(319 days)
No
The device description focuses on mechanical components and pressure sensing, with no mention of AI/ML terms or data processing that would suggest such technology.
Yes
The device is used for direct measurement of intracranial pressure and CSF drainage, which are medical interventions aimed at treating a patient's condition.
Yes
Explanation: The device is used for "direct measurement of intracranial pressure," which is a diagnostic activity.
No
The device description clearly outlines multiple hardware components including a ventricular catheter, probes, a bolt, a pressure sensor (air-based system with a deformable chamber), an external transducer, procedure accessories, a device for setting probe length, a tripod, tubes, a drill bit stop, and a pump. This is not a software-only device.
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.
- Device Function: The description clearly states the device is used for the direct measurement of intracranial pressure and CSF drainage within the patient's brain. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- Intended Use: The intended use is for direct clinical management based on physiological measurements within the patient.
Therefore, this device falls under the category of a medical device used for monitoring and intervention within the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The use of a Trilogy system by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care and when data from one or more parameters may be deemed useful in providing optimum patient management.
Product codes (comma separated list FDA assigned to the subject device)
GWM
Device Description
This submittal covers a device that allows the placement of a ventricular catheter and up to three probes through one bolt. The pressure sensor is an air-based system that has a deformable chamber. The pressure in the chamber mirrors ICP. It is transmitted to an external transducer. The submittal also includes several procedure accessories, a device that sets the proper length of a probe to be inserted into the Trilogy, a tripod that indicates the correct drill angle, a series of tubes that fit on the shank of the bolt that cause the distal end of the bolt to stop when it reaches the inner table, an improved drill bit stop and an improved pump that injects air into the catheter's sensing system.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
brain, skull, ventricle, parenchymal tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified neurosurgeon
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): 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.
K072379 MPS Oxiport Plus.
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.
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
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).
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083378
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SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Submitted by: InnerSpace 1622 Edinger Ave. Suite C, Tustin CA 92780 Ph 714 259 7900 Fax 714 259 7999
Contact person: Don Bobo (dbobo@innerspacemedical.com)
Approved 510K Device Name: MPS Oxiport and MPS Oxiport Plus
New Device Names: Trilogy
Predicate Device Predicate device: K072379 MPS Oxiport Plus.
Summary
This submittal covers a device that allows the placement of a ventricular catheter and up to three probes through one bolt. The pressure sensor is an air-based system that has a deformable chamber. The pressure in the chamber mirrors ICP. It is transmitted to an external transducer. The submittal also includes several procedure accessories, a device that sets the proper length of a probe to be inserted into the Trilogy, a tripod that indicates the correct drill angle, a series of tubes that fit on the shank of the bolt that cause the distal end of the bolt to stop when it reaches the inner table, an improved drill bit stop and an improved pump that injects air into the catheter's sensing system.
Device modifications
Three probe capability
The present design provides the ability to guide 2 probes into the brain. A 3rd probe capability has been added to the manifold through which probes pass en route to the brain. The manifold is a component that snaps into a well in the bolt. The pigtails through which the probe will pass are bonded to the top of the manifold. The probe guidance features extend from the distal face of the manifold body. The guidance system provides two functions, that of guiding the probe to the brain and that of changing the probe's trajectory to direct it away from tissue disturbed by the ventricular catheter. The present manifold incorporates both functions in a single injection-molded part. A straight section guides the catheter to the brain and a curved segment molded into the distal end of the guide tube changes the trajectory of the probe. The modified manifold, in contrast, uses a separate part for each function. A thin-wall tube guides the probe to the brain. A second tube is used to change the trajectory of the probe. The guide tube is bonded to the
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distal side of the main body of the manifold. It enters the brain when the manifold is placed in the bolt. Once the guide tube is in place, the 2nd tube is inserted through the guide tube. As it exits the guide tube, it forms a curved shape that will define the trajectory of the probe as it passes through the curve. The second tube in essence acts as an introducer for a probe that is to be inserted into the brain. The exact trajectory of a probe is defined by a key and keyway design. The introducer has a small axial ridge that acts as a key. The body of the manifold has a keyway. The user must align the key and keyway to advance the introducer through the guide tube. The orientation of the keyway thereby defines the exit direction of the introducer. The design is particularly compact. The brain volume displaced by the 3-probe manifold design that uses two thin-wall tubes is the same as that of the 2-probe injection molded design used in the present device. The bolt diameter is enlarged 10% to provide the space required to accommodate a third pigtail on top of the body of the manifold.
