SHUNTCHECK

K123554 · Neurodx Development, LLC · JXG · Mar 7, 2013 · Neurology

Device Facts

• Record ID: K123554
• Device Name: SHUNTCHECK
• Applicant: Neurodx Development, LLC
• Product Code: JXG · Neurology
• Decision Date: Mar 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 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.

Device Story

ShuntCheck III is a non-invasive diagnostic aid for detecting CSF shunt flow via transcutaneous thermal dilution. The system comprises a disposable thermosensor array patch, a data acquisition unit (DAQ), and a tablet/laptop computer. A handheld Micro-Pumper vibrates the shunt valve to induce temporary flow in patent but non-flowing shunts. The shunt is cooled transcutaneously using an instant ice pack; the thermosensor patch, placed downstream on the skin, measures temperature changes relative to control locations. Data is processed by the DAQ and analyzed by software on the computer. The system outputs a 'Flow Confirmed' or 'Flow Not Confirmed' result alongside a time-temperature graph. Used in neurosurgery clinics or emergency departments by clinicians, the device provides objective flow data to assist neurosurgeons in diagnosing shunt function or malfunction. It benefits patients by providing a non-invasive method to assess shunt patency, potentially reducing the need for more invasive diagnostic procedures.

Clinical Evidence

Clinical testing conducted at Boston Children's Hospital on pediatric patients (≥5 years). 38 asymptomatic patients tested without Micro-Pumper; 12 asymptomatic/functioning shunt patients and 4 patients with confirmed obstructed shunts tested with ShuntCheck III including Micro-Pumper. Results: 75% (9/12) of functioning shunts showed 'Flow Confirmed' with Micro-Pumper; 100% (4/4) of obstructed shunts showed 'Flow Not Confirmed'. No adverse events reported. Bench testing verified 100% accuracy in detecting 10 ml/hr flow and 0% detection for 0 ml/hr flow.

Technological Characteristics

System uses transcutaneous thermal dilution with three GE thermistors in Lexan cradles on an EVA foam patch with Avery medical-grade adhesive. DAQ performs signal conditioning and A/D conversion. Connectivity via wired connection to Windows 7 tablet/laptop. Micro-Pumper is a polyurethane handheld vibration device. Standards met: IEC 60601 (electrical safety), ISO 10993-1 (biocompatibility). Non-sterile, single-use sensor patch.

Indications for Use

Indicated for use as an aid in detecting flow in implanted CSF shunts in patients, including pediatric patients 5 years and older. Contraindicated for use of the Micro-Pumper component in patients under age five, patients with small or slit ventricles, or where the ventricular catheter tip is within the brain parenchyma.

Regulatory Classification

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.

Predicate Devices

• ShuntCheck (version 2.2) (K080168)

Submission Summary (Full Text)

