IMAGE VUE EEG

K980477 · Sam Technology, Inc. · OLX · Aug 6, 1998 · Neurology

Device Facts

• Record ID: K980477
• Device Name: IMAGE VUE EEG
• Applicant: Sam Technology, Inc.
• Product Code: OLX · Neurology
• Decision Date: Aug 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The software is intended for use by a qualified/trained EEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function and structure by fusing a variety of EEG information with MRI images.

Device Story

Image Vue EEG software imports digital EEG data and MRI data; performs data fusion to visualize human brain function and structure. Used in clinical settings by EEG technologists or physicians. No direct patient treatment, intervention, or real-time monitoring. Output allows clinicians to view fused EEG/MRI data to assist in clinical assessment of brain activity. Benefits include enhanced visualization of brain function relative to anatomical structures.

Clinical Evidence

Bench testing and user testing performed. No clinical data provided.

Technological Characteristics

Software-based electroencephalograph visualization tool. Imports digital EEG and MRI data formats. Operates as a standalone software application for data fusion and display.

Indications for Use

Indicated for use by qualified EEG technologists or physicians on adult and pediatric patients for visualization of human brain electrical activity via fusion of EEG data with MRI images.

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

• Radionics Image Correlation System (K960071)
• Nicolet Biomedical Instruments Brain Function Mapping Option For Pathfinder (K843598)
• The Grass Electroencephalograph Software (K970951)

Submission Summary (Full Text)

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> EXHIBIT 2 SAM Technology, Inc. One Rincon Center 101 Spear Street Suite 203 San Francisco CA 94105 Tel [phone] Fax [phone] sam(@eeg.com

980477

Contact: Alan S. Gevins, President July 28, 1998 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: IMAGE VUL LEG Software Clessification Name: Electroencephalograph, OL, X, Regulation # 882.1400 Common/Usual Name: Electroencephalograph Software
- 2. Equivalent legally marketed devices This product has features which are similar in design and function to the K960071, Radionics Image Correlation System; K843598, Nicolet Biomedical Instruments Brain Function Mapping Option For Pathfinder, and K970951, The Grass Electroencephalograph Software .
- 3. Indications for Use (intended use) The software is intended for use by a qualified/trained EEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function and structure by fusing a variety of EEG information with MRI images.
- 4. Description of the Device: The software imports digital EEG data (in a variety of formats) and MKI data and permits the fusing and viewing of both types of data. No direct intervention, treatment, or on-line monitoring of the patient is performed.
- 5. Safety and Fifectiveness, comparison to predicate device. The results of hench and user testing indicate that the new device is as safe and effective as the predicate devices.

## 6. Conclusion

After analyzing both bench and user testing data, it is the conclusion of SAM Technology, Inc. that the IMAGE. VUF. F.F.G. software is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Sam Technology, Inc. c/o Daniel Kamm. P.E. Regulatory Engineer Kamm and Associates P.O. Box 7007 Deerfield, Illinois 60015

APR - 9 2012

Re: K980477

Trade/Device Name: Image Vue EEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX Dated (Date on orig SE ltr): May 15, 1998 Received (Date on orig SE Itr): June 5, 1998

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of August 6, 1998.

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. Daniel Kamm

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/Resourcesfor You/Industry/default.htm.

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

Kesia A

Malvina B. Eyd
Director

Sincerely yours.

Malvina B. Eydelman, M.D. 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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j) Indications for Use

510(k) Number _ K980477

Device Name: IMAGE VUE EEG Software

Indications for Use:

The software is intended for use by a qualified/trained EEG technologist or physician on I no solvide is intended to the visualization of human brain electrical activity by fusing a variety of Lilit information with MKI images.

| Concurrence of CDRH, Office of Device Evaluation (ODF.) | |
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| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K980477 |

Prescription Use OR Over the Counter Use

(Per 21 CFR 801.109)

NI