(270 days)
The Sophy Mini Monopressure Valve is designed for the treatment of hydrocephalus by shunting cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.
The Sophy® Mini Monopressure Valve is intended for the treatment of hydrocephalus by shunting the cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.
The complete CSF shunting system provides shunting of CSF from the ventricular cavities in the brain to another part of the body where the CSF can be absorbed in blood.
At the minimum, a complete CSF shunt consists of:
- A proximal catheter to drain CSF from either lateral brain ventricles;
- A distal catheter to drain CSF to a body cavity where it can be absorbed in blood (most often, the peritoneal cavity or the right atrium of the heart so respectively called peritoneal or atrial catheter also);
- Between the two, a valve which regulates the flow of CSF.
N/A
FDA 510(k) Clearance Letter - Sophy Mini Monopressure Valve
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
November 28, 2025
SOPHYSA
Lucie Dubois
Regulatory Affairs Manager, CSF
5 Rue Guy Moquet
Orsay, 91400
France
Re: K250636
Trade/Device Name: Sophy Mini Monopressure Valve
Regulation Number: 21 CFR 882.5550
Regulation Name: Central Nervous System Fluid Shunt and Components
Regulatory Class: Class II
Product Code: JXG
Dated: March 3, 2025
Received: October 31, 2025
Dear Lucie Dubois:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K250636 - Lucie Dubois Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the QS regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K250636 - Lucie Dubois Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
XIAOLIN ZHENG -S
For Jaime Raben, Ph.D.
Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250636
Device Name: Sophy Mini Monopressure Valve
Indications for Use (Describe):
The Sophy Mini Monopressure Valve is designed for the treatment of hydrocephalus by shunting cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 5
510(k) SUMMARY
K250636 Page 1 on 10
1. 807.92(a)(1) Sponsor Information
Applicant Name: Sophysa
Address: 5 Rue Guy Moquet
ORSAY, FRANCE, 91400
Phone and Fax Number: +33 (0)1 69 35 35 00 (phone)
+33 (0)1 69 35 36 90 (fax)
Contact Person: Julie LOPEZ
QMS & Regulatory Affairs Director
jlopez@sophysa.fr
Date Prepared: 2025-November-26
2. 807.92(a)(2) Device Name and Classification
Trade/Proprietary Name: Sophy® Mini Monopressure Valve
Common Name: Hydrocephalus Shunt System
510(k) Submitter: Sophysa
Device Class: Class II
Product code: JXG
Regulation: 21 CFR 882.5550
There are 15 different Sophy SM1 valve references as listed in the table below:
| Product Reference | Designation |
|---|---|
| SM1-H | Sophy® Mini Monopressure valve HP |
| SM1-L | Sophy® Mini Monopressure valve LP |
| SM1-M | Sophy® Mini Monopressure valve MP |
| SM1-2010H | Sophy® HP kit preattached with BO19-10 |
| SM1-2010L | Sophy® LP kit preattached with BO19-10 |
| SM1-2010M | Sophy® MP kit preattached with BO19-10 |
| SM1A-2010H | Sophy® HP kit preattached with BO19-10 |
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K250636 Page 2 on 10
| Product Reference | Designation |
|---|---|
| SM1A-2010L | Sophy® LP kit preattached with BO19-10 |
| SM1A-2010M | Sophy® MP kit preattached with BO19-10 |
| SM1A-H | Sophy® HP valve with antechamber |
| SM1A-L | Sophy® LP valve with antechamber |
| SM1A-M | Sophy® MP valve with antechamber |
| SM1B-H | Sophy® HP valve with burr hole reservoir |
| SM1B-L | Sophy® LP valve with burr hole reservoir |
| SM1B-M | Sophy® MP valve with burr hole reservoir |
3. 807.92(a)(3) Predicate Device
Predicate: Polaris® Adjustable Pressure Valve, Sophysa (K141227)
4. 807.92(a)(4) Device Description
The Sophy® Mini Monopressure Valve is intended for the treatment of hydrocephalus by shunting the cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.
The complete CSF shunting system provides shunting of CSF from the ventricular cavities in the brain to another part of the body where the CSF can be absorbed in blood.
At the minimum, a complete CSF shunt consists of:
- A proximal catheter to drain CSF from either lateral brain ventricles;
- A distal catheter to drain CSF to a body cavity where it can be absorbed in blood (most often, the peritoneal cavity or the right atrium of the heart so respectively called peritoneal or atrial catheter also);
- Between the two, a valve which regulates the flow of CSF.
5. 807.92(a)(5) Indications for Use
The Sophy® Mini Monopressure Valve is designed for the treatment of hydrocephalus by shunting the cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.
6. 807.92(a)(5) Intended Population
This device can be used on patients of all ages, excluding pre-term infants.
7. 807.92(a)(6) Comparison of Technological Characteristics with the Predicate Device
The Sophy® Mini Monopressure Valve is substantially equivalent to Polaris® Adjustable Pressure Valve, Sophysa (K141227) according to Table 1.
