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No
The summary describes a hardware amplifier system and associated software for recording neurophysiological signals. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is designed for recording EEG and PSG, which are diagnostic and monitoring applications, not therapeutic interventions.
Yes
The device is described as being for "recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications," which are activities performed to diagnose neurological and sleep disorders.
No
The device description explicitly states that the Comet-PLUS includes an "AS40-PLUS Amplifier" and "Comet-PLUS Personality Modules (headboxes)", which are hardware components. The software is part of a larger system that includes hardware for signal acquisition.
Based on the provided information, the Comet-PLUS® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for recording physiological signals (EEG and PSG) from the human body. This is a direct measurement of biological activity, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as an amplifier system for recording electrical signals. This aligns with its intended use of measuring physiological activity.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Comet-PLUS® is a device that measures electrical activity within the body.
N/A
Intended Use / Indications for 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.
Product codes
OLV, GWQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 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 Testing – Bench: The Comet-PLUS was verified for performance in accordance with internal requirements and the applicable clauses of the following standards:
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 essential performance of electroencephalographs.
IEC 62366: 2007, Am1: 2014, Medical devices – Application of usability engineering to medical devices.
ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Results indicate that the Comet-PLUS complies with its predetermined specifications and the applicable standards.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the Comet-PLUS. The results of these activities demonstrate that the Comet-PLUS is as safe, as effective, and performs as well as or better than the predicate devices. Therefore, the Comet-PLUS is considered substantially equivalent to the predicate devices.
Key Metrics
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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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.
1
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
2
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)
| 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 Circle | |||
| Oakville, Ontario, L6H 5S1 | |||
| Canada | |||
| Submitter and | |||
| Application | |||
| Correspondent | Mr. Sanjay Mehta | ||
| 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: | Comet-PLUS® | ||
| Common and | |||
| Classification | |||
| Name: | Standard Polysomnograph With Electroencephalograph | ||
| Classification | |||
| Regulation: | 21 CFR §882.1400 | ||
| Product Code: | OLV, GWQ | ||
| Substantially | |||
| Equivalent Devices: | New Model | Predicate 510(k) | |
| Number | Predicate | ||
| Manufacturer / Model | |||
| XLTEK / Comet-PLUS® | K021807 | Grass-Telefactor | |
| Product Group, Astro- | |||
| Med, Inc. / Grass- | |||
| Telefactor AS40 | |||
| Amplifier System | |||
| 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. | | |
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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-Telefactor
AS40 Amplifier System
(K021807) | XLTEK Comet-PLUS
(Proposed Device) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Channels | Up to 50 | Up to 57 |
| Referential AC
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-
plethysmography (PPG), and
plethysmogram |
| Photic Stimulator
Connection | Yes | Same |
| Patient Event Button | Yes | Same |
| User Interface | Liquid Crystal Diode (LCD) with
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 | |
| 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 | |
| Testing – Bench | The Comet-PLUS was verified for performance in accordance with |
| internal requirements and the applicable clauses of the following | |
| standards: | |
| 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 essential | |
| performance of electroencephalographs. IEC 62366: 2007, Am1: 2014, Medical devices – Application of | |
| usability engineering to medical devices. ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61: | |
| Particular requirements for basic safety and essential performance of | |
| pulse oximeter equipment. Results indicate that the Comet-PLUS complies with its predetermined | |
| specifications and the applicable standards. | |
| Conclusion | Verification and validation activities were conducted to establish the |
| performance and safety characteristics of the device modifications made | |
| to the Comet-PLUS. The results of these activities demonstrate that the | |
| Comet-PLUS is as safe, as effective, and performs as well as or better | |
| than the predicate devices. |
Therefore, the Comet-PLUS is considered substantially equivalent to the
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.