The NeuroSensor™ System is intended for use by a qualified neurosurgeon in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.

Device Description

The NeuroSensor™ system consists of a single-use combined 2mm diameter parenchymal probe for the real-time measurement of cerebral blood flow (CBF) and intracranial pressure (ICP) and a monitor for the display and storage of these measured variables and the computation and display of derived variables. CBF is measured using Laser Doppler flowmetry and provides real-time measurements of local blood flow in the brain. In the NeuroSensor™ system, low power laser light at 780nm is transmitted down a central fiber to the tip of the probe and illuminates the cerebral tissue. The laser light is scattered by the moving red blood cells and is collected by an array of collecting fibers at the tip of the probe. The reflected light is measured and the resulting signal processed to produce a measure of the perfusion or flux of blood in the local tissue sample volume. The flow measurement is converted into absolute units of ml/min/100g using an algorithm determined by a comparison between measurements made using the combined Laser Doppler probe and the reference method of Quantitative Autoradiography. ICP is monitored directly by a solid state sensor mounted on the side of the NeuroSensor™ probe close to its tip. The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe and there is no requirement for the user to calibrate the probe before use. The NeuroSensor™ monitor uses a color LCD display to show the two measured variables CBF and ICP continuously in real time, both in digital form and as a realtime trace. The monitor can accept measured arterial pressure from an external patient monitor, and can use this data and the measured CBF and ICP to derive cerebral perfusion pressure (CPP) and cerebrovascular resistance (CVR). Data is stored by the monitor and can be displayed as a trend graph over a period of 15 minutes, or 1,2,8 or 24 hours. Completing the system is a single-use cranial access port featuring a titanium alloy bolt, and a convenience procedure kit for cranial access.

AI/ML Overview

The provided text is a 510(k) summary for the NeuroSensor™ system, which measures cerebral blood flow (CBF) and intracranial pressure (ICP). This document does not contain a study that proves the device meets specific acceptance criteria with reported device performance metrics. Instead, it states that "In vitro testing shows that the device meets similar performance specifications as those for the predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions about sample sizes, ground truth establishment, or specific study designs (like MRMC) as this information is not present.

However, I can extract information related to the device and its claimed equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document implies that the acceptance criteria are "similar performance specifications as those for the predicate devices." However, the exact quantitative specifications for either the predicate devices or the NeuroSensor™ system are not provided within this text.
Reported Device Performance: The text states, "In vitro testing shows that the device meets similar performance specifications as those for the predicate devices." No specific performance values (e.g., accuracy, precision, bias) are reported for either CBF or ICP measurements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document mentions "In vitro testing," but it does not provide details on the sample size used, whether the data was retrospective or prospective, or the country of origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

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:

The device is a monitoring system (hardware and software for physiological measurements), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device and no such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies that the device's performance was evaluated in "in vitro testing." This would typically be a standalone performance evaluation of the device's measurement capabilities. The text states:
- "CBF is measured using Laser Doppler flowmetry... The flow measurement is converted into absolute units of ml/min/100g using an algorithm determined by a comparison between measurements made using the combined Laser Doppler probe and the reference method of Quantitative Autoradiography."
- "ICP is monitored directly by a solid state sensor... The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe..."
These descriptions suggest a standalone evaluation was performed for the measurement algorithms and sensors, but specific study details are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For Cerebral Blood Flow (CBF) measurement, the ground truth mentioned for algorithm determination is the "reference method of Quantitative Autoradiography."
For Intracranial Pressure (ICP) measurement, the ground truth is established through "precalibrated" sensors in the factory.

8. The sample size for the training set:

This information is not provided. The document mentions an "algorithm determined by a comparison" for CBF, implying some form of training or calibration data was used, but the sample size is not stated.

9. How the ground truth for the training set was established:

For the CBF measurement algorithm, the ground truth was established by "a comparison between measurements made using the combined Laser Doppler probe and the reference method of Quantitative Autoradiography."
For ICP, the sensors are "precalibrated in the factory," indicating that the factory calibration process itself establishes the ground truth for the sensor's accuracy.

Summary

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FEB 2 0 2002

510(k) Summary

November 26th 2001

013930 1/3

Submitter 1

Novus Monitoring Ltd Greenways Abbotts Ann, Andover
Hampshire, SP11 7BH United Kingdom

Contact Person:	Prof. Peter F Gibson
Telephone:	+44 1264 711080
Facsimile:	+44 1264 711083

2 Name of Device

Proprietary Name:	NeuroSensor TM system, comprising:a) NeuroSensorTM monitorb) NeuroSensorTM parenchymal probec) NeuroSensorTM cranial access portd) NeuroSensorTM cranial access procedure kit
Common Name:	a) Cerebral Blood Flow and Intracranial Pressuremonitorb) Parenchymal probe for cerebral blood flow andintracranial pressure measurementc) Intracranial boltd) Convenience procedure kit for cranial access
Device Classification:	Intracranial pressure monitoring devices have been placed inClass II as per 21 CFR Regulation Number 882.1620 andassigned the Product Code GWM.Extravascular blood flow probes and blood flowmeters havebeen placed in Class II as per 21 CFR Regulation Number870.2120 (Product Code DPT) and 21 CFR 870.2100

Predicate Devices 3

The components of the NeuroSensor™ system are substantially equivalent to the following legally marketed devices:

(Product Code DPW), respectively.

K914479	Codman ICP monitoring system and Microsensor™ ICP transducer
K896515	Vasamedics Model BPM2 Laser Doppler Perfusion Monitor

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Vasamedics Trimflo™ parenchymal blood flow monitoring K961368 kit

Codman Intracranial Bolt K974088

This statement is based on the subject device's similarity to the predicate devices in intended use, materials, design and principles of operation.

Device Description 4

CBF is measured using Laser Doppler flowmetry and provides real-time measurements of local blood flow in the brain. In the NeuroSensor™ system, low power laser light at 780nm is transmitted down a central fiber to the tip of the probe and illuminates the cerebral tissue. The laser light is scattered by the moving red blood cells and is collected by an array of collecting fibers at the tip of the probe. The reflected light is measured and the resulting signal processed to produce a measure of the perfusion or flux of blood in the local tissue sample volume. The flow measurement is converted into absolute units of ml/min/100g using an algorithm determined by a comparison between measurements made using the combined Laser Doppler probe and the reference method of Quantitative Autoradiography.

ICP is monitored directly by a solid state sensor mounted on the side of the NeuroSensor™ probe close to its tip. The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe and there is no requirement for the user to calibrate the probe before use.

The NeuroSensor™ monitor uses a color LCD display to show the two measured variables CBF and ICP continuously in real time, both in digital form and as a realtime trace. The monitor can accept measured arterial pressure from an external patient monitor, and can use this data and the measured CBF and ICP to derive cerebral perfusion pressure (CPP) and cerebrovascular resistance (CVR). Data is stored by the monitor and can be displayed as a trend graph over a period of 15 minutes, or 1,2,8 or 24 hours.

Completing the system is a single-use cranial access port featuring a titanium alloy bolt, and a convenience procedure kit for cranial access.

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5 Intended Use

The NeuroSensor™ system has been designed for use by a qualified neurosurgeon in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.

Summary of Substantial Equivalence 6

The NeuroSensor™ system is similar in design, construction, materials, intended use and performance characteristics to the predicate devices. It differs in combining the measurement of CBF and ICP into a single combined probe. In vitro testing shows that the device meets similar performance specifications as those for the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

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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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter F. Gibson Managing Director Novus Monitoring Ltd. Greenways Abbotts Ann, Andover Hampshire, SP11 7BH United Kingdom

FEB 2 0 2002

Re: K013930

Trade/Device Name: NeuroSensor™ System Regulation Number: 870.2120, 882.1620 Regulation Name: Extravascular blood flow probe Intracranial pressure monitoring device

Regulatory Class: II Product Code: DPW, GWM Dated: November 26, 2001 Received: November 28, 2001

Dear Mr. Gibson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo neve reviewed your be devere is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the entrebate) it 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 r ou mayy affects 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 r hat 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 or mr) i 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 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.

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Page 2 - Mr. Peter F. Gibson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. 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

Ver/ 3 - 4/24/96

Novus Monitoring Ltd

510(k) Number (if known): Kol 393 3

Device Name:

Applicant:

NeuroSensor™ System

Indications For Use:

Miriam C. Prorost

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

K013930 510(k) Number _

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTH

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.1620 Intracranial pressure monitoring device.

(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).