(51 days)
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Not Found
No
The summary describes a device for acquiring and transmitting physiological signals (EEG, polysomnography) and explicitly states it does not involve patient monitoring or diagnosis. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
Explanation: The device is described as acquiring and transmitting EEG and polysomnography signals for neurophysiology examinations, explicitly stating it "does not involve any patient monitoring or diagnosis." It is used for signal acquisition, not for treating any condition.
No
The device is described as acquiring and transmitting EEG and polygrasomnography signals, but the Intended Use explicitly states, "It does not involve any patient monitoring or diagnosis." Its purpose is signal acquisition for neurophysiology examinations, not interpretation or diagnosis.
No
The intended use explicitly states the device is for "acquisition of EEG and polygrasomnography signals and transmission of these signals to a PC". Signal acquisition typically requires hardware (electrodes, amplifiers, etc.), which is not described as being excluded or separate from the device itself.
Based on the provided information, the Artisan™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the acquisition and transmission of physiological signals (EEG and polysomnography). It explicitly states it "does not involve any patient monitoring or diagnosis." IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No Mention of Specimen Analysis: There is no indication that the device interacts with or analyzes any biological specimens.
The Artisan™ appears to be a device for collecting physiological data directly from the patient's body for later analysis by a healthcare professional. This falls under the category of a medical device used for physiological signal acquisition, not an IVD.
N/A
Intended Use / Indications for Use
The Artisan™ is intended to be used by Physicians or trained technicians for acquisition of EEG and polygrasomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations commonly used in clinics. It does not involve any patient monitoring or diagnosis.
Product codes
OLV, GWQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Physicians or trained technicians / clinics
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
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 curved lines forming the body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Greg Dziomba Quality Assurance Manager AirSep Corporation 290 Creekside Drive Buffalo, New York 14228
APR - 9 2012
Re: K992283
Trade/Device Name: Artisan™ Acquisitions System for EEG and Polysomnography Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): July 23, 1999 Received (Date on orig SE ltr): July 27, 1999
Dear Mr. Dziomba:
This letter corrects our substantially equivalent letter of August 27, 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/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/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 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
Enclosure
for
2
510(k) Number:
Device Name:
Artisan™ Acquisition System for EEG and polysomnography
Indications For Use:
The Artisan™ is intended to be used by Physicians or trained technicians for acquisition of EEG and polygrasomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations commonly used in clinics. It does not involve any patient monitoring or diagnosis.
Mark n Mikkelsen
(Division Sign-Off) Division of General Restorative Devices K992283 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ర్ Pr ription Use ( 1 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)