TWIN PLUS

K012976 · Grass-Telefactor Divison · OLV · Feb 12, 2002 · Neurology

Device Facts

• Record ID: K012976
• Device Name: TWIN PLUS
• Applicant: Grass-Telefactor Divison
• Product Code: OLV · Neurology
• Decision Date: Feb 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical 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.

Device Story

TWin PLUS software functions as a universal review and analysis platform for EEG/PSG systems. It collects, formats, and displays real-time physiological waveforms and numeric data; records synchronized video/audio of patients. Operates on Windows OS; interfaces with various hardware amplifiers via digital interface cards or USB. Features include: real-time seizure/spike event marking (SZAC algorithm), semi-automatic sleep staging, and automated analysis of SaO2, respiration, and EMG (periodic leg movements). Data stored in TUFF format on local/network disks or archived to CD-ROM. Used by trained medical professionals in clinical/research settings. Output provided as waveform displays, numeric reports, and event markers. Healthcare providers review all automated markers; no diagnostic classification is made by the software. Benefits include efficient data management, synchronized review of EEG and video, and streamlined analysis of long-term recordings for epilepsy and sleep disorders.

Clinical Evidence

Bench testing only. No clinical data provided. The device relies on proven algorithms from previously cleared predicate devices (e.g., SZAC seizure analysis, SASSY sleep scoring).

Technological Characteristics

Software-based EEG/PSG review system. Operates on Windows 98/2000. Supports up to 136 channels, 1000 Hz max sample rate. Connectivity via RS232 or digital interface cards. Data storage in proprietary TUFF format. Features include digital filtering, frequency/amplitude measurement, potential mapping, and spectral analysis. No specific material standards or sterilization required as it is a software-only device.

Indications for Use

Indicated for use by qualified research and clinical professionals for digital recording, playback, and analysis of EEG and PSG physiological signals, including epilepsy diagnosis and sleep studies.

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 GAMMA software package
• Telefactor BEEHIVE
• Telefactor SZAC Seizure Analysis Computer (K870450)

Reference Devices

• SASSY (K860219)

Submission Summary (Full Text)

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K 012976
2-12-02

# EXHIBIT A

Grass-Telefactor Division

Astromed-Med, Inc.

#### West-Warwick, RI 02893 USA

Tel: [phone]

Fax: [phone]

Contact Person: Jim Bryan

August 15, 2001

#### 1. Identification of the Device

Classification Name: Electroencephalograph, 84GWQ, Reg. #882.1400 (1)

Common/Usual Name: EEG Review Software

Proprietary-Trade Name: Grass-Telefactor TWin PLUS Software

## 2. Equivalent Legally Marketed Devices

This software is functionally equivalent in design and function to that of the GRASS GAMMA software package and the Telefactor BEEHIVE, and the Telefactor SZAC Seizure Analysis Computer.

## 3. 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. Its specifications and features are especially well suited to electroencephilography, polysomnographic sleep recordings, and long term recordings used in epilepsy diagnosis.

## 4. Theory of Operation and Description of the Device

TWin PLUS will become the universal review package for all GRASS-Telefactor EEG systems. Further the TWin PLUS software package is intended for use with a number of hardware EEG inourterlices. It utilizes the windows operating system to manage four or more simultaneous ongoing tasks which include:

- Real-time collection and formating of real time EEG and other physiological parameters ●

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- Real-time display of the foregoing parameters in waveform or numeric format as the data and user . may require.
- . Real time analysis of EEG waveform data to identify events which may be epileptoform in nature and hence require special attention from professionals in attendance - SZAC analysis.
- Data collection and recording to disk of real time video and audio data, usually an image of the patient ● being monitored.
- Review and analysis of previously recorded data including the ability to look-back to old data while ● real-time recording of ongoing data is in progress.

#### EEG Input Ampliffers:

The TWin PLUS software package is intended to work with a number of different amplifier systems with various digital interface modes. Each of these hardware devices have or will have their own separate 510(k) marketing authority, ---

These amplifiers choices include:

- Current BEEHIVE amplifiers which use a special purpose digital interface card for already digitized . data.
- The same BEEHIVE amplifiers using a USB interface for the data. .
- GRASS-Telefactor TS amplifiers using a computer resident card for A to D conversion of their . multiplexed analog data stream.

#### Data Formatting and Storage:

All data is stored in a format (TUFF) as near the original input as possible at sample rates appropriate for the data type. Primary storage is either local or remote hard disk (network server). Provisions exist for archiving to several appropriate digital archive media, most frequently CD ROM.

#### Montaging Capability:

The TWIN PLUS software has provision for labeling data channels with electrode names and then displaying waveforms as the algebraic difference of any electrode pair. The playback montage also specifies default digital filter settings.

#### Analysis;

Specific sections of data can be selected easily for further analysis including frequency and amplitude measurement, potential mapping, spectral analysis, and frequency band mapping.

#### Flagging of Epileptoform EEG Data Sequences (SZAC):

The SZAC program module uses the identical software algorithm developed and proven in the SZAC Computer previously marketed by Telefactor (K870450) This system is in wide use in the medical community, particularly in epilepsy centers around the world. Grass-Telefactor makes no claims for diagnostic accuracy of this algorithm, it is merely a device which marks particular EEG passages for diagnostic consideration either as seizures or as spikes.

#### EEG Data BASE:

An EEG data base feature associates stored EEG data with patient name, date and appropriate clinical parameters entered by the operator, and provides convenient means for accessing that data for review.

#### Digital Video Recording:

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TWIN software uses the output of an appropriate video capture card in the host computer to digitize, compress and store patient image data. Provision is included to play back video data synchronized with the EEG waveform display.

## Semi Automatic Sleep Scoring:

TWin PLUS includes the next iteration of the Semi Automatic Sleep Scoring System (SASSY K860219). This system functions to display polysomnographic data in standard page sizes and provides means a review operator to assign a sleep stage notation to each page.

Report generation and printout are provided for each study with reported parameters which can be tailored by the particular laboratory using the device.

A software option is provided for automatic analysis of SaO2 and respiration data to mark apnea and desaturation events for professional review and classification. A similar module analyzes EMG waveforms to mark periodic leg movements. In each case no diagnostic classification is made without a decision based on the review of a qualified professional.

These routines are supplied without any claims for accuracy and the professional can use or ignore them at his own discretion. In each case decision thresholds are adjustable and can be set by the person reviewing the data.

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### 5 Comparison Matrix

| Technical<br>Characteristic | GRASS-Telefactor<br>TWin PLUS | GRASS<br>GAMMA | Telefactor<br>SZAC 16<br>Seizure Analysis<br>Computer | Telefactor<br>BEEHIVE 64 |
|-------------------------------|-------------------------------|------------------------------|-------------------------------------------------------|------------------------------|
| Device Class | CLASS II | CLASS II | CLASS II | CLASS II |
| Intended User | Medical<br>Professional | Medical<br>Professional | Medical<br>Professional | Medical<br>Professional |
| Operating System | Windows 98 or<br>2000 | Windows 98 Or<br>2000 | DOS | DOS |
| Max Channels | 136 | 36 | 16 | 64 (128 for other<br>models) |
| Sample Rate | 1000 Hz Max | 1000 Hz Max | 200 | 200 |
| Amplifier control | RS232 | RS232 | Manual | RS232 |
| Recorder Update<br>Mode | Wiper Bar | Wiper Bar | Scrolled Display | Scrolled Display |
| Monitor<br>Resolution | 1600 x 1200 | 1600 x 1200 | 1024 x 440 | 1024 x440 |
| Data Storage | Local or Remote<br>hard disk | Local or remote<br>hard disk | Local or remote<br>hard disk | Digital VCR |
| Primary Data<br>Access | Random | Random | Random | VCR sequential |
| User Input | Mouse/keyboard | Mouse/keyboard | Keyboard | Keyboard |
| Synchronized<br>Patient Video | Yes | | | Yes |
| Seizure Event<br>Marking | Yes | | Yes | |
| Spike Event<br>Marking | Yes | | Yes | |
| Apnea Event<br>Marking | Yes | Yes | | |
| Desaturation Event<br>Marking | Yes | Yes | | |
| PLM Marking | Yes | Yes | | |
| Staging/scoring<br>method | Manual/computer<br>assisted | Manual/computer<br>assisted | | |
| Sleep Report<br>Parameters | Yes | Yes | | |
| Epilepsy<br>Parameters | Yes | | Yes | Beehive 7 |

#### 6 Discussion:

The TWin PLUS software is primarily a composite of the three referenced substantially equivalent devices with enhanced capacity permitted by the state-of-the-art in electronic data handling. Faster computers, less expensive disk capacity and multi-tasking operating systems have permitted combining all the figatives, of the referenced products into a single useful modular software package.

None of the products features have any impact on the safety of the patient or operator. Although both TWin PLUS and GRASS GAMMA (NIGHT VISION) have the capability to control the data aquisition

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amplifier settings, neither are required for the safe operation of the amplifiers that they are designed to control, nor are they capable of impacting on the safety of the amplifier systems.

All of the products are designed to be operated by trained medical professionals and the data collected is reviewed in its entirety by trained medical professionals. None of the products claims to be in and of itself "diagnostic".

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Mr. John B. Chatten President Grass-Telefactor Division Astro-Med, Inc. West-Warwick. Rhode Island 02893

Re: K012976

Trade/Device Name: Grass-Telefactor Twin PLUS Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): December 7, 2001 Received (Date on orig SE Itr): December 11, 2001

APR - 9 2012

Dear Mr. Chatten:

This letter corrects our substantially equivalent letter of February 12, 2002.

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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Page 2 - Mr. John B. Chatten

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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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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12012976 510(k) Number (if known):

Device Name: _TWIN_Plus

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, analysis, and archiving of EEG potentials and other rapidly changing physiological parameters.

(PL.FASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IIT NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODDE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012976

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