WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS

K990522 · Lamont Medical, Inc. · OLV · May 19, 1999 · Neurology

Device Facts

• Record ID: K990522
• Device Name: WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
• Applicant: Lamont Medical, Inc.
• Product Code: OLV · Neurology
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

For long term unattended EEG or other electrophysiological sigmal monitoring and recording. This device is intended for use by physicians skilled in alectroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologists or the equivalent or Ph.D. level Electroencephalographers. We recommend placement of electrodes in accordance with the 10.20 International System.

Device Story

Digital EEG and Sleep Acquisition System captures electrophysiological signals (EEG) via electrodes placed per 10-20 International System; optional pulse oximetry function included. Device intended for use by skilled physicians (neurologists, neurophysiologists, or Ph.D. electroencephalographers) in clinical settings for long-term unattended monitoring. System records and displays physiological data to assist clinicians in diagnostic assessment of neurological or sleep-related conditions. Output facilitates clinical decision-making by providing continuous signal data for review.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital EEG and sleep acquisition system; supports optional pulse oximetry; utilizes standard electrode placement (10-20 International System); class II device (21 CFR 882.1400).

Indications for Use

Indicated for patients requiring long-term unattended EEG or other electrophysiological signal monitoring and recording.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Mr. Tony Montgomery President and Chief Executive Officer La Mont Medical, Inc. 555 D'Onofrio Drive Madison, Wisconsin 53719

APR - 9 2012

Re: K990522

Trade/Device Name: DigitaEEG and Sleep Acquisition System With or Without Pulse Oximetry Function Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE Itr): February 16, 1999 Received (Date on orig SE ltr): February 18, 1999

Dear Mr. Montgomery:

This letter corrects our substantially equivalent letter of May 19, 1999.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Kesia Alexander

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

for

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: LA MONT HEDICAL: Inc. WARATAH.and CARDING, DIGITAL ESG/SLER Anguisition System Device (in various models/sets) with or without Internal Publication. Oximetry Function. Indications For Use:

- For long term unattended EEG or other electrophysiological sigmal ı monitoring and recording.
- This device is intended for use by physicians skilled in alectroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologists or the equivalent or Ph.D. level Electroencephalographers.
- We recommend placement of electrodes in accordance with the ﺍ 10.20 International System.

(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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| | (Division Sign-Off)<br>Division of General Restorative Devices |
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| 510(k) Number | K456577 |

| Prescription Use | <span style="text-decoration: underline;">✓</span> | OR | Over-The-Counter Use | |
|----------------------|----------------------------------------------------|----|----------------------|--------------------------|
| (Per 21 CFR 801.109) | | | | (Optional Format 1-2-96) |