(291 days)
Not Found
No
The description focuses on the mechanical function of a variable resistance valve for CSF drainage and does not mention any computational or learning components.
Yes
The device is explicitly described as an "implantable system used in the treatment of patients with hydrocephalus" to shunt CSF, which signifies its role in managing a medical condition.
No
Explanation: The Integra Flow Regulating Valve Systems are implantable devices designed to shunt cerebrospinal fluid and regulate its drainage, classifying them as therapeutic devices rather than diagnostic ones. They are used for treatment of hydrocephalus, not for diagnosis.
No
The device is described as an implantable system consisting of physical components like catheters and valves, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The Integra Flow Regulating Valve Systems are described as implantable systems used to shunt CSF from one part of the body to another. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly states the device is used in the treatment of patients with hydrocephalus by shunting CSF. This is a therapeutic purpose.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic information being generated by the device.
Therefore, the Integra Flow Regulating Valve Systems are medical devices used for treatment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Models for ventricular application:
The Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with hydocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
Models for lumbar application:
The Lumbar Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The Integra Flow Regulating Hydrocephalus Valve Systems are implantable devices for controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium (ventricular application) or from the lumbar subarachnoid region to the peritoneal cavity (lumbar application). Unlike conventional valves, these are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure. The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension.
The various models include two flow regulating ranges, two antechamber sizes, and various accessories allowing either a ventricular or a lumbar application. The two flow regulating ranges are:
Standard flow regulating: maintains a drainage rate close to the normal CSF secretion rate, around 20ml/hr (18-30ml/h).
Low flow regulating: maintains a lower drainage rate than OSV II Valve Systems, around 10ml/hr (8-17ml/h).
The systems are available in different configurations. A system generally consists of a ventricular or lumbar (proximal) catheter, a valve unit, and a drainage (distal) catheter. Some configurations contain an antechamber (standard or low profile) or a burr hole cap.
Various accessories are available for the implantation procedure or to be implanted in addition to the valves.
All products are sold sterilized, for single use only.
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, lumbar subarachnoid region
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)
Nonclinical tests were submitted, including Load Testing (up to 15N), Water Testing (at 37℃ for 28 days), and Biocompatibility testing (Sensitization ISO 10993-10:2010, Genotoxicity ISO 10993-3:2003, Pyrogen USP35, NF30). Additional testing was conducted for MR Conditional status, including Radio Frequency Induced Heating Test ASTM F2182-09, MR Image Artifacts ASTM F2119-07, Magnetically Induced Displacement Force test ASTM F2052-06e1, and Magnetically Induced Torque Test ASTM F2213-06. The biocompatibility testing and design verification testing verified that the change of glue (from the predicate device) has no impact on product specifications, performance, and reliability.
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.
K042192, K081773, K093968, K092395
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2015
Integra Lifesciences Corporation Janet Kay Director, Regulatory Affairs 22 Terry Avenue Burlington, Massachusetts 01803
Re: K140722
Trade/Device Name: OSV II Valve Systems, Integra Flow Regulating Valve Low Flow Valve Systems 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, 2014 Received: December 24, 2014
Dear Ms. Kay,
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 (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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena =5/△
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140722
Device Name OSV II Valve Systems Integra Flow Regulating Valve Low Flow Valve Systems
Indications for Use (Describe)
Models for ventricular application:
The Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with hydocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
Models for lumbar application:
The Lumbar Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| 807.92(a)(1) - Submitter information | ||
|---|---|---|
| Name | Integra LifeSciences Corporation | |
| Address | 22 Terry Avenue | |
| Burlington, MA 01830 | ||
| Phone Number | (781) 565-1347 | |
| Fax Number | (781) 238-0645 | |
| Establishment | ||
| Registration Number | 1222895 | |
| Name of Contact Person | Janet Kay | |
| Date Prepared | January 5, 2015 | |
| 807.92(a)(2) – Name of device | ||
| Trade or Propriety Names | OSV II® Valve Systems | |
