(30 days)
The NeuroLink IP is intended to be used as an electroencephalograph: to acquire, digitize and transmit electroencephalographic and other physiological signals) for EEG studies in research and clinical environments.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called NeuroLink IP, an electroencephalograph. The document specifies that the device model is PK1117 and is regulated under 21 CFR 882.1400.
The provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter primarily addresses the substantial equivalence determination for the device, regulatory compliance, and general information for manufacturers.
Therefore, I cannot provide the requested information from the given text. A 510(k) clearance typically means the device is substantially equivalent to a previously cleared device, and often relies on demonstrating similar technological characteristics and performance to a predicate device, rather than requiring a detailed new clinical study with specific acceptance criteria outlined in the clearance letter itself.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Natus Medical Incorporated c/o Ms. Goldy Singh Director of QA/RA 2568 Bristol Circle Oakville; Ontario L6H 5S1 Canada
APR - 9 2010
Re: K100683
Trade/Device Name: NeuroLink IP Model: PK1117 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: March 3, 2010 Received: March 10, 2010
Dear Ms. Singh:
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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Page 2 - Ms. Goldy Singh
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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eilition
Melvin R. Baldwin, D.M.D.
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
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Special 510(k)
Section 4 - Statement of Indications for Use
510(k) Number (if known): K100683
Device Name: NeuroLink IP
Indications for Use:
The NeuroLink IP is intended to be used as an electroencephalograph: to acquire, digitize and transmit electroencephalographic and other physiological it acquire, uignize and signals) for EEG studies in research and clinical environments.
Prescription Use X AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
SK Du
vision Sign-Off Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K100683
§ 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).