Comet-PLUS

K172711 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · OLV · Nov 3, 2017 · Neurology

Device Facts

• Record ID: K172711
• Device Name: Comet-PLUS
• Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
• Product Code: OLV · Neurology
• Decision Date: Nov 3, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Comet-PLUS® is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.

Device Story

Comet-PLUS (AS40-PLUS Amplifier System) is a compact AC amplifier for EEG and PSG monitoring labs. It records neurophysiological signals via up to 57 channels (EEG/PSG) and personality modules (headboxes). Inputs include EEG/PSG electrodes, oximetry (SpO2, HR, PPG, plethysmogram), photic stimulator, and patient event button. Operated by trained medical professionals in clinical settings. Device features an LCD interface with push buttons on the amplifier. Output data is used by clinicians for diagnostic monitoring of neurological and sleep-related conditions. Benefits include enhanced channel capacity and monitoring capabilities compared to previous models.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366), and performance testing for electroencephalographs (IEC 60601-2-26) and pulse oximeters (ISO 80601-2-61).

Technological Characteristics

Compact AC amplifier with up to 57 channels; >20 MΩ input impedance; supports EEG, PSG, SpO2, HR, and PPG. Connectivity includes photic stimulator and patient event button. User interface features LCD and push buttons. 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 patients requiring routine EEG, overnight sleep/EEG (PSG), or other neurophysiological monitoring. Intended for use by trained physicians, technicians, or medical professionals.

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

• Grass-Telefactor AS40 Amplifier System (K021807)

Submission Summary (Full Text)

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November 3, 2017

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Saniav Mehta Senior Manager, Quality Assurance & Regulatory Affairs 2568 Bristol Circle Oakville, L6H 5S1 Ontario, Canada

### Re: K172711

Trade/Device Name: Comet-PLUS Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV, GWQ Dated: September 7, 2017 Received: September 8, 2017

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, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS 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) K172711

Device Name Comet-PLUS®

Indications for Use (Describe)

The Comet-PLUS® is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.

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

| <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------------|
| <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with the "n" slightly larger than the other letters. Below "natus" is the word "neurology" in a smaller, italicized, black sans-serif font. The logo is simple and modern.

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| Submission Date: | 07 September 2017 | | |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------|
| 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>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: | Comet-PLUS® | | |
| Common and<br>Classification<br>Name: | Standard Polysomnograph With Electroencephalograph | | |
| Classification<br>Regulation: | 21 CFR §882.1400 | | |
| Product Code: | OLV, GWQ | | |
| Substantially<br>Equivalent Devices: | New Model | Predicate 510(k)<br>Number | Predicate<br>Manufacturer / Model |
| | XLTEK / Comet-PLUS® | K021807 | Grass-Telefactor<br>Product Group, Astro-<br>Med, Inc. / Grass-<br>Telefactor AS40<br>Amplifier System |
| Device Description: | The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd.<br>(XLTEK) Comet-PLUS® (also known as the AS40-PLUS Amplifier<br>System) is designed specifically for the EEG and PSG monitoring lab.<br><br>The different configurations of the Comet-PLUS feature the AS40-PLUS<br>Amplifier with electroencephalograph (EEG) or polysomnograph (PSG)<br>Comet-PLUS Personality Modules (headboxes) and Natus software. The<br>Comet-PLUS Amplifier is a compact AC Amplifier with up to 57<br>channels for EEG and PSG recording applications. | | |

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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, teal-colored font, while the word "neurology" is in a smaller, dark blue font and is positioned below and slightly to the right of "natus". The logo appears to be for a company or organization related to neurology.

The Comet-PLUS® is designed for use in the recording of routine EEG, Intended Use: overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.

Technology The Comet-PLUS employs the same technological characteristics as the Comparison: predicate device.

| System Characteristic | Grass-Telefactor Product Group,<br>Astro-Med, Inc. Grass-Telefactor<br>AS40 Amplifier System<br>(K021807) | XLTEK Comet-PLUS<br>(Proposed Device) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Channels | Up to 50 | Up to 57 |
| Referential AC<br>Channels | Up to 32 | Same |
| Bipolar AC Channels | Up to 8 | Up to 8 |
| DC Channels | Up to 8 | Up to 12 |
| Oximeter Connection | SpO2 and heart rate (HR) | SpO2, HR, photo-<br>plethysmography (PPG), and<br>plethysmogram |
| Photic Stimulator<br>Connection | Yes | Same |
| Patient Event Button | Yes | Same |
| User Interface | Liquid Crystal Diode (LCD) with<br>eight (8) push buttons on Amplifier | Same. |
| AC Signal Range | 4 mVp-p full-scale | Same. |
| DC Signal Range | $\pm$ 2.5 V, $\pm$ 10 V | Same. |
| Input Impendence | > 10 ΜΩ | > 20 ΜΩ |

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Image /page/5/Picture/0 description: The image contains the logo for "natus neurology". The word "natus" is in a larger, teal-colored, sans-serif font. Below it, "neurology" is written in a smaller, italicized, dark blue font. The logo is simple and modern.

SPECIAL 510(K): COMET-PLUS® 510(K) SUMMARY

## Summary of Performance Testing:

| Software | The Comet-PLUS 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 Comet-PLUS firmware complies with its predetermined specifications, the applicable guidance documents, and the applicable standards. |
| Electrical Safety | The Comet-PLUS 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 Comet-PLUS complies with the applicable standards. |
| Electromagnetic<br>Compatibility | The Comet-PLUS was verified for performance in accordance with the following standard: |
| • | IEC 60601-1-2: 2007, 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 Comet-PLUS complies with the applicable standards. |
| Performance<br>Testing – Bench | The Comet-PLUS was verified for performance in accordance with<br>internal requirements and the applicable clauses of the following<br>standards:<br>IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6:<br>General requirements for basic safety and essential performance –<br>Collateral standard: Usability IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26:<br>Particular requirements for the basic safety and essential<br>performance of electroencephalographs. IEC 62366: 2007, Am1: 2014, Medical devices – Application of<br>usability engineering to medical devices. ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61:<br>Particular requirements for basic safety and essential performance of<br>pulse oximeter equipment. Results indicate that the Comet-PLUS complies with its predetermined<br>specifications and the applicable standards. |
| Conclusion | Verification and validation activities were conducted to establish the<br>performance and safety characteristics of the device modifications made<br>to the Comet-PLUS. The results of these activities demonstrate that the<br>Comet-PLUS is as safe, as effective, and performs as well as or better<br>than the predicate devices.<br><br>Therefore, the Comet-PLUS is considered substantially equivalent to the<br>predicate devices. |

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Image /page/6/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is written in a teal sans-serif font in all lowercase letters. Below it, the word "neurology" is written in a smaller, italicized, dark blue sans-serif font. The logo is simple and modern.