(29 days)
The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (< 30 days) recording and monitoring of brain electrical activity.
The NeuroPort System, when connected to the NeuroPort Array Electrode, supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort Array is not modified by this 510(k) submission. The NeuroPort Electrode Array has 100 electrode contacts on a substrate of 4mm. The NeuroPort Electrode array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Electrode Array passes neural activity of the brain cortex to the NeuroPort System through a Patient Cable assembly. The modification described within this 510(k) submission is summarized as: a) the addition of an impedance test switch to the Patient Cable, b) a hardware change to support automated impedance testing of the NeuroPort Electrode Array, and c) a software change to support automated impedance testing of the NeuroPort Electrode Array.
This document describes the 510(k) submission for a modified NeuroPort System, focusing on the addition of an automated impedance test function. It is a modification to an existing device, and the submission primarily addresses the verification and validation of these specific changes.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it indicates that "Testing is completed. No safety or effectiveness concerns remain." for the automated impedance test modification.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functions as intended | "Software verification and validation" completed, no safety or effectiveness concerns. |
| Hardware meets design input requirements | "Hardware verification of design output meeting design input requirements" completed, no safety or effectiveness concerns. |
| The modification does not negatively impact the safety or effectiveness of the NeuroPort System | "No new questions of safety or effectiveness are raised." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a sample size for a test set. The testing performed was related to "Software verification and validation" and "Hardware verification of design output meeting design input requirements" for the impedance test modification. These typically involve internal testing and validation rather than a clinical "test set" in the traditional sense for AI/machine learning. The data provenance is internal to Cyberkinetics, Inc., and is retrospective in the sense that it evaluates the modifications to an existing device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. Given the nature of the modifications (software and hardware changes for an impedance test), the "ground truth" would likely be established through engineering specifications, functional requirements, and direct measurement/testing by qualified engineers and validation specialists within the company.
4. Adjudication Method for the Test Set
This information is not provided because the type of study described does not involve a "test set" requiring expert adjudication in the context of diagnostic or interpretive accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was mentioned. The device modification is for an automated impedance test, not an AI-assisted diagnostic or interpretive tool intended for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is the NeuroPort System with an automated impedance test. The "algorithm only" performance would be its ability to accurately and reliably perform the impedance test as designed. The document states "Testing included: 1. Software verification and validation, 2. Hardware verification of design output meeting design input requirements." This implies standalone testing of the automated function.
7. The Type of Ground Truth Used
For the software and hardware verification, the ground truth would be based on:
- Design Input Requirements: The original specifications and intended functionality of the impedance test.
- Engineering Specifications: Technical documentation detailing how the impedance test should operate.
- Direct Measurement/Comparison: For hardware, this would involve comparing outputs to known standards or expected values. For software, it would involve executing test cases and verifying expected behavior.
8. The Sample Size for the Training Set
No information is provided about a "training set." The device modification involves an automated impedance test, which does not typically rely on machine learning or AI models that require a training set in the conventional sense. The software and hardware are designed and verified against specifications, not trained on data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, this information is not applicable.
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Foxborough, MA 02035 508.549.9981 F. 508.549.9985 w cyberkineticsinc com _______________________________________________________________________________________________________________________________________________________
510(k) Summary
| Company Name: | Cyberkinetics Neurotechnology Systems, Inc. |
|---|---|
| Device Name: | NeuroPort System |
| 510(k) Sponsor: | Cyberkinetics, Inc.A/k/a Cyberkinetics Neurotechnology Systems, Inc.F/k/a Trafalgar Ventures, Inc.100 Foxborough Blvd., Suite 240Foxborough, MA 02035 |
| 510(k) Contact: | Jon JosephVice President R+D and Applications DevelopmentCyberkinetics Neurotechnology Systems, Inc.391 Chipeta Way, Suite GSalt Lake City, UT 84108Phone: (801) 582-5533Fax: (801) 582-1509 |
| Summary Date: | March 23, 2006 |
| Trade Name: | NeuroPort System |
| Common Name: | Electroencephalograph |
| Classification Name: | Electroencephalograph, CFR 882.1400, Product Code: GWQ, Class II |
| Predicate Device: | NeuroPort System, 510(k) K042626 |
Description of Device 1.0
The NeuroPort System, when connected to the NeuroPort Array Electrode, supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort Array is not modified by this 510(k) submission.
The NeuroPort Electrode Array has 100 electrode contacts on a substrate of 4mm. The NeuroPort Electrode array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Electrode Array passes neural activity of the brain cortex to the NeuroPort System through a Patient Cable assembly.
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The modification described within this 510(k) submission is summarized as:
- a) the addition of an impedance test switch to the Patient Cable,
- b) a hardware change to support automated impedance testing of the NeuroPort Electrode Array, and
- c) a software change to support automated impedance testing of the NeuroPort Electrode Array.
1.2 Clinical Application
The NeuroPort System is used in clinical, operating room and epilepsy monitoring unit environments. This 510(k) does not affect the environment of use of the NeuroPort System.
By the automated impedance test option, the user is provided the feature of an impedance test of the NeuroPort Electrode Array.
2.0 Intended use of Device
The intended use of the modified NeuroPort System is the same as the unmodified NeuroPort System:
The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (< 30 days) recording and monitoring of brain electrical activity.
3.0 Technological Characteristics
The technical characteristics of the modified NeuroPort System are the same as those of the unmodified NeuroPort System.
4.0 Data Summary
Testing of the automated impedance test of the NeuroPort Electrode Array modification was performed in compliance with the Cyberkinetics, Inc. design control process. Testing included:
-
- Software verification and validation,
-
- Hardware verification of design output meeting design input requirements.
Testing is completed. No safety or effectiveness concerns remain.
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5.0 Conclusions
The safety and effectiveness of the modified NeuroPort System was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the modified NeuroPort System is the same as the unmodified NeuroPort System. No new questions of safety or effectiveness are raised.
File: NeuroPort Impedance Test 510k Reply 3-23-2006
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Public Health Service
MAR 2 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cyberkinetics Inc. c/o Quality & Regulatory Associates, I.LC Mr. Gary Syring 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K060523
Trade/Device Name: Modified NeuroPort System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: February 17, 2006 Received: February 27, 2006
Dear Mr. Syring:
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 – Mr. Gary Syring
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. production of the manation begin marketing your device as described in your Section 510(k) I mo letter will and hy a 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 n you a the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Hubert Lenoir
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
510(k) Number (if known): KU60523
Device Name: Modificd NeuroPort System
Indications for Use:
The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (< 30 days) recording and monitoring of brain electrical activity.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kb60523
Helen Lewis
(Division Sig Division of General, Restorative, and Neurological Devices
510(k) Number_
Page 1 of 1
§ 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).