(497 days)
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.
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.
The provided document is a 510(k) summary for the Mdoloris HFVI Monitor. It outlines the device's indications for use, its technological comparison to a predicate device, and a summary of performance testing related to software, electrical safety, electromagnetic compatibility, and bench performance.
However, the document does not contain specific acceptance criteria, a detailed study design, or reported device performance metrics in the way typically expected for a clinical study proving a device meets acceptance criteria for diagnostic efficacy or accuracy. The performance testing summary primarily focuses on compliance with general safety and engineering standards (e.g., IEC, AAMI) and internal requirements, rather than a clinical validation of the HFVI measurement against a gold standard or a comparison of its diagnostic performance.
Therefore, many of the requested details cannot be extracted from this document, particularly those related to clinical accuracy, sample sizes for test/training sets, expert involvement, and ground truth establishment for clinical performance.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Software: Designed and developed according to a robust software development process, rigorously verified and validated. Complies with FDA guidance documents: "The content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," and "General principles of software validation." | Test results indicate that the Mdoloris HFVI Monitor complies with its predetermined specifications and the guidance documents. |
| Electrical Safety: Tested in accordance with IEC 60601-1: 2005. | Test results indicated that the Mdoloris HFVI Monitor complies with the applicable Standards. |
| Electromagnetic Compatibility (EMC): Tested in accordance with IEC 60601-1-2: 2007. | Test results indicated that the Mdoloris HFVI Monitor complies with the applicable Standard. |
| Performance Testing – Bench: Tested in accordance with internal requirements and 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. Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications. The results demonstrate that the Mdoloris HFVI Monitor is as safe, as effective, and performs as well as or better than the predicate device. |
Missing Information Regarding Clinical Performance or Diagnostic Accuracy:
- Specific numerical acceptance criteria for the accuracy of HFVI measurement itself (e.g., "HFVI measurement shall be within X% of a gold standard").
- Reported accuracy, sensitivity, specificity, or other performance metrics for the HFVI values.
- Clinical validation study results comparing the HFVI monitor's output to any reference method or clinical outcome.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified for clinical or performance evaluation beyond compliance and engineering standards. The document only mentions "test results" for software validation, electrical safety, EMC, and bench performance without detailing sample sizes of patients or data points.
- Data Provenance: Not specified. The document primarily refers to engineering and software testing, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The document does not describe any clinical test set where experts would establish ground truth for a diagnostic or prognostic performance claim. The device measures HRV, and states "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." This implies a lack of a direct diagnostic claim that would necessitate expert-established ground truth in a clinical validation study.
4. Adjudication Method for the Test Set
- Not applicable as no clinical test set requiring adjudication by experts is described in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No MRMC comparative effectiveness study is mentioned. The device is a monitor that provides a physiological parameter (HFVI), not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was Done
- The document implies standalone performance validation for the general operation of the device and its algorithm in the context of engineering and software testing. The "Mdoloris HFVI Monitor analyzes the ECG information using a proprietary algorithm that results in the calculation of the High Frequency Variability Index (HFVI)." However, the specifics of how the algorithm's accuracy in calculating HFVI was verified against a known gold standard for HRV measurement are not detailed. The provided studies revolve around compliance with basic safety and engineering standards rather than the accuracy of the HFVI calculation itself.
7. The Type of Ground Truth Used
- For the engineering and safety tests, the "ground truth" was compliance with established industry standards (IEC, AAMI) and the device's own predetermined internal specifications.
- For the HFVI measurement itself, the document does not specify a separate "ground truth" or a direct validation study against a gold standard for HRV measurements. The comparison is primarily in terms of technological characteristics and overall safety/effectiveness relative to a predicate device, rather than absolute accuracy of the HFVI value against a definitive reference.
8. The Sample Size for the Training Set
- Not applicable/Not provided. The document focuses on performance testing for regulatory clearance, not on details of algorithm development or training data.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not provided, as details about a training set for an algorithm are not included in this regulatory submission summary.
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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
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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
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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 SAS270 rue Salvador Allende59120 LoosFrance | ||
| SubmitterCorrespondent | Mrs. Mathilde ColletMdoloris Medical Systems SASPhone: +011 33 3 62 09 20 81Fax: +011 33 9 72 38 75 27Email: mathilde.collet@mdoloris.com | ||
| ApplicationCorrespondent: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 | ||
| Manufacturing Site: | Mdoloris Medical Systems SAS270 rue Salvador Allende59120 LoosFrance | ||
| Trade Name: | Mdoloris HFVI Monitor | ||
| Common Name: | Heart Rate Variability Monitor | ||
| ClassificationName: | Electrocardiograph | ||
| ClassificationRegulation: | 21 CFR §870.2340 | ||
| Product Code: | DPS | ||
| SubstantiallyEquivalent Devices: | New Mdoloris Model | Predicate510(k) Number | PredicateManufacturer / Model |
| Mdoloris MedicalSystems SAS HFVIMonitor | K071168 | DyAnsys, Inc. ThePortable ANSiscope™ |
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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 |
|---|---|---|
| DisplayedParameters | Real-time ECG waveformReal-time heart rateReal-time sympathovagalbalANS (from -50 to 50)Real-time sympathetic ANS₁index (from -50 to 50)Real-time parasympathetic ANS₁index (from -50 to 50)ECG lead selectionDysfunctionStatic balANSPercent of dysfunction | ECG graph (not for diagnosis)Instantaneous HFVIMedium trend HFVIHFVI graphFiltered RR SeriesEnergy Index valueSignal quality indicator (colorindicator of Energy Index) |
| Number ofElectrodes | Three (3) for HRVOne (1) for groundingChest lead for ECG functionality | Three (3) for HRV |
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| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Type ofAnalysis | Separation of sympathetic andparasympathetic components ofthe Autonomic Nervous System(ANS) by scale covarianceapproachSympathetic response is real partof complex wave functionParasympathetic response isimaginary part of complex wavefunction | R-R series artifacts removalR-R series re-samplingNormalization of the signal |
Summary of Performance Testing:
| Software | The Mdoloris HFVI Monitor software was designed and developedaccording to a robust software development process, and wererigorously verified and validated. Software information is provided inaccordance with internal requirements and the following guidancedocuments: |
|---|---|
| FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09Sep 99; and FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02. | |
| Test results indicate that the Mdoloris HFVI Monitor complies with itspredetermined specifications and the guidance documents. | |
| Electrical Safety | The Mdoloris HFVI Monitor was tested for patient safety in accordancewith the following standards: |
| IEC 60601-1: 2005, Medical electrical equipment – Part 1: Generalrequirements for basic safety and essential performance. | |
| Test results indicated that the Mdoloris HFVI Monitor complies withthe applicable Standards. | |
| ElectromagneticCompatibility | The Mdoloris HFVI Monitor was tested for EMC in accordance with thefollowing standard: |
| IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part1-2: General Requirements for Safety – Collateral Standard:Electromagnetic Compatibility-Requirements and Tests. | |
| Test results indicated that the Mdoloris HFVI Monitor complies withthe applicable Standard. |
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| 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. |
§ 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).