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510(k) Data Aggregation
(147 days)
LPV II Valves and Kits
The Standard-LPV II and Mini-LPV II Valves, utilized in the treatment of hydrocephalic patients in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. The Mini-LPV II Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.
Novus Valves and Kits
The Novus and Novus Mini Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum. The Novus Mini Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients. Valves with a Physiological Flow Device are intended to reduce the hazard of negative intraventricular pressure (with respect to atmospheric pressure) when the patient is sitting, standing or semi-recumbent.
Multi-Purpose Valve
The Multi-Purpose Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the perioneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.
Mishler Dual Chamber Valve with Integral Connectors
The Mishler Dual Chamber Flushing Valve, Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.
Pudenz Flushing Valve with Integral Connectors
The Pudenz Flushing Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the intraventricular pressure when the patient is sitting, semi-recumbent or standing.
Ultra VS In-Line Valve System
The Ultra VS In-Line Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles into either the peritoneal cavity or the right atrium of the heart. The in-line and burr-hole systems are designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneal cavity. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated. The Small and Neonate Models can be used in (but are not restricted to) situations where skin erosion may be a problem, as with premature infants, pediatric patients and older patients.
Pudenz Cardiac and Infant Catheter
The Pudenz Cardiac Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart. The Infant Cardiac Catheter is utilized when the common facial and/or internal jugular veins are too small to accommodate the larger cardiac catheter.
Pudenz Ventricular Catheter
The Pudenz Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum.
Pudenz Peritoneal Catheter
The Pudenz Peritoneal Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventriculoperitoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.
Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter With Slits
The Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter with Slits, utilized in the treatment of hydrocephalic patients, are components for systems designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.
Portnoy Ventricular Catheter
The Portnoy Ventricular Catheter, utilized in the treatments, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Neuroview Endoscopic Ventricular Catheter
The Neuroview Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Integra CSF Reservoir with Integral Connectors
The Integra CSF Reservoir provides access to the lateral cerebral ventricles via hypodermic puncture for sampling and/or injection of fluids. It is useful in obtaining CSF samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The Convertible Integra CSF Reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Essential Shunt Kit Burr Hole Design
The CSF Control Valve, utilized in the treatments, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum.
Essential Shunt Kit Flat Bottom Design
The Essential Shunt Kit – Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. The Essential Shunt Kit – Flat Bottom Design, can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.
Connectors for Neurosurgical Use
Integra connectors are utilized principally in the treatment of hydrocephalic patients, as components in systems designed to shunt cerebrospinal fluid from the lateral cerebral ventricles of the right atrium of the heart or the peritoneum.
On-Off Flushing Reservoirs
The On-Off Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the peritoneum. Reservoirs with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.
Braden Flushing Reservoir
The Braden Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Foltz Flushing Reservoir
The Foltz Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Anti-Siphon Device
The Anti-Siphon Device, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the heart or the peritoneum. The device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when the patient is in a sitting, standing or erect position.
Integra Neurological Shunts and Accessories are used in the treatment of hydrocephalus. Hydrocephalus is commonly treated by creating a CSF flow pathway from a cerebral ventricle to the peritoneal spaces in the abdomen or to the right atrium of the heart. This is commonly referred to as "shunting". Integra markets a full line of products for CSF shunting procedures including catheters, valves, reservoir devices, connectors and accessories to aid in implantation.
A shunt system may comprise of a catheter, valve, reservoir and connectors, depending on clinician preference and use. In practice, a catheter is implanted into the space where CSF drainage is necessary (ventricles of the brain or lumbar subarachnoid space) and connected to a valve. The valve is used to control the CSF drainage rate. The other side of the valve is connected to a catheter which is placed to allow drainage to the desired site, typically the right atrium of the heart or the peritoneal cavity. As needed, a clinician may also incorporate a reservoir, for a closed ventricular access site, and/or additional connectors into the shunt system.
Catheters are silicone elastomer and some models are made from high durometer silicone elastomer. Valve mechanisms are categorized as diaphragm and miter. For diaphragm valves, the mechanism is an umbrella shaped component oriented at right angles to the flow path. Miter valves incorporates two silicone flaps in the shape of a duckbill. The flaps part in response to a pressure differential to allow flow. Some vales are available with low, medium or high closing pressure ranges and some contain an anti-siphon component. Reservoirs are available as standard or side-inlet or convertible and in various sizes; some have an on-off flushing feature. A variety of connectors, made of nylon or silicone elastomer material, are also available.
The provided text describes a 510(k) summary for Integra Neurological Shunts and Accessories. The summary focuses on establishing substantial equivalence to previously marketed devices, particularly regarding the addition of MRI safety information.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Focus of the Study: MRI Safety Information
The key aspect of the study described is the demonstration of MRI safety for the Integra Neurological Shunts and Accessories. The acceptance criteria and testing are designed to support an "MR Conditional" claim on the device labeling.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Magnetically Induced Displacement Force (ASTM F2052-06e1): Amount of magnetically induced force on the device is less than or equal to the force on the device due to gravity. | The magnetically induced force for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environments, thus supporting the MR Conditional claim. The maximum acceptable spatial gradient was determined on the basis of the component with the largest deflection, and is listed in the labeling. |
| Magnetically Induced Torque Test (ASTM F2213-06): Amount of magnetically induced torque on the device is less than or equal to the gravitational torque. | The magnetically induced torque for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environments, thus supporting the MR Conditional claim. |
| RF Heating Test (ASTM F2182-09): No portion of the implanted device exhibits an increase in temperature of more than 2℃ at a whole body averaged specific absorption rate (SAR) of 2W/kg and head average SAR of 3.2 W/kg (Normal Operating Mode). | All tested implants met this acceptance criterion. The labeling includes a statement that the expected temperature rise is less than 0.4℃ after 15 minutes of continuous scanning (in both 1.5 T and 3.0 T MR environments). |
2. Sample Size Used for the Test Set and Data Provenance
The text does not specify a numerical "sample size" in terms of number of individual devices tested. It refers to "the devices" or "all tested implants" for the RF Heating Test, implying that representative samples of the various Integra Neurological Shunts and Accessories products listed were tested. The data provenance is described as non-clinical testing performed by the applicant, Integra LifeSciences Corporation, in a laboratory setting to demonstrate MRI compatibility. There is no mention of country of origin of data or retrospective/prospective clinical data for these specific tests, as they are engineering/physical property tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to the non-clinical engineering tests performed for MRI safety. Ground truth in this context is established by the physical laws and measurement protocols defined by the ASTM standards.
4. Adjudication Method for the Test Set
This is not applicable. The data from these tests are quantitative measurements against predefined criteria, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The document describes non-clinical engineering tests related to MRI safety, not a clinical study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (shunts and accessories), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
The ground truth for these non-clinical tests is based on:
- ASTM Standard Operating Procedures and Definitions: For displacement force (ASTM F2052-06e1), torque (ASTM F2213-06), and RF heating (ASTM F2182-09). These standards define how the measurements are taken and what constitutes safe limits.
- Physical Properties: The inherent physical response of the device materials to magnetic fields and radiofrequency energy.
There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for these MRI safety tests.
8. The Sample Size for the Training Set
This is not applicable. There is no training set mentioned or implied, as the described tests are non-clinical hardware evaluation, not a machine learning model development.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
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