(134 days)
The NeuroLink IP system is intended to be used as an electroencephalograph: to acquire, store, display and archive electroencephalographic signals.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "NeuroLink IP, Model PK1113," an electroencephalograph. The letter confirms that the device is substantially equivalent to a legally marketed predicate device.
Unfortunately, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone).
The document primarily focuses on:
- The FDA's decision of substantial equivalence.
- Regulatory classification (Class II).
- General controls and applicable regulations.
- Contact information for various FDA divisions.
- The intended use of the device (to acquire, store, display, and archive electroencephalographic signals).
Therefore, I cannot provide the requested table and detailed information based solely on the provided text. To answer your questions, the original 510(k) submission document would be required, as it typically contains the technical details, performance data, and study methodologies supporting the device's clearance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Excel-Tech Ltd. % Ms. Goldy Singh Director of Quality and Regulatory 2568 Bristol Circle Oakville, Ontario Canada, L6H 5S1
OCT 31 2008
Re: K081741
Trade Name: Ncurolink IP, Model PK1113 Regulation Number: 21 CFR 882.1400 Regulation Name: Electrocncephalograph Regulatory Class: Class II Product Code: GWQ Dated: October 22, 2008 Received: October 23, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); good manufacturing practice requirements as set
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Page 2 - Ms. Goldy Singh
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Survcillance and Biometric's (OSB's) Division of Postmarket Survcillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: NeuroLink IP
Indications for Use:
The NeuroLink IP system is intended to be used as an electroencephalograph: to acquire, store, display and archive electroencephalographic signals.
Prescription Use X (Per 21 CFR 801 109) OR
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mellersen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
(Optional Format 1-2-96)
510(k) Number
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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).