(90 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description and intended use focus on standard EEG acquisition.
No.
The device is described as an "EEG or other electrophysiological signal monitoring and recording" system, which is used for diagnostic purposes rather than direct treatment. The intended use focuses on monitoring and recording signals.
Yes
The device is intended for "long term unattended EEG or other electrophysiological signal monitoring and recording," which are activities associated with diagnostics in electroencephalography. The intended users are also highly specialized medical professionals (neurologists, neurophysiologists, electroencephalographers) who perform diagnostic procedures using such data.
No
The device description explicitly mentions "DigitaEEG and Sleep Acquisition System With or Without Pulse Oximetry Function," which implies hardware components for signal acquisition and potentially pulse oximetry. The intended use also describes "long term unattended EEG or other electrophysiological signal monitoring and recording," which requires hardware to capture these signals.
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 such as blood, urine, or tissue to detect diseases or other conditions. They are used outside of the body ("in vitro").
- Device Function: The description clearly states the device is for "long term unattended EEG or other electrophysiological signal monitoring and recording." This involves measuring electrical activity directly from the body (in vivo), not analyzing samples outside the body.
- Intended Use: The intended use is for monitoring and recording physiological signals, not for analyzing biological samples.
- Anatomical Site: While not explicitly stated, EEG involves placing electrodes on the scalp, which is an anatomical site on the body.
- No Mention of Samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
OLV, GWQ
Device Description
DigitaEEG and Sleep Acquisition System With or Without Pulse Oximetry Function (stated in the main letter body).
LA MONT HEDICAL: Inc. WARATAH.and CARDING, DIGITAL ESG/SLER Anguisition System Device (in various models/sets) with or without Internal Publication. Oximetry Function. (stated in the Indications for Use enclosure).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians skilled in electroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologists or the equivalent or Ph.D. level Electroencephalographers.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K990522 (stated as the subject device, but the letter is a correction to a previous substantial equivalence letter dated May 19, 1999, which usually indicates the K-number of the device being cleared and thus the one for which substantial equivalence was claimed relative to a predicate. The device name referenced as “the device referenced above” is K990522. There is no explicit predicate device K-number listed in this document.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three thick lines forming the body and wings. The bird is positioned diagonally, facing towards the upper right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
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.
1
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.
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
2
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) | |
|---|---|
| -- | -------------------------------------------------------- |
| | (Division Sign-Off)
Division of General Restorative Devices |
|---------------|----------------------------------------------------------------|
| 510(k) Number | K456577 |
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |