The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort Microelectrode Array System is for temporary (< 30 days) recording and monitoring of brain electrical activity.

Device Description

The NeuroPort Array connects to the NeuroPort System (510(k) K042626 and K060523). This combination of devices supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort System is not modified by this 510(k) submission. The NeuroPort Array has 100 electrode contacts on a silicon substrate of 4 mm by 4 mm. The NeuroPort Array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Array passes neural activity of the brain cortex to the NeuroPort System through the Patient Cable. The NeuroPort Array consists of high impedance electrodes. The NeuroPort Array impedance is in the range of 0.1 to 1.0 Meg ohms per electrode. The modification described within this 510(k) submission is summarized as providing a 1.5 mm length NeuroPort Array option in addition to the cleared to market 1,0 mm NeuroPort Array option. Along with the longer NeuroPort Array, the Inserter Wand applied to place the NeuroPort Array is modified to support a variation with the 0.5 mm additional insertion depth.

AI/ML Overview

Here's an analysis of the provided text regarding the NeuroPort Microelectrode Array System, presented in the requested format.

It's important to note that this 510(k) submission is for a modification to an already cleared device (the 1.5mm NeuroPort Array option compared to the 1.0mm NeuroPort Array). As such, the "study" described is primarily focused on confirming that the modification does not alter the fundamental characteristics or safety/effectiveness of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Confirmation of NeuroPort Array impedance characteristics.	Testing completed. No safety or effectiveness concerns remain. (Implicitly, impedance characteristics were confirmed to be acceptable, though specific values are not provided in this summary.)
Confirmation of Inserter Wand dimensional changes.	Testing completed. No safety or effectiveness concerns remain. (Implicitly, dimensional changes were confirmed to be acceptable for proper function.)
Overall Goal: Maintain safety and effectiveness of the modified device (1.5mm NeuroPort Array) compared to the predicate (1.0mm NeuroPort Array).	"The safety and effectiveness of the modified NeuroPort Array was demonstrated by testing in compliance with the Design Control process."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is engineering verification and validation of the physical and functional characteristics of the device modification. Therefore, the sample size would pertain to the number of devices or components tested, which is not detailed in this summary.

Test Set Sample Size: Not explicitly stated as this was not a clinical study on patient data.
Data Provenance: The document implies in-house testing by Cyberkinetics Neurotechnology Systems, Inc. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This submission does not involve a clinical study requiring ground truth established by medical experts. The "ground truth" for the engineering tests would be the design specifications and performance requirements for the device components (e.g., impedance range, dimensional tolerances). The experts would be the engineers and quality personnel involved in the design and testing processes, though their specific number and qualifications are not listed.

4. Adjudication Method for the Test Set

Not applicable. As this was primarily engineering verification/validation, an adjudication method for a "test set" of clinical cases is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the substantial equivalence of a device modification through engineering testing, not on clinical effectiveness in interpreting results by human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

Not applicable. This device is a microelectrode array, not an AI algorithm. Its performance is evaluated through physical and electrical characteristics, rather than as a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on engineering specifications and performance standards. For example, the acceptable impedance range for electrodes, and the dimensional tolerances for the Inserter Wand.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" in manufacturing would refer to process parameters and quality control, not a data training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set (in the context of AI/machine learning) was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Cyberkinetics Neurotechnology Systems, Inc. The logo features a silhouette of a head with a series of dots arching over it. The text "Cyberkinetics" is written in a stylized font, with "Neurotechnology Systems, Inc." written in a smaller font underneath.

K070272

AUG - 3 2007

100 Foxborough Blvd. Suite 240 Foxborough, MA 02035 508.549.9981 F. 508.549.9985 www.cyberkineticsinc.com

510(k) Summary

Company Name:	Cyberkinetics Neurotechnology Systems, Inc.
Device Name:	NeuroPortTM Microelectrode Array System (NeuroPort Array)
510(k) Sponsor:	Cyberkinetics Neurotechnology Systems, Inc.A/k/a Cyberkinetics, Inc.F/k/a Trafalgar Ventures, Inc.100 Foxborough Blvd., Suite 240Foxborough, MA 02035
510(k) Contact:	Timothy Surgenor, President and Chief Executive OfficerCyberkinetics Neurotechnology Systems, Inc.391 Chipeta Way, Suite GSalt Lake City, UT 84108Phone: (801) 582-5533Fax: (801) 582-1509
Summary Date:	January 22, 2007
Trade Name:	NeuroPort Array
Common Name:	Depth Electrode
Classification Name:	Depth Electrode, CFR 882.1330, Product Code: GZL, Class II
Predicate Device:	NeuroPortTM Microelectrode Array System (NeuroPort Array)K042384

