(139 days)
No
The document describes a device for acquiring and displaying physiological signals (EEG, PSG) and facilitating functional mapping. There is no mention of AI, ML, or any algorithms that would process or interpret the signals using these technologies. The focus is on signal acquisition, digitization, transmission, and display.
No.
The device is used to acquire, display, store, and archive electrophysiological signals (EEG/PSG) for diagnostic purposes, not to treat a condition. While it can connect to an external cortical stimulator, the amplifier itself is for recording signals, not for delivering therapeutic stimulation.
Yes.
Explanation: The device is described as an electroencephalograph, which acquires and records electrophysiological signals (EEG and PSG) for later review and analysis to assess neurological conditions, which falls under the definition of a diagnostic device.
No
The device description explicitly states that the Natus Quantum amplifier is comprised of a base unit and several breakout boxes, and is part of a system that includes hardware components like a personal computer, photic stimulator, and isolation transformer. The device itself is an amplifier that acquires and digitizes signals, which is a hardware function.
Based on the provided information, the Natus Quantum Amplifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to acquire, display, store, and archive electrophysiological signals (EEG and PSG) from the human body. This involves measuring electrical activity directly from the patient.
- Device Description: The description details the acquisition of physiological signals from electrodes placed on or in the body, and the processing and display of these signals.
- Anatomical Site: The listed anatomical sites are all locations on or within the human body where electrodes are placed to measure physiological signals.
- Lack of Mention of In Vitro Testing: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue, etc.) in a laboratory setting. IVD devices are specifically designed for testing such samples.
The Natus Quantum Amplifier is a medical device used for in vivo (within the living body) physiological monitoring.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, OLV
Device Description
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.
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp, Intracranial, Thorax, Abdomen, Nasal/Oral, Finger, Nasion/cheek/chin or side of the neck
Indicated Patient Age Range
patients of all ages, but is not designed for fetal use.
Intended User / Care Setting
trained medical professionals, in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms.
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)
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:
- 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.
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.
EMU128 (K040360); Neurolink IP 256 (K100683)
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.
K090019, K090277, K982053, K082474, K923033, K043132, K922112, K092101, K941759, K922112, K991903, K072964
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
§ 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).
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 .: (905) 829-5300 ext 388 Fax .: (905) 829-5304 E-mail: sanjay.mehta@natus.com
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.
4
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.
5
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.
6
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 | ||
| (K982053) | Scalp (according to 10- | ||
| 20 & 10-10 system) | Referential and differential inputs | ||
| (labeled numerically) | |||
| 2 | Single Use Intracranial Grids, Strips | ||
| and Depth Electrodes. (K082474) | Intracranial recordings | Referential and differential inputs | |
| (labeled numerically) | |||
| 3 | Body position sensor (K923033) | Thorax | DC input |
| 4 | Xactrace (K043132) | Respiratory belts | Differential input |
7
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
EMU128S (K040360) | Predicate Device
NeuroLink IP (K100683) | Subject Device
Natus Quantum |
|---------------------------------------------------------------------|--------------------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------|
