(136 days)
Not Found
No
The description focuses on the mechanical operation of a variable resistance valve and does not mention any computational or learning components.
Yes
The device is described as "an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site." This clearly states its use in treating a medical condition.
No
The device is described as an implantable system used for shunting CSF in patients with hydrocephalus, indicating its therapeutic function rather than a diagnostic one.
No
The device description clearly states it is an "implantable system" with physical components like a diaphragm, seat, and pin, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The OSV II is an implantable system designed to shunt cerebrospinal fluid (CSF) from the brain to another part of the body. It is a mechanical device that regulates fluid flow within the body.
- Lack of Diagnostic Testing: The description does not mention any testing of samples or providing diagnostic information based on those tests. Its purpose is therapeutic (treating hydrocephalus by managing CSF flow), not diagnostic.
Therefore, based on the provided information, the OSV II is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The OSVII is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The OSV II is designed to shunt cerebrospinal fluid (CSF) from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. Unlike conventional valves, it is a variable resistance valve which maintains a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure.
The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pin. The diaphragm, held between two polysulfone parts of the casing, reacts to variations in pressure. A synthetic ruby seat is inserted into the center of the diaphragm. As pressure varies, the clearance between the seat and the pin increases or decreases depending on seat movement along the pin.
Three Stages of Operation are defined:
Stage I - Low Differential Pressure
This stage begins when the flow rate through the valve reaches 5ml/hr (Differential Pressure (DP) will be between 30 and 80 mm H20). The valve remains in Stage I with CSF flow rates up to 18 ml/hr (DP will be between 40 and 120 mm H20).
Stage II - Flow Regulation
When the DP increases, the valve operates as a variable resistance flow regulator. At DP ranges between 120 and 300 mm H20, the valve restricts flow between 18 and 30 ml/hr.
Stage III - Pressure Relief Mode
Should the intraventricular pressure (IVP) elevate abruptly, the shunt operates in a rapid flow rate mode to facilitate IVP normalization. The valve then reverts to Stage II or I, depending upon conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles, peritoneal cavity, heart's right atrium
Indicated Patient Age Range
Not Found
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)
The correlation established between the unmodified and modified test methods demonstrated that the modification did not adversely affect the safety or effectiveness of the product. The connector modification to the OSV II had been tested for leakage and for resistance of the connections at time of manufacturing, after shelf life simulation and after transport and environmental conditions.
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
Ko8173
OSVII Hydrocephalus Valve 510(k) SUMMARY
Submitter's name and address:
Integra NeuroSciences Implants SA 2905 Route des Dolines 06921 Sophia Antipolis Cedex, France
NOV - 6 2008
Contact person and telephone number:
Anne Bigeard Regulatory Affairs Manager Telephone: +33 (0)4 93 95 5667 Facsimile: +33 (0)4 93 65 4030
Date summary was prepared:
June 10, 2008
Name of the device:
| Proprietary Name: | OSVII Hydrocephalus Valve |
|---|---|
| Common Name: | Hydrocephalus Shunt Systems and Components |
| Classification Name: | Central Nervous System Shunt and Components JXG |
Substantial Equivalence:
The modified OSV II is substantially equivalent to the OSV II cleared by the FDA under 510(k) (K911799). The design, principle of operation, intended use, materials of composition, manufacturing process is equivalent to the previously cleared OSV II.
Intended use:
The OSVII is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
Device Description:
The OSV II is designed to shunt cerebrospinal fluid (CSF) from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. Unlike conventional valves, it is a variable resistance valve which maintains a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure.
The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pin. The diaphragm, held between two polysulfone parts of the casing, reacts to variations in pressure. A synthetic ruby seat is inserted into the center of the diaphragm. As pressure varies, the clearance between the seat and the pin increases or decreases depending on seat movement along the pin.
1
Three Stages of Operation are defined:
Stage I - Low Differential Pressure
This stage begins when the flow rate through the valve reaches 5ml/hr (Differential Pressure (DP) will be between 30 and 80 mm H20). The valve remains in Stage I with CSF flow rates up to 18 ml/hr (DP will be between 40 and 120 mm H20).
Stage II - Flow Regulation
When the DP increases, the valve operates as a variable resistance flow regulator. At DP ranges between 120 and 300 mm H20, the valve restricts flow between 18 and 30 ml/hr.
Stage III - Pressure Relief Mode
Should the intraventricular pressure (IVP) elevate abruptly, the shunt operates in a rapid flow rate mode to facilitate IVP normalization. The valve then reverts to Stage II or I, depending upon conditions.
Safety and Effectiveness:
- . The OSV II Hydrocephalus Valve is provided sterile and non-pyrogenic.
- The correlation established between the unmodified and modified test methods . demonstrated that the modification did not adversely affect the safety or effectiveness of the product.
- . The connector modification to the OSV II had been tested for leakage and for resistance of the connections at time of manufacturing, after shelf life simulation and after transport and environmental conditions.
Conclusion:
The modified OSV II is considered substantially equivalent to the unmodified OSV II cleared by the FDA under 510(k) (K911799). The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness.
2
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings forming three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 6 2008
Integra LifeSciences Corporation % Mr. Jon Caparotta, RAC Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K081773
Trade/Device Name: OSV II Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: October 2, 2008 Received: October 7, 2008
Dear Mr. Caparotta:
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.
3
Page 2 -- Mr. Jon Caparotta, RAC
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K081773
Device Name: OSV II
Indications For Use:
The OSV II is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
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)
Neil Reath forman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081773
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