(30 days)
The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus New Yorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery.
The Natus Quantum Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monits, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
The Natus Quantum Amplifier is the front end hardware of an electroencephalograph, and consists of amplifier circuitry, A/D Converters, Digital Signal Processing, digital switch matrix, LCD touch screen interface as well as TCP/IP & USB connection options of PC communication.
The Natus Quantum Amplifier can record either in Tethered mode or in Ambulatory Mode. In Ambulatory Mode, data is stored in the Quantum Breakout's internal memory and automatically uploaded to the main study folder when the Quantum Breakout is reconnected to the Natus Base unit.
The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery by an external cortical stimulator.
The provided text describes the 510(k) summary for the Natus Quantum, an electroencephalograph (EEG) device. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications, intended use, and adherence to various safety and performance standards.
However, the document does not contain information about the development and testing of a medical device that uses artificial intelligence (AI) or machine learning. Therefore, it does not provide details for the following requested information:
- A table of acceptance criteria and the reported device performance: The document lists various technical specifications (e.g., input impedance, input noise, sampling frequency) for the device and its predicate, along with general statements about compliance with standards (e.g., "Results indicate that the Natus Quantum complies with the applicable standards"). It does not outline specific acceptance criteria in the format of a table with numerical performance results directly tied to those criteria, especially not in the context of an AI/ML algorithm's performance.
- Sample size used for the test set and the data provenance: No data sets for AI/ML model testing are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no mention of a ground truth for an AI/ML component.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance (as present in the document):
The document provides a "Summary of Performance Testing" for the Natus Quantum, focusing on:
- Software: "The Natus Quantum firmware was designed and developed according to a robust software development process, and was rigorously verified and validated." It states that the firmware complies with predetermined specifications and applicable guidance documents/standards (e.g., "The content of premarket submissions for software contained in medical devices, IEC 62304: 2006").
- Electrical Safety: "The Natus Quantum was verified for performance in accordance with the following standard: IEC 60601-1: 2005, Am1: 2012." It concludes that the device "complies with the applicable standards."
- Electromagnetic Compatibility: "The Natus Quantum was verified for performance in accordance with the following standard: IEC 60601-1-2 Edition 4.0 2014-02." It concludes that the device "complies with the applicable standards."
In essence, this 510(k) pertains to a traditional medical device (an EEG amplifier) and its compliance with established electrical and software engineering standards, not the performance evaluation of an AI-powered diagnostic or assistive tool.
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February 22, 2018
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta Director, Quality Assurance & Regulatory Affairs 2568 Bristol Circle Oakville, Ontario L6H 5S1 CA
Re: K180181
Trade/Device Name: Natus Quantum Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. OLV. GYC Dated: January 22, 2018 Received: January 23, 2018
Dear Sanjay Mehta:
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 (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 mediation-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
for
Carlos Peña, Ph.D. 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) K180181
Device Name Natus Quantum
Indications for Use (Describe)
The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus New Yorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery.
The Natus Quantum Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monits, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
PAGE 1 of 5
| Submission Date: | 22 January 2018 | ||
|---|---|---|---|
| Submitter: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada | ||
| Submitter andApplicationCorrespondent | Mr. Sanjay MehtaDirector, Quality and Regulatory AffairsPhone: +1 (905) 287-5055Fax: +1 (905) 829-5304Email: sanjay.mehta@natus.com | ||
| Manufacturing Site: | Ducommun LaBarge Technologies2222 East Pensar DriveAppleton, WI 54911USA | ||
| Trade Name: | Natus Quantum | ||
| Common andClassificationName: | Full-Montage Standard Electroencephalograph | ||
| ClassificationRegulation: | 21 CFR §882.1400 | ||
| Product Code: | GWQ, OLV, GYC | ||
| SubstantiallyEquivalent Devices: | New Model | Predicate 510(k)Number | PredicateManufacturer / Model |
| Natus Quantum | K143440 | Natus MedicalIncorporated DBAExcel-Tech Ltd.(XLTEK)2568 Bristol CircleOakville, Ontario,L6H 5S1, Canada |
/ Natus Quantum
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| Device Description: | The Natus Quantum Amplifier is the front end hardware of an electroencephalograph, and consists of amplifier circuitry, A/D Converters, Digital Signal Processing, digital switch matrix, LCD touch screen interface as well as TCP/IP & USB connection options of PC communication.The Natus Quantum Amplifier can record either in Tethered mode or in Ambulatory Mode. In Ambulatory Mode, data is stored in the Quantum Breakout's internal memory and automatically uploaded to the main study folder when the Quantum Breakout is reconnected to the Natus Base unit.The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery by an external cortical stimulator. |
|---|---|
| Intended Use: | The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery.The Natus Quantum Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use. |
The subject and predicate devices have the same Indications for Use and the same intended use.
