The SiphonGuard™ CSF Control Device is a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.

The SiphonGuard™ CSF Control Device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

Device Description

The SiphonGuard™ CSF Control Device is a siphon control device that is designed with two internal passages. The primary passage is a ruby ball-in-seat valve design that opens and closes depending on the CSF flow rate. The secondary passage is a longer spiral passage that remains permanently open but effectively slows the progress of the CSF through the device. The device has two basic modes of operation:

Normal CSF Flow Conditions: Maiority of the CSF flows through the ruby ball-in-seat valve and exits directly out of the distal port of the SiphonGuard™ CSF Control Device. The remaining CSF travels through a spiral passage that surrounds the primary passage, and reioins the fluid that passes through the primary passage, distal to the ball-in-seat valve.
Excessive CSF Flow Conditions: Ball-in-seat valve closes and the entire volume of CSF is forced through the longer spiral passage, effectively slowing the rate at which CSF is shunted from the brain. Once the CSF flow rate is reduced. the ruby ball separates from the valve seat, reopening the primary passage, and returning the SiphonGuard™ CSF Control Device to normal CSF flow conditions.

As long as CSF continues to be shunted from the ventricles, flow through the secondary passage never stops, regardless of patient position. The rigid device shell prevents inadvertent closure of the device by externally applied pressure.

AI/ML Overview

The provided document describes the SiphonGuard™ CSF Control Device, a component of hydrocephalus shunt systems. The information primarily focuses on establishing substantial equivalence to existing devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way a diagnostic AI device would.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Reduction of CSF flow rate (implicit, as main function)	"Pressure-flow test results showed that the SiphonGuard™ CSF Control Device is substantially equivalent to the Delta® Valve antisiphon component and the Transguard™ antisiphon device in reducing CSF flow rate."
Material compatibility (implicit for safety and function)	"use of the identical materials used in the CODMAN HAKIM™ Micro Precision Valve (K973774)."
Intended Use (similarity to predicate)	"similarity in intended use... to the Delta® Valve (K902783), and Transquard™ device (preamendment)"
Design (similarity to predicate)	"similarity in... design... to the Delta® Valve (K902783), and Transquard™ device (preamendment)"

Note: The document explicitly states "Performance: Pressure-flow test results showed that the SiphonGuard™ CSF Control Device is substantially equivalent to the Delta® Valve antisiphon component and the Transguard™ antisiphon device in reducing CSF flow rate." This implies that the acceptance criteria for performance were met by demonstrating equivalence to established predicate devices in pressure-flow characteristics that are relevant to reducing CSF flow rate. Specific quantitative thresholds for pressure or flow rate are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a test set or data provenance in the context of a clinical study for performance evaluation. The "pressure-flow test results" mentioned are likely bench testing (laboratory-based) to compare the device's physical properties to predicate devices. Information regarding human patient data, its origin, or whether it was retrospective or prospective is not available in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided. The device is a medical device (antisiphon component) and its performance evaluation for FDA clearance (510(k)) focuses on engineering design, materials, and substantial equivalence to existing devices, not on diagnostic accuracy requiring expert ground truth in the context of imaging or clinical decision-making. The "ground truth" here would be established by the physical laws of fluid dynamics and established engineering standards for such devices.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted and is not applicable to this type of device and its 510(k) submission. This is a physical device, not an AI or diagnostic algorithm that human readers would interact with.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study in the context of an "algorithm only (without human-in-the-loop performance)" was not conducted and is not applicable. This is a physical medical device, not a software algorithm. The "performance" described relates to its physical function in controlling CSF flow.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on engineering and physical performance metrics (e.g., pressure-flow characteristics) as measured in a lab setting, comparing it to well-established predicate devices. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be. The overarching ground truth is that the device "reduces the potential hazards of excessive lowering of intraventricular pressure" as demonstrated by its substantial equivalence to other devices proven to do so.

8. Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" in the context of machine learning or AI as this is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons as point 8.

Summary

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Exhibit I

510(k) Summary SiphonGuard™ CSF Control Device

K99217

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

1. Contact Person:
  Laura O'Grady Requlatory Affairs Specialist (508) 828-3164

2. Device Information:

SiphonGuard™ CSF Control Device Proprietary Name: Common Name: Antisiphon Device Classification Name: Central Nervous system Fluid Shunt and Components Regulatory Class: Class II by 21 CFR §882.5550 Product Code: JXG

3. Indications for Use:

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4. Device Description:

Normal CSF Flow Conditions: Maiority of the CSF flows through the ruby ball-in-seat valve and exits directly out of the distal port of the SiphonGuard™ CSF Control Device. The remaining CSF travels through a spiral passage that surrounds the primary passage, and reioins the fluid that passes through the primary passage, distal to the ball-in-seat valve.
Excessive CSF Flow Conditions: Ball-in-seat valve closes and the entire volume of CSF is forced through the longer spiral passage, effectively slowing the rate at which CSF is shunted from the brain. Once the CSF flow rate is reduced. the ruby ball separates from the valve seat, reopening the primary passage, and returning the SiphonGuard™ CSF Control Device to normal CSF flow conditions.

5. Performance:

Pressure-flow test results showed that the SiphonGuard™ CSF Control Device is substantially equivalent to the Delta® Valve antisiphon component and the Transguard™ antisiphon device in reducing CSF flow rate.

6. Substantial Equivalence:

The substantial equivalence of the SiphonGuard™ CSF Control Device to predicate products, is substantiated by its similarity in intended use, design, and performance to the Delta® Valve (K902783), and Transquard™ device (preamendment), as well as by the use of the identical materials used in the CODMAN HAKIM™ Micro Precision Valve (K973774).

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

APR 7 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura O'Grady, RAC Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K992173

Trade Name: SiphonGuard™ CSF Control Device Regulatory Class: II Product Code: JXG Dated: January 7, 2000 Received: January 10, 2000

Dear Ms. O'Grady:

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 - Ms. Laura O'Grady, RAC

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.

Donna R. Lochner.

( A 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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510(k) Number (if known) Device Name

992173 SiphonGuard™ CSF Control Device

Indications For Use

The SiphonGuard™ device can be used as a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.

The SiphonGuard™ device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Duane R. Vorhies.

(Division Sign-Off) Division of General Restorative Devices 510(k) Number_k 992173

Prescription Use ✓ (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).