SIPHONX GRAVITATIONAL ANTISIPHON DEVICE

K091328 · Sophysa SA · JXG · Jan 22, 2010 · Neurology

Device Facts

• Record ID: K091328
• Device Name: SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
• Applicant: Sophysa SA
• Product Code: JXG · Neurology
• Decision Date: Jan 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SiphonX® gravitational anti-siphon device is designed to control the siphon effect during the treatment of hydrocephalus by shunting Cerebrospinal Fluid (CSF).

Device Story

SiphonX is an implantable, single-use gravitational anti-siphon device for hydrocephalus treatment. It consists of a plastic housing with inflow/outflow channels, a weight ball, and an orifice-sealing ball. In horizontal positions, the device allows free CSF flow; in vertical positions, gravity causes the weight ball to press on the orifice-sealing ball, increasing resistance to counteract siphoning. The device is used in conjunction with pressure-adjustable valves (e.g., Polaris, Sophy). It is implanted by neurosurgeons to manage CSF pressure, potentially preventing over-drainage complications in patients with hydrocephalus.

Clinical Evidence

Bench testing only. Functional testing performed per ISO/FDIS 7197:2006(E) and ASTM F 647. Biocompatibility established via transfer of data from the Sophy Adjustable Pressure Valve (ISO 10993-1) and additional genotoxicity testing for laser markings.

Technological Characteristics

Implantable plastic housing with silicone seals; weight-ball/orifice-sealing ball mechanism; gravity-dependent resistance; single-use; sterile. Complies with ISO/FDIS 7197:2006(E) and ASTM F 647.

Indications for Use

Indicated for patients requiring treatment of hydrocephalus via CSF shunting to control siphon effect.

Regulatory Classification

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.

Predicate Devices

• Shunt Assistant (K011030)
• Aesculap-Miethke proGAV Shunt (K062009)

Reference Devices

• SOPHYSA Sophy Adjustable Pressure Valve (K013488)

Submission Summary (Full Text)

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# JAN 22 2010

## Section 3. 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.

#### 3.1 Name, Address, Phone and Fax Number of the Applicant

Jean-Christophe Audras 22 rue Jean Rostand Parc Club Orsay Université 91893 ORSAY Cedex, France Tel: [phone] Fax: [phone]

#### 3.2 Applicant

Jean-Christophe Audras 22 rue Jean Rostand Parc Club Orsay Université 91893 ORSAY Cedex, France Tel: [phone] email: [e-mail]

#### 3.3 Application Correspondent

Gustavo Kobrin Strategic Regulatory Solutions 8502 E. Chapman Ave., #234 Orange, CA 92869 Email: [e-mail] 3.4 Date Prepared December 21, 2009

#### 3.4 Device Name

SiphonX® Gravitational Anti-siphon Device

#### 3.5 Device Description

The SiphonX® Gravitational Anti-sibhon Device is a siphon requlating accessory device used in the treatment of hydrocephalus.

SiphonX® Gravitational Anti-siphon Device is an implantable, single-use device. The SiphonX® Gravitational Anti-siphon Device consists of a plastic housing with integral inflow and outflow

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Image /page/1/Picture/0 description: The image shows the word "SOPHYSA" in a stylized font. To the left of the word is a circular logo with a vertical line through the center. The text and logo are in a dark color, contrasting with the white background. The overall impression is that of a company logo or brand name.

channels that are separated by a conical valve seat. The housing contains a weight ball that rests upon a smaller, orifice-sealing ball. The device contains two silicone seals. Gravitational effect is provided by a weight ball which pushes on the valve sealing ball, under the effect of gravity, as the device transitions from a horizontal to a vertical position. The cerebrospinal fluid (CSF) flows in through the inlet connector, past the orifice-sealing ball and flows out by way of the outlet connector when the fluid pressure is greater than the sum of the pressure exerted by the weight ball and the operating pressure of the valve.

