(98 days)
No
The summary describes a device for acquiring and analyzing electrophysiological signals using standard techniques (NCS, EMG, EP, etc.). There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies summary.
No
The device is described as being for "acquisition, display, analysis, storage, reporting, and management of electrophysiological information" and used to "support the diagnosis of neuromuscular disease or condition," indicating a diagnostic rather than therapeutic purpose.
Yes
The device "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." This directly indicates a diagnostic purpose.
No
The device description explicitly mentions "system" and "configurations, portable and cart-based," which strongly implies the inclusion of hardware components beyond just software. The intended use also describes the acquisition of electrophysiological information, which requires hardware for signal capture.
Based on the provided information, the Natus VikingQuest is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Natus VikingQuest Function: The Natus VikingQuest acquires, displays, analyzes, stores, reports, and manages electrophysiological information directly from the human nervous and muscular systems. It does this by measuring electrical signals generated by the body (e.g., nerve conduction, muscle activity, brain activity).
- No Specimen Examination: The device does not examine specimens (like blood or tissue) outside of the body. It interacts directly with the patient's body to collect data.
Therefore, the Natus VikingQuest falls under the category of a medical device that performs physiological measurements, but it is not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IKN, JXE, GWF, OLT, GWJ, GWE, GZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human nervous and muscular systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare provider
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)
The Natus VikingQuest software was designed and developed according to a robust software development process, and was rigorously verified and validated consistent with FDA guidance documents and standards. Results indicate that the Natus VikingQuest software complies with its predetermined specifications, applicable guidance documents, and applicable standards. Electrical Safety and Electromagnetic Compatibility were also verified for performance according to applicable standards, with results indicating compliance. Performance testing was conducted in accordance with Bench internal requirements and applicable clauses of IEC 60601-1-6, IEC 60601-2-40, and IEC 62366-1. Results indicate compliance with predetermined specifications and applicable standards. Conclusion: Verification and validation activities demonstrated that the Natus VikingQuest is as safe, as effective, and performs as well as or better than the predicate devices, leading to a determination of substantial equivalence.
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.
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
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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.
1
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
2
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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3
| Submission Date: | 07 September 2017 | ||
|---|---|---|---|
| Submitter: | Natus Neurology Incorporated | ||
| 3150 Pleasant View Road | |||
| Middleton, WI 53562 | |||
| USA | |||
| Submitter and | |||
| Application | |||
| Correspondent | Mr. Shane T. Sawall | ||
| Phone: +1 (608) 829-8673 | |||
| Fax: +1 (608) 829-8771 | |||
| Email: shane.sawall@natus.com | |||
| Manufacturing Site: | Natus Neurology Incorporated | ||
| 3150 Pleasant View Road | |||
| Middleton, WI 53562 | |||
| USA | |||
| Trade Name: | Natus VikingQuest | ||
| Common and | |||
| Classification | |||
| Name: | Diagnostic electromyograph, and evoked response stimulator | ||
| Classification | |||
| Regulation: | 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 | ||
| Substantially | |||
| Equivalent Devices: | New Model | Predicate 510(k) | |
| Number | Predicate | ||
| Manufacturer / Model | |||
| Natus VikingQuest | K130346 | ||
| (Primary | |||
| predicate) | Natus Neurology | ||
| Incorporated Synergy | |||
| Focus Desktop Version | |||
| Synergy Focus Laptop | |||
| Version | |||
| K120979 | |||
| (Reference | |||
| predicate) | Carefusion 209, Inc. | ||
| (now Natus Neurology | |||
| Incorporated) / | |||
| Carefusion Nicholet | |||
| EDX |
4
| 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.
5
Technology Comparison:
The Natus VikingQuest employs the same technological characteristics as the predicate device.
| EMG System
Characteristic | Natus Neurology
Synergy Focus
(K130346) | Natus Neurology
VikingQuest
(Proposed Device) |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Modalities | Nerve Conduction (NCS)
Electromyography (EMG)
Evoked Potential (EP)
Other Tests
Intra-operative Monitoring (IOM) | Same |
| Software Features | Electrical Stimulus Automation
Automatic Report Narrative
Generation | Same |
| Number of Amplifier
Signal Recording
Channels | 1 to 3 | 1 to 4 |
| Stimulator Options | Constant Current | Selectable:
Constant Current
or Constant Voltage |
| Number of Stimulators | 1 | Same |
| Bi-phasic Stimulator | Yes | No |
| Auditory Stimulation
Types (Click, pip and
burst) | 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.
6
| 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. |
7
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.