(98 days)
The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).
Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP) , Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Natus VikingQuest may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The VikingQuest is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.
The listed modalities do include overlap in functionality. In general. Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.
The Natus VikingQuest is intended to be used by a qualified healthcare provider.
The Natus VikingQuest is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). VikingQuest provides a variety of tests spanning the various modalities. There are two configurations, portable and cart-based.
The provided text describes the 510(k) premarket notification for the Natus VikingQuest, a diagnostic electromyograph. The information focuses on its substantial equivalence to predicate devices and adherence to various medical device standards. However, it does not contain specific details about acceptance criteria, reported device performance in terms of clinical accuracy or effectiveness, sample sizes for test sets, data provenance, ground truth establishment, or clinical study designs (like MRMC or standalone performance).
The document primarily outlines the regulatory compliance, technological characteristics, and intended use of the device, rather than detailed clinical performance evaluations against specific acceptance criteria.
Therefore, for aspects related to acceptance criteria and a study proving device performance, the information is largely absent in the provided text.
Here's what can be extracted based on your request, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Accessories with patient contact materials must be made from medical grade biocompatible materials in accordance with ISO 10993-1: 2009. | Appropriate component materials for accessories were previously verified to be biocompatible in accordance with ISO 10993-1: 2009. |
| Software Compliance | Software designed and developed according to a robust software development process, verified and validated consistent with FDA guidance documents and standards (e.g., "The content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," "General principles of software validation," "Content of premarket submissions for management of cybersecurity in medical devices," IEC 62304: 2006+A1:2015). | Results indicate that the Natus VikingQuest software complies with its predetermined specifications, applicable guidance documents, and applicable standards. |
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1: 2005/(R)2012, A1: 2012. | Results indicate that the Natus VikingQuest complies with the applicable standards. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2: 2014. | Results indicate that the Natus VikingQuest complies with the applicable standards. |
| Usability & Safety of EMG/Evoked Response Equipment | Compliance with IEC 60601-1-6: 2013, IEC 60601-2-40: 2016, and IEC 62366-1: 2015. | Results indicate that the Natus VikingQuest complies with its predetermined specifications and the applicable standards. |
| Clinical Performance (Accuracy/Effectiveness for diagnosis/monitoring) | Not specified in the provided text. | Not specified in the provided text. The document states "Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications... The results... demonstrate that the Natus VikingQuest is as safe, as effective, and performs as well as or better than the predicate devices." This is a general statement of equivalence, not a detailed performance report. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified. The document describes engineering and regulatory compliance testing rather than clinical study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set or ground truth establishment by experts for performance against a diagnosis is described. The "ground truth" mentioned pertains to compliance with engineering and safety standards.
4. Adjudication method for the test set:
- Not applicable as no human adjudication of clinical results is described.
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 mention of an MRMC study or AI assistance. The Natus VikingQuest is a diagnostic electromyograph for acquiring, displaying, analyzing, and reporting electrophysiological information, not an AI-driven interpretation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document describes a medical device (electromyograph) for use by a qualified healthcare provider. It does not describe a standalone algorithm or AI performance. The performance verified is for the entire device as a system.
7. The type of ground truth used:
- For the regulatory and engineering tests (biocompatibility, software, electrical safety, EMC, usability), the "ground truth" is compliance with established international standards (ISO, IEC, AAMI/ANSI) and FDA guidance documents. There is no mention of pathology, expert consensus on clinical findings, or outcomes data in the context of the device's diagnostic accuracy proving.
8. The sample size for the training set:
- Not applicable. The document describes a medical device, not an AI/machine learning algorithm with distinct training and test sets in the typical sense. Software development was "rigorously verified and validated consistent with FDA guidance documents and standards," implying traditional software testing, not machine learning model training.
9. How the ground truth for the training set was established:
- Not applicable, for the same reasons as point 8.
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December 19, 2017
Natus Neurology Incorporated Shane Sawall Manager, Regulatory Affairs 3150 Pleasant View Road Middleteon, Wisconsin 53562
Re: K172743
Trade/Device Name: Natus VikingOuest Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN, JXE, GWF, OLT, GWJ, GWE, GZP Dated: September 7, 2017 Received: September 12, 2017
Dear Mr. Sawall:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172743
Device Name Natus VikingQuest
Indications for Use (Describe)
The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).
Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP) , Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Natus VikingQuest may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The VikingQuest is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.
The listed modalities do include overlap in functionality. In general. Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.
