(181 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data fusion and visualization without mentioning any learning or predictive capabilities.
No
The device description explicitly states: "No direct intervention, treatment, or on-line monitoring of the patient is performed," indicating it's not a therapeutic device. Its purpose is visualization, not therapy.
No
The device is described as software for "visualization of human brain function and structure" and "visualization of human brain electrical activity" by fusing EEG and MRI data. It explicitly states, "No direct intervention, treatment, or on-line monitoring of the patient is performed." While it helps in visualizing data, it does not provide a diagnosis or aid in making clinical decisions directly based on analyzing the data for disease detection or characterization. Its function is to present information that might be used by a clinician for diagnosis, but the device itself is not performing the diagnostic function.
Yes
The device description explicitly states "The software imports digital EEG data... and MKI data and permits the fusing and viewing of both types of data." It also clarifies that "No direct intervention, treatment, or on-line monitoring of the patient is performed," indicating its function is solely data processing and visualization. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the software imports and fuses digital EEG data and MKI data (likely MRI data, given the context). It is used for the visualization of human brain function and structure by fusing this data.
- No Sample Analysis: There is no mention of analyzing biological samples taken from the patient. The input is data from medical imaging and electrical activity measurements.
- Purpose: The purpose is visualization and fusion of existing medical data, not the analysis of biological samples to diagnose or monitor a condition.
Therefore, this device falls under the category of medical imaging software or data analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
OLX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, EEG
Anatomical Site
human brain
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained EEG technologist or physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The results of hench and user testing indicate that the new device is as safe and effective as the predicate devices.
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.
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).
0
e 1938 AUG
EXHIBIT 2 SAM Technology, Inc. One Rincon Center 101 Spear Street Suite 203 San Francisco CA 94105 Tel 415-227-4900 Fax 415-546-7122 sam(@eeg.com
980477
Contact: Alan S. Gevins, President July 28, 1998 510(k) Summary of Safety and Effectiveness
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- Identification of the Device: Proprietary-Trade Name: IMAGE VUL LEG Software Clessification Name: Electroencephalograph, OL, X, Regulation # 882.1400 Common/Usual Name: Electroencephalograph Software
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- 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.
-
- 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.
-
- 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.
ਤ
1
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.
2
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 (800) 638-2041 or (301) 796-7100 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
3
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.) | |
|---|---|
| (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