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K250636 Page 3 on 10
Table 1: Predicate Device Comparison
| Predicate: Polaris Valve 510(k): K031097, K042481, K090342, K141227 | Subject Device: Sophy Mini Monopressure Valve (SM1) K250636 | Rationale of Why No New Issues of Safety and Effectiveness | |
|---|---|---|---|
| Clinical equivalence: | |||
| Intended use | The treatment of hydrocephalus by shunting the cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart. | The treatment of hydrocephalus by shunting the cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart. | Same |
| Single use | Single use | Single use | Same |
| Sterility status | Sterile | Sterile | Same |
| Sterilization method | EO sterilization | EO sterilization | Same |
| Re-sterilization status | Cannot be resterilized | Cannot be resterilized | Same |
| Technical equivalence: |
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K250636 Page 4 on 10
| Predicate: Polaris Valve 510(k): K031097, K042481, K090342, K141227 | Subject Device: Sophy Mini Monopressure Valve (SM1) K250636 | Rationale of Why No New Issues of Safety and Effectiveness | |
|---|---|---|---|
| Principle mode of action | "Ball-in-cone" design. The pressure is based on the pressure variation exerted on a ruby ball by the spring. | "Ball-in-cone" design. The pressure is based on the pressure variation exerted on a ruby ball by the spring. | Same |
| Product composition & design | |||
| Magnets | Two micro magnets enclosed in polysulfone shuttles located on rotor. | No magnets | Adjustment by magnetism implies the presence of magnets inside the predicate Polaris valve. The SM1 valve has no magnets, and therefore reduce artifact and induced heating during MRI compared with the predicate Polaris valve. |
| Rotor design | Rotor has two radially movable magnets englobed in shuttle (providing magnetic lock function) and can rotate when shuttle is influenced by magnetic force (of the setting tool). | Fixed rotor | SM1 is a single-pressure valve, so there is rotor, but it is fixed because it is not an adjustable valve like the predicate Polaris. Therefore, there is no impact on the safety and effectiveness because both have a rotor inside but the rotor for SM1 is |
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K250636 Page 5 on 10
| Predicate: Polaris Valve 510(k): K031097, K042481, K090342, K141227 | Subject Device: Sophy Mini Monopressure Valve (SM1) K250636 | Rationale of Why No New Issues of Safety and Effectiveness | |
|---|---|---|---|
| fixed and the rotor for Polaris is movable. | |||
| Shuttle | Shuttle can move radially to lock/unlock the rotor. | No shuttle | SM1 is a single-pressure valve; it is not possible to vary pressure by rotating a rotor, and it has no magnets for rotation. This means that it has no shuttles for locking these magnets and has no impact on the absence of these shuttles because it is in accordance with the operating principle of SM1. |
| Spring fixation | Spring fixed on rotor by ultrasonic welding. | Spring fixed on rotor by ultrasonic welding. | Same |
| Pressure determinants | Pressure varies when the ruby ball is at different points on the spring's curvature. | SM1 has the same mechanism as Polaris with the ruby ball on the spring's curvature. But SM1 is a single-pressure valve therefore there is no pressure adjustment. | There is no pressure adjustment because SM1 is a single-pressure valve and is available in 3 variant pressure positions included in the pressure range of the Polaris SPV valve. The pressure determinant |
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K250636 Page 6 on 10
| Predicate: Polaris Valve 510(k): K031097, K042481, K090342, K141227 | Subject Device: Sophy Mini Monopressure Valve (SM1) K250636 | Rationale of Why No New Issues of Safety and Effectiveness | |
|---|---|---|---|
| stays the same because it is also the ruby ball on the spring's curvature. | |||
| Shape/dimension | |||
| Shape | The valve is a teardrop shaped valve with slight curve to fit the skull. | The valve is a teardrop shaped valve with slight curve to fit the skull. | Same |
| Dimension | 16 mm in diameter, 32.5 mm in length and 5 mm in thickness | 16 mm in diameter, 32.5 mm in length and 4.9 mm in thickness | Similar - SM1 valve is identical in diameter and length to Polaris but is 0.1 mm thinner. Since the SM1 valve is thinner than Polaris, there are no additional risks compared to those associated with Polaris. |
| Compatible products | |||
| Adjustment kits | References: PAK2, PAK2-LI, PAK2-RI, PAK2-SI 510K Number: K141227 | Not necessary | Similar - SM1 is a single-pressure valve, it does not need an adjustment kit. |
| Catheters | References: B905S, BO19-10 510K Number: | References: B905S, BO19-10 510K Number: | Same |
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K250636 Page 7 on 10
| Predicate: Polaris Valve 510(k): K031097, K042481, K090342, K141227 | Subject Device: Sophy Mini Monopressure Valve (SM1) K250636 | Rationale of Why No New Issues of Safety and Effectiveness | |
|---|---|---|---|
| K141227 | K141227 | ||
| Anti-siphon | Reference: SX-200 510K Number: K091328 | Reference: SX-200 510K Number: K091328 | Same - The connection between the valve and the anti-siphon is identical for SM1 and the predicate SPV. The Sophy Mini Monopressure Valve does not include a shunt kit reference with the anti-siphon SX200, unlike the predicate Polaris® valve. The anti-siphon SX-200 is compatible with the Sophy Mini Monopressure Valve. |