| Manufacturer | Excel-Tech Ltd.(Xltek) | Excel-Tech Ltd.(Xltek) | Excel-Tech Ltd.(Xltek) |
| Technological Characteristics
Analog Specifications EEG Channels | | | |
| EEG Channels | 128 | 64-256 | 64-256 |
| Reference
Channels | Dedicated separate
reference and ground | Dedicated separate reference
and ground | Dedicated separate reference
and ground |
| Input Impedance | >47 MOhms | > 100 MOhms | >1000 MOhm |
| Input Noise | 110dB@60Hz | >40dB@60Hz | >110dB@60Hz |
| Digital Specifications | | | |
| Sampling
Frequency | 256, 512, 1024, 2048 | 256, 512, 1024 Hz | 256, 512, 1024, 2048, 4096,
8192, 16384 Hz |
| Sampling
Resolution - EEG
channels | 22 bits | 16 bits | 24 bits |
| Sampling
Quantization -
EEG channels | 310 nV | 179 nV | 305nV |
| Storage Resolution
- 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
9
Safety Standard of Compliance and normative references
| Standards | Title |
|---|---|
| CAN /CSA-C22.2 No. 60601-1: 08(R2013) + | |
| C2:2011 | Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential | |
| performance | |
| ANSI/AAMI ES60601-1:2005/(R)2012 + | |
| C1:2009/(R)2012 and A2:2010/(R)2012 | |
| IEC 60601-1:2005 + C1:2006 and C2:2007, | |
| Third Edition | |
| CENELEC EN 60601-1:2006 + A1:2013 | |
| IEC 60601-1-6:2010, Edition 3.0 | Medical electrical equipment - Part 1-6: |
| General requirements for basic safety and | |
| essential performance - Collateral standard: | |
| Usability | |
| IEC 62366:2007, Edition 1.0 | Medical devices - Application of usability |
| engineering to medical devices | |
| IEC 60601-2-26:2012, Edition 3 | |
| CENELEC EN 60601-2-26L2003, Edition 2 | Medical electrical equipment - Part 2-26: |
| Particular requirements for the safety of | |
| electroencephalographs | |
| EN ISO 80601-2-61:2011, Edition 1 | Medical electrical equipment - Part 2-61: |
| Particular requirements for basic safety and | |
| essential performance of pulse oximeter | |
| equipment |
EMC Standard of Compliance and normative references
| Standards | Title |
|---|---|
| IEC 60601-1-2:2007, Edition 3.0 | Medical electrical equipment - Part 1-2: |
| General requirements for safety - collateral | |
| standard: electromagnetic compatibility – | |
| requirements and tests | |
| IEC 61000-4-2:2008, ed 2.0 | Electromagnetic Compatibility (EMC) Part 4-2: |
| Testing and Measurement Techniques - | |
| Electrostatic Discharge Immunity Test | |
| IEC 61000-4-3 ed 3.0 with A1:2007+A2:2010 | Electromagnetic Compatibility (EMC) Part 4-3: |
| Testing and Measurement Techniques - | |
| Radiated, Radio-frequency, Electromagnetic | |
| Field Immunity Test | |
| IEC 61000-4-4:2012, ed 3.0 | Electromagnetic Compatibility (EMC) Part 4-4: |
| Testing and Measurement Techniques - | |
| Electrical Fast Transient/Burst Immunity Test | |
| IEC 61000-4-5:2014, ed 3.0 | Electromagnetic Compatibility (EMC) Part 4-5: |
| Testing and Measurement Techniques - Surge | |
| Immunity Test | |
| IEC 61000-4-6 ed 2.0 with A1:2004 + A2:2006 | Electromagnetic Compatibility (EMC) Part 4-6: |
| Testing and Measurement Techniques - | |
| Immunity to Conducted Disturbances, Induced | |
| by Radio-frequency Fields | |
| IEC 61000-4-8:2009, ed 2.0 | Electromagnetic Compatibility (EMC) Part 4-8: |
| Testing and Measurement Techniques - | |
| Power Frequency Magnetic Field Immunity | |
| Test | |
| IEC 61000-4-11:2004, ed 2.0 | Electromagnetic Compatibility (EMC) Part 4- |
| 11: Testing and Measurement Techniques - | |
| Voltage Dips, Short Interruptions and Voltage | |
| Variations Immunity Tests | |
| IEC 61000-3-2:2014, ed 4.0 | Electromagnetic Compatibility (EMC) Part 3-2: |
| Limits - Limits for Harmonic Current Emissions | |
| IEC 61000-3-3:2013, ed 3.0 | Electromagnetic Compatibility (EMC) Part 3-3: |
| Limits - Limitation of Voltage Changes, | |
| Voltage Fluctuations and Flicker in Public Low- | |
| voltage Supply Systems | |
| CISPR 11 ed 5.0 with A1:2010 | Industrial, Scientific and Medical (ISM) Radio- |
| Frequency Equipment - Electromagnetic | |
| Disturbance Characteristics - Limits and | |
| Methods of Measurement |
10
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:
11
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.