(182 days)
The Polaris® Adjustable Pressure Valves are indicated to drain cerebrospinal fluid (CSF) for the management of hydrocephalus.
The Polaris® Adjustable Pressure 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 Models SPV, SPVA, and SPVB are 30, 70, 110, 150 and 200. Adjustments to intermediate pressures are made manually in 40-50 mm Hz0 increments (decrements) in three operating ranges, low pressure (LP =30 mm Hz0), medium pressure (MP = 110 mm H20), and high pressure (HP = 200 mm H20).
The basic settings of the Polaris® SPV-140 Valve are 10, 40, 80, 110 and 140 mm H₂0; adjustments to intermediate pressures are made manually in 30-40 mm H20 increments (decrements).
The basic settings of the Polaris® SPV-300 Valve are 50, 100, 150, 220 and 300 mm H₂0; adjustments to intermediate pressures are made manually in 50-80 mm H20 increments (decrements).
The basic settings of the Polaris® SPV-400 Valve are 80, 150, 230, 330 and 400 mm H-0; 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 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.
The provided text describes specific verification and validation testing for the Polaris® Adjustable Pressure Valves related to their MRI compatibility, rather than a clinical study evaluating the device's functional performance in treating hydrocephalus. Therefore, some of the requested information, such as effect size of human readers improving with AI, sample size for training sets, or number of experts for ground truth, is not applicable or available in the given text.
Here's the information that can be extracted from the provided text:
Acceptance Criteria and Device Performance for MRI Compatibility
The acceptance criteria are implicitly met if the test results "supported the MRI labeling statements for exposure of the Polaris Adjustable Pressure Valves to a 3-Tesla MRI environment." The specific quantitative thresholds for these criteria are not detailed in the provided text.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Magnetic Field Interactions | Supported MRI labeling for 3-Tesla MRI exposure. |
| Heating | Supported MRI labeling for 3-Tesla MRI exposure. |
| Artifacts | Supported MRI labeling for 3-Tesla MRI exposure. |
| Alteration of Functional Aspects | No alteration of functional aspects after exposure to 3-Tesla MRI environment. |
Study Details:
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Sample size used for the test set and the data provenance: Not specified. The testing was conducted on "Polaris Adjustable Pressure Valves," implying a physical sample of devices, but the exact number or how they were selected is not provided. No patient data (retrospective or prospective) was used for this specific testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this engineering verification study would be based on validated physical measurements and performance standards, not expert clinical interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was a technical verification and validation study, not a clinical study involving adjudication of clinical findings.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study focuses on the device's physical compatibility with MRI, not AI assistance for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
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The type of ground truth used: For magnetic field interactions, heating, and artifacts, the ground truth would be based on established engineering standards and validated measurement techniques (e.g., temperature probes for heating, specific protocols for artifact assessment). For the functional aspects, the ground truth would be the device's functional specifications (e.g., pressure settings) before and after MRI exposure, measured using calibrated equipment.
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The sample size for the training set: Not applicable. This is a physical device testing, not a machine learning study requiring a training set.
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How the ground truth for the training set was established: Not applicable.
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ATTACHMENT 2. 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax Number of the Applicant 3.1
Sophysa SA
22 rue Jean Rostand Parc Club Orsay Université 91893 ORSAY Cedex, France Tel: 011-331-69 35 35 00 Fax: 011 331 69 35 36 90
Contact Person 3.2
Jean-Christophe Audras 22 rue Jean Rostand Parc Club Orsay Université 91893 ORSAY Cedex, France Tel: 011-331-69 35 35 06
3.3 Date Prepared
February 6, 2009
3.4 Device Name
Polaris® Adjustable Pressure Valve (Models SPV, SPVA, and SPVB), and
Polaris® Adjustable Pressure Valve System (Models SPV-140, SPV-300, and SPV-400)
Device Description 3.5
The Polaris® Adjustable Pressure 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 Models SPV, SPVA, and SPVB are 30, 70, 110, 150 and 200. Adjustments to intermediate pressures are made manually in 40-50 mm Hz0 increments (decrements) in three operating ranges, low pressure (LP =30 mm Hz0), medium pressure (MP = 110 mm H20), and high pressure (HP = 200 mm H20).
AUG 1 1 2009
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The basic settings of the Polaris® SPV-140 Valve are 10, 40, 80, 110 and 140 mm H₂0; adjustments to intermediate pressures are made manually in 30-40 mm H20 increments (decrements).
The basic settings of the Polaris® SPV-300 Valve are 50, 100, 150, 220 and 300 mm H₂0; adjustments to intermediate pressures are made manually in 50-80 mm H20 increments (decrements).
The basic settings of the Polaris® SPV-400 Valve are 80, 150, 230, 330 and 400 mm H-0; 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 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.
3.6 Indications for Use
The Polaris® Adjustable Pressure Valves are indicated to drain cerebrospinal fluid (CSF) for the management of hydrocephalus.
Description of Modifications 3.7
There have been no changes to the device design. The changes involve labeling changes to upgrade the MRI characteristics of the valves for use in an MRI environment from 1.5 Tesla to up to 3 Tesla. Additional changes were made to the IFU to update instructions for the Polaris Adiustment Kit (PAK) handling procedure as well as numerous other minor changes for clarification of to the procedures.
Verification & Validation Testing of Changes 3.8
Testing was conducted to evaluate the presence of magnetic filed interactions, heating, and artifacts for the Polaris Adjustable Pressure Valves after exposure to a 3-Tesla MRI environment; and to determine if exposure to a 3-Tesla MRI environment alters the functional aspects of Polaris Adjustable Pressure Valves. The results supported the MRI labeling statements for exposure of the Polaris Adjustable Pressure Valves to a 3-Tesla MRI environment.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-00002
Sophysa SA c/o Jean-Christophe Audras Director, Regulatory Affairs 22 Rue Jean Rostand Parc Club Orsay Université 91893 Orsay Cedex France
AUG 1 1 2009
Re: K090342
Trade/Device Name: Polaris® Adjustable Pressure Valve (Models SPV, SPVA, and
SPVB), and Polaris® Adjustable Pressure Valve System (Models
SPV-140, SPV-300, and SPV-400)
Regulation Number: 21 CFR 882.5550
Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: II
Product Code: JXG Dated: June 5, 2009 Received: June 10, 2009
Dear Mr. Audras:
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 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-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.
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Page 2 - Mr. Jean-Christophe Audras
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Eydelman, M.D
Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090342
Polaris® Pressure Adjustable Valve System, Models SPV, SPVA, Device Name:_ SPVB, SPV-140, SPV-300, and SPV-400
Indications For Use:
To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kristen Bowsher
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_ K 0 9 0 3 Y Z
Page 1 of
§ 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).