The Neurorecovery™, Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit is designed to be used for external monitoring of intracranial pressure (ICP), cerebrospinal fluid (CSF) sampling, and CSF drainage from the lateral ventricles of the human brain. The Main Valve Assembly is designed to facilitate the monitoring, sampling, clearing, and drainage function in an aseptic manner.

Device Description

The Neurorecovery", Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit consists of legally marketed ventricular catheter, stylet, trocar, valves, tubing, associated connectors, caps, check-valves, needle-free valve, and stopcocks.

AI/ML Overview

The provided 510(k) summary for the Neurorecovery™ Ventricular Catheter & Main Valve Assembly Kit (K022638) does not contain the detailed study information needed to fully answer all aspects of your request, particularly regarding specific acceptance criteria metrics and a comprehensive study report. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a full performance study report with quantitative acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

Acceptance Criteria and Device Performance

The 510(k) summary states that "Testing submitted in the 510(k) demonstrates that the Neurorecovery™ Ventricular Catheter & Main Valve Assembly Kit complies with specifications for biocompatibility, sterility, and functional performance."

This indicates that acceptance criteria were established for these three general categories. Without the full submission, specific quantitative thresholds for "biocompatibility," "sterility," or "functional performance" are not available in this public summary.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Complies with specifications
Sterility	Complies with specifications
Functional Performance	Complies with specifications

Study Details

Given that this is a 510(k) application for a Class II device, the primary study is a demonstration of substantial equivalence to predicate devices rather than a de novo clinical trial with novel performance metrics. The information provided heavily emphasizes this substantial equivalence.

1. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided summary. Performance testing would likely involve testing of manufactured device units, but the number of units tested is not disclosed.
Data Provenance: Not specified. Testing would be conducted by the manufacturer or a contracted lab. The summary does not indicate retrospective or prospective clinical data from patients for establishing performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of information (experts, ground truth, clinical data) is typically associated with clinical studies or performance studies involving human subjects or real-world data analysis, which are not detailed in this 510(k) summary for this type of device. The stated performance testing relates to material properties and functional operation.

3. Adjudication method for the test set:

Not applicable as the provided information does not detail a clinical or comparative expert review scenario.

4. 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 study mentioned. This device (Ventricular Catheter & Main Valve Assembly Kit) is a physical medical device for fluid management and pressure monitoring, not an AI/software device that assists human readers in diagnostic tasks. Therefore, an MRMC study or AI assistance is not relevant to its stated function.

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

Not applicable. As above, this is a physical medical device, not an algorithm or AI.

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

For biocompatibility: Ground truth would be defined by established ISO standards (e.g., ISO 10993 series) and corresponding test results (e.g., cytotoxicity, sensitization, irritation tests).
For sterility: Ground truth would be defined by regulatory standards for sterilization (e.g., ISO 11135 or 11137 for EO or radiation sterilization) and sterility assurance level (SAL).
For functional performance: Ground truth would be defined by engineering specifications and testing against those specifications (e.g., flow rates, pressure resistance, connection integrity, material strength, valve function).

7. The sample size for the training set:

Not applicable in the context of this device type and the provided 510(k) summary. "Training set" typically refers to data used to train AI models, which is not relevant here.

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

Not applicable for the reasons mentioned above.

Summary

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510(k) Summary (per 21 CFR807.92)

K022638

Neurorecovery™ Ventricular Catheter & Main Valve Assembly Kit

1. APPLICANT

NeurorecoveryTM, Inc. 325 Queen City Avenue Tuscaloosa, AL 35401

Landon C. G. Miller; JD, RPA, MSA, BA Contact Person: Telephone: (205) 345-8606

Date Prepared: August 7, 2002

2. DEVICE NAME

Proprietary Name:	Neurorecovery™ Ventricular Catheter & Main ValveAssembly Kit
Common/Usual Name:	Ventricular Catheter and Accessories
Classification Names:	Ventricular CatheterIntracranial Pressure Monitoring Accessories

3. DEVICE CLASSIFICATION

Ventricular Catheter (21 CFR 882.4100; ProCode: HCA) and Intracranial Pressure Monitoring Accessories (21 CFR 882.1620; ProCode: GWM) have been classified as Class II devices.

4. PREDICATE DEVICES

. Codman EDS II (K902257) Johnson & Johnson Professional, Inc.
. Heyer-Schulte NeuroCare External Drainage Management System (K972994) [now believed to be MiniTorr CSF Drainage Systems marketed by Integra LifeSciences]

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ર. DEVICE DESCRIPTION

INTENDED USE 6.

The Neurorecovery", Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit is designed to be used for external monitoring of intracranial pressure (ICP), cerebrospinal fluid (CSF) sampling, and CSF drainage from the lateral ventricles of the human brain. The Main Valve Assembly is designed to facilitate the monitoring, sampling, clearing, and drainage function in an aseptic manner.

7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Neurorecovery", Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit is equivalent to cited predicate devices based on its indications for use, design, materials, and operational characteristics. Neurorecovery", Inc., believes that differences between devices are minor and raise no new issues of safety or effectiveness.

PERFORMANCE TESTING 8.

Testing submitted in the 510(k) demonstrates that the Neurorecovery™ Ventricular Catheter & Main Valve Assembly Kit complies with specifications for biocompatibility, sterility, and functional performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract design of three wavy lines that resemble a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2002

Neurorecovery, Inc. c/o Medical Device Consultants, Inc. Rosina Robinson Senior Staff Consultant 49 Plain Street North Attleboro, Massachusetts 02760

Re: K022638

Trade/Device Name: Neurorecovery™ Ventricular Catheter and Main Valve Assembly Kit Regulation Number: 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: Class II Product Code: GWM Dated: August 7, 2002 Received: August 8, 2002

Dear Ms. Robinson:

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 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 – Ms. Rosina Robinson

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" (21 CFR 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,

mirano. Provos

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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510(k) Number (if known): K 0226

Neurorecovery *, Inc., Neurorecovery * Ventricular Catheter Device Name: & Main Valve Assembly Kit

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K022638

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(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).