(325 days)
Not Found
No
The description details a mechanical, pressure-adjustable valve system with a magnetic locking mechanism. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes.
The device drains cerebrospinal fluid to manage hydrocephalus, which is a therapeutic intervention aimed at treating a medical condition.
No
This device is an implantable shunting device designed to treat hydrocephalus by draining cerebrospinal fluid, not to diagnose the condition.
No
The device description clearly states it is an "implantable device" and describes physical components like a "ball-in-cone valve seat design" and a "self-locking rotor-shuttle micro-magnet system," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Polaris® Pressure Adjustable Valve is an implantable device designed to drain cerebrospinal fluid (CSF) directly from the cerebral ventricles to another part of the body (abdominal cavity or right atrium). It is a therapeutic device, not a diagnostic one.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. It physically manages fluid flow.
Therefore, based on the provided information, the Polaris® Pressure Adjustable Valve is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral ventricles, abdominal cavity or to the right atrium of the heart
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 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 35 35 00 | |
| Fax: 011 331 69 35 36 90 | |
| Website : 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
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
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,
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
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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
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