Natus Quantum

K143440 · Natus Medical Incorporated · GWQ · Apr 20, 2015 · Neurology

Device Facts

• Record ID: K143440
• Device Name: Natus Quantum
• Applicant: Natus Medical Incorporated
• Product Code: GWQ · Neurology
• Decision Date: Apr 20, 2015
• Decision: SESE
• Submission Type: Traditional
• 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 Amplifier acquires electrophysiological signals (scalp/intracranial EEG, PSG, SpO2, pulse rate, pleth) via electrodes and sensors; digitizes and transmits data to PC running Natus NeuroWorks/SleepWorks software for display, storage, and review. Features internal Digital Switch Matrix (hardware relays/software controls) to toggle electrode pairs between EEG amplifier and external cortical stimulator for functional mapping. Used in hospitals, epilepsy monitoring units, ICUs, and ORs by physicians or technologists. Provides real-time signal visualization and impedance testing in patient room. Benefits include high-density channel recording (up to 256) and integrated stimulus delivery control, facilitating clinical diagnosis and monitoring of neurological conditions.

Clinical Evidence

Bench testing only. Verification and validation performed per design control processes, including signal quality and functionality verification tests. Compliance with IEC 60601-1, 60601-2-26, and 80601-2-61 standards confirmed.

Technological Characteristics

128-256 referential channels; 24-bit sampling resolution; 16,384 Hz max sampling frequency; >1000 MOhm input impedance. Connectivity via TCP/IP and USB. Includes Digital Switch Matrix for cortical stimulation. Modular wearable breakout box. Complies with IEC 60601-1, IEC 62366, and IEC 62304 standards.

Indications for Use

Indicated for patients of all ages (excluding fetal use) requiring acquisition, display, storage, and archiving of electrophysiological signals, including scalp/intracranial EEG and PSG, and functional mapping via digital switch matrix in clinical settings.

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

• EMU128 (K040360)
• Neurolink IP 256 (K100683)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a central graphic. The graphic consists of three stylized human profiles facing to the right, with flowing lines that suggest movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 20, 2015

Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta Quality and Regulatory Affairs Manager 2560 Bristol Circle Oakville, Ontario, Canada, L6H5S1

Re: K143440

Trade/Device Name: Natus Ouantum Amplifier Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. OLV. GYC Dated: March 18, 2015 Received: March 19, 2015

Dear Mr. 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. Isting 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

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device-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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Felipe Aquel -S

Carlos Peña, PhD, MS for Division 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) K143440

Device Name Natus Quantum Amplifier

#### 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 monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is written in blue, block letters, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in smaller, italicized, black letters.

## 510K Summary

Date: April 15, 2015

Submitted by: Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1

Contact Person: Sanjay Mehta Senior Manager QA/RA Natus Medical Incorporated Tel .: [phone] ext 388 Fax .: [phone] E-mail: [e-mail]

Proprietary Name: Natus Quantum

Common Name: Electroencephalograph

Regulation Number : 21CFR 882.1400

Classification Name: Full-montage standard electroencephalograph

Product code: GWQ, OLV

Device Class: II

Predicate Device: EMU128 (K040360); Neurolink IP 256 (K100683)

#### Description:

#### 1. Overview: Natus Quantum Amplifier

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™ 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.

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Image /page/4/Picture/0 description: The image contains the logo for "natus. neurology". The word "natus" is in a larger, bold, blue font on the top line. The word "neurology" is in a smaller, italicized, black font on the second line.

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.

#### 2. Operating Principle of the Quantum Amplifier

The Natus Quantum amplifier is comprised of a base unit and several breakout boxes. It is part of a system that is made up of a personal computer, a photic stimulator, an isolation transformer, video and audio equipment, networking equipment, and mechanical supports. The amplifier also contains an internal switch matrix to allow for a connection to an external cortical stimulator.

