(108 days)
Not Found
No
The description focuses on thermal dilution and data acquisition, with no mention of AI/ML algorithms for data analysis or interpretation. The decision logic appears to be based on a simple threshold ("characteristic downstream transcutaneous temperature dip").
No
The device aids in the detection of flow in CSF shunts but does not directly treat or prevent a disease or condition. It is a diagnostic aid.
Yes
Explanation: The "Intended Use / Indications for Use" states that ShuntCheck is "an aid to the detection of flow in implanted cerebrospinal fluid (CSF) shunts." While it explicitly states that it "cannot alone diagnose CSF shunt function or malfunction," it provides information (flow vs. no flow) that is used by a qualified neurosurgeon to make a clinical diagnosis. This role of providing data for diagnosis qualifies it as a diagnostic device.
No
The device description explicitly states that ShuntCheck consists of hardware components including a single use disposable thermosensor array patch, a data acquisition unit (DAQ), a laptop or tablet computer, and a Micro-Pumper. While software is involved in data capture and reporting, it is not the sole component of the medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of ShuntCheck clearly states it is a non-invasive device that detects flow in a CSF shunt via transcutaneous thermal dilution. It uses a thermosensor placed on the skin and an ice pack applied externally. There is no mention of collecting or analyzing any biological specimens from the patient.
- The intended use is to aid in the detection of flow in implanted cerebrospinal fluid shunts. This is a measurement of a physiological process (fluid flow) within the body, not an analysis of a biological sample.
Therefore, ShuntCheck falls outside the definition of an In Vitro Diagnostic device. It is a non-invasive diagnostic device that measures a physical parameter (temperature change related to fluid flow) externally.
N/A
Intended Use / Indications for Use
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 generate flow in suspected temporarily 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thermosensor on clavicle
Ice above sensor
Micro-Pumping on shunt valve (on scalp)
Indicated Patient Age Range
The Micro-Pumper should not be used when conducting ShuntCheck tests on patients under the age of five, patients with small or slit ventricles or where the ventricular catheter tip is within the brain parenchyma.
Intended User / Care Setting
Neurosurgery clinic, hospital emergency department
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)
Functional and Safety Non-Clinical Testing:
ShuntCheck Bench Testing without Micro-Pumper:
- Test of occluded shunt (no flow) - 0% detection
- Test of patent, non-flowing shunt with Micro-Pumper generated flow of 15 to 100 ml/hr - 100% detection
- Test of patent flowing shunt with Micro-Pumper generated flow of 15 to 200 ml/hr - 100% detection
- Detect flow of 10 ml/hr: 100% (100% accurate)
- Detect flow of 0 ml/hr: 0% (100% accurate)
- Threshold of detection: Between 3.5 and 5 ml/hr
- Detect 10 ml/hr flow with sensor misalignment: 100% at 20° rotation, 100% at 4mm lateral misplacement
ShuntCheck Bench Testing with Micro-Pumper: - Shunt flow generated by 60 second Micro-Pumper application: Testing of eight shunt valves: Flow in patent non-flowing shunts (at 0 ICP) 0.3 to 0.9 cc. Flow in clogged shunts 0.0 to 0.03 cc. Maximum flow (in patent flowing shunts) 0.9 to 2.8 cc. These results indicate that Micro-Pumper generates flow in a patent, non-flowing shunts but does not generate flow in occluded shunts. It does not generate sufficient flow to cause overdrainage.
- Micro-Pumper Impact on shunt valve function: Testing of eight shunt valves - Change in natural flow pre vs post Micro-Pumping
§ 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
mar 0 7 2013
K123554, page 1 of 6
5.0 510(k) Summary
The proposed device, ShuntCheck III is substantially equivalent to its predicate, ShuntCheck v2.2 (K080168) by virtue of a common indication for use and similar technical characteristics. Performance test results confirm that ShuntCheck III performed as intended and that minor differences from the predicate device do not impact safety or effectiveness.
| Submitter: | NeuroDx Development LLC 3333 Street Rd, Suite 210, Bensalem PA
19020 | |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Frederick J. Fritz, CEO, 609-865-4426 (telephone) 215-645-1268(fax) | |
| Date Prepared: | October 2, 2012 | |
| Trade Name: | ShuntCheck | |
| Classification: | Class II
Central Nervous System Fluid Shunt and Components
21 CFR 882.5550 | |
| Product Code: | JXG | |
| Predicate
Device(s): | The subject device is equivalent to the following devices:
ShuntCheck (version 2.2) (K080168) | |
| Device
Description: | 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. | |
| | ShuntCheck III | ShuntCheck v2.2 |
| Indications for
Use: | 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
generate flow in suspected
temporarily 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 an aid to the
detection of flow in implanted
cerebrospinal fluid (CSF) shunts.
