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 Description

The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Comet-PLUS® (also known as the AS40-PLUS Amplifier System) is designed specifically for the EEG and PSG monitoring lab. The different configurations of the Comet-PLUS feature the AS40-PLUS Amplifier with electroencephalograph (EEG) or polysomnograph (PSG) Comet-PLUS Personality Modules (headboxes) and Natus software. The Comet-PLUS Amplifier is a compact AC Amplifier with up to 57 channels for EEG and PSG recording applications.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Comet-PLUS device. It details various performance tests and compliance with standards rather than specific acceptance criteria for a medical AI device and the results of a study demonstrating those criteria being met. The device described, Comet-PLUS, is an electroencephalograph (EEG) and polysomnograph (PSG) system, a hardware device for recording neurophysiological signals.

Based on the content, the document does not contain the information requested in points 1-9 regarding acceptance criteria for an AI device and a study proving those criteria are met.

Specifically:

No acceptance criteria or device performance for an AI algorithm: The document focuses on hardware (amplifier, headboxes) and firmware compliance with electrical safety, electromagnetic compatibility, and usability standards for an EEG/PSG system. There are no performance metrics like sensitivity, specificity, or AUC which are typical for AI-based diagnostic or assistive devices.
No mention of AI or machine learning: The document describes a medical device for signal acquisition and monitoring, not an AI algorithm.
No details on sample sizes, ground truth establishment, or expert reviews for an AI study: Since no AI study is described, this information is absent.
No MRMC comparative effectiveness study: The document does not describe any human-in-the-loop studies comparing human readers with and without AI assistance.
No standalone algorithm performance: The device is a system for recording signals, not a standalone algorithm.

The "Summary of Performance Testing" section (page 5) details the types of tests conducted:

Software (firmware) validation: Compliance with FDA guidance documents and standards for medical device software.
Electrical Safety: Compliance with IEC 60601-1:2005, Am1:2012.
Electromagnetic Compatibility: Compliance with IEC 60601-1-2:2007.
Bench Performance Testing: Compliance with internal requirements and applicable clauses of IEC 60601-1-6, IEC 60601-2-26, IEC 62366, and ISO 80601-2-61.

The conclusion states that these activities demonstrate the device's safety, effectiveness, and performance are as good as or better than predicate devices, leading to a substantial equivalence determination. However, this is for the hardware and its embedded firmware functionality, not an AI or machine learning algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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 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.

Page 1 of 4

Submission Date:	07 September 2017
Submitter:	Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada
Submitter andApplicationCorrespondent	Mr. Sanjay MehtaPhone: +1 (905) 287-5055Fax: +1 (905) 829-5304Email: sanjay.mehta@natus.com
Manufacturing Site:	Ducommun LaBarge Technologies2222 East Pensar DriveAppleton, WI 54911USA
Trade Name:	Comet-PLUS®
Common andClassificationName:	Standard Polysomnograph With Electroencephalograph
ClassificationRegulation:	21 CFR §882.1400
Product Code:	OLV, GWQ
SubstantiallyEquivalent Devices:	New Model	Predicate 510(k)Number	PredicateManufacturer / Model
	XLTEK / Comet-PLUS®	K021807	Grass-TelefactorProduct Group, Astro-Med, Inc. / Grass-Telefactor AS40Amplifier System
Device Description:	The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd.(XLTEK) Comet-PLUS® (also known as the AS40-PLUS AmplifierSystem) is designed specifically for the EEG and PSG monitoring lab.The different configurations of the Comet-PLUS feature the AS40-PLUSAmplifier with electroencephalograph (EEG) or polysomnograph (PSG)Comet-PLUS Personality Modules (headboxes) and Natus software. TheComet-PLUS Amplifier is a compact AC Amplifier with up to 57channels 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,Astro-Med, Inc. Grass-TelefactorAS40 Amplifier System(K021807)	XLTEK Comet-PLUS(Proposed Device)
Channels	Up to 50	Up to 57
Referential ACChannels	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-plethysmography (PPG), andplethysmogram
Photic StimulatorConnection	Yes	Same
Patient Event Button	Yes	Same
User Interface	Liquid Crystal Diode (LCD) witheight (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.
ElectromagneticCompatibility	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.
PerformanceTesting – Bench	The Comet-PLUS was verified for performance in accordance withinternal requirements and the applicable clauses of the followingstandards:IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6:General requirements for basic safety and essential performance –Collateral standard: Usability IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26:Particular requirements for the basic safety and essentialperformance of electroencephalographs. IEC 62366: 2007, Am1: 2014, Medical devices – Application ofusability engineering to medical devices. ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61:Particular requirements for basic safety and essential performance ofpulse oximeter equipment. Results indicate that the Comet-PLUS complies with its predeterminedspecifications and the applicable standards.
Conclusion	Verification and validation activities were conducted to establish theperformance and safety characteristics of the device modifications madeto the Comet-PLUS. The results of these activities demonstrate that theComet-PLUS is as safe, as effective, and performs as well as or betterthan the predicate devices.Therefore, the Comet-PLUS is considered substantially equivalent to thepredicate 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.

Regulation Number and Section

§ 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).