POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX

K141227 · Sophysa SA · JXG · Apr 2, 2015 · Neurology

Device Facts

• Record ID: K141227
• Device Name: POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
• Applicant: Sophysa SA
• Product Code: JXG · Neurology
• Decision Date: Apr 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polaris® Adjustable Pressure Valve is designed for the treatment of hydrocephalus by shunting the Cerebrospinal Fluid (CSF) to the abdominal cavity or right atrium of the heart.

Device Story

The Polaris Pressure Adjustable Valve System is a cerebrospinal fluid (CSF) shunt system used for the treatment of hydrocephalus. The device functions by shunting excess CSF from the ventricles to the abdominal cavity or right atrium. It features an adjustable pressure valve mechanism, allowing clinicians to modify the valve's opening pressure settings non-invasively to manage patient-specific drainage requirements. The system includes the Polaris Adjustable Valve, the SiphonX anti-siphon device, and an adjustment kit. It is intended for use by neurosurgeons in a clinical or surgical setting. The device helps manage intracranial pressure by regulating CSF flow, thereby mitigating symptoms associated with hydrocephalus.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design characteristics.

Technological Characteristics

The system consists of an adjustable pressure valve and an anti-siphon device (SiphonX). It is a mechanical CNS fluid shunt system. No software, electronics, or energy sources are utilized. Materials are standard for implantable shunts. Sterilization is performed per standard medical device manufacturing practices.

Indications for Use

Indicated for the treatment of hydrocephalus in patients requiring CSF shunting to the abdominal cavity or right atrium.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 2, 2015

Sophysa SA Mr. Gustavo Kobrin Regulatory Consultant 25108 Marguerite Parkway, Suite A-354 Mission Viejo, California 92692

Re: K141227

Trade/Device Name: Polaris Pressure Adiustable Valve System / Polaris Adjustable Valve with SiphonX / Polaris Adjustment Kit Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: February 4, 2015 Received: February 5, 2015

Dear Mr. Gustavo Kobrin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -550/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K141227

Device Name

Polaris Pressure Adjustable Valve System / Polaris Adjustable Valve with SiphonX / Polaris Adjustment Kit

Indications for Use (Describe)

The Polaris® Adjustable Pressure Valve is designed for the treatment of hydrocephalus by shunting the Cerebrospinal Fluid (CSF) to the abdominal cavity or right atrium of the heart.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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