K Number
K081741
Device Name
NEUROLINK IP, MODEL PK1113
Date Cleared
2008-10-31

(134 days)

Product Code
Regulation Number
882.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NeuroLink IP system is intended to be used as an electroencephalograph: to acquire, store, display and archive electroencephalographic signals.
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary only describes a standard electroencephalograph for signal acquisition, storage, display, and archiving, with no mention of AI or ML terms or functionalities.

No
The device is described as an electroencephalograph, which is used for diagnostic purposes (acquiring, storing, displaying, and archiving signals), not for treating a condition.

Yes
The device is described as an "electroencephalograph" which acquires, stores, displays, and archives "electroencephalographic signals," indicating its use in diagnosing neurological conditions through the measurement of brain activity.

Unknown

The provided 510(k) summary lacks a device description, making it impossible to determine if the NeuroLink IP system is solely software or includes hardware components for acquiring the electroencephalographic signals.

Based on the provided information, the NeuroLink IP system is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to acquire, store, display, and archive electroencephalographic signals. This involves measuring electrical activity of the brain, which is a physiological process within the body.
  • Input Modality: The input is electroencephalographic signals, which are electrical signals measured directly from the patient.
  • Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. The NeuroLink IP system is interacting directly with the patient's body to acquire signals.

Therefore, the NeuroLink IP system falls under the category of a medical device that measures physiological signals in vivo (within the body), not an IVD.

N/A

Intended Use / Indications for Use

The NeuroLink IP system is intended to be used as an electroencephalograph: to acquire, store, display and archive electroencephalographic signals.

Product codes

GWQ

Device Description

Not Found

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

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body.

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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