The Sophy® Pressure Adjustable Valve System SU8 is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball-in-cone valve seat design, and the valve is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The Sophy® Pressure Adjustable Valve System SU8 technology allows for the non-invasive manual adjustment of the operating pressure via 8 pressure settings, ranging from 50 mm H20 to 170 mm, as follows: 50 = Low, 110 = Medium (intermediate 65,80,95), and 170 = High (intermediate 130, 150). The principle of the Sophy® Adiustable Valve System SU8, identical to that of several existing FDA cleared hydrocephalus valves, is based on the pressure change exerted on a synthetic ruby ball by a semi-circular spring at different points of its curvature. This spring is connected to a magnetic rotor whose position can be adjusted non-invasively by using a programming magnet oriented at different angles with selected orientations corresponding to different pressures. Radio-opaque identification dots indicate three main positions of the rotor corresponding to Low, Medium, and High operating pressures. For pressure setting, a specific programming kit is necessary, including a compass, magnet, and pressure selector.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria & Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Tests Conducted	Reported Device Performance
Mechanical/Physical Performance	Material and Corrosion	Complies with ASTM F647-94; suitable for intended use.
	Diffusion of Samarium and Cobalt into the Valve	Complies with ASTM F647-94; suitable for intended use.
	Sensitivity to Angular Accelerations and Shocks	Complies with ASTM F647-94; suitable for intended use.
	Pressure-Flow Studies	Complies with ASTM F647-94; suitable for intended use.
	Pressure-Adjustment and Rotor Programming	Complies with ASTM F647-94; suitable for intended use.
	Magnetic and MRI Tests	Complies with ASTM F647-94; suitable for intended use.
Biocompatibility	Biocompatibility tests per Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993	Device materials are biocompatible.
Clinical Performance (Safety & Effectiveness)	Perform "as well as" and be "safe and effective as currently marketed hydrocephalus shunts."	Retrospective clinical study results indicated that the Sophy® Pressure-Adjustable Valve System SU8 performs as well as, and is safe and effective as currently marketed hydrocephalus shunts. Specifically, it demonstrated near identical performance to the Hakim Programmable Valve (K974739).

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

Sample Size for Clinical Study (Test Set): 43 consecutive patients (25 pediatric, 18 adults)
Data Provenance: The study was a retrospective clinical study. The document does not specify the country of origin of the data.

3. Number of Experts Used to Establish Ground Truth for Test Set & Qualifications:
This information is not provided in the given text. The text only states that a "retrospective clinical study" was conducted and "results indicated that the Sophy® Pressure-Adjustable Valve System SU8 performs as well as, and is safe and effective as currently marketed hydrocephalus shunts." There's no mention of specific experts establishing ground truth for individual cases within this study.

4. Adjudication Method for the Test Set:
The adjudication method is not specified in the provided text.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not explicitly described as being performed in the provided text. The clinical study was a direct patient outcome study, not a study comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This is not applicable as the device described is a physical medical device (hydrocephalus shunt), not an AI-driven algorithm. The testing described focuses on the device's physical and clinical performance.

7. Type of Ground Truth Used:
The ground truth for the clinical study was based on patient outcomes/clinical performance data over a follow-up period (1 year follow-up in 93% of patients, 2 year follow-up in 59%). The comparison was made against the performance of "currently marketed hydrocephalus shunts."

8. Sample Size for the Training Set:
This is not applicable as the device is a physical medical device, not a machine learning algorithm that requires a training set. The performance testing was based on engineering and clinical evaluations.

9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as above (physical medical device, no training set).

Summary

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SEP.21 2000

SMDA Summary of Safety and Effectiveness 10.

K992465

510(k) Summary Sophy® Pressure Adjustable Valve System

A. Submittor Information

Sponsor:

Manufacturer:

SOPHYSA SA c/o Interactive Consulting Inc. 70 Walnut Street Wellesley, MA 02481 Tel: (781) 239-8108 Fax:(781) 863-6497

SOPHYSA SA 22 rue Jean Rostand Parc Club Orsay Université 91893 ORSAY Cedex, France Tel: 011-331-69-41-3500

Contact Person: Jean-Christophe Audras, Requlatory Affairs Date Prepared: July 21, 1999

B. Device Identification

Common/Usual Name Proprietary Name: Regulatory Class:

Hydrocephalus Shunt Sophy® Pressure Adjustable Valve System Class II by 21 CFR 882.5550

C. Identification of Predicate Device(s)

The Sophy® SU8 is substantially equivalent to the following previously cleared and currently marketing devices Johnson Hakim Programmable Valve (K974739) and Cordis Standard/Pediatric Valve (K861377).