| Functional characteristics | |||
| Pressure program | Non-invasive reading and adjustment transcutaneously. | Calibration pressure easily identifiable to the naked eye in all phases of deconditioned valve handling and no adjustment possible. Easily identifiable after implantation by radiography. | SM1 is a single-pressure valve and is available in 3 variant pressure positions included in the pressure range of the Polaris SPV valve. |
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K250636 Page 8 on 10
| Predicate: Polaris Valve 510(k): K031097, K042481, K090342, K141227 | Subject Device: Sophy Mini Monopressure Valve (SM1) K250636 | Rationale of Why No New Issues of Safety and Effectiveness | |
|---|---|---|---|
| Operating pressure | 4 models providing 4 operating pressure ranges (10-140, 30-200, 50-300, 80-400 mmH2O), each with 5 pressure settings | 3 models providing 3 operating pressures (50, 110, 170 mmH2O) with 1 pressure setting | SM1 is a single-pressure valve and is available in 3 variant pressure positions included in the pressure range of the Polaris SPV valve. |
| Lock up design | Magnetic lock, maintain the pressure by resisting daily shock, daily magnetic field and MRI exposure. | There is no rotor with magnets in the SM1; therefore, no pressure variation and the lock up design is not necessary. | The valve contains no magnets and no movable rotor. |
| MRI safety information | MR Conditional | MR Conditional | Same |
| Radiopaque marks | Marking points (made with titanium) plotted alongside the valve body. | Marking points (made with titanium) plotted alongside the valve body. | Same |
| Applicable standards | ISO 7197 | ISO 7197 | Same |
| Shelf life | 5 years | 5 years | Same |
| Primary packaging system | Double tray + Tyvek | Double tray + Tyvek | Same |
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K250636 Page 9 on 10
8. 807.92(b)(1) Performance Data
The biological safety of the Sophy® Mini Monopressure Valve has been established through the demonstration of equivalency with the predicate Polaris® Adjustable Pressure Valve, Sophysa (K141227) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
The following performance testing has been conducted in support of the substantial equivalence determination. The testing was performed according to FDA-recognized consensus standards and internal test methods according to Table 2.
Table 2: Performance bench test results
| Test | Test Method Summary | Results |
|---|---|---|
| Radiopacity per ISO 7197, ASTM F647 and ASTM F640. | To verify whether the entire shunt is visible on X-ray and to differentiate between all variants of a product range and the direction of shunt implantation. | Pass |
| Resistance to leakage per ISO 7197 and ASTM F647. | To check the shunt's air and water tightness. | Pass |
| Functional property pressure flow characteristics per ISO 7197. | To evaluate if the pressure range of the shunt corresponds to the pressure range of the SM1. | Pass |
| Dynamic breaking strength per ISO 7197 and ASTM F647. | To verify the tensile and flexion fatigue resistance of shunt connectors. | Pass |
| Functional property reflux performance per ISO 7197 and ASTM F647. | To check the anti-reflux performance of the shunt. | Pass |
| Shock resistance test per ISO 7197 and ASTM F647. | To verify whether the device's performance remains compliant after drops. | Pass |
| Dimensional control. | Check the dimensional conformity of products. | Pass |
| Long term stability per ISO 7197 and ASTM F647. | To verify whether the device's performance remains compliant after prolonged use. | Pass |
| Functional property influence of the changed posture on the valve performance per ISO 7197. | Measure the flow rate and pressure of the shunt in the vertical and horizontal positions. | Pass |
| Bursting pressure per ISO 7197 and ASTM F647. | To verify whether the device's performance remains compliant after burst pressure. | Pass |
| Overpressure per ISO 7197 and ASTM F647. | To verify whether the device's performance remains compliant after overpressure. | Pass |
| MRI compatibility – magnetic displacement force, induced torque, induced heating per ASTM F2052, ASTM F2213 and ASTM F2182. | To verify the shunt's compatibility with an MRI scan. | Pass |
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K250636 Page 10 on 10
| Test | Test Method Summary | Results |
|---|---|---|
| Visual control per ISO 20698 and ASTM F647. | To check for surface defects. | Pass |
| Resistance to dynamic breaking of the complete shunt system per ISO 7197 and ASTM F647. | To verify the resistance to dynamic breaking of the complete shunt system. | Pass |
| Hydrodynamic resistance catheters per ISO 7197. | To measure flow rate and pressure and calculate the hydrodynamic resistance of the catheter. | Pass |
9. 807.92(b)(3) Summary of Non-clinical testing
Bench testing has been performed on the representative samples of the Sophy® Mini Monopressure Valve, according to design requirements. All tests have passed the acceptance criteria.
The information summarized above demonstrates that the Sophy® Mini Monopressure Valve is substantially equivalent to and is as safe and as effective as the legally marketed predicate device. Due to the high similarity to the predicate device (design, material, catheter, reservoir), most non-clinical performance test results are identical between SM1 and the predicate device. Only the MRI test results are better due to the absence of magnets.
§ 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).