The Natus VikingQuest is intended to be used by a qualified healthcare provider.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submission Date: | 07 September 2017 | ||
|---|---|---|---|
| Submitter: | Natus Neurology Incorporated3150 Pleasant View RoadMiddleton, WI 53562USA | ||
| Submitter andApplicationCorrespondent | Mr. Shane T. SawallPhone: +1 (608) 829-8673Fax: +1 (608) 829-8771Email: shane.sawall@natus.com | ||
| Manufacturing Site: | Natus Neurology Incorporated3150 Pleasant View RoadMiddleton, WI 53562USA | ||
| Trade Name: | Natus VikingQuest | ||
| Common andClassificationName: | Diagnostic electromyograph, and evoked response stimulator | ||
| ClassificationRegulation: | 21 CFR §890.1375, 21 CFR §882.1550, 21 CFR §882.1870,21 CFR §882.1400, 21 CFR §882.1900, 21 CFR §882.1890,21 CFR §882.1880 | ||
| Product Code: | IKN, JXE, GWF, OLT, GWJ, GWE, GZP | ||
| SubstantiallyEquivalent Devices: | New Model | Predicate 510(k)Number | PredicateManufacturer / Model |
| Natus VikingQuest | K130346(Primarypredicate) | Natus NeurologyIncorporated SynergyFocus Desktop VersionSynergy Focus LaptopVersion | |
| K120979(Referencepredicate) | Carefusion 209, Inc.(now Natus NeurologyIncorporated) /Carefusion NicholetEDX |
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| Device Description: | The Natus VikingQuest is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). VikingQuest provides a variety of tests spanning the various modalities. There are two configurations, portable and cart-based. |
|---|---|
| Intended Use: | The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP) , Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Natus VikingQuest may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The VikingQuest is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. |
The Natus VikingQuest is intended to be used by a qualified healthcare provider.
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Technology Comparison:
The Natus VikingQuest employs the same technological characteristics as the predicate device.
| EMG SystemCharacteristic | Natus NeurologySynergy Focus(K130346) | Natus NeurologyVikingQuest(Proposed Device) |
|---|---|---|
| Modalities | Nerve Conduction (NCS)Electromyography (EMG)Evoked Potential (EP)Other TestsIntra-operative Monitoring (IOM) | Same |
| Software Features | Electrical Stimulus AutomationAutomatic Report NarrativeGeneration | Same |
| Number of AmplifierSignal RecordingChannels | 1 to 3 | 1 to 4 |
| Stimulator Options | Constant Current | Selectable:Constant Currentor Constant Voltage |
| Number of Stimulators | 1 | Same |
| Bi-phasic Stimulator | Yes | No |
| Auditory StimulationTypes (Click, pip andburst) | Yes | Same |
| Visual Stimulation | Yes | Same |
Summary of Performance Testing:
The Natus VikingQuest has no patient contact materials, and therefore this Biocompatibility section does not apply to them.
Accessories for use with the Natus VikingQuest have patient contact materials and are made from medical grade biocompatible materials.
The appropriate component materials for these accessories were previously verified to be biocompatible in accordance with the following standard:
- ISO 10993-1: 2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
Verification results indicate that the appropriate component materials comply with the standard.
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| Software | The Natus VikingQuest software was designed and developed according to a robust software development process, and was rigorously verified and validated consistent with the following FDA guidance documents and standards: | |
|---|---|---|
| • | The content of premarket submissions for software contained in medical devices, 11 May 05. | |
| • | Off-the-shelf software use in medical devices, 09 Sep 99. | |
| • | General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. | |
| • | Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14. | |
| • | IEC 62304: 2006+A1:2015, Medical device software – Software life cycle processes | |
| Results indicate that the Natus VikingQuest software complies with its predetermined specifications, applicable guidance documents, and applicable standards. | ||
| Electrical Safety | The Natus VikingQuest was verified for performance in accordance with the following standard: | |
| • | AAMI/ANSI ES60601-1: 2005/(R)2012, A1: 2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. | |
| Results indicate that the Natus VikingQuest complies with the applicable standards. | ||
| Electromagnetic Compatibility | The Natus VikingQuest was verified for performance in accordance with the following standard: | |
| • | IEC 60601-1-2: 2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. | |
| Results indicate that the Natus VikingQuest complies with the applicable standards. |
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The Natus VikingQuest was verified for performance in accordance with Performance Testing – Bench internal requirements and the applicable clauses of the following standards:
- . IEC 60601-1-6: 2013, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
- . IEC 60601-2-40: 2016, Medical electrical equipment – Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment.
- . IEC 62366-1: 2015, Medical devices – Application of usability engineering to medical devices.
Results indicate that the Natus VikingQuest complies with its predetermined specifications and the applicable standards.
Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the Natus VikingQuest. The results of these activities demonstrate that the Natus VikingQuest is as safe, as effective, and performs as well as or better than the predicate devices.
Therefore, the Natus VikingQuest is considered substantially equivalent to the predicate devices.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).