Pressure Sensor
This modification involves moving the sensor high enough on the catheter that it does not enter the ventricle. Moving the sensor into parenchymal tissue addresses a problem common to all ventricular catheters. If CSF is over drained, the ventricular wall will collapse around the catheter. Should this happen, CSF cannot be drained nor pressure read. This modification solves the slit ventricle problem by placing the sensor high enough on the catheter that it never gets into the ventricle. The ability of the sensor to work in parenchymal tissue is described in K003905.
The sensor uses the same dip-molded bladder as used in the present MPS. The end of the bladder is cut off thereby forming an opened ended tube. The sensor is manufactured by bonding a ring on the catheter on either side of a hole leading to the air lumen. The bladder is placed over the rings and then bonded to them. The principle of operation is unchanged, i.e., it is a variable volume sensor based on Boyle's Law.
Evolutionary Modifications Entered For The Record
The system has evolved in minor ways since the approved K072379. They are entered for the record.
Air Injection System
The pressure sensor consists of a partially filled bladder that transmits pressure via an airline to an external transducer. The bladder needs to be recharged once per shift to compensate for air lost by diffusion. As described in the prior submission and IFU, the sensor is unable to read pressure if it is recharged when ICP is This drawing shows the catheter, guide tube, introducer and probe when the probe placement procedure is completed. The thin wall guide tubes are more space efficient than an injection molded part. The footprint of the 3-probe design of the modified device is therefore similar to that of the current 2-probe design. The modified manifold requires a 10% larger diameter bolt to make room for the 3rd pigtail on the top face of the manifold.
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Probes must sometimes be moved several mm at times in order Measuring tube to find a suitable monitoring site. The probes are therefore fixed to the introducer by a T-B fitting. A measuring tube sets the length of the probe that will enter the brain. The measuring tube is a polyurethane tube that has been pushed on the distal end of the T-B. The probe is passed through the T-B until it reaches the end of the measuring tube. The T-B is the tightened. The TB with probe attached is pulled from the tube and inserted into the introducer. A drawing of the tube is presented in Set 2 of the drawings.
The placement procedure once the bolt is in place is as follows. A catheter is passed through the bolt and placed in a ventricle. The manifold is then moved down the catheter and snapped to the bolt. The guide tubes of the manifold pass 2 mm below the dura. When the surgeon elects to place a probe, an introducer is placed through the guide tube and its luer joined to the luer of the pigtail that leads to the guide tube. Next, the probe is passed through the introducer. The T-B luer is connected to the luer of the introducer and tightened.
Drawings - Set 2 Evolutionary changes
The following drawings describe several evolutionary changes in the system since the original 510 (k) submission and are set forth as a matter of record
Image /page/4/Picture/6 description: The image shows a close-up of a mechanical device, possibly a switch or sensor, with a metallic or dark-colored housing. A long, thin lever or arm extends from one side of the device, suggesting it is activated by movement or pressure. The device has a complex structure with multiple components, including what appears to be a small roller or wheel on one side and electrical connectors on another, indicating it is part of a larger system or circuit.
Air Management System The air in the sensor is recharged once per shift to replace air lost by diffusion. The amount of air remaining in the sensor at the time the sensor is open to air varies with the extent to which the ICP has collapsed it. If ICP is