Natus Quantum

K180181 · Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) · GWQ · Feb 22, 2018 · Neurology

Device Facts

• Record ID: K180181
• Device Name: Natus Quantum
• Applicant: Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)
• Product Code: GWQ · Neurology
• Decision Date: Feb 22, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Natus Quantum is an electroencephalograph front-end amplifier; acquires scalp/intracranial EEG and PSG signals. Features include A/D converters, digital signal processing, and a Digital Switch Matrix (hardware relays/software controls) for functional mapping; allows switching electrode pairs between EEG amplifier and external cortical stimulator. Operates in tethered or ambulatory modes; ambulatory mode stores data in internal memory for later upload to Natus Base unit. Used by physicians/technologists in clinical environments (hospitals, EMUs, ICUs, ORs). Provides signal data for display and analysis via Natus NeuroWorks/SleepWorks software; assists clinicians in diagnostic monitoring and functional mapping procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through software validation, electrical safety testing (IEC 60601-1), and electromagnetic compatibility testing (IEC 60601-1-2).

Technological Characteristics

Amplifier circuitry with A/D converters, digital signal processing, and digital switch matrix. Connectivity via TCP/IP and USB. Supports 64-256 EEG channels; 24-bit sampling resolution; >1000 MOhm input impedance. Operates in tethered or ambulatory (internal memory) modes. Firmware developed per IEC 62304. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-26, IEC 62366, and ISO 80601-2-61.

Indications for Use

Indicated for acquisition, display, storage, and archiving of electrophysiological signals, including scalp/intracranial EEG and PSG. Intended for use by trained medical professionals in clinical settings (hospital, EMU, ICU, OR) on patients of all ages; contraindicated for fetal use.

Regulatory Classification

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.

Predicate Devices

• Natus Quantum (K143440)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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K180181

Image /page/3/Picture/1 description: The image shows the logo for Natus Neurology. The word "natus" is in a large, teal, sans-serif font. Below it, the word "neurology" is in a smaller, black, italicized, sans-serif font. The logo is simple and modern.

510(k) Summary

PAGE 1 of 5

| Submission Date: | 22 January 2018 | | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)<br>2568 Bristol Circle<br>Oakville, Ontario, L6H 5S1<br>Canada | | |
| Submitter and<br>Application<br>Correspondent | Mr. Sanjay Mehta<br>Director, Quality and Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Manufacturing Site: | Ducommun LaBarge Technologies<br>2222 East Pensar Drive<br>Appleton, WI 54911<br>USA | | |
| Trade Name: | Natus Quantum | | |
| Common and<br>Classification<br>Name: | Full-Montage Standard Electroencephalograph | | |
| Classification<br>Regulation: | 21 CFR §882.1400 | | |
| Product Code: | GWQ, OLV, GYC | | |
| Substantially<br>Equivalent Devices: | New Model | Predicate 510(k)<br>Number | Predicate<br>Manufacturer / Model |
| | Natus Quantum | K143440 | Natus Medical<br>Incorporated DBA<br>Excel-Tech Ltd.<br>(XLTEK)<br>2568 Bristol Circle<br>Oakville, Ontario,<br>L6H 5S1, Canada |

/ Natus Quantum

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Image /page/4/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal color and a larger font. Below that, the word "neurology" is in a smaller, black font. The logo is simple and clean, with a focus on the company name.

| 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.<br><br>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.<br><br>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.<br><br>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 Device<br>Natus Quantum<br>(K143440) | Subject Device<br>Natus Quantum<br>(Modified) |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <b>Analog Specifications EEG Channels</b> | | |
| EEG Channels | 64-256 | 64-256 |
| Reference<br>Channels | Dedicated separate reference<br>and ground | Dedicated separate<br>reference and ground |
| Input Impedance | >1000 MOhm | >1000 MOhm |
| Input Noise | < 1.5uV pk to pk @ .1....100Hz bandwidth<br>(<0.53uV rms@1....100Hz<br>bandwidth) | < 2.0uV pk to pk @<br>.1....100Hz bandwidth<br>(<0.53uV rms@1....100Hz<br>bandwidth) |
| Input signal<br>range | 20mV pk-to-pk | 20mV pk-to-pk |
| Maximum<br>Operational DC<br>input voltage<br>electrode offset | ±300mV | ±300mV |
| Input Bias<br>Current | <1nA | <1nA |
| Common mode<br>Rejection Ratio | >110dB@60Hz | >106dB@60Hz |
| <b>Digital Specifications</b> | | |
| Sampling<br>Frequency | 256, 512, 1024, 2048, 4096,<br>8192, 16384 Hz | 256, 512, 1024, 2048,<br>4096, 8192, 16384 Hz |
| Sampling<br>Resolution - EEG<br>channels | 24 bits | 24 bits |
| Sampling<br>Quantization -<br>EEG channels | 305nV | 305nV |
| Storage<br>Resolution - EEG<br>Channels | 16 bits | 16 bits |
| <b>Quantum Breakout Box Feature</b> | | |
| Referential<br>Channels | 128 referential channels per<br>breakout, 2 breakouts<br>cascade-able up to 256<br>channels | 128 referential channels<br>per breakout, 2 breakouts<br>cascade-able up to 256<br>channels |
| Differential<br>channels | Up to 8 configurable<br>differential channels per 128<br>channel breakout (2 inputs<br>per channel) | Up to 8 configurable<br>differential channels per<br>128 channel breakout (2 |

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Image /page/6/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol to the right of the "s". Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font. The logo is simple and clean, with a focus on the company name.

## 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. |
| Electromagnetic<br>Compatibility | 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.