable Standard.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the Mdoloris HFVI Monitor. The results of these activities demonstrate that the Mdoloris HFVI Monitor is as safe, as effective, and performs as well as or better than the predicate device. Therefore, the Mdoloris HFVI Monitor is considered substantially equivalent to the 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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2016
Mdoloris Medical Systems SAS % Thomas Kroenke Principal Consultant Speed to Market, Inc. PO Box 3018 Nederland, Colorado 80466
Re: K142969
Trade/Device Name: Mdoloris Medical Systems SAS HFVI Monitor Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 11, 2016 Received: January 14, 2016
Dear Thomas Kroenke:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142969
Device Name Mdoloris HFVI Monitor
Indications for Use (Describe)
The Mdoloris Medical Systems SAS HFVI Monitor is intended to acquire, display, and analyze electrocardiographic information and to measure-heart rate variability (HRV). These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submission Date: | 28 January 2016 | ||
|---|---|---|---|
| 510(k) Number: | K142969 | ||
| Submitter: | Mdoloris Medical Systems SAS | ||
| 270 rue Salvador Allende | |||
| 59120 Loos | |||
| France | |||
| Submitter | |||
| Correspondent | Mrs. Mathilde Collet | ||
| Mdoloris Medical Systems SAS | |||
| Phone: +011 33 3 62 09 20 81 | |||
| Fax: +011 33 9 72 38 75 27 | |||
| Email: mathilde.collet@mdoloris.com | |||
| Application | |||
| Correspondent: | Thomas Kroenke | ||
| Principal Consultant | |||
| Speed To Market, Inc. | |||
| PO Box 3018 | |||
| Nederland, CO 80466 USA | |||
| tkroenke@speedtomarket.net | |||
| 303 956 4232 | |||
| Manufacturing Site: | Mdoloris Medical Systems SAS | ||
| 270 rue Salvador Allende | |||
| 59120 Loos | |||
| France | |||
| Trade Name: | Mdoloris HFVI Monitor | ||
| Common Name: | Heart Rate Variability Monitor | ||
| Classification | |||
| Name: | Electrocardiograph | ||
| Classification | |||
| Regulation: | 21 CFR §870.2340 | ||
| Product Code: | DPS | ||
| Substantially | |||
| Equivalent Devices: | New Mdoloris Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Mdoloris Medical | |||
| Systems SAS HFVI | |||
| Monitor | K071168 | DyAnsys, Inc. The | |
| Portable ANSiscope™ |
4
Device Description: The Mdoloris Medical Systems SAS (Mdoloris) HFVI Monitor is a heart rate variability monitor intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use. The HFVI Sensor acquires electrocardiographic (ECG) signals from the patient, and the Mdoloris HFVI Monitor analyzes the ECG information using a proprietary algorithm that results in the calculation of the High Frequency Variability Index (HFVI). The HFVI is a measure of heart rate variability (HRV), and has a value between 0 and 100. It is intended for use on adult and pediatric patients. Intended Use: The Mdoloris Medical Systems SAS HFVI Monitor is intended to acquire, display, and analyze electrocardiographic information and to measure-heart rate variability (HRV). These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.
Technology The Mdoloris HFVI Monitor employs the same technological Comparison: characteristics as the predicate device.
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Displayed | ||
| Parameters | Real-time ECG waveform | |
| Real-time heart rate | ||
| Real-time sympathovagal | ||
| balANS (from -50 to 50) | ||
| Real-time sympathetic ANS₁ | ||
| index (from -50 to 50) | ||
| Real-time parasympathetic ANS₁ | ||
| index (from -50 to 50) | ||
| ECG lead selection | ||
| Dysfunction | ||
| Static balANS | ||
| Percent of dysfunction | ECG graph (not for diagnosis) | |
| Instantaneous HFVI | ||
| Medium trend HFVI | ||
| HFVI graph | ||
| Filtered RR Series | ||
| Energy Index value | ||
| Signal quality indicator (color | ||
| indicator of Energy Index) | ||
| Number of | ||
| Electrodes | Three (3) for HRV | |
| One (1) for grounding | ||
| Chest lead for ECG functionality | Three (3) for HRV |
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| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Type of | ||
| Analysis | Separation of sympathetic and | |
| parasympathetic components of | ||
| the Autonomic Nervous System | ||
| (ANS) by scale covariance | ||
| approach | ||
| Sympathetic response is real part | ||
| of complex wave function | ||
| Parasympathetic response is | ||
| imaginary part of complex wave | ||
| function | R-R series artifacts removal | |
| R-R series re-sampling | ||
| Normalization of the signal |
Summary of Performance Testing:
| Software | The Mdoloris HFVI Monitor software was designed and developed
according to a robust software development process, and were
rigorously verified and validated. Software information is provided in
accordance with internal requirements and the following guidance
documents: |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FDA guidance: The content of premarket submissions for software
contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09
Sep 99; and FDA guidance: General principles of software validation; Final
guidance for industry and FDA staff, 11 Jan 02. |
| | Test results indicate that the Mdoloris HFVI Monitor complies with its
predetermined specifications and the guidance documents. |
| Electrical Safety | The Mdoloris HFVI Monitor was tested for patient safety in accordance
with the following standards: |
| | IEC 60601-1: 2005, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance. |
| | Test results indicated that the Mdoloris HFVI Monitor complies with
the applicable Standards. |
| Electromagnetic
Compatibility | The Mdoloris HFVI Monitor was tested for EMC in accordance with the
following standard: |
| | IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part
1-2: General Requirements for Safety – Collateral Standard:
Electromagnetic Compatibility-Requirements and Tests. |
| | Test results indicated that the Mdoloris HFVI Monitor complies with
the applicable Standard. |
6
| Performance Testing – Bench |
|---|
| The Mdoloris HFVI Monitor was tested for performance in accordance with internal requirements and the following standard. |
| • AAMI EC12: 2000, Disposable ECG Electrodes; |
| • IEC 62366: 2007, Medical devices – Application of usability engineering to medical devices; and |
| • ISTA Procedure 2A, Partial simulation performance test procedure – Packaged-products 150 lb (68 kg) or less. |
| Test results indicated that the Mdoloris HFVI Monitor complies with internal requirements and the applicable Standard. |
| Conclusion |
| Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the Mdoloris HFVI Monitor. The results of these activities demonstrate that the Mdoloris HFVI Monitor is as safe, as effective, and performs as well as or better than the predicate device. |
| Therefore, the Mdoloris HFVI Monitor is considered substantially equivalent to the predicate device. |