Not Found
No
The summary describes standard electrophysiological signal acquisition and processing hardware and software, with no mention of AI or ML algorithms for analysis, interpretation, or other functions. The "Digital Signal Processing" mentioned is a common component in such devices and does not inherently imply AI/ML.
No
The device is described as an electroencephalograph (EEG) amplifier intended to acquire, display, store, and archive electrophysiological and polysomnographic signals. While used in a clinical setting by medical professionals, its primary function is diagnostic (recording signals) rather than providing direct therapy or treatment. The functional mapping feature allows switching to an external stimulator for stimulus delivery, but the device itself is not the stimulator or therapeutic agent.
Yes
The device is described as an "electroencephalograph" intended to "acquire, display, store and archive electrophysiological signals" from "scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals." These functions are consistent with a diagnostic device used to assess physiological activity to aid in identifying medical conditions.
No
The device description explicitly states that the Natus Quantum Amplifier is the "front end hardware of an electroencephalograph" and lists several hardware components including amplifier circuitry, A/D Converters, Digital Signal Processing, digital switch matrix, and LCD touch screen interface. While it uses software, it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an electroencephalograph used to acquire, display, store, and archive electrophysiological signals (EEG and PSG). This involves measuring electrical activity from the body, not analyzing samples taken from the body (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description focuses on the hardware for acquiring and processing electrical signals, including amplifier circuitry, A/D converters, and a digital switch matrix. There is no mention of components or processes related to analyzing biological samples.
- Lack of IVD-related terms: The text does not contain any terms typically associated with IVD devices, such as "sample," "reagent," "assay," "analyte," "in vitro," or "diagnostic test."
The device is clearly described as a medical device used for physiological monitoring and functional mapping, which falls under a different regulatory category than IVD devices.
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
GWO, OLV, GYC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp and intracranial
Indicated Patient Age Range
all ages, but is not designed for fetal use.
Intended User / Care Setting
trained medical professionals, and is designed for use 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)
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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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);
1
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
2
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 Circle | |||
| Oakville, Ontario, L6H 5S1 | |||
| Canada | |||
| Submitter and | |||
| Application | |||
| Correspondent | Mr. Sanjay Mehta | ||
| Director, Quality and Regulatory Affairs | |||
| Phone: +1 (905) 287-5055 | |||
| Fax: +1 (905) 829-5304 | |||
| Email: sanjay.mehta@natus.com | |||
| Manufacturing Site: | Ducommun LaBarge Technologies | ||
| 2222 East Pensar Drive | |||
| Appleton, WI 54911 | |||
| USA | |||
| Trade Name: | Natus Quantum | ||
| Common and | |||
| Classification | |||
| Name: | Full-Montage Standard Electroencephalograph | ||
| Classification | |||
| Regulation: | 21 CFR §882.1400 | ||
| Product Code: | GWQ, OLV, GYC | ||
| Substantially | |||
| Equivalent Devices: | New Model | Predicate 510(k) | |
| Number | Predicate | ||
| Manufacturer / Model | |||
| Natus Quantum | K143440 | Natus Medical | |
| Incorporated DBA | |||
| Excel-Tech Ltd. | |||
| (XLTEK) | |||
| 2568 Bristol Circle | |||
| Oakville, 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 Device
Natus Quantum
(K143440) | Subject Device
Natus Quantum
(Modified) |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Analog Specifications EEG Channels | | |
| EEG Channels | 64-256 | 64-256 |
| Reference
Channels | Dedicated separate reference
and ground | Dedicated separate
reference and ground |
| Input Impedance | >1000 MOhm | >1000 MOhm |
| Input Noise | 110dB@60Hz | >106dB@60Hz |
| Digital Specifications | | |
| Sampling
Frequency | 256, 512, 1024, 2048, 4096,
8192, 16384 Hz | 256, 512, 1024, 2048,
4096, 8192, 16384 Hz |
| Sampling
Resolution - EEG
channels | 24 bits | 24 bits |
| Sampling
Quantization -
EEG channels | 305nV | 305nV |
| Storage
Resolution - EEG
Channels | 16 bits | 16 bits |
| Quantum Breakout Box Feature | | |
| Referential
Channels | 128 referential channels per
breakout, 2 breakouts
cascade-able up to 256
channels | 128 referential channels
per breakout, 2 breakouts
cascade-able up to 256
channels |
| Differential
channels | Up to 8 configurable
differential channels per 128
channel breakout (2 inputs
per channel) | Up to 8 configurable
differential channels per
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 | |
| 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.