NOTTA AMBULATORY RECORDER

K013450 · Stellate Systems · OLV · Jan 14, 2002 · Neurology

Device Facts

• Record ID: K013450
• Device Name: NOTTA AMBULATORY RECORDER
• Applicant: Stellate Systems
• Product Code: OLV · Neurology
• Decision Date: Jan 14, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Notta Ambulatory Recorder is indicated for the recording and study of EEG and other physiological signals obtained during routine EEG exams, long-term monitoring in epilepsy (LTM) and sleep studies (PSG or polysomnography) either at home, at a clinical setting, or other suitable environment under physician's order. The Notta Ambulatory Recorder is indicated for use with children and adults under the supervision of a physician or other trained health care professional. The device is intended to be worn by the patient during a recording session. The Notta Ambulatory Recorder is not intended to be used for the monitoring of vital sigus, in critical care or intra-operative settings. In no way are any of the device functions represented as being in and of themselves diagnostic. The system requires competent user input, and its output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

Device Story

Ambulatory recorder for EEG and physiological signal acquisition; worn by patient during recording sessions. Used in home or clinical environments under physician supervision. Device captures signals for later review; does not provide automated diagnosis. Output requires interpretation by physician or trained professional to inform clinical decision-making. Benefits include enabling long-term monitoring outside traditional hospital settings.

Technological Characteristics

Ambulatory EEG recorder; portable form factor for patient wear. Records EEG and physiological signals. Connectivity and specific material standards not disclosed.

Indications for Use

Indicated for recording/study of EEG and physiological signals in children and adults for routine EEG, epilepsy monitoring (LTM), and sleep studies (PSG). Used in home or clinical settings under physician order. Contraindicated for vital sign monitoring, critical care, or intra-operative settings.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Mr. George Papagiannis, M.Eng. Quality Assurance and Regulatory Affairs Stellate Systems 345 Victoria Avenue, Suite 300 Canada H3Z 2N2

APR - 9 2012

Re: K013450 Trade/Device Name: Notta Ambulatory Recorder Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE Itr): October 9, 2001 Received (Date on orig SE ltr): October 17, 2001

Dear Mr. Papagiannis:

This letter corrects our substantially equivalent letter of January 14, 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 (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.

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 (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.

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/CDRH0ffices/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/ReportaProblem/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.

Kesia Alexander

Sincerely vours.

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

for

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Enclosure

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Notta Ambulatory Recorder

## Attachment A

## Indications for Use Statement

| 510(k) Number: | K013456 |
|----------------|---------|
|----------------|---------|

Device Name:

Notta Ambulatory Recorder

Indications for Use:

The Notta Ambulatory Recorder is indicated for the recording and study of EEG and other physiological signals obtained during routine EEG exams, long-term monitoring in epilepsy (LTM) and sleep studies (PSG or polysomnography) either at home, at a clinical setting, or other suitable environment under physician's order.

The Notta Ambulatory Recorder is indicated for use with children and adults under the supervision of a physician or other trained health care professional. The device is intended to be worn by the patient during a recording session.

The Notta Ambulatory Recorder is not intended to be used for the monitoring of vital sigus, in critical care or intra-operative settings.

In no way are any of the device functions represented as being in and of themselves diagnostic. The system requires competent user input, and its output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| <img alt="signature" src="signature.png"/> | |
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K013450 |

Prescription Usc _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 109) OR

Over-The-Counter Use