EEG and other physiological signals, from scalp electrodes, grid or needle electrodes, and other accessories such as pulse oximeters can be acquired by the Natus Quantum amplifier. These signals are digitized and transmitted to the personal computer running the Natus NeuroWorks software. The signals are displayed on the personal computer and can be recorded to the computer's local storage or to remote networked storage for later review.

Image /page/4/Picture/6 description: The image shows three pieces of Natus Neurology equipment. On the left is a large, black, rectangular device with rounded corners and a small silver knob on the top. To the right are two smaller, square devices with gray tops and black sides. The Natus Neurology logo is visible on all three devices.

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Image /page/5/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in blue, block letters, with a small registered trademark symbol after the "s". Below that, the word "neurology" is in a smaller, italicized, black font. The logo is simple and clean, with a focus on the company name.

### Quantum features include

- . 128 referential channels (cascade-able up to 256).
- . 16 referential inputs per 128 can be configured as 8 differential inputs
- 16 DC channels,
- Pulse Oximeter including SpO2, Pulse Rate and Pleth signals .
- . Digital Trigger Input
- . Ability to initiate an impedance test, change the threshold, and view the results in the patient room
- . Digital Switch Matrix
- A small and lightweight wearable breakout box .
- . TCP/IP and USB connectivity
- . Patient-event switch interface on both the breakout box and base units
- . Photic stimulator interface for EEG applications
- . Modular pouch for belt or backpack harness

## System Setup Overview

The Natus Quantum amplifier connects to the Natus NeuroWorks (K090019) & Natus SleepWorks (K090277) software for the acquisition storage, analysis, and review of Electroencephalographic & Polysomnographic data in conjunction with synchronized digital video. The system overview is as follows.

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Image /page/6/Picture/0 description: The image contains the logo for "natus neurology". The word "natus" is in a larger, blue font, while "neurology" is in a smaller, black font. The logo is simple and clean, with a focus on the company name.

Image /page/6/Figure/2 description: This image shows a diagram of a system for recording and digitizing a patient's physiological data. The diagram includes an acquisition PC connected to a network, which is connected to Natus Quantum Breakout Boxes. The breakout boxes are connected to electrodes and sensors placed on the patient's scalp, as shown in the "Patient Electrode Placement International 10-20 System (example)" diagram.

### Device-patient interaction Accessories List:

The table below lists all accessories to the subject device. Accessories (1) to (9) enter in contact with the patient. These sensors guarantees acquisition of the physiological signals and passively transfer them to the head box. Characteristics of the sensors vary and are described (cleared) under their respective 510K submissions (see table).

| | Description | Body contact location | Device connection |
|---|--------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------------|
| 1 | Reusable gold disk electrode<br>(K982053) | Scalp (according to 10-<br>20 & 10-10 system) | Referential and differential inputs<br>(labeled numerically) |
| 2 | Single Use Intracranial Grids, Strips<br>and Depth Electrodes. (K082474) | Intracranial recordings | Referential and differential inputs<br>(labeled numerically) |
| 3 | Body position sensor (K923033) | Thorax | DC input |
| 4 | Xactrace (K043132) | Respiratory belts | Differential input |

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Image /page/7/Picture/1 description: The image shows the logo for Natus Neurology. The word "natus" is written in blue, block letters. Below that, the word "neurology" is written in a smaller, italicized font. The logo is simple and professional.

| | | Thorax/Abdomen | |
|----|-----------------------------------|---------------------------------------|---------------------------------------------|
| 6 | Thermistor (K922112) | Nasal/Oral | DC input |
| 7 | Pulse Oximeter Sensor (K092101) | Finger | Channel labeled "oximeter/photic" |
| 8 | Snoring microphone (K941759) | Nasion/cheek/chin or side of the neck | DC input |
| 9 | Airflow Pressure Sensor (K922112) | Nasal | DC input |
| 10 | Photic Stimulator (K991903) | None | Channel labeled "oximeter/photic" |
| 11 | Cortical Stimulator (K072964) | Intracranial contacts | Amplifier Digital Switch Matrix input port. |

