The Radionics Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ are indicated for the treatment of hydrocephalus. They are devices designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the peritoneal cavity. The Equi-Flow™ Valve with EZ-Coat™ is indicated for patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the distal catheter of the shunt system.

Device Description

The Equi-Flow Valve™ with EZ-Coat, the EZ-Coat™ Ventricular Catheter, and the EZ-Coat™ Peritoneal Catheter are designed for use as a cerebrospinal fluid shunts. The Equi-Flow Valve with EZ-Coat is a membrane valve with an integral Siphon Limiting Device. The Siphon Limiting Device limits the reduction of the intraventricular pressure and volume caused by the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter (often caused by the patient sitting or standing). This 510(k) covers the use of a hydrophilic surface modification that has been incorporated into the commercially available Equi-Flow Valve and Catheters. This material was subjected to and passes biocompatibility testing like the unmodified commercially available valves and catheters designed to meet the requirements of the ISO Standard 10993. In addition, performance testing was performed on the valves with the EZ-Coat modification to confirm valve performance. There is no change to the designs. dimensions, or specifications of the valves with the use of the EZ-Coat surface modification.

AI/ML Overview

This 510(k) submission (K980903) for the Radionics Equi-Flow™ Valve and Catheters with EZ-Coat™ describes a modification to an existing device (addition of a hydrophilic surface modification). As such, the study primarily focuses on demonstrating that the modified device performs similarly to the predicate device and meets established biocompatibility standards. This is not a typical AI/ML device submission, and therefore many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable.

Here's the information that can be extracted or inferred from the provided text according to your request:

Acceptance Criteria and Device Performance (for a physically modified medical device)

The submission focuses on demonstrating that the addition of the "EZ-Coat™" hydrophilic surface modification does not negatively impact the device's safety or performance compared to the unmodified predicate and that it meets biocompatibility standards.

Acceptance Criteria	Reported Device Performance Statement
Biocompatibility	"This material was subjected to and passes biocompatibility testing like the unmodified commercially available valves and catheters designed to meet the requirements of the ISO Standard 10993."
Valve Performance after Modification	"Performance testing was performed on the valves with the EZ-Coat modification to confirm valve performance." (Note: Specific performance metrics or thresholds are not detailed in this summary, but the statement implies successful confirmation).
Design, Dimensions, and Specifications	"There is no change to the designs, dimensions, or specifications of the valves with the use of the EZ-Coat surface modification." (This implies the modified device maintains the established physical properties of the predicate).
Safe and Effective Use (Overall)	"The labeling for the Radionics Equi-Flow Valve™ with EZ-Coat, the EZ-Coat™ Ventricular Catheter, and the EZ-Coat™ Peritoneal Catheter contains instructions for the proper use of the device. The labeling includes a description of the product, directions for use, and applicable safety information including contraindications, precautions, and warnings. These instructions ensure safe and effective use of the device when followed by the physician."

Study Details (as inferable for a non-AI/ML device modification)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable / Not provided for specific performance testing. The submission confirms biocompatibility testing and performance testing were done, but the sample sizes or provenance of these tests are not detailed in this summary. These are typically laboratory-based engineering and biological tests, not clinical studies with patient data.
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):
- Not Applicable. This is a physical device modification, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. Biocompatibility and performance testing are typically assessed by engineers and toxicologists against established standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is for clinical data interpretation, which is not the focus here.
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. This is a physical medical device, not an AI/ML product that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in the context of device performance. The performance testing mentioned ("Performance testing was performed on the valves with the EZ-Coat modification to confirm valve performance") would be a standalone evaluation of the device's physical properties against its specifications. There is no "algorithm" or "human-in-the-loop" concept here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Established engineering specifications and ISO standards. For biocompatibility, the ground truth is compliance with ISO Standard 10993. For valve performance, the ground truth would be the pre-defined performance specifications of the predicate device.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device. There is no concept of a "training set."
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML algorithm.

Summary

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Summary of Safety and Effectiveness

980903

General Information

Classification:	Class II
Common Name:	Central nervous system fluid shunt component
Device Trade Name:	Radionics Equi-Flow™ Valve with EZ-Coat™
	Radionics EZ-Coat™ Ventricular Catheter
	Radionics EZ-Coat™ Peritoneal Catheter
Intended Uses:	The Equi-Flow™ Valve, Ventricular Catheter, and
	Peritoneal Catheter with EZ-Coat™ are designed to shunt
	cerebrospinal fluid from the ventricles of the brain to an
	appropriate drainage site, such as the peritoneal cavity.
Predicate Device:	Radionics Contour Flex Plus Valve and the Radionics
	Mini and Standard Shunt Valve Systems
Establishment Name and Address:	Radionics, Inc.
	22 Terry Avenue
	Burlington, MA 01803
Contact Name and Phone:	Michael Arnold (781) 272-1233
Establishment registration number:	1219140
Performance Standard:	None established under Section 514

Substantial Equivalence Determination

A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.

Safety Summary

The labeling for the Radionics Equi-Flow Valve™ with EZ-Coat, the EZ-Coat™ Ventricular Catheter, and the EZ-Coat™ Peritoneal Catheter contains instructions for the proper use of the device. The labeling includes a description of the product, directions for use, and applicable safety information including contraindications, precautions, and warnings. These instructions ensure safe and effective use of the device when followed by the physician.

Description of the Device and Basis for Substantial Equivalence

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 1999

Michael A. Arnold, Ph.D. Vice President Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803

K980903 Re:

Trade Name: Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ Regulatory Class: II Product Code: JXG Dated: January 13, 1999 Received: January 19, 1999

Dear Dr. Arnold:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Michael A. Arnold, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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980903

Indications for Use

Prescription Use (Per 21 CFR 801.109)

signature

(Division Sign-Off)
Division of General Restorative Devices, K980903
510(k) Number

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).