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No
The summary describes software for digital recording, playback, and analysis of physiological signals (EEG, PSG, LTM). There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on data acquisition, display, comparison, and archiving, which are standard functions for this type of software.
No
The software is intended for digital recording, playback, and analysis of physiological signals, not for direct therapeutic intervention.
Yes
This device is designed for the "digital recording, playback, and analysis of physiological signals," specifically "Electroencephalography (EEG), Polysomnography (PSG), and Long-term Epilepsy Monitoring (LTM)." The analysis of these signals by qualified professionals is used to diagnose various neurological and sleep disorders.
Yes
The device description explicitly states, "Grass TWin is a software product only, and does not include any hardware."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the software is for the digital recording, playback, and analysis of physiological signals (EEG and PSG). IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description confirms it's a software program for EEG, PSG, and LTM, which are all methods of recording electrical activity in the body. It explicitly states it's software only and does not include any hardware, which further supports it's not for analyzing biological samples.
- Lack of IVD Indicators: There are no mentions of analyzing biological specimens, laboratory procedures, or any of the typical characteristics associated with IVD devices.
Therefore, this device falls under the category of medical software used for the acquisition and analysis of physiological signals, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
This software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. It is suitable for digital acquisition, display, comparison, and archiving of EEG potentials and other rapidly changing physiological parameters.
Product codes
OLV, GWQ
Device Description
The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Grass® TWin ® (Grass TWin) is a comprehensive software program intended for Electroencephalography (EEG), Polysomnography (PSG), and Long-term Epilepsy Monitoring (LTM). TWin is incredibly powerful and flexible, but also designed for easy and efficient day-to-day use. Grass TWin is a software product only, and does not include any hardware.
Mentions image processing
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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
Qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation.
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
The Grass TWin software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software 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.
- . Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 Jan 05
- . IEC 62304: 2006, Medical device software – Software life cycle processes
Results indicate that the Grass TWin software complies with its predetermined specifications, the applicable guidance documents, and the applicable standards.
Performance Testing - Bench The Grass TWin was verified for performance in accordance with internal requirements and the applicable clauses of the following standards:
- . IEC 60601-1-6: 2010, Am1: 2013, Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- . IEC 62366: 2007, Am1: 2014, Medical devices – Application of usability engineering to medical devices.
Results indicate that the Grass TWin complies with its predetermined specifications and the applicable standards.
Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the Grass TWin. The results of these activities demonstrate that the Grass TWin is as safe, as effective, and performs as well as or better than the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Shane Sawall Manager, Regulatory Affairs 2568 Bristol Circle Oakville, Ontario L6H 5S1 CA
March 9, 2018
Re: K173690
Trade/Device Name: Grass TWin Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV, GWQ Dated: February 12, 2018 Received: February 14, 2018
Dear Shane Sawall:
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
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 medical devices and radiation-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
Carlos Peña, Ph.D. for 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) K173690
Device Name Grass® TWin®
Indications for Use (Describe)
This software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. It is suitable for digital acquisition, display, comparison, and archiving of EEG potentials and other rapidly changing physiological parameters.
Type of Use (Select one or both, as applicable)
| ☒ 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 4
| Submission Date: | 30 November 2017 | ||
|---|---|---|---|
| Submitter: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | ||
| 2568 Bristol Circle | |||
| Oakville, Ontario, L6H 5S1 | |||
| Canada | |||
| Submitter and | |||
| Application | |||
| Correspondent | Mr. Shane Sawall | ||
| Phone: +1 (608) 829-8673 | |||
| Fax: +1 (608) 829-8771 | |||
| Email: shane.sawall@natus.com | |||
| Manufacturing Site: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | ||
| 2568 Bristol Circle | |||
| Oakville, Ontario, L6H 5S1 | |||
| Canada | |||
| Trade Name: | Grass® TWin® | ||
| 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 / Grass TWin | K012976 | Grass-Telefactor | |
| Division, Astro-Med, | |||
| Inc. / Grass-Telefactor | |||
| TWin PLUS | |||
| Device Description: | The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. | ||
| (XLTEK) Grass® TWin ® (Grass TWin) is a comprehensive software | |||
| program intended for Electroencephalography (EEG), Polysomnography | |||
| (PSG), and Long-term Epilepsy Monitoring (LTM). TWin is incredibly | |||
| powerful and flexible, but also designed for easy and efficient day-to-day | |||
| use. Grass TWin is a software product only, and does not include any | |||
| hardware. |
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Image /page/4/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is written in a teal sans-serif font, with a small registered trademark symbol to the right of the word. Below "natus", the word "neurology" is written in a dark blue sans-serif font.
