(30 days)
Not Found
No
The description focuses on the mechanical design and function of a variable resistance valve for shunting CSF, with no mention of AI or ML for control, analysis, or any other function.
Yes
The device is an implantable system used in the treatment of patients with hydrocephalus, indicating it is intended for the medical treatment of a disease.
No
The device is an implantable shunting system designed to treat hydrocephalus by draining CSF, not to diagnose a condition.
No
The device description clearly states it is an "implantable system" consisting of a valve unit and catheters, which are physical hardware components.
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, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The OSV II Low Flow Low Pro Valve is an implantable system designed to be placed inside the body to manage cerebrospinal fluid flow. It is a mechanical device that directly interacts with the patient's internal systems.
- Intended Use: The intended use is to shunt CSF from the ventricles to other body cavities, which is a therapeutic intervention performed in vivo.
The description clearly indicates that this device is an implantable medical device used for treatment within the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The OSV II® Low Flow Low Pro Valve 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
JXG
Device Description
The proposed OSV II Low Flow Low Pro Valve (OSV II LFLP) and the currently marketed Integra NPH Low Flow Valve System (NPH Valve) are implantable hydrocephalus valve systems for shunting controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, these valves are variable resistance valves which maintain a drainage rate constant within the physiological range for the specified populations and disorders of intracranial pressure. These valves were designed to maintain a lower drainage rate than that of normal CSF production (approximately 20 ml/hr), and are intended to accommodate the needs of patients requiring a drainage rate between 8-17 ml/hr. The proposed OSV II LFLP Valve is designed to maintain the same lower drainage rate of 8-17 ml/hr, but with a smaller overall height and diameter to accommodate the needs of patients requiring a smaller valve.
The proposed OSV II Low Flow Low Pro Valve (OSV II LFLP) is similar to the currently marketed Integra NPH Low Flow Valve. The proposed valve is designed to maintain the same lower drainage rate of 8-17 ml/hr, but with a smaller overall height and diameter to accommodate patients requiring a smaller valve. The modifications include a reduction in the silicone boot (external envelope) and replacement of the needle stop.
The proposed OSV II LFLP Valve System is available in different configurations in order to accommodate the needs of the patient. A system typically consists of a valve unit, a ventricular (proximal) catheter, and a drainage (distal) catheter. Depending on the configuration, the ventricular catheter is fully radiopaque length markings at 2cm intervals from the tip, or, with a barium stripe and non radiopaque length markers every 1cm. Connectors are designed for use with 1.1 to 1.4 mm inner diameter silicone elastomer tubing.
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)
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
Integra LifeSciences Corporation-Special 510(k) OSV II® Low Flow Low Pro Valve
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 22 2010
Submitter's Name and Address:
.
ﭘﺎﯾﺎ ﮐﮯ ﻧﺎﻡ ﮐﮯ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾ
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Telephone: (609) 654-2873 Facsimile: (609) 275-9445
Contact Person and Telephone Number:
Donna Millisky Regulatory Associate II Integra LifeSciences Corporation Integra NeuroSciences Division Telephone: (609) 936-2454 Facsimile: (609) 275-9445 E-mail: donna.millisky@Integra-LS.com
Date Summary was Prepared: December 22, 2009
Name of the Device:
Trade Names: Common Name: Classification Name: Product Code: Classification Panel:
OSV II® Low Flow Low Pro Valve Central Nervous System Shunt and Components Hydrocephalus Valve JXG Neurology
Device Description:
The proposed OSV II Low Flow Low Pro Valve (OSV II LFLP) and the currently marketed Integra NPH Low Flow Valve System (NPH Valve) are implantable hydrocephalus valve systems for shunting controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, these valves are variable resistance valves which maintain a drainage rate constant within the physiological range for the specified populations and disorders of intracranial pressure. These valves were designed to maintain a lower drainage rate than that of normal CSF production (approximately 20 ml/hr), and are intended to accommodate the needs of patients requiring a drainage rate between 8-17 ml/hr. The proposed OSV II LFLP Valve is designed to maintain the same lower drainage rate of 8-17 ml/hr, but with a smaller overall height and diameter to accommodate the needs of patients requiring a smaller valve.
The proposed OSV II Low Flow Low Pro Valve (OSV II LFLP) is similar to the currently
1
Integra LifeSciences Corporation-Special 510(k) OSV II® Low Flow Low Pro Valve
marketed Integra NPH Low Flow Valve. The proposed valve is designed to maintain the same lower drainage rate of 8-17 ml/hr, but with a smaller overall height and diameter to accommodate patients requiring a smaller valve. The modifications include a reduction in the silicone boot (external envelope) and replacement of the needle stop.
Indications for Use:
:
The Indications For Use for the proposed OSV II Low Flow Low Pro Valve are:
The OSV II Low Flow Low Pro Valve 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.
The proposed OSV II LFLP Valve System is available in different configurations in order to accommodate the needs of the patient. A system typically consists of a valve unit, a ventricular (proximal) catheter, and a drainage (distal) catheter. Depending on the configuration, the ventricular catheter is fully radiopaque length markings at 2cm intervals from the tip, or, with a barium stripe and non radiopaque length markers every 1cm. Connectors are designed for use with 1.1 to 1.4 mm inner diameter silicone elastomer tubing.
Substantial Equivalence:
The proposed OSV II Low Flow Low Pro Valve is substantially equivalent to the currently marketed NPH Valve, which was cleared to market by the United States Food and Drug Administration on September 2, 2004 under K042192. The only differences between the proposed valve and the NPH Valve are the silicone boot (external envelope) and the needle stop. The proposed silicone boot is identical to the current silicone boot in the NPH Valve, but smaller in height and diameter. The needle stop was replaced with a smaller needle stop, which is substantially equivalent to the needle stop used in the currently marketed Contour-Flex Valve System cleared to market by FDA on December 17, 2003 under K033698.
The proposed OSV II LFLP Valve and the NPH Valve are identical in principal of operation, performance specifications, materials of composition, technology, manufacturing and sterilization processes, and packaging. The designs are the same, except that the proposed OSV II LFLP Valve profile is smaller. The current NPH labeling has been revised to reflect the proposed device. The needle stop of the proposed OSV II LFLP and the needle stop of the current Contour-Flex Valve are identical in design, materials, intended use, body contacts and duration of use. The proposed modifications do not change the Indications for Use, the intended use, or the fundamental scientific technology of the devices and they do not raise new issues of safety and effectiveness.
The proposed OSV II LFLP is substantially equivalent to the current NPH Valve (K042192); and the proposed needle stop feature is substantially equivalent to the current needle stop feature of the Contour-Flex Valve (K033698).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. 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 20993-00002
Integra LifeSciences Corp. c/o Ms. Donna Millisky Regulatory Associate II 311 Enterprise Drive Plainsboro, NJ 08536
JAN 22 2010
Re: K093968
Trade/Device Name: OSV II Low Flow Low Pro Valve (Models: 909500P, 909512P, 90S512P, 90S502P)
Regulation Number: 21 CFR 882.5550
Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: II Product Code: JXG Dated: December 22, 2009 Received: December 23, 2009
Dear Ms. Millisky:
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 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); 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.
3
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/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Mishranding 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/cdrh/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html,
Sincerely yours,
R. K. Tani 1/2
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1093968
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: OSV II® Low Flow Low Pro Valve
Indications for Use:
The OSV II® Low Flow Low Pro Valve 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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joe HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093968
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