### Indications for 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.

| Specification | Predicate Device<br>EMU128S (K040360) | Predicate Device<br>NeuroLink IP (K100683) | Subject Device<br>Natus Quantum |
|---------------------------------------------------------------------|--------------------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------|
| Manufacturer | Excel-Tech Ltd.(Xltek) | Excel-Tech Ltd.(Xltek) | Excel-Tech Ltd.(Xltek) |
| Technological Characteristics<br>Analog Specifications EEG Channels | | | |
| EEG Channels | 128 | 64-256 | 64-256 |
| Reference<br>Channels | Dedicated separate<br>reference and ground | Dedicated separate reference<br>and ground | Dedicated separate reference<br>and ground |
| Input Impedance | >47 MOhms | > 100 MOhms | >1000 MOhm |
| Input Noise | < 2uV pk to pk @ full<br>bandwidth | < 1uV rms @ 1....70Hz<br>bandwidth | < 1.5uV pk to pk @ .1....100Hz<br>bandwidth<br>(<0.53uV rms@1....100Hz<br>bandwidth) |

### Comparison to Predicate Device

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Image /page/8/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in blue, block letters, and the word "neurology" is in black, italicized letters. The logo is simple and modern.

| Maximum<br>Operational DC<br>input voltage<br>electrode offset | ±300V | ±300V | ±300V |
|----------------------------------------------------------------|----------------------|-------------------|-----------------------------------------------|
| Input Bias Current | < 20pA | < 1 nA | <1nA |
| Common mode<br>Rejection Ratio | >110dB@60Hz | >40dB@60Hz | >110dB@60Hz |
| Digital Specifications | | | |
| Sampling<br>Frequency | 256, 512, 1024, 2048 | 256, 512, 1024 Hz | 256, 512, 1024, 2048, 4096,<br>8192, 16384 Hz |
| Sampling<br>Resolution - EEG<br>channels | 22 bits | 16 bits | 24 bits |
| Sampling<br>Quantization -<br>EEG channels | 310 nV | 179 nV | 305nV |
| Storage Resolution<br>- EEG Channels | 16 bits | 16 bits | 16 bits |

For a detailed discussion covering any differences between devices and why they do not raised any new safety or effectiveness issues, the reviewer is referred to VOL_007_Substantial Equivalence discussion.

### Brief Summary of Performance Tests

#### Non-clinical:

Testing of the Natus Quantum was performed in compliance with Natus Corporation design control process. The validation was carried out as part of verification. Testing included:

| Test | Results |
|----------------------------------|---------|
| Signal Quality Verification Test | Pass |
| Functionality Verification Test | Pass |

It was found that the Natus Quantum system meets the design specification and performs as specified.

The device is in compliance with the following industrial standards

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## Safety Standard of Compliance and normative references

| Standards | Title |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| CAN /CSA-C22.2 No. 60601-1: 08(R2013) +<br>C2:2011 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance |
| ANSI/AAMI ES60601-1:2005/(R)2012 +<br>C1:2009/(R)2012 and A2:2010/(R)2012 | |
| IEC 60601-1:2005 + C1:2006 and C2:2007,<br>Third Edition | |
| CENELEC EN 60601-1:2006 + A1:2013 | |
| IEC 60601-1-6:2010, Edition 3.0 | Medical electrical equipment - Part 1-6:<br>General requirements for basic safety and<br>essential performance - Collateral standard:<br>Usability |
| IEC 62366:2007, Edition 1.0 | Medical devices - Application of usability<br>engineering to medical devices |
| IEC 60601-2-26:2012, Edition 3<br>CENELEC EN 60601-2-26L2003, Edition 2 | Medical electrical equipment - Part 2-26:<br>Particular requirements for the safety of<br>electroencephalographs |
| EN ISO 80601-2-61:2011, Edition 1 | Medical electrical equipment - Part 2-61:<br>Particular requirements for basic safety and<br>essential performance of pulse oximeter<br>equipment |