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. |
| Contraindications | The Micro-Pumper should not be used when conducting ShuntCheck tests
on patients under the age of five, patients with small or slit ventricles or | |
| | where the ventricular catheter tip is within the brain parenchyma. | |
| Substantial
Equivalence of
Technological
Characteristics | ShuntCheck III and its predicate ShuntCheck v2.2 detect flow through CSF
shunts via transcutaneous thermal dilution.
Both utilize an external cooling source to cool the skin over the shunt. Both
utilize a single use disposable thermosensor patch comprised of multiple
thermistors which adheres to the patient's skin via medical grade adhesive
to monitor skin temperature directly over the shunt and at separate control
skin locations.
Both employ an electronic unit which conditions, amplifies and converts the
thermosensor signal to digital form.
Both employ custom software running on a digital device to provide step-by-
step instructions, analyze thermosensor data and display a test result (Flow
Confirmed or Flow Not Confirmed plus a time-temperature graph).
ShuntCheck III utilizes a tablet or laptop computer while the predicate used
a Personal Digital Assistant (PDA).
Both employ a method for generating increased flow in temporarily non-
flowing patent shunts.
A detailed comparison of the technological characteristics of ShuntCheck III
versus its predicate, ShuntCheck v2.2, follows | |
| | ShuntCheck III | ShuntCheck v2.2 |
| Anatomical Sites | Thermosensor on clavicle
Ice above sensor
Micro-Pumping on shunt valve (on
scalp) | Same
Same
If manual pumping is conducted,
same |
| Where Used | Neurosurgery clinic, hospital
emergency department | Same |
| Energy Used or
Delivered | None | Same |
| Thermosensor | Single use only | Same |
| Thermosensor
Thermistor
Materials | Three fast response GE thermistors
in Lexan cradles. | Same thermistors
Thermistors adhered to patch |
| Thermosensor
Patch Materials | Avery Medical grade adhesive &
EVA foam | 3M medical grade adhesive &
Rogers medical grade Poron foam |
| Thermosensor
Cable & Connector | Insulated wire, molded plastic
connection box, RJ45 connector | Same |
| Thermistor
Orientation | Single Test thermistor placed directly
over the subcutaneous shunt flanked
by two control thermistors which
record ambient skin temperature:
Ice
Test Control
Control Test
(Shunt) | Two test thermistors which overly
the subcutaneous shunt. Single
control thermistor which flanks the
proximal test thermistor:
Ice
Test Control
Test
(Shunt) |
| Thermosensor
orientation | Single array patch indicates correct
orientation | Same |
| Ice placement | Array patch indicates correct ice
position | Same |
| Ice-to-thermistor
distance | 28 mm | 16 mm |
1
2
| Ice | Commercially available 4½" x 6"
instant cold pack | Commercially available water-filled
1" plastic ice cube |
|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Hardware | NeuroDx supplied Data Acquisition
Unit (signal conditioning and A to D
converter - called "DAQ") which
attaches by wire to a NeuroDx
supplied CyberMed T10 tablet
computer or a user supplied
Windows 7 laptop or tablet.
Handheld Micro-Pumper which is
held against and vibrates the shunt
valve to generate a temporary
increase in shunt flow | BioDisplay Unit (a Dell Axim PDA
with application software packed
into an off-the-shelf robust case) is
a single hand-held device for
collecting and integrating data |
| Displayed Results | Computer displays "Flow Confirmed"
or "Flow not Confirmed", time-
temperature graph and temperature
decrease (amplitude) on a single
results screen. PDF of results
screen is available for printing or
saving. | BioDisplay Unit displays "Flow
Confirmed" or "Flow not Confirmed".
Time-temperature graph is
accessed on subsequent display
screen. Temperature decrease
(amplitude) is determined by
interpreting the time-temperature
graph. Results cannot be
downloaded or printed. |
| Display Device
Materials | NeuroDx supplied tablet is in
ruggedized case | Glass reinforced ABS case |
| DAQ Size &
Materials | Length 3" x Width 2" x Depth 3/4"
ABS case | Integrated into BioDisplay |
| Micro-Pumper | A handheld component which is held
against and vibrates the shunt valve
for 60 seconds, generating a
temporary increase in shunt flow in
patent shunts. This temporary
increase can be detected thermally
by ShuntCheck. Micro-Pumping
therefore allows ShuntCheck to
detect flow in temporarily non-flowing
patent shunts. | Patent shunts flow intermittently.
