The Polaris® Pressure Adjustable Valve 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 value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The basic settings of the Polaris® Valve are 30, 70, 110, 150 and 200. Adjustments to intermediate pressures are made manually in 40 mm Hy0 increments (decrements) in three operating ranges, low pressure (LP = 30 mm H20), medium pressure (MP = 110 mm H20), and high pressure (HP = 200 mm H20).

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

AI/ML Overview

The provided text describes the Polaris® Pressure Adjustable Valve, a device for treating hydrocephalus, and its substantial equivalence to a predicate device. However, the document does not contain information about specific acceptance criteria, a study demonstrating the device meets those criteria, or quantitative performance metrics.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria.

Here's a breakdown of the requested information based on the provided text, highlighting what is missing:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document. The 510(k) focuses on demonstrating substantial equivalence to a predicate device rather than specific acceptance criteria for a new performance study.	Not specified in the document. No quantitative performance metrics such as accuracy, sensitivity, or specificity are provided. The document states that the Polaris® valve is "substantially equivalent to the Sophy® Pressure Adjustable Valve System" in terms of "biocompatibility, Industry, and operating characteristics." This is a qualitative statement of equivalence, not a quantitative performance report against pre-defined criteria.

Acceptance Criteria

Reported Device Performance

Not specified in the document. The 510(k) focuses on demonstrating substantial equivalence to a predicate device rather than specific acceptance criteria for a new performance study.

Not specified in the document. No quantitative performance metrics such as accuracy, sensitivity, or specificity are provided. The document states that the Polaris® valve is "substantially equivalent to the Sophy® Pressure Adjustable Valve System" in terms of "biocompatibility, Industry, and operating characteristics." This is a qualitative statement of equivalence, not a quantitative performance report against pre-defined criteria.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not specified.
Data provenance: Not specified. The document refers to the predicate device (Sophy® SM8 Valve, K013488) but doesn't detail any specific clinical or performance testing data for the Polaris® valve itself in the context of a new study to establish performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new performance study with a test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set:

Not applicable. No new performance study with a test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC comparative effectiveness study is mentioned.

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

Not applicable. This device is a mechanical shunt, not an algorithm.

7. The type of ground truth used:

Not applicable. No new performance study with ground truth is described. The basis for clearance is substantial equivalence to a predicate device, which implies the predicate's established performance serves as the benchmark.

8. The sample size for the training set:

Not applicable. This device is a mechanical shunt, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a mechanical shunt, not an AI/ML algorithm that requires a training set.

In summary: The provided document is a 510(k) summary for a medical device (a hydrocephalus shunt). Its purpose is to demonstrate that the new device (Polaris® Pressure Adjustable Valve) is "substantially equivalent" to an already legally marketed device (Sophy® SM8 Valve). This regulatory pathway typically relies on comparison of design, materials, and intended use, rather than extensive new clinical performance studies with specific acceptance criteria and ground truth, as would be expected for novel devices or AI algorithms. The document explicitly states the basis for substantial equivalence is "biocompatibility, Industry, and operating characteristics" to the predicate device.

Summary

{0}------------------------------------------------

K03/097

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

510(k) Summary Polaris® Pressure Adjustable Valve

A. Submittor Information

Sponsor:	Manufacturer:
SOPHYSA SAC/o Interactive Consulting Inc.70 Walnut StreetWellesley, MA 02481Tel: (781) 239-8108Fax: (781) 863-6497	SOPHYSA SA22 rue Jean RostandParc Club Orsay Université91893 ORSAY Cedex, FranceTel: 011-331-69 35 35 00Fax: 011 331 69 35 36 90Website : www.sophysa.com

Contact Person:	Jean-Christophe Audras, Regulatory Affairs
Date Prepared:	April 4, 2003

B. Device Identification

Common/Usual Name:	Hydrocephalus Shunt
Proprietary Name:	Polaris® Pressure Adjustable Valve System
Regulatory Class:	Class II by 21 CFR 882.5550

C. Identification of Predicate Device(s)

The Polaris® Pressure Adjustable Valve is substantially equivalent to the SOPHYSA Sophy® SM8 Valve (K013488) previously cleared and currently marketed.

D. Device Description

{1}------------------------------------------------

E. Substantial Equivalence

The Polaris® Pressure Adjustable Valve is substantially equivalent to the Sophy® Pressure The Folans® I ressure Aujustable Valve is Subtanian) Capitalian biocompatibility, Adjustable Valvo System. Industry, and operating characteristics.

F. Indications for Use

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 2004

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

Re: K031097

Trade/Device Name: Polaris Pressure Adjustable Valve SPV, SPVA, SPVB Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: November 25, 2003 Received: November 28, 2003

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Jacqueline F. Masse

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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,

R. Mark A. Milken

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K031097

Device Name: Polaris Pressure Adjustable Valve SPV, SPVA, SPVB

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)

Mark N. Millican

al, Restorative, and Neurolog Jal Devices

510(k) Number: K031097

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).