(159 days)
No
The description focuses on a mechanical, pressure-adjustable valve system with manual adjustment and no mention of AI or ML components.
Yes
The device is used to treat hydrocephalus by shunting CSF, which is a therapeutic intervention.
No
The device is designed to drain cerebrospinal fluid and maintain intraventricular pressure, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is an "implantable device" and describes physical components like a valve, ball-in-cone seat, spring, magnetic rotor, and an adjustment kit including a compass, magnet, and pressure selector. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Sophy® Pressure Adjustable Valve System SM8 is an implantable device designed to drain cerebrospinal fluid (CSF) and manage hydrocephalus by shunting CSF from the cerebral ventricles to other parts of the body.
- Mechanism of Action: Its function is based on mechanical principles (pressure adjustment of a valve) and is directly involved in the physical management of a medical condition within the body. It does not analyze or test biological specimens in vitro.
Therefore, the Sophy® Pressure Adjustable Valve System SM8 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 Sophy® Pressure Adjustable Valve System SM8 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 deign, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The Sophy® Pressure Adjustable Valve System SM8 technology allows for the non-invasive manual adjustment of the operating pressure via 8 pressure settings, ranging from 30 mm H20 to 200 mm H20, as follows: 30 = Low, 110 = Medium (intermediate 50, 70, 90) and 200 = High (intermediate 140, 170).
The principle of the Sophy® Pressure Adjustable Valve System SM8, nearly identical to that of its predicate Sophy@SU8 FDA cleared hydrocephalus valve (K992465), is based on the pressure change exerted on a synthetic ruby ball by a semi-circular spring at different points of its curvature. This spring is connected to a magnetic rotor whose position can be adjusted noninvasively by using a adjustment magnet oriented at different angles with selected orientations corresponding to different pressures. Radio-opaque identification dots indicate three main positions of the rotor corresponding to Low, Medium, and High operating pressures. For manual pressure setting, a specific adjustment kit is necessary, including a compass, magnet, and pressure selector.
The Sophy® Pressure Adjustable Valve System SM8 is a miniaturized version of the predicate Sophy®SU8 (K992465), with a nearly 50% volume reduction and an approximately 45% weight reduction.
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)
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
MAR 2 7 2002
10. SMDA Summary of Safety and Effectiveness SMDA Summary of Safety and Effectiveness
510(k) Summary Sophy® SM8 Pressure Adjustable Valve System
A. Submittor Information
Sponsor:
SOPHYSA SA Clo Interactive Consulting Inc. 70 Walnut Street Wellesley, MA 02481 Tel: (781) 239-8108 Fax: (781) 863-6497
Manufacturer:
SOPHYSA SA 22 rue Jean Rostand Parc Club Orsav Université 91893 ORSAY Cedex, France Tel: 011-331-69-41-3500
Contact Person: Jean-Christophe Audras, Regulatory Affairs Date Prepared; October 15, 2001
B. Device Identification
Common/Usual Name: Proprietary Name: Regulatory Class:
Hydrocephalus Shunt Sophy® Pressure Adjustable Valve System, Model SM8 Class II by 21 CFR 882.5550
C. Identification of Predicate Device(s)
The Sophy® SM8 is substantially equivalent to the SOPHYSA Sophy® SU8 (K992465) previously cleared and currently marketed.
D. Device Description
The Sophy® Pressure Adjustable Valve System SM8 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 deign, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The Sophy® Pressure Adjustable Valve System SM8 technology allows for the non-invasive manual adjustment of the operating pressure via 8 pressure settings, ranging from 30 mm H20 to 200 mm H20, as follows: 30 = Low, 110 = Medium (intermediate 50, 70, 90) and 200 = High (intermediate 140, 170).
The principle of the Sophy® Pressure Adjustable Valve System SM8, nearly identical to that of its predicate Sophy@SU8 FDA cleared hydrocephalus valve (K992465), is based on the pressure change exerted on a synthetic ruby ball by a semi-circular spring at different points of its curvature. This spring is connected to a magnetic rotor whose position can be adjusted noninvasively by using a adjustment magnet oriented at different angles with selected orientations corresponding to different pressures. Radio-opaque identification dots indicate three main positions of the rotor corresponding to Low, Medium, and High operating pressures. For manual pressure setting, a specific adjustment kit is necessary, including a compass, magnet, and pressure selector.
1/2
1
The Sophy® Pressure Adjustable Valve System SM8 is a miniaturized version of the predicate Sophy®SU8 (K992465), with a nearly 50% volume reduction and an approximately 45% weight reduction.
E. Substantial Equivalence
The Sophy® Pressure Adjustable Valve System SM8 is substantially equivalent to the Sophy® Pressure Adjustable Valve System SU8 (K992465) in terms of intended use, materials, design, performance, function, 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 is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a flame.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
Sophysa SA c/o Ms. Jacqueline E. Masse Interactive Consulting, Inc. 70 Walnut Street Wellesley. Massachusetts 02481
Re: K013488
Trade Name: Sophy® Pressure Adjustable Valve System, Model SM8 Regulation Number: 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: January 22, 2002 Received: January 24, 2002
Dear Ms. Masse:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
3
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
iriam C. Provost
AN 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
4
510(k) Number (if known):
Kol3488
Device Name:
Sophy® SM8 Pressure Adjustable Valve
Indications For Use:
To drain cerebrospinal fluid (CSF) for the management of hydrocephalus
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Muriane C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013488