(92 days)
Not Found
No
The device description details a purely mechanical, pressure-adjustable valve system with a magnetic locking mechanism. There is no mention of any computational or learning components.
Yes
The device is designed to drain cerebrospinal fluid and maintain intraventricular pressure, directly treating hydrocephalus.
No
Explanation: The device is designed for the treatment of hydrocephalus by shunting CSF and maintaining intraventricular pressure, which are therapeutic functions, not diagnostic ones. It does not provide information about a patient's condition.
No
The device description clearly states it is an "implantable device" and describes physical components like a "ballin-cone valve seat design" and a "self-locking rotor-shuttle micro-magnet system," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or 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) and regulate intraventricular pressure within the body. It is a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- Intended Use: The intended use is for the management of hydrocephalus by shunting CSF, which is a treatment, not a diagnostic process.
Therefore, the Polaris® Pressure Adjustable Valve falls under the category of an implantable medical device used for treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.
Product codes
JXG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral ventricles, abdominal cavity, 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 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
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_________________________________________________________________________________________________________________________________________________________________
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