D. Device Description

The principle of the Sophy® Pressure Adiustable Valve System SU8, identical to that of several existing FDA cleared hydrocephalus valves, is based on the pressure change exerted on a synthetic ruby ball by a semi-circular spring at different points of its curvature. This spring is connected to a magnetic rotor whose position can be adjusted non-invasively by using a programming magnet oriented at different angles with selected orientations corresponding to different pressures. Radio-opaque identification dots indicate three main positions of the rotor corresponding to Low, Medium, and High operating pressures. For pressure setting, a specific programming kit is necessary, including a compass, magnet, and pressure selector.

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E. Device Testing Summary

Performance Testing .

Performance testing was conducted per and complies with the applicable sections of ASTM F647-94 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Applications. Performance testing included the following areas: Material and Corrosion, Diffusion of Samarium and Cobalt into the Valve, Sensitivity to Angular Accelerations and Shocks, Pressure-Flow Studies, Pressure-Adjustment and Rotor Programming, Magnetic and MRI Tests, Testing results demonstrated that the device was suitable for its intended used.

Biocompatibility Testing .

Biocompatibility tests were performed per the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993 Biological Evaluation of Medical Devices. Testing results demonstrated that the device materials are biocompatible.

Clinical Evaluation .
A retrospective clinical study of 43 consecutive patients (25 pediatric, 18 adults) was conducted to support a claim of substantial equivalence. One year follow-up data was obtained in 93% of the patients, and 2 year follow-up was achieved in 59% of the patients. Results indicated that the Sophy ® Pressure-Adjustable Valve System SU8 performs as well as, and is safe and effective as currently marketed hydrocephalus shunts.

F. Substantial Equivalence

The Sophy ® Pressure-Adiustable Valve System SU8 is substantially equivalent to the Cordis Standard/Pediatric Shunt (K861377) and to the Hakim Programmable Valve (K974739) in terms of intended use, materials, design, function, and operating characteristics. All three devices utilize the same ball-in-cone mechanism to maintain intraventricular pressure. The valve design maintains intraventricular pressure at a constant selected level. Depending on the CSF flow rate and/or viscosity, the ball moves up or down within the control of the callbrated stainless steel spring to maintain the selected pressure. While the pressure regulating mechanism is identical in all 3 devices, the variable pressure adjustment capability is only available with the Hakim Programmable Valve and the Sophy® Pressure-Adiustable Valve System SU8. In the case of the Cordis Standard/Pediatric Valve, pressure selection is available in five fixed pressure ranges. The non-invasive transcutaneous pressure adjustment capability together with the ability to monitor the pressure setting in-situ is available in the Hakim Programmable Valve (K974739) and the Sophy® Pressure-Adjustable Valve System SU8, with near identical performance. The Sophy® Pressure-Adiustable Valve System SU8 is thus determined to be Substantially Equivalent to the Cordis Standard/Pediatric Shunt (K861377) and the Hakim Programmable Shunt (K974739).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble an eagle or bird in flight.

Public Health Service

SEP 21 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sophysa SA c/o Jean-Luc Boulnois, Ph.D. President Interactive Consulting, Inc. 70 Walnut Street Wellesley, Massachusetts 02481

K992465 Re:

Trade Name: Sophy® Pressure Adjustable Valve System Regulatory Class: II Product Code: JXG Dated: July 14, 2000 Received: July 17, 2000

Dear Dr. Boulnois:

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 - Jean-Luc Boulnois, 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,

R. lochner.

A 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 992 4 65

Device Name: SOPHY® Pressure-Adjustable Valve System

Indications For Use:

To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dvina R. Lochner.

(Division Sign-Off) Division of General Restorative Devices 510(k) Number_K 99 2465

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).