(182 days)
The NeuroPort™ NSP System is intended for temporary (<30 days) recording and monitoring of brain electrical activity.
The intended use of the Cyberkinetics, Inc. Neuroport Neural Signal Processor System is monitoring of brain electrical activity.
The Neuroport Neural Signal Processing (NSP) System is intended for recording and monitoring. Its functionality includes routine brain activity recording, monitoring, retrieval and replay. The Neuroport supports up to 96 channels of recording and is comprised of the following hardware components: Patient Cable, Amplifier, CPU and a Display monitor. The Neuroport System also includes the following software functions: acquisition, amplification and display.
This K042626 submission for the NeuroPort™ NSP System does not describe specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) or a study with a test set, ground truth establishment, or clinical performance evaluation against such criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (BMSI 5000 (Nicolet), Ceegraph (Bio-Logic), and EMU 128 (XLTek)) primarily through:
- Intended Use Comparison: Stating that the NeuroPort™ NSP System has similar indications for use (temporary recording and monitoring of brain electrical activity) as the predicate devices.
- Functionality Comparison: Asserting that the functionality (recording, amplification, digitization, monitoring, retrieval, display) is identical to the predicate devices.
- Compliance with Safety Standards: Listing compliance with relevant safety standards for intra-operative and hospital monitoring settings (IEC 60601-2-26, IEC 60601-1-2, UL 2601-1, CAN/CSA-C22.2 no. 601.1-M90).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert qualifications, or comparative effectiveness studies, as these types of data were not presented in this 510(k) summary for the NeuroPort™ NSP System. The device's "performance data" as mentioned in the summary refers to its compliance with safety standards, not to the diagnostic or analytical performance often seen with AI/clinical decision support devices.
Since this device is a neural signal amplifier and not an AI-powered diagnostic tool, the typical AI study parameters (e.g., sample size for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance) are not applicable or reported in this 510(k) summary.
{0}------------------------------------------------
| Submitter Name: | Cyberkinetics, Inc. |
|---|---|
| Submitter Address: | 100 Foxborough Boulevard, Suite 240Foxboro, MA 02035 |
| Contact Person: | Nandini Murthy, V.P. Regulatory Affairs and Quality Systems |
| Phone Number: | (508) 549-9981, Extn 103 |
| Fax Number: | (508) 549-9985 |
| Date Prepared: | Sept 24, 2004 |
| Device Trade Name: | NeuroPort™ NSP System |
| Device Common Name: | Neural Signal Amplifier |
| Predicate Devices: | BMSI 5000 (Nicolet), Ceegraph (Bio-Logic) and EMU 128(XLTek) |
| Device Description: | The Neuroport Neural Signal Processing (NSP) System isintended for recording and monitoring. Its functionality includesroutine brain activity recording, monitoring, retrieval and replay.The Neuroport supports up to 96 channels of recording and iscomprised of the following hardware components: Patient Cable,Amplifier, CPU and a Display monitor. The Neuroport Systemalso includes the following software functions: acquisition,amplification and display. |
| Intended Use: | The NeuroPort™ NSP System is intended for temporary (<30days) recording and monitoring of brain electrical activity. |
| Performance Data: | The NeuroPort™ NSP conforms to the relevant safety standardsfor intra-operative and hospital monitoring settings: IEC 60601-2-26, IEC 60601-1-2, UL 2601-1, CAN/CSA-C22.2 no. 601.1-M90. |
| Conclusion: | The NeuroPort™ Neural Signal Processing (NSP) System hassimilar indications statements as the predicate devices. All areused for monitoring brain electrical activity. The functionality ofthe Neuroport NSP System and predicate devices is identical andincludes routine brain activity recording, amplification,digitization, monitoring, retrieval and display. Therefore theNeuroport NSP is substantially equivalent to the predicatedevices. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its 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
Cyberkinetics. Inc. c/o Ms. Nandini Murthy Vice President, Vice President Regulatory Affairs and Quality Systems 100 Foxborough Boulevard. Suite 240 Foxborough, Massachusetts 02035
APF - y 2012
Re: K042626
Trade/Device Name: Neuroport™ Neural Signal Processor System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWO Dated (Date on orig SE ltr): February 8, 2005 Received (Date on orig SE ltr): February 9, 2005
Dear Ms. Murthy:
This letter corrects our substantially equivalent letter of March 28, 2005.
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.
{2}------------------------------------------------
Page 2 - Ms. Murthy
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.
Kesia Alexander
Image /page/2/Picture/8 description: The image shows a close-up of a handwritten signature or symbol, positioned to the left of some printed text. The signature is characterized by a flowing, cursive style, with a prominent loop or curve that dominates its form. The printed text to the right is partially visible, with the letters and words appearing in a clear, legible font. The overall composition suggests a document or page where a signature is required, with the handwritten element serving as an authentication or endorsement.
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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K042626
Neuroport"™ Neural Signal Processor System Device Name:
Indications For Use:
The intended use of the Cyberkinetics, Inc. Neuropprt Neural Signal Processor System is I he mendou ass of also of all monitoring of brain electrical activity.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styck Clark
(Divisio Division of General, Restorative, and Neurological Devices
Page 1 of _ 1
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).