| Integra Flow Regulating Valve Low Flow Valve Systems | ||
| Common or Usual Name | Hydrocephalus Shunt System and Components | |
| Classification Name | Central Nervous System Fluid Shunt and Components | |
| Classification Panel | Neurology | |
| Regulation | Class II, under 21 CFR 882.5550 | |
| Product Code(s) | JXG | |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | ||
| Equivalence is claimed to current Integra Flow Regulating Valves cleared under the | ||
| following Premarket Notifications: | ||
| K042192 - Integra Flow Regulating Valve Low Flow (Standard) | ||
| K081773 – OSV II and OSV II Low Pro | ||
| K093968- Integra Flow Regulating Valve Low Flow (Mini) | ||
| K092395 - OSV II Lumbar and Integra Flow Regulating Valve Low Flow (Lumbar) | ||
| 807.92(a)(4) - Device description | ||
| The Integra Flow Regulating Hydrocephalus Valve Systems are implantable devices for | ||
| controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity | ||
| or other appropriate drainage site such as the heart's right atrium (ventricular application) | ||
| or from the lumbar subarachnoid region to the peritoneal cavity (lumbar application). | ||
| Unlike conventional valves, these are variable resistance valves which maintain a | ||
| 807.92(a)(5) – Intended use of the device | ||
| Indications for Use | ||
| Models for ventricular application: | ||
| The Integra Flow Regulating Valve Systems are implantable | ||
| systems 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. | ||
| Models for lumbar application: | ||
| The Lumbar Integra Flow Regulating Valve Systems are | ||
| implantable systems used in the treatment of patients with | ||
| communicating hydrocephalus to shunt CSF from the | ||
| lumbar subarachnoid region to the peritoneal cavity. |
drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure. The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension.
The various models include two flow regulating ranges, two antechamber sizes, and
4
various accessories allowing either a ventricular or a lumbar application. The two flow regulating ranges are:
Standard flow regulating: maintains a drainage rate close to the normal CSF secretion rate, around 20ml/hr (18-30ml/h).
Low flow regulating: maintains a lower drainage rate than OSV II Valve Systems, around 10ml/hr (8-17ml/h).
The systems are available in different configurations. A system generally consists of a ventricular or lumbar (proximal) catheter, a valve unit, and a drainage (distal) catheter. Some configurations contain an antechamber (standard or low profile) or a burr hole cap.
Various accessories are available for the implantation procedure or to be implanted in addition to the valves.
All products are sold sterilized, for single use only
807.92(a)(5) - Intended use of the device
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
The modified devices have the same design, materials (except a change of epoxy glue), indications, contraindications, packaging, manufacturing and sterilization processes as the predicate devices. There is no change to the products except for the epoxy glue.
807.92(b)(1-2) – Nonclinical tests submitted
The following tests were performed and described below. Samples were environmentally conditioned, aged, and 2x sterilized by Ethylene Oxide.
Load Testing Load testing was conducted up to 15N (1.5kg).
Water Test
5
Water testing was conducted at 37℃ for 28 days.
Biocompatibility testing
The biocompatibility evaluation for the modification to the Integra Flow Regulating Valve Systems (Integra Flow Regulating Valve Low Flow (Standard), OSV II and OSV II Low Pro and Integra Flow Regulating Valve Low Flow (Mini)) and the Lumbar Integra Flow Regulating Valve Systems (OSV II Lumbar and Integra Flow Regulating Valve Low Flow (Lumbar)) devices were conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
| Sensitization | ISO 10993-10:2010 |
|---|---|
| Genotoxicity | |
| Bacterial Reverse Mutation Study | ISO 10993-3:2003 |
| In Vitro Chromosomal Aberration Study in Mammalian Cells | ISO 10993-3:2003 |
| Mouse Peripheral Blood Micronucleus Test | ISO 10993-3:2003 |
| Pyrogen | |
| Rabbit Pyrogen Study | USP35, NF30 |
The flow regulating valve systems are considered implantable devices. tissue and/or bone contacting and are permanent implants (>30 days). The biocompatibility testing and design verification testing have verified that the change of glue has no impact on the product specifications, performance and reliability.
Additional testing was conducted and concluded to the MR Conditional status of the valves. The battery of testing included the following tests: Radio Frequency Induced Heating Test ASTM F2182-09 MR Image Artifacts ASTM F2119-07 Magnetically Induced Displacement Force test ASTM F2052-06e1 Magnetically Induced Torque Test ASTM F2213-06
807.92(b)(3) - Conclusions drawn from non-clinical data
The predicate devices were cleared based on the results of non-clinical data. The modified devices and predicate device performance data were compared to support the safety of the modified devices and demonstrate that the Integra Flow Regulating Hydrocephalus Valve Systems should perform as intended in the specified use conditions.