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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<br>19020 | |
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| Contact: | Frederick J. Fritz, CEO, 609-865-4426 (telephone) 215-645-1268(fax) | |
| Date Prepared: | October 2, 2012 | |
| Trade Name: | ShuntCheck | |
| Classification: | Class II<br>Central Nervous System Fluid Shunt and Components<br>21 CFR 882.5550 | |
| Product Code: | JXG | |
| Predicate<br>Device(s): | The subject device is equivalent to the following devices:<br>ShuntCheck (version 2.2) (K080168) | |
| Device<br>Description: | ShuntCheck is a non-invasive device which detects flow in a CSF shunt via<br>transcutaneous thermal dilution. The device consists of a single use<br>disposable thermosensor array patch which is connected to a data<br>acquisition unit (a DAQ) which is connected to a laptop or tablet computer.<br>The device also includes a Micro-Pumper which vibrates the shunt valve<br>during the test procedure to generate a temporary increase in flow in patent<br>but temporarily non-flowing shunts. The shunt is cooled transcutaneously<br>by placing an instant ice pack over the shunt cephalic to the thermosensor.<br>The thermosensor array patch, which is placed on the skin over the shunt<br>"downstream" of the ice, reads the change in skin temperature over the<br>shunt as cooled fluid flows downstream and also at a two nearby control<br>locations. Data is transferred through the DAQ and captured in the<br>computer. If the device detects a characteristic downstream<br>transcutaneous temperature dip, the computer reports "flow confirmed" and<br>presents a time-temperature graph of test data. If no temperature dip is<br>detected, the unit reports "flow not confirmed" and presents a time-<br>temperature graph. | |
| | ShuntCheck III | ShuntCheck v2.2 |
| Indications for<br>Use: | ShuntCheck® is an aid to the<br>detection of flow in implanted<br>cerebrospinal fluid (CSF) shunts.<br>ShuntCheck includes Micro-Pumper,<br>a component which may be used to<br>generate flow in suspected<br>temporarily non-flowing, patent<br>shunts during the ShuntCheck test.<br>ShuntCheck cannot alone diagnose<br>CSF shunt function or malfunction.<br>The clinical diagnosis of CSF shunt<br>function or malfunction, incorporating<br>the flow information from<br>ShuntCheck, should be made only<br>by a qualified neurosurgeon. | ShuntCheck is an aid to the<br>detection of flow in implanted<br>cerebrospinal fluid (CSF) shunts.<br>ShuntCheck cannot alone diagnose<br>CSF shunt function or malfunction.<br>The clinical diagnosis of CSF shunt<br>function or malfunction,<br>incorporating the flow information<br>from ShuntCheck, should be made<br>only by a qualified neurosurgeon. |
| Contraindications | The Micro-Pumper should not be used when conducting ShuntCheck tests<br>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<br>Equivalence of<br>Technological<br>Characteristics | ShuntCheck III and its predicate ShuntCheck v2.2 detect flow through CSF<br>shunts via transcutaneous thermal dilution.<br>Both utilize an external cooling source to cool the skin over the shunt. Both<br>utilize a single use disposable thermosensor patch comprised of multiple<br>thermistors which adheres to the patient's skin via medical grade adhesive<br>to monitor skin temperature directly over the shunt and at separate control<br>skin locations.<br>Both employ an electronic unit which conditions, amplifies and converts the<br>thermosensor signal to digital form.<br>Both employ custom software running on a digital device to provide step-by-<br>step instructions, analyze thermosensor data and display a test result (Flow<br>Confirmed or Flow Not Confirmed plus a time-temperature graph).<br>ShuntCheck III utilizes a tablet or laptop computer while the predicate used<br>a Personal Digital Assistant (PDA).<br>Both employ a method for generating increased flow in temporarily non-<br>flowing patent shunts.<br>A detailed comparison of the technological characteristics of ShuntCheck III<br>versus its predicate, ShuntCheck v2.2, follows | |
| | ShuntCheck III | ShuntCheck v2.2 |
| Anatomical Sites | Thermosensor on clavicle<br>Ice above sensor<br>Micro-Pumping on shunt valve (on<br>scalp) | Same<br>Same<br>If manual pumping is conducted,<br>same |
| Where Used | Neurosurgery clinic, hospital<br>emergency department | Same |
| Energy Used or<br>Delivered | None | Same |
| Thermosensor | Single use only | Same |
| Thermosensor<br>Thermistor<br>Materials | Three fast response GE thermistors<br>in Lexan cradles. | Same thermistors<br>Thermistors adhered to patch |
| Thermosensor<br>Patch Materials | Avery Medical grade adhesive &<br>EVA foam | 3M medical grade adhesive &<br>Rogers medical grade Poron foam |
| Thermosensor<br>Cable & Connector | Insulated wire, molded plastic<br>connection box, RJ45 connector | Same |
| Thermistor<br>Orientation | Single Test thermistor placed directly<br>over the subcutaneous shunt flanked<br>by two control thermistors which<br>record ambient skin temperature:<br><br>Ice<br><br>Test Control<br>Control Test<br>(Shunt) | Two test thermistors which overly<br>the subcutaneous shunt. Single<br>control thermistor which flanks the<br>proximal test thermistor:<br><br>Ice<br><br>Test Control<br>Test<br>(Shunt) |
| Thermosensor<br>orientation | Single array patch indicates correct<br>orientation | Same |
| Ice placement | Array patch indicates correct ice<br>position | Same |
| Ice-to-thermistor<br>distance | 28 mm | 16 mm |