## EMC Standard of Compliance and normative references

| Standards | Title |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2:2007, Edition 3.0 | Medical electrical equipment - Part 1-2:<br>General requirements for safety - collateral<br>standard: electromagnetic compatibility –<br>requirements and tests |
| IEC 61000-4-2:2008, ed 2.0 | Electromagnetic Compatibility (EMC) Part 4-2:<br>Testing and Measurement Techniques -<br>Electrostatic Discharge Immunity Test |
| IEC 61000-4-3 ed 3.0 with A1:2007+A2:2010 | Electromagnetic Compatibility (EMC) Part 4-3:<br>Testing and Measurement Techniques -<br>Radiated, Radio-frequency, Electromagnetic<br>Field Immunity Test |
| IEC 61000-4-4:2012, ed 3.0 | Electromagnetic Compatibility (EMC) Part 4-4:<br>Testing and Measurement Techniques -<br>Electrical Fast Transient/Burst Immunity Test |
| IEC 61000-4-5:2014, ed 3.0 | Electromagnetic Compatibility (EMC) Part 4-5:<br>Testing and Measurement Techniques - Surge<br>Immunity Test |
| IEC 61000-4-6 ed 2.0 with A1:2004 + A2:2006 | Electromagnetic Compatibility (EMC) Part 4-6:<br>Testing and Measurement Techniques -<br>Immunity to Conducted Disturbances, Induced<br>by Radio-frequency Fields |
| IEC 61000-4-8:2009, ed 2.0 | Electromagnetic Compatibility (EMC) Part 4-8:<br>Testing and Measurement Techniques -<br>Power Frequency Magnetic Field Immunity<br>Test |
| IEC 61000-4-11:2004, ed 2.0 | Electromagnetic Compatibility (EMC) Part 4-<br>11: Testing and Measurement Techniques -<br>Voltage Dips, Short Interruptions and Voltage<br>Variations Immunity Tests |
| IEC 61000-3-2:2014, ed 4.0 | Electromagnetic Compatibility (EMC) Part 3-2:<br>Limits - Limits for Harmonic Current Emissions |
| IEC 61000-3-3:2013, ed 3.0 | Electromagnetic Compatibility (EMC) Part 3-3:<br>Limits - Limitation of Voltage Changes,<br>Voltage Fluctuations and Flicker in Public Low-<br>voltage Supply Systems |
| CISPR 11 ed 5.0 with A1:2010 | Industrial, Scientific and Medical (ISM) Radio-<br>Frequency Equipment - Electromagnetic<br>Disturbance Characteristics - Limits and<br>Methods of Measurement |

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Image /page/10/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in blue, blocky, sans-serif font. Below it, in a smaller, italicized, sans-serif font, is the word "neurology" in black. The logo is simple and modern.

Quality System Compliance:

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Image /page/11/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a larger, blue, sans-serif font. Below it, the word "neurology" is in a smaller, italicized, blue, sans-serif font. The logo is simple and clean, with a focus on the company name.

- . ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes.
- SOR/98-282 Canadian Medical Device Regulations .
- . 21 CFR Part 820 US Food and Drug Administration's Quality System Requilation
- . 93/42/EEG European Medical Device Directives
- . ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices
- EN 980:2008 Medical Devices Symbols for Use of labeling of medical device .
- EN 1041:2008 Information supplied by the manufacturer of medical devices .
- ISO 15223-1:2012,Medical Devices Symbols to be Used With Medical Device Labels, Labeling, . and Information to be Supplied - Part 1: General requirements
- . IEC 62304:2006 Medical device software - Software life-cycle processes

### Conclusions

The substantial equivalence of the Natus Quantum with EMU128S and Neurolink IP products was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Natus Quantum is similar to that of the predicate device XLTEK-EMU128S and Neurolink IP. Verification and Validation was performed to ensure no new questions of safety or effectiveness are raised.