1.0 Description of Device

The NeuroPort Array has 100 electrode contacts on a silicon substrate of 4 mm by 4 mm. The NeuroPort Array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Array passes neural activity of the brain cortex to the NeuroPort System through the Patient Cable.

File: 1-5 mm Array 510k 1-23-2007

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The NeuroPort Array consists of high impedance electrodes. The NeuroPort Array impedance is in the range of 0.1 to 1.0 Meg ohms per electrode.

The modification described within this 510(k) submission is summarized as providing a 1.5 mm length NeuroPort Array option in addition to the cleared to market 1,0 mm NeuroPort Array option. The 1,5 mm length variation has the following features and properties in common with the 1.0 mm NeuroPort Array:

1. Same materials.
1. Same manufacturing processes.
1. Same insertion technique,
Same package and terminal sterilization process. 4.

Along with the longer NeuroPort Array, the Inserter Wand applied to place the NeuroPort Array is modified to support a variation with the 0.5 mm additional insertion depth.

1.2 Clinical Application

The NeuroPort Array, with 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 Array and NeuroPort System.

The NeuroPort Array is placed in brain tissue to support recording of cell potentials. Placement of the NeuroPort Array is accomplished by an Inserter Wand. The Inserter Wand is a pneumatic device that supports placement of the NeuroPort Array to the desired depth. The Inserter Wand is modified to two variations, a 1.0 mm and a 1.5 mm variation. The 1.0 mm Inserter Wand is cleared to market with the 1.0 mm NeuroPort Array, 510(k) K042384.

The 1.0 mm Inserter Wand variation is modified to allow the inserter to travel an additional 0.5 mm to support insertion of the 1.5 mm NeuroPort Array. Section 7.0 explains the Inserter Wand changes and evaluation of conformance.

With the 1.5 mm electrode length option, the user is given the opportunity to acquire signals from a deeper level of the brain than the 1.0 mm NeuroPort Array. The selection of NeuroPort Array variation is at the discretion of the user.

File: 1-5 mm Array 510k 1-23-2007

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2.0 Intended use of Device

The intended use of the modified NeuroPort Array is the same as the unmodified NeuroPort Array:

The intended use of the Cyberkinetics Neurotechnology Systems. Inc. NeuroPort Microelectrode Array System is for temporary (< 30 days) recording and monitoring of brain electrical activity.

3.0 Technological Characteristics

The technical characteristics of the modified NeuroPort Array are the same as those of the unmodified NeuroPort Array.

4.0 Data Summary

Testing of the NeuroPort Array modification was performed in compliance with the Cyberkinetics Neurotechnology Systems, Inc. design control process. Testing included:

1. Confirmation of NeuroPort Array impedance characteristics,
1. Confirmation of Inserter Wand dimensional changes.

Testing is completed. No safety or effectiveness concerns remain.

5.0 Conclusions

The safety and effectiveness of the modified NeuroPort Array was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the modified NeuroPort Array is the same as the unmodified NeuroPort Array. No new questions of safety or effectiveness are raised.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2007

Cyberkinetics Neurotechnology Systems, Inc. % Gary Syring Principal Consultant Quality & Regulatory Associates 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K070272

Trade/Device Name: NeuroPort™ Electrode Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: Class II Product Code: GZL Dated: March 22, 2007 Received: March 23, 2007

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

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Page 2 - Mr. Gary Syring

or any Federal statutes and regulations administered by other Federal agencies. You must or any I odetar statuated and states including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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 promated 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 premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson, M.S.

Mark N Melkerson. M S 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):

Device Name: Modified NeuroPort™ Microelectrode Array System (NeuroPort Array) Indications for Use:

The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort Microelectrode Array 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)

Page 1 of 1

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number_ L070272

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).