The Radionics Burr Hole Valve is indicated for the treatment of hydrocephalus. It is a device The Racebook and fluid from the ventricles of the brain to an appropriate drainage ate, such as the atrium of the heart or the peritoneal cavity. The Burr Hole Valve is designed to fit into a formal burr hole.

Device Description

The Burr Hole Valve is designed for use as a cerebrospinal fluid shum. It is the commercially available Radionics Contour Flex membrane valve with an alternate shaped reservoir/ pumping chamber; the Burr Hole Valve is shaped to fit into a burr hole. The Radionics Burr Hole Valve has the same intended use and design characteristics as the PS Medical Burr Hole Valve and the Radionics Contour Flex Valve. The Radionics Burr Hole Valve has the same reservoir shape and similar dimensions to the PS Medical Burr Hole Valve. Both of these valves are designed in two sizes to fit a 12 mm and 16 mm burr hole. The fluid flow path is the same for the Radionics Burr Hole Valve and the Contour Flex Valve. In addition, the flow control element is the same for the Burr Hole and Contour Flex Valves. The same polypropylene base/ silicone membrane valve component is used in both systems resulting in the same pressure flow specifications for each type of valve.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Radionics Burr Hole Valve, which is a cerebrospinal fluid shunt. This submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting data from a study designed to meet specific acceptance criteria for performance.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this type of document. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing it shares similar design, materials, and intended use as the predicate, rather than through extensive clinical trials for de novo performance evaluation.

Here's an analysis based on the information provided:

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

Acceptance Criterion	Reported Device Performance	Study that Proves the Device Meets the Criterion
Design/Functionality Equivalence to Predicate	The Burr Hole Valve has the same intended use and design characteristics as the PS Medical Burr Hole Valve and the Radionics Contour Flex Valve. It has the same reservoir shape and similar dimensions to the PS Medical Burr Hole Valve. The fluid flow path and flow control element are the same as the Contour Flex Valve. The same polypropylene base/silicone membrane valve component is used, resulting in the same pressure flow specifications.	Substantial Equivalence Determination (as described in the document)
Fit into Burr Hole	Designed to fit into a formal burr hole. Designed in two sizes to fit a 12mm and 16mm burr hole.	Not explicitly detailed as a separate test, but implied by design specifications and comparison to predicate device.
Pressure Flow Specifications	Same pressure flow specifications as the Contour Flex Valve.	Not explicitly detailed as a separate test, but implied by using the same valve component as the predicate.
Safe and Effective Use (when instructions followed)	Labeling includes description, directions for use, and safety information (contraindications, precautions, warnings).	Not explicitly detailed as a separate test for this specific device, but generally assumed for medical devices with proper labeling.

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

Not applicable. This submission is a 510(k) for substantial equivalence, not a clinical study with a test set of patient data to evaluate performance. The comparison is primarily based on device design, materials, and intended use to predicate devices.

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)

Not applicable. No test set requiring ground truth establishment by experts is described in this 510(k). The evaluation is based on a comparison to predicate devices and their established safety and effectiveness.

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

Not applicable. No test set requiring adjudication is described.

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

No. This is a mechanical device (cerebrospinal fluid shunt) and does not involve AI or human readers for diagnostic interpretation.

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

No. This is a mechanical device, not an algorithm, so this concept is not applicable.

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

Indirect Ground Truth: The "ground truth" in a 510(k) context for this type of device is implicitly the established safety and effectiveness of the predicate devices (Radionics Contour Flex Valve and PS Medical Burr Hole Valve). The argument is that because the new device is substantially equivalent in design, materials, and intended use to these already-approved devices, it can be considered safe and effective.

8. The sample size for the training set

Not applicable. As this is a mechanical device and not an AI/machine learning algorithm, there is no training set in the conventional sense.

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

Not applicable. (See point 8).

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" or evidence proving the device meets its "acceptance criteria" in this 510(k) submission is a comparison to predicate devices.

Device Under Review: Radionics Burr Hole Valve
Predicate Devices: Radionics Contour Flex Valve and PS Medical Burr Hole Valve.
Methodology: The manufacturer demonstrated substantial equivalence by detailing that the Radionics Burr Hole Valve has:
- The same intended use (shunting cerebrospinal fluid from ventricles to a drainage site for hydrocephalus).
- Similar design characteristics and dimensions (reservoir shape, fit for 12mm/16mm burr holes).
- The same fluid flow path and flow control element as the Contour Flex Valve.
- The same polypropylene base/silicone membrane valve component as the Contour Flex Valve, leading to the same pressure flow specifications.
- Instructions for proper use and safety information.
Conclusion: Based on these comparisons, the FDA determined the device to be substantially equivalent to the predicate devices, thereby establishing its safety and effectiveness without requiring new clinical trials or performance studies specific to the new device itself.

Summary

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K970578

Summary of Safety and Effectiveness Page 4 JUN - 4 1997 General Information Class II Classification: Central nervous system fluid shunt component Common Name: Radionics Burr Hole Valve Device Trade Name: The Burr Hole Valve is designed to shunt cerebrospinal fluid Intended Uses: from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. It is designed to fit into a formal burr hole. Radionics Contour Flex Valve and PS Medical Burr Hole Predicate Device: Valve Radionics, Inc. Establishment Name and Address: 22 Terry Avenue Burlington, MA 01803 Linda Jalbert, (617) 272-1233 Contact Name and Phone: Establishment registration number: 1219140 None established under Section 514 Performance Standard:

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 Burr Hole contains instructions for the proper use of this device. The labeling includes a description of the product, directions for use, and applicable safety information including contraindications, precautions, and warnings. These instructions promote 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of three overlapping human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 1997

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

Re: K970578 Trade Name: Radionics Burr Hole Valve Regulatory Class: II Product Code: 84JXG Dated: May 12, 1997 Received: May 13, 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, labelinq, 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 Druq 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 miqht 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. Callahan

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

Enclosure

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Indications For Use:

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Cleeves
(Division Sign Off)

Division Sion-C Division of Cardiovascular and Neurological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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Over The Counter Use

(Optional Format 1-2-96)

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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).