(155 days)
Integra DP Valve Systems are implantable devices which serve as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired. The very low pressure valve (blue band) is used for postoperative drainage of hygromas and other extraventricular conditions.
Burr Hole Reservoirs: Hydrocephalus valve components are elements used in the implantation of hydrocephalus valve systems. In addition, the burr hole reservoir may be used in conjunction with a ventricular catheter to access ventricular CSF.
Gravity Compensating Accessory: The Gravity Compensating Accessory is an implantable device which is implanted in series with a hydrocephalus valve to control cerebrospinal fluid (CSF) drainage from the cerebral ventricles to an appropriate drainage site. It is designed to minimize the excessive reduction in intraventricular pressure (relative to atmosphere) and CSF volume caused by the "pull" exerted by the fluid column within the outflow catheter when the patient is sitting or standing.
The Integra DP™ Valve Systems are implantable central nervous system fluid shunt devices which incorporate two ball-in-cone valve mechanisms. They provide constant differential pressure across the valve and continuous, controlled drainage of cerebrospinal fluid (CSF) from the cerebral ventricles to the peritoneal cavity (or another appropriate drainage site). Each unidirectional valve unit consists of two ball-in-cone valve mechanisms, each enclosed in a stainless steel housing. In each ball-in-cone valve mechanism, a synthetic ruby ball is held against a cone-shaped, stainless steel seat by a stainless steel spring.
The tension of the spring determines the operating pressure of the valve. Depending on the CSF flow rate and/or the viscosity, the ball moves back and forth within the cone under the control of the spring. As the ball moves, the effective cross section of the valve through which CSF flows increases or decreases. Thus, the size of the valve opening is adjusted automatically, and the differential pressure is controlled.
A variety of system configurations are available (Standard Valve Systems, Pediatric Valve Systems, Burr Hole Shunt Systems, Valve Unit only). Most valve systems include the necessary components required for an implantation procedure (such as peritoneal and ventricular catheters, plastic subcutaneous tube passers, introducing rod, and connectors). Several color-coded pressure ranges are offered.
The Burr Hole Reservoir is a component of a central nervous system fluid shunt. It is used to connect the ventricular catheter to a silicone elastomer burr hole reservoir cap with integral side-arm leading to the valve tubing. In this configuration, it serves to transmit CSF from this catheter to the valve. It may also be used as a CSF reservoir with a ventricular catheter alone when a burr hole cap without side-arm is used. This reservoir facilitates CSF sampling or intracranial pressure measurement when the burr hole reservoir cap is punctured with a small gauge needle. Configurations include 6.4 mm or 10 mm outer diameter reservoir and regular (2.5 mm) or shallow (0.8 mm) depth. The Burr Hole reservoirs are included as a part of the Integra DPTM Burr Hole Shunt System, or the Burr Hole reservoir and cap can be ordered separately.
The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity's effects on the fluid column within the outflow (drainage) catheter of an implanted shunt system. The GCA can be placed anywhere deemed appropriate by the surgeon along the distal shunt tubing. Its operating characteristics are not dependent on its location along the tubing.
The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. Each ball contributes resistance to flow within the system. Depending on the number of balls, resistance to flow is added to the resistance of the implanted valve system when the patient assumes a vertical posture. In the horizontal orientation, a minimal resistance to flow is added to the svstem.
Based on the provided text, the document is a 510(k) premarket notification for the Integra DP Valve Systems and Gravity Compensating Accessory. It focuses on demonstrating substantial equivalence to previously marketed predicate devices, particularly regarding the addition of MRI safety information to the labeling.
The document does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, I cannot provide information on the following points:
- 1. A table of acceptance criteria and the reported device performance: The document describes non-clinical testing for MRI compatibility, not performance criteria for an AI device. The "acceptance criteria" mentioned relate to physical properties (e.g., magnetically induced displacement force, torque, temperature increase).
- 2. Sample size used for the test set and the data provenance: No test set for an AI model is described. The "samples" refer to physical devices undergoing MRI compatibility tests.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable as there's no AI model or human reading component described.
- 4. Adjudication method: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: No such study is described.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable for an AI device. The "ground truth" for the physical device testing is the adherence to ASTM standards and accepted physical limits.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
However, I can extract information related to the non-clinical testing performed for MRI labeling, which serves as the "study that proves the device meets the acceptance criteria" in this specific context:
Acceptance Criteria and Study for MRI Compatibility of Integra DP Valve Systems
The study described is a series of non-clinical tests performed to support MRI Safety Labeling for the Integra DP™ Valve Systems, Burr Hole Reservoirs, Gravity Compensating Accessory, and associated connectors. The purpose was to demonstrate that the devices are MR Conditional, meaning they can be safely used in an MRI environment under specific conditions.
1. Table of Acceptance Criteria and Reported Device Performance (for MRI Compatibility):
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Magnetically Induced Displacement Force (ASTM F2052-06e1) | 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 Integra DPTM Valve Systems, Burr Hole Reservoirs, Gravity Compensating Accessory, and connectors were considered to meet the acceptance criteria in both 1.5T and 3.0T MR environment, 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 our labeling." |
| Magnetically Induced Torque Test (ASTM F2213-06) | Magnetically induced torque on the device is less than or equal to the gravitational torque. | "The magnetically induced torque for the Integra DPTM Valve Systems, Burr Hole Reservoirs, Gravity Compensating Accessory, and connectors were 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, thus supporting the MR Conditional Claim. Our labeling includes a statement on RF heating 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)." |
| Image Artifact Test (ASTM F2119-07) | (Implicit: Characterize artifacts for labeling) | "Image Artifact information was collected for the devices in both 1.5T and 3.0T MR environments. For each device, scans were made in three planes (sagittal, coronal, and axial) for T1 weighted Spin Echo. Our labeling lists the worst-case image artifact for T1 weighted Spin Echo." |
| Functionality Verification Test (Internal Procedures) | MR exposure had no impact on the functionality (pressure-flow characteristics) of the valves. | "Results demonstrated that MR exposure had no impact on the functionality of the valves, thus supporting the MR Conditional claim." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document implies that "All tested implants" and various components (Integra DP™ Valve Systems, Burr Hole Reservoirs, Gravity Compensating Accessory, and connectors) were included in the testing. However, specific numerical sample sizes for each test or component are not stated in the provided text.
- Data Provenance: This refers to non-clinical laboratory testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA. The tests are prospective in nature, as they involve actively performing experiments
on devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This question is not applicable as the ground truth is established by physical measurements and adherence to international standards (ASTM). No human expert interpretation of images or clinical data is described as part of these tests.
4. Adjudication Method:
- None described. The tests are objective physical measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This submission pertains to physical device attributes and MRI compatibility, not the comparative effectiveness of a diagnostic algorithm or human interpretation.
6. If a Standalone Performance Study was done:
- Yes, in essence. The entire set of tests are "standalone" in the sense that they evaluate the physical device's characteristics in an MRI environment, independent of human interaction or a complex AI algorithm interpreting data. The "functionality verification test" specifically checks the device's performance (pressure-flow characteristics) after MRI exposure.
7. The Type of Ground Truth Used:
- For the physical tests, the "ground truth" is defined by the acceptance criteria established by recognized standards (ASTM F2052-06e1, ASTM F2213-06, ASTM F2182-09, ASTM F2119-07) and internal procedures for functionality. These standards define the acceptable physical limits for MRI compatibility.
8. The Sample Size for the Training Set:
- Not applicable. This submission describes the testing of a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. See point 8.
§ 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).