Technology
Comparison:
This software is intended for use by qualified research and clinical Intended Use: professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. It is suitable for digital acquisition, display, comparison, analysis, and archiving of EEG potentials and other rapidly changing physiological parameters.
The Grass TWin employs the same technological characteristics as the predicate device.
| System Characteristic | Grass-Telefactor Division,
Astro-Med, Inc.
Grass-Telefactor TWin PLUS
(K012976) | XLTEK Grass TWin
(Proposed Device) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Intended Use | This software is intended for use
by qualified research and clinical
professionals with specialized
training in the use of EEG and
PSG recording instrumentation
for the digital recording.
playback, and analysis of
physiological signals. It is
suitable for digital acquisition,
display, comparison, analysis, and
archiving of EEG potentials and
other rapidly changing
physiological parameters. | Same. |
| Personal Computer
Operating System | Microsoft® Windows 98 or 2000 | Microsoft® Windows 7 and
Windows Server 2008 |
| Recording System
Compatibility | AURA PSG Wireless/Ambulatory
Recorder | AURA PSG Wireless/Ambulatory
Recorder |
| | AURA PSG Lite
Ambulatory/Wireless Sleep
Screener | AURA PSG Lite
Ambulatory/Wireless Sleep
Screener |
| | SleepTrek3 Portable Sleep
Screener | SleepTrek3 Portable Sleep
Screener |
| | Comet Series PSG | Comet and Comet-PLUS Series
PSG |
| | Comet Series EEG | Comet and Comet-PLUS Series
EEG |
| | AURA24 Ambulatory EEG | AURA24 Ambulatory EEG |
| | TREA Ambulatory EEG | TREA Ambulatory EEG |
| | Beehive Horizon for Long-Term
Monitoring | Beehive Horizon for Long-Term
Monitoring |
| Pulse Transit Time
(PTT) Trend Option | No | Yes |
| Montage Editor
Summation Feature | No | Yes |
5
Image /page/5/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, black font and is positioned below and to the right of "natus". The logo is simple and modern, with a clean design.
510(K) SUMMARY
Summary of Performance Testing:
Software
The Grass TWin software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software 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.
- . Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 Jan 05
- . IEC 62304: 2006, Medical device software – Software life cycle processes
Results indicate that the Grass TWin software complies with its predetermined specifications, the applicable guidance documents, and the applicable standards.
Performance Testing - Bench The Grass TWin was verified for performance in accordance with internal requirements and the applicable clauses of the following standards:
- . IEC 60601-1-6: 2010, Am1: 2013, Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- . IEC 62366: 2007, Am1: 2014, Medical devices – Application of usability engineering to medical devices.
Results indicate that the Grass TWin complies with its predetermined specifications and the applicable standards.
6
Image /page/6/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol next to it. Below that, the word "neurology" is in a smaller, italicized, dark blue font.
510(K) SUMMARY
PAGE 4 of 4
Verification and validation activities were conducted to establish the Conclusion performance and safety characteristics of the device modifications made to the Grass TWin. The results of these activities demonstrate that the Grass TWin is as safe, as effective, and performs as well as or better than the predicate devices.
Therefore, the Grass TWin is considered substantially equivalent to the predicate devices.