TWIN NEUROTRAC-III

K081551 · Astro-Med, Inc. · OMA · Dec 24, 2008 · Neurology

Device Facts

• Record ID: K081551
• Device Name: TWIN NEUROTRAC-III
• Applicant: Astro-Med, Inc.
• Product Code: OMA · Neurology
• Decision Date: Dec 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K081551 · Dec 24, 2008	TWIN NEUROTRAC-III	Astro-Med, Inc.	Previously recorded clinical EEG studies	Retrospective clinical EEG data were used to verify the device's design and performance functional requirements during non-clinical testing.	Retrospective data; Performance validation; EEG

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective analysis of previously recorded clinical data	Patients undergoing EEG monitoring	Not applicable for this study	Design and performance functional requirements

Indications for Use

The intended use for TWin Neurotrac-III is: To record the electroencephalogram (EEG) and the computed EEG trends over extended periods of time in order for trained health care professionals to observe changes over time. TWin Neurotrac-III does not provide any diagnostic conclusion about the patient's condition. TWin-Neurotrac-III is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.

Device Story

TWin Neurotrac-III is a software-based EEG monitoring system used with Grass Technologies TWin software and compatible amplifiers (AS40, AURA, AURA-LTM64, Beehive). It accepts raw EEG signals from patient-applied electrodes; processes and displays raw EEG waveforms; computes and displays long-term trends of user-selectable EEG features. Used in ICU, NICU, OR, and long-term monitoring units by physicians, nurses, or technicians. Healthcare providers view trends and waveforms to observe changes over time; device provides no diagnostic conclusions. Benefits include continuous monitoring of brain state over prolonged periods. Operates as an add-on to existing Grass EEG recording systems.

Clinical Evidence

No clinical testing was necessary. Evidence consists of bench testing using simulated signals and real EEG data from previously recorded studies, plus beta site testing under supervision of qualified medical personnel. Testing confirmed the device meets design/performance requirements and does not adversely alter the functionality of the TWin software or connected EEG amplifiers.

Technological Characteristics

Software-based EEG processing system. Integrates with Grass Technologies TWin software (#K012976) and specific amplifiers (AS40, AURA, AURA-LTM64, Beehive). Processes up to 16 user-selected EEG channels; total raw channel capacity depends on amplifier (up to 128). Connectivity via proprietary Grass Technologies hardware/software ecosystem. No diagnostic algorithm; provides raw waveform display and trend computation.

Indications for Use

Indicated for patients of all age groups requiring continuous EEG monitoring in ICU, NICU, OR, EEG/PSG laboratories, or inpatient long-term seizure monitoring units. Intended for use by medically trained personnel in hospital/medical environments.

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

• Neurotrac II-EP (K960170)
• Neurotrac II (K914571)
• Nervus Monitor (K021185)
• Olympic CFM6000 (K031149)
• BRM3 Brain Monitor (K071449)

Submission Summary (Full Text)

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K081537

Image /page/0/Picture/1 description: The image shows the logo for GRASS Technologies. The logo is in black and white and features the word "GRASS" in large, bold letters. Below the word "GRASS" is the word "TECHNOLOGIES" in a smaller font. Underneath the word "TECHNOLOGIES" is the phrase "An Astro-Med, Inc Product Group" in an even smaller font.

Grass Technologies, An Astro-Med, Inc. Product Group 600 East Greenwich Avenue West Warwick, RI 02893 USA Tel. [phone] FAX: [phone]

# 5. 510(k) Summary

June 2, 2008 Submission Date:

Grass Technologies, an Astro-Med, Inc. Product Group Submitted by: 600 East Greenwich Avenue West Warwick, RI 02803 USA Tel: [phone] FAX: [phone]

- Alfredo Bustamante Contact Person: Product Manager Tel: [phone] or direct# 610-941-6138 e-mail: [e-mail]
## Proprietary Name: TWin Neurotrac-III

# Common/Usual Name: Electroencephalography (EEG)

#### Product Classification:

Category: Electroencephalograph Regulation Number: 882.1400 Product Code: OMA, DLT, OKT Product Class: Class II

## Substantial Equivalent Predicate Devices:

- · Neurotrac II-EP, 510(k) #K960170, Moberg Medical, Inc., Purchased by Astro-Med, Inc.
- · Neurotrac II. 510(k) # K914571, Moberg Medical, Inc., Purchased by Astro-Med, Inc.
- · Nervus Monitor, 510(k) # K021185, Taugagreining HF, now Nicolet Biomedical, a Viasys Healthcare/Cardinal Health Brand
- · Olympic CFM6000, 510(k) # K031149, Olympic Medical Corp, now a division of Natus Medical Inc.
- · BRM3 Brain Monitor, 510(k) #K071449, BrainZ Instruments LTD., Auckland. New Zeland

#### Device Description:

TWin Neurotrac-III is used with Grass-Technologies TWin (#K012976) EEG Recording and Review systems for displaying and recording long term trends of EEG features during continuous EEG monitoring in the ICU, NICU, OR, EEGIPSG laboratories, and/or inpatient long-term seizure monitoring units. TWin Neurotrac-III can be used with EEG acquisition systems configured with any of Grass-Technologies' amplifiers, including AS40 (#K021807), AURA (#K033978), AURA-LTM64 (#K053606) and Beehive (#K884937) amplifiers. The number of EEG channels recorded is dependent on the amplifiers used, the number of electrodes applied to the patient. and the user selected EEG display montage. In addition to displaying and recording the EEG waveforms. TWin Neurotrac-III can also display and record trends of user selectable EEG features in the EEG over prolonged periods of time. The number and the EEG channels processed are selected by the user.

