The Polaris® Pressure Adjustable Valve models SPV-140, SPV-300, SPV-400 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 ballin-cone valve seat design, and the value is pressure-adjustable transcutaneously. Drroinage is directed to the abdominal cavity or to the right atrium of the heart.

The basic settings of the Polaris® SPV-140 Valve are 10, 40, 80, 110 and 140 mm H₂O; adjustments to intermediate pressures are made manually in 30 mm H20 increments (decrements).

The basic settings of the Polaris® SPV-300 Valve are 50, 100, 150, 220 and 300 mm H2O; adjustments to intermediate pressures are made manually in 50-70 mm H20 increments (decrements).

The basic settings of the Polaris® SPV-400 Valve are 80, 150, 230, 330 and 400 mm H2O; adjustments to intermediate pressures are made manually in 70-100 mm H20 increments (decrements).

The specific feature of the self-locking rotor-shuttle micro-magnet system of the passive Polaris® SPV Valve is that the adjustment position of each pressure setting cannot be changed by a unidirectional magnetic field. A domestic magnetic field or an exposure to MRI attracts the shuttles in the same direction and thus cannot unlock them simultaneously, therefore the rotor cannot be mobilized and the pressure setting remains fixed and constant.

AI/ML Overview

This application (K042481) for the Polaris® SPV-140, SPV-300, SPV-400 Pressure Adjustable Valve is a 510(k) Special Summary and does not contain the detailed study information needed to answer all aspects of your request. This type of submission relies on substantial equivalence to a previously cleared device (predicate device K031097), often meaning that extensive new studies are not required if the new device has only minor changes from the predicate.

However, based on the provided text, I can infer some information and identify what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a table of acceptance criteria or specific reported device performance metrics for the Polaris® SPV-140, SPV-300, SPV-400 system. The submission states that the device is "substantially equivalent to the SOPHYSA Sophy® Polaris® SPV Valve (K031097) previously cleared and currently marketed" in terms of "intended use, materials, biocompatibility, design, performance, function, and operating characteristics." This implies that the performance is expected to be the same as the predicate device, but no specific performance data for this particular submission is presented.

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

The provided text does not describe a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is typical for a 510(k) Special Summary where the focus is on demonstrating substantial equivalence to a predicate, rather than presenting new clinical study data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention any experts being used to establish ground truth for a test set. As no new clinical study data is presented, this information would not be part of this submission.

4. Adjudication Method

The provided text does not describe any adjudication method. This is because no new clinical study data requiring adjudication is presented.

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

The provided text does not mention any MRMC comparative effectiveness study. This type of study would typically be performed for new, more complex diagnostic or AI-driven devices, which is not the case for this hydrocephalus shunt.

6. Standalone (Algorithm Only) Performance Study

The device described is a physical medical device (a pressure adjustable valve), not an algorithm or AI system. Therefore, a "standalone algorithm performance study" is not applicable and not mentioned in the document.

7. Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) is not directly applicable in the context of this 510(k) submission for a physical device. The "truth" here revolves around the device's physical and functional characteristics being equivalent to a known, safe, and effective predicate device.

8. Sample Size for the Training Set

The provided text does not describe a training set or its sample size. This device is a physical product, not a machine learning model that would require a training set.

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

As no training set is applicable, the establishment of ground truth for a training set is not relevant to this submission.

Summary of Device and Evidence Presented:

The Polaris® SPV-140, SPV-300, SPV-400 Pressure Adjustable Valve is an implantable device used to treat hydrocephalus by draining cerebrospinal fluid. It is designed to maintain constant intraventricular pressure and is transcutaneously adjustable. The key feature highlighted is a self-locking rotor-shuttle micro-magnet system that prevents accidental pressure setting changes by unidirectional magnetic fields (like domestic magnets or MRI).

