The Contour Flex and Contour Flex Plus Valves 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 atrium of the heart or the peritoneal cavity. The Contour Flex Plus Valve 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

AI/ML Overview

The provided text does not contain the detailed information required to fully answer the questions regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

This document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and performance metrics.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred/Stated)
Biocompatibility: Meet requirements of ISO Standard 10993 for alternate material.	"This material was subjected to and passes biocompatability testing like the unmodified commercially available valves, designed to meet the requirements of the ISO Standard 10993."
Performance Testing: Confirm valve performance with alternate material. (Specific metrics not provided)	"In addition, performance testing was performed on the valves with the alternate material to confirm valve performance." (No specific quantitative performance metrics are provided, but the statement implies it met internal performance criteria for successful confirmation.)
Design, dimensions, or specifications: No change from predicate device with alternate material.	"There is no change to the design, dimensions, or specifications of the valves with the use of the alternate material."
Substantial Equivalence: Device is as safe and effective as predicate.	The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This implies that the device met the criteria for substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission. No specific numerical performance endpoints (e.g., sensitivity, specificity, accuracy) are mentioned as this is not a diagnostic device and the focus is on material change.

Missing Information for Questions 2-9:

The document is a 510(k) summary, primarily focused on demonstrating substantial equivalence (SE) for a material change in an existing cerebrospinal fluid shunt valve. It is not a detailed clinical study report for a novel device, nor does it present the kind of performance data (e.g., sensitivity, specificity, or reader studies) that would typically be associated with AI/software devices. Therefore, most of the requested information is not present in this type of regulatory document.

2. Sample size used for the test set and the data provenance: Not mentioned. The testing mentioned (biocompatibility, performance) would likely involve laboratory or bench testing of device components, not a "test set" of patient data in the sense of a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic performance, is not discussed here. The "truth" for biocompatibility and performance testing refers to adherence to engineering standards and prior established device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a shunt valve, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth is the ISO 10993 standard. For performance testing, it would be the established performance specifications of the predicate device.
8. The sample size for the training set: Not applicable. No algorithms or machine learning models are discussed.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission successfully demonstrated that a material change to an existing device (the Radionics Contour Flex Valve and Contour Flex Plus Valve) did not alter its fundamental safety or effectiveness. The "study" proving this involved biocompatibility testing against ISO standards and performance testing to confirm the valve's function, implying that the new material performed equivalently to the original. The specifics of these tests (e.g., number of units tested, precise measurement thresholds) are not included in this summary.

Summary

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K971511

JUL 2 4 1997

Summary of Safety and Effectiveness

General Information
Classification:	Class II
Common Name:	Central nervous system fluid shunt component
Device Trade Name:	Radionics Contour Flex Valve and Contour Flex Plus Valve
Intended Uses:	The Contour Flex Plus Valve is designed to shuntcerebrospinal fluid from the ventricles of the brain to anappropriate drainage site, such as the atrium of the heart orthe peritoneal cavity.
Predicate Device:	Radionics Contour Flex Valve and Contour Flex Plus Valve
Establishment Name and Address:	Radionics, Inc.22 Terry AvenueBurlington, MA 01803
Contact Name and Phone:	Linda Jalbert (617) 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 Contour Flex Valve and Contour Flex Plus 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

The Contour Flex Valve and Contour Flex Plus Valve are designed for use as a cerebrospinal fluid shunts. The Contour Flex Plus Valve is the Contour Flex membrane valve with an integral Siphon Limiting Device. The Siphon 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 an alternate material for the upper housing of these valves. This material was subjected to and passes biocompatability testing like the unmodified commercially available valves, designed to meet the requirements of the ISO Standard 10993. In addition, performance testing was performed on the valves with the alternate material to confirm valve performance. There is no change to the design, dimensions, or specifications of the valves with the use of the alternate material.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 1997

Ms. Linda Jalbert Manager, Regulatory Affairs Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516

Re: K971511 Trade Name: Radionics Contour Flex Valve and Contour Flex Plus Valve Requlatory Class: II Product Code: 84JXG Dated: April 25, 1997 Received: April 28, 1997

Dear Ms. Jalbert:

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 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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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Paqe 2 - Ms. Linda Jalbert

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) 594-4648. 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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:____ Radionics Contour Flex Valve and Contour Flex Plus Valve

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Callifon

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K991511

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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).