#### Indications for Use:

The intended use for TWin Neurotrac-III is to record the electroencephalogram (EEG) and the computed EEG trends over extended periods of time in order for trained health care professionals to observe changes over time. TWin Neurotrac-III does not provide any diagnostic conclusion about the patient's condition.

TWin-Neurotrac-III is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.

DEC 2 4 2008

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#### 510(k) Summary (continued) Page 2 of 2

#### Grass Technologies Twin Neurotrac-III

### Summary of Comparison to Predicate Devices:

In general, TWin Neurotrac-III and the predicate devices are similar in features and lechnical characteristics. There are no major differences that would alter intended use or jeopardize patient safety. TWin Neurotrac-III and the predicate devices have indication of use: to record and process EEG signals to monitor the state of the patient's brain; for use by medically trained and qualified personnel; for use in various areas of the hospital or medical institution; and for use with patients in all age groups.

Twin Neurotrac-III and all predicate devices display and record raw EEG waveforms, as well as processed EEG data to facilitate viewing changes in the EEG over prolonged periods of time. All devices use computer software for displaying, recording, and processing EEG data. TWin Neurotrac-III and the predicate devices are not life supporting or life sustaining devices, and no claims are made that the device is in and of itself diagnostic.

The only significant difference between TWin Neurotrac-III and the predicate devices is the number of EEG channels displayed, processed, and recorded: predicate devices Olympic CFM6000 and BRM3 Brain Monitor record 2 and 3 channels; predicate devices Neurotrac II-EP record up to 8 channels; predicate device Nervus Monitor records 16 or 32 channels. TWin Neurotrac-III can process up to 16 user selected channels, and the total number of raw EEG channels recorded and displayed is a function of the Grass Technologies amplifiers used as listed in the above device description (up to 128 channels), the number of electrodes applied by the user, and the selected display montage. With TWin Neurotrac-III, the number of raw EEG channels and processed channels displayed and recorded is defined by the user. Another difference is that predicate device Neurotac II-EP can monitor evoked electrical activity (EPs) in addition to EEG. TWin Neurotrac-III does not monitor Evoked Potentials and no claims are made that it can. Excluding the Evoked Potentials function, Moberg's Neurotrac II predicate devices are the basic foundations for TWin Neurotrac-III's EEG display, recording and processing function.

#### Non-Clinical Testing:

In house testing using simulated signals, as well as real EEG from previously recorded studies show that TVVin Neurotrac-III meets design and performance functional requirements. Testing has also shown that TWin Neurotrac-III does not adversely aller the functionality of the TWin software, it does not aller the functionality of the EEG amplifiers used, it does not jeopardize the safety of the patient connected to the EEG amplifiers, nor does it jeopardize the safety of the operator.

## Beta Site Testing:

Testing of TWin Neurotrac-III was performed at Beta sites under the supervision of qualified medical gersonnel. This testing showed that TWin Neurotrac-III meets design and performance functional requirements. Testing has also shown that TWin Neurotrac-III does not adversely alter the functionality of the TWin software, it does not alter the functionality of the EEG amplifiers used, it does not jeopardize the safety of the patient connected to the EEG amplifiers, nor does it jeopardize the safety of the operator. No clinical testing was necessary to demonstrate substantial equivalence for this product.

#### Conclusion Demonstrating Safety, Effectiveness, and Performance:

The testing carried out for the TWin Neurotrac-III indicates that it meets design and performance functional requirements. When used with TWin software ((#K012976) and Grass Technologies EEG amplifiers [AS40 (#K021807), AURA (#K033978), AURA-LTM64 (#K053606, Beehive (#K884937)], TWin Neurotrac-III is equivalent to the predicate devices in terms of safety, effectiveness, and performance. TWin Neurotrac-III can not be used with any other company's software and EEG amplifiers.

Alfredo Bustamante Product Manager Grass Technologies, an Astro-Med, Inc. Product Group

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ASTRO-MED INC. c/o Mr. Alfredo Bustamante 600 East Greenwich Ave West Warwick, RI 02893

Re: K081551 Trade/Device Name: Twin Neurotrac-III Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMA, OLT, ORT Dated (Date on orig SE ltr): December 10, 2008 Received (Date on orig SE ltr): December 15, 2008

APR - 9 2012

Dear Mr. Bustamante:

This letter corrects our substantially equivalent letter of December 24, 2008.

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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,.
Kesici Alexander

for

MAY
DEC
DEC

C

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 4. Indications for Use

# 510(k) Number (if known): K081551

Device Name: TWin Neurotrac-III, Grass-Technologies, an Astro-Med, Inc. Product Group

Indications for Use:

The intended use for TWin Neurotrac-III is:

To record the electroencephalogram (EEG) and the computed EEG trends over extended periods of time in order for trained health care professionals to observe changes over time. TWin Neurotrac-III does not provide any diagnostic conclusion about the patient's condition.

TWin-Neurotrac-III is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.

Prescription Use × (Part 21 CFR 801 Subpart D)

・(

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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**510(k) Number**

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