(108 days)
ShuntCheck is an aid to the detection of flow in implanted cerebrospinal fluid (CSF) shunts. ShuntCheck includes Micro-Pumper, a component which may be used to temporarily increase CSF flow in suspected non-flowing, patent shunts during the ShuntCheck test. ShuntCheck cannot alone diagnose CSF shunt function or malfunction. The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheck, should be made only by a qualified neurosurgeon.
ShuntCheck is a non-invasive device which detects flow in a CSF shunt via transcutaneous thermal dilution. The device consists of a single use disposable thermosensor array patch which is connected to a data acquisition unit (a DAQ) which is connected to a laptop or tablet computer. The device also includes a Micro-Pumper which vibrates the shunt valve during the test procedure to generate a temporary increase in flow in patent but temporarily non-flowing shunts. The shunt is cooled transcutaneously by placing an instant ice pack over the shunt cephalic to the thermosensor. The thermosensor array patch, which is placed on the skin over the shunt "downstream" of the ice, reads the change in skin temperature over the shunt as cooled fluid flows downstream and also at a two nearby control locations. Data is transferred through the DAQ and captured in the computer. If the device detects a characteristic downstream transcutaneous temperature dip, the computer reports "flow confirmed" and presents a time-temperature graph of test data. If no temperature dip is detected, the unit reports "flow not confirmed" and presents a time-temperature graph.
The ShuntCheck III device is intended as an aid to detect flow in implanted cerebrospinal fluid (CSF) shunts. The study presented is a 510(k) submission for substantial equivalence to a predicate device, ShuntCheck v2.2. The evaluation includes both bench testing and limited clinical testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (ShuntCheck III) | Reported Device Performance (ShuntCheck III) |
|---|---|---|
| Bench Testing without Micro-Pumper | ||
| Detect flow of 10 ml/hr | Not explicitly defined, but predicate was 100% accurate | 100% (100% accurate) |
| Detect flow of 0 ml/hr | Not explicitly defined, but predicate was 0% accurate | 0% (100% accurate) |
| Threshold of detection | Not explicitly defined, but predicate was 5-7.5 ml/hr | Between 3.5 and 5 ml/hr (Improved) |
| Detect 10 ml/hr flow with 20° rotation misalignment | Not explicitly defined, but predicate was 0% | 100% (Improved) |
| Detect 10 ml/hr flow with 4mm lateral misplacement | Not explicitly defined, but predicate was 0% | 100% (Improved) |
| Bench Testing with Micro-Pumper | ||
| Shunt flow generated by Micro-Pumper (patent, non-flowing shunts at 0 ICP) | Generate flow in patent shunts, but not in occluded. No overdrainage. | 0.3 to 0.9 cc (Flow in patent non-flowing shunts) |
| Shunt flow generated by Micro-Pumper (clogged shunts) | Generate flow in patent shunts, but not in occluded. No overdrainage. | 0.0 to 0.03 cc (Flow in clogged shunts) |
| Max flow generated by Micro-Pumper (patent flowing shunts) | Generate flow in patent shunts, but not in occluded. No overdrainage. | 0.9 to 2.8 cc |
| Impact on shunt valve function (change in natural flow) |
§ 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).