The study that "proves the device meets the acceptance criteria" in this context is the demonstration of substantial equivalence to the predicate device, the SOPHYSA Sophy® Polaris® SPV Valve (K031097). This means that the FDA has determined that the new device is as safe and effective as the predicate based on comparisons of:

Intended Use: Both devices are for draining CSF for hydrocephalus management.
Materials: Implied to be the same or similar, leading to similar biocompatibility.
Biocompatibility: Assumed to be equivalent due to similar materials.
Design: The new models are variations of the predicate.
Performance: Expected to be equivalent to the predicate.
Function: Operates in the same manner as the predicate.
Operating Characteristics: Similar pressure ranges, adjustment increments, and mechanism for pressure setting.

The provided document does not contain new experimental data or clinical trials for the K042481 submission itself, but rather references the predicate device (K031097) as the basis for its safety and effectiveness.

Summary

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042481

10. SMDA Summary of Safety and Effectiveness SMDA Summary of Safety and Effectiveness

510(k) Summary Polaris® SPV-140, SPV-300, SPV-400 Pressure Adjustable Valve

A. Submittor Information

Sponsor: Manufacturer: SOPHYSA SA SOPHYSA SA C/o Interactive Consulting Inc. 22 rue Jean Rostand 70 Walnut Street Parc Club Orsay Université Wellesley, MA 02481 91893 ORSAY Cedex, France Tel: (781) 239-8108 Tel: 011-331-69 35 35 00 Fax: (781) 239-8005 Fax: 011 331 69 35 36 90 Website : www.sophysa.com

Contact Person:	Jean-Christophe Audras, Regulatory Affairs
Date Prepared:	September 10, 2004

B. Device Identification

Common/Usual Name: Proprietary Name:

Regulatory Class:

Hydrocephalus Shunt Polaris® SPV-140, SPV-300, SPV-400 Pressure Adjustable Valve System Class II by 21 CFR 882,5550

C. Identification of Predicate Device(s)

The Polaris® Pressure Adjustable Valve models SPV-140, SPV-300, SPV-400 is substantially equivalent to the SOPHYSA Sophy® Polaris® SPV Valve (K031097) previously cleared and currently marketed.

D. Device Description

The basic settings of the Polaris® SPV-140 Valve are 10, 40, 80, 110 and 140 mm H₂O; adjustments to intermediate pressures are made manually in 30 mm H20 increments (decrements).

The basic settings of the Polaris® SPV-300 Valve are 50, 100, 150, 220 and 300 mm H2O; adjustments to intermediate pressures are made manually in 50-70 mm H20 increments (decrements).

The basic settings of the Polaris® SPV-400 Valve are 80, 150, 230, 330 and 400 mm H2O; adjustments to intermediate pressures are made manually in 70-100 mm H20 increments (decrements).

Image /page/0/Picture/18 description: The image shows the number 20020. The numbers are written in a simple, sans-serif font. The numbers are slightly faded, but still legible. The image is a close-up of the numbers.

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shuttles in the same direction and thus cannot unlock them simultaneously, therefore the rotor cannot be mobilized and the pressure setting remains fixed and constant.

E. Substantial Equivalence

The Polaris® Pressure Adjustable Valve models SPV-140, SPV-300, SPV-400 is substantially equivalent to the Polaris® SPV Pressure Adjustable Valve System (K031097) in terms of intended use, materials, biocompatibility, design, performance, function, and operating characteristics.

F. Indications for Use

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

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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 symbol of an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

Sophysa SA c/o Ms. Jackie Masse Interactive Consulting, Inc. 70 Walnut Street Wellesley, Massachusetts 02481

Re: K042481

Trade/Device Name: Polaris® Pressure Adjustable Valve System Models Polaris® SPV-140, SPV-300, SPV-400 Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: November 8, 2004 Received: November 9, 2004

Dear Ms. Masse:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Jackie Masse

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and h yourse of substantial equivalence of your device to a legally premailed 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C Provost

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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Indications for Use

K042481 510(k) Number (if known):

Device Name:

Polaris® Pressure Adjustable Valve System Models Polaris® SPV-140, SPV-300, SPV-400

Indications For Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

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).