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Technology Comparison: The Natus Quantum employs the same technological characteristics as the predicate device.
| Specification | Predicate DeviceNatus Quantum(K143440) | Subject DeviceNatus Quantum(Modified) |
|---|---|---|
| Analog Specifications EEG Channels | ||
| EEG Channels | 64-256 | 64-256 |
| ReferenceChannels | Dedicated separate referenceand ground | Dedicated separatereference and ground |
| Input Impedance | >1000 MOhm | >1000 MOhm |
| Input Noise | < 1.5uV pk to pk @ .1....100Hz bandwidth(<0.53uV rms@1....100Hzbandwidth) | < 2.0uV pk to pk @.1....100Hz bandwidth(<0.53uV rms@1....100Hzbandwidth) |
| Input signalrange | 20mV pk-to-pk | 20mV pk-to-pk |
| MaximumOperational DCinput voltageelectrode offset | ±300mV | ±300mV |
| Input BiasCurrent | <1nA | <1nA |
| Common modeRejection Ratio | >110dB@60Hz | >106dB@60Hz |
| Digital Specifications | ||
| SamplingFrequency | 256, 512, 1024, 2048, 4096,8192, 16384 Hz | 256, 512, 1024, 2048,4096, 8192, 16384 Hz |
| SamplingResolution - EEGchannels | 24 bits | 24 bits |
| SamplingQuantization -EEG channels | 305nV | 305nV |
| StorageResolution - EEGChannels | 16 bits | 16 bits |
| Quantum Breakout Box Feature | ||
| ReferentialChannels | 128 referential channels perbreakout, 2 breakoutscascade-able up to 256channels | 128 referential channelsper breakout, 2 breakoutscascade-able up to 256channels |
| Differentialchannels | Up to 8 configurabledifferential channels per 128channel breakout (2 inputsper channel) | Up to 8 configurabledifferential channels per128 channel breakout (2 |
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Summary of Performance
Testing:
| Software | The Natus Quantum firmware was designed and developed according to a robust software development process, and was rigorously verified and validated. Firmware information is provided in accordance with internal requirements and 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, Am1: 2015, Medical device software – Software life cycle processes Results indicate that the Natus Quantum firmware complies with its predetermined specifications, the applicable guidance documents, and the applicable standards. |
|---|---|
| Electrical Safety | The Natus Quantum was verified for performance in accordance with the following standard: IEC 60601-1: 2005, Am1: 2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Results indicate that the Natus Quantum complies with the applicable standards. |
| ElectromagneticCompatibility | The Natus Quantum was verified for performance in accordance with the following standard: IEC 60601-1-2 Edition 4.0 2014-02, 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 Quantum complies with the applicable standards |
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Image /page/7/Picture/0 description: This document is a 510(k) Summary, page 5 of 5, for the Natus Quantum, document number K180181. The document states that the Natus Quantum was verified for performance in accordance with internal requirements and the applicable clauses of the following standards, including IEC 60601-1-6 Edition 3.1 2013-10, IEC 60601-2-26: 2012, IEC 62366: 2007, Am1: 2014, and ISO 80601-2-61: 2011. The document concludes that the Natus Quantum is considered substantially equivalent to the predicate devices.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).