To differentiate temporarily non-
flowing patent shunts from occluded
shunts, ShuntCheck users have
induced flow by changing patient
position (supine to sitting) or via
manual shunt pumping. In manual
pumping, the valve dome (or
reservoir) is depressed and
released, creating a surge of CSF
flow. |
| Micro-Pumper Size
& Materials | Oval cylinder Length 3.5" x Width
2.5" x Height 3.25"
Polyurethane plastic | N/A |
| Performance
Specifications | Repeatability 0.03
Accuracy $\pm$ 0.3°C
Sampling Rate | Repeatability 0.06
Same
Same |
| Application
Software | Windows 7 based software program
is preloaded onto the NeuroDx
supplied tablet PC or supplied to
end-user for installation onto their
PC | Windows Mobile based software
preloaded onto the PDA-based
BioDisplay |
| Pre-test Error
Checks | Software checks that the computer is
operating on battery power (not
plugged into AC power), that the
thermosensor and DAQ are
connected and that thermosensor
readings are in biological range. | Software checks that BioDisplay is
operating on battery power (not
plugged into AC power), that the
thermosensor is connected and that
thermosensor readings are in
biological range. |
| | Additionally checks for temperature fluctuations indicating inadequate sensor to skin contact and alerts user correct contact. | |
| Post-Test Error
Checks | Software conducts post-test check of data errors. Test errors are summarized and retesting is recommended | Software conducts post-test check of data errors. Test errors result in Flow Not Confirmed result; no retest recommendation |
| Software Data
Output | Results are displayed either flow confirmed or flow not confirmed (bivariate output) according to a validated algorithm. Time-temperature graph and temperature decrease (amplitude) displayed on same screen. | Results are displayed either flow confirmed or flow not confirmed (bivariate output) according to a validated algorithm. Time-temperature graph available on a subsequent screen. |
| Standards Met | 60601,
ISO 10093-1 | Same |
| Biocompatibility | All skin contacting materials are medical grade, biocompatible | Same |
| Sterilization | None | Same |
| Electrical Safety | 60601 tested | Same |
| Mechanical Safety | Medical grade adhesive
Micro-Pumper generates less ventricular suction than manual shunt pumping, no valve damage or alteration | Same
If manual pumping is used to induce flow, ventricular suction generated exceeds that generated by Micro-Pumping |
| Chemical Safety | Biocompatible materials | Same |
| Thermal Safety | Over the counter instant ice pack placed for 60 seconds and used according to label | 1" plastic ice cube placed for 60 seconds |
| Radiation Safety | No radiation | Same |
| Functional and
Safety Non-
Clinical Testing: | To verify that device design meets the functional and performance requirements, each device was submitted to bench testing and performance verification to confirm accuracy when reading resistances (thermistor input simulation) and the expected temperature output displayed by the device software.
To verify that device design meets its safety requirements, a representative sample of the device has been subjected to safety testing in accordance with IEC 60601 and biocompatibility tests per ISO 10993.
To verify the functionality of the device, bench testing was conducted in which the device was found to be substantially equivalent to the predicate device.
Bench test results follow: | |
| ShuntCheck
Bench Testing
without Micro-
Pumper | ShuntCheck bench testing employs a thermal bench which simulates the transcutaneous cooling of the ShuntCheck test. Flow is regulated with an infusion pump. The ShuntCheck thermosensor is placed over the embedded catheter and the ShuntCheck test is conducted normally. | |
| | ShuntCheck III | ShuntCheck v2.2 |
| Detect flow of 10
ml/hr | 100% (100% accurate) | 100% (100% accurate) |
| Detect flow of 0
ml/hr | 0% (100% accurate) | 0% (100% accurate) |
| Threshold of
detection | Between 3.5 and 5 ml/hr | Between 5 and 7.5 ml/hr |
| Detect 10 ml/hr
flow with sensor
misalignment | 100% at 20° rotation
100% at 4mm lateral misplacement | 0% at 20° rotation
0% at 4mm lateral misplacement |
| ShuntCheck
Bench Testing
with Micro-
Pumper | Micro-Pumper bench testing employs a vertical bench where shunt valves
are mounted under artificial skin to simulate the implanted shunt valve.
Shunt tubing is connected at the proximal and distal end to height-
adjustable fluid reservoirs to simulate pressure changes within the shunt
system. At the distal end of the shunt catheter is a drop counter which
measure the fluid flow rate. The Micro-Pumper vibrates the shunt valve for
60 seconds while flow rate is recorded.
The test of ShuntCheck's ability to detect Micro-Pumper-generated flow
employed the thermal bench described above. | |
| Shunt flow
generated by 60
second Micro-
Pumper
application | Testing of eight shunt valves:
Flow in patent non-flowing shunts (at 0 ICP) 0.3 to 0.9 cc Flow in clogged shunts 0.0 to 0.03 cc Maximum flow (in patent flowing shunts) 0.9 to 2.8 cc These results indicate that Micro-Pumper generates flow in a patent, non-
flowing shunts but does not generate flow in occluded shunts. It does not
generate sufficient flow to cause overdrainage | |
| Micro-Pumper
Impact on shunt
valve function | Testing of eight shunt valves
Change in natural flow pre vs post Micro-Pumping