When the SiphonX® Gravitational Anti-siphon Device is in a horizontal position, no resistance to the flow is provided by the weight ball and orifice-sealing ball thereby allowing CSF to flow freely as regulated by the upstream shunt. On the contrary, when the SiphonX® Gravitational Antisiphon Device is in a vertical position, maximum CSF resistance is applied as the weight ball presses on the orifice-sealing ball. The CSF is directed towards the orifice-sealing ball creating an opposing force to that which is generated by the weight ball. Upon sufficient CSF flow and combined valve pressure and Gravitational Anti-siphon Device pressure, CSF is able to push up the orifice-sealing ball and weight ball and flow through the outlet channel and connector. The device will be distributed by itself or in combination with the Polaris® and Sophy® Pressure Adiustable valves and valve kits.

#### 3.6 Device Intended Use

The SiphonX® gravitational anti-siphon device is designed to control the siphon effect during the treatment of hydrocephalus by shunting Cerebrospinal Fluid (CSF).

#### 3.7 Substantial Equivalence Summary

The SiphonX® Gravitational Anti-siphon Device is substantially equivalent to the Shunt Assistant® siphon requlating device that is cleared for use in the Aescular®-Miethke Shunt System (K011030) and Aesculap®-Miethke proGAV® Shunt (K062009). The predicate siphon requlating device is distributed in kits as well as individually.

The SiphonX® device and the predicate utilize the same technology (Weight ball) to regulate the siphon effect.

#### 3.8 Device Testing

The SiphonX® Gravitational Anti-siphon Device was subjected to laboratory testing to demonstrate device safety and efficacy. Testing included mechanical, functional and biological tests.

Functional tests were conducted based upon the requirements of international standard ISO/FDIS 7197:2006(E), Neurological implants- Sterile single use hydrocephalus shunts and components and ASTM F 647, Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurological Application. Results of the testing showed that the SiphonX® Gravitational Anti-siphon Device design is safe for its intended use.

The SiphonX uses the same materials as the SOPHYSA Sophy® Adjustable Pressure Valve (K013488) so biocompatibility test results performed on the Sophy® Adjustable Pressure Valve are considered to be transferable to the SiphonX device. The original biocompatibility studies

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Image /page/2/Picture/0 description: The image shows the word "SOPHYSA" with a symbol to the left of the word. The symbol is a circle with a vertical line through the center and two smaller lines extending from the bottom of the circle. The text is in a simple, sans-serif font and appears to be slightly faded or textured.

were conducted according to ISO 10993-1 standard and had demonstrated that the SOPHYSA Sophy® Adjustable Pressure Valve was biocompatible, and therefore the SiphonX is considered to be biocompatible. One slight difference between the devices is the presence of laser marking on the SiphonX. The impact of laser marking on biocompatibility was tested and successfully passed genotoxicity testing.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle with its wings spread, and three lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

## JAN 22 2010

Sophysa SA c/o Gustavo Kobrin Application Correspondent for Sophysa SA 8502 E. Chapman Ave., #234 Orange, CA 92869

Re: K091328

Trade/Device Name: Siphon X Gravitational Anti-siphon Device Regulation Number: 21 CFR 882,5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: December 22, 2009 Received: December 24, 2009

Dear Mr. Kobrin:

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. 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 (sec 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.

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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.

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/MedicalDevices/Safety/ReportalProblem/default.htm 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Ruhm Rhm m of

Malvina B. Eydelman, M 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 Statement

### 1091328 510(k) Number (if known): _

Device Name: SiphonX® Gravitational Anti-siphon Device.

Indications for Use:

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The SiphonX® gravitational anti-siphon device is designed to control the siphon effect during the treatment of hydrocephalus by shunting Cerebrospinal Fluid CSF).

Prescription Use V Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Comments of the volume of the many would be and the complete the commentation of the commentation of the commentation of the commentation of the commentation of the comments

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 (Posted November 13, 2003)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K091328