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| Ice | Commercially available 4½" x 6"<br>instant cold pack | Commercially available water-filled<br>1" plastic ice cube |
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| Device Hardware | NeuroDx supplied Data Acquisition<br>Unit (signal conditioning and A to D<br>converter - called "DAQ") which<br>attaches by wire to a NeuroDx<br>supplied CyberMed T10 tablet<br>computer or a user supplied<br>Windows 7 laptop or tablet.<br>Handheld Micro-Pumper which is<br>held against and vibrates the shunt<br>valve to generate a temporary<br>increase in shunt flow | BioDisplay Unit (a Dell Axim PDA<br>with application software packed<br>into an off-the-shelf robust case) is<br>a single hand-held device for<br>collecting and integrating data |
| Displayed Results | Computer displays "Flow Confirmed"<br>or "Flow not Confirmed", time-<br>temperature graph and temperature<br>decrease (amplitude) on a single<br>results screen. PDF of results<br>screen is available for printing or<br>saving. | BioDisplay Unit displays "Flow<br>Confirmed" or "Flow not Confirmed".<br>Time-temperature graph is<br>accessed on subsequent display<br>screen. Temperature decrease<br>(amplitude) is determined by<br>interpreting the time-temperature<br>graph. Results cannot be<br>downloaded or printed. |
| Display Device<br>Materials | NeuroDx supplied tablet is in<br>ruggedized case | Glass reinforced ABS case |
| DAQ Size &<br>Materials | Length 3" x Width 2" x Depth 3/4"<br>ABS case | Integrated into BioDisplay |
| Micro-Pumper | A handheld component which is held<br>against and vibrates the shunt valve<br>for 60 seconds, generating a<br>temporary increase in shunt flow in<br>patent shunts. This temporary<br>increase can be detected thermally<br>by ShuntCheck. Micro-Pumping<br>therefore allows ShuntCheck to<br>detect flow in temporarily non-flowing<br>patent shunts. | Patent shunts flow intermittently.<br>To differentiate temporarily non-<br>flowing patent shunts from occluded<br>shunts, ShuntCheck users have<br>induced flow by changing patient<br>position (supine to sitting) or via<br>manual shunt pumping. In manual<br>pumping, the valve dome (or<br>reservoir) is depressed and<br>released, creating a surge of CSF<br>flow. |
| Micro-Pumper Size<br>& Materials | Oval cylinder Length 3.5" x Width<br>2.5" x Height 3.25"<br>Polyurethane plastic | N/A |
| Performance<br>Specifications | Repeatability 0.03<br>Accuracy $\pm$ 0.3°C<br>Sampling Rate | Repeatability 0.06<br>Same<br>Same |
| Application<br>Software | Windows 7 based software program<br>is preloaded onto the NeuroDx<br>supplied tablet PC or supplied to<br>end-user for installation onto their<br>PC | Windows Mobile based software<br>preloaded onto the PDA-based<br>BioDisplay |
| Pre-test Error<br>Checks | Software checks that the computer is<br>operating on battery power (not<br>plugged into AC power), that the<br>thermosensor and DAQ are<br>connected and that thermosensor<br>readings are in biological range. | Software checks that BioDisplay is<br>operating on battery power (not<br>plugged into AC power), that the<br>thermosensor is connected and that<br>thermosensor readings are in<br>biological range. |
| | Additionally checks for temperature fluctuations indicating inadequate sensor to skin contact and alerts user correct contact. | |
| Post-Test Error<br>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<br>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,<br>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<br>Micro-Pumper generates less ventricular suction than manual shunt pumping, no valve damage or alteration | Same<br>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<br>Safety Non-<br>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.<br>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.<br>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.<br>Bench test results follow: | |
| ShuntCheck<br>Bench Testing<br>without Micro-<br>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<br>ml/hr | 100% (100% accurate) | 100% (100% accurate) |
| Detect flow of 0<br>ml/hr | 0% (100% accurate) | 0% (100% accurate) |
| Threshold of<br>detection | Between 3.5 and 5 ml/hr | Between 5 and 7.5 ml/hr |
| Detect 10 ml/hr<br>flow with sensor<br>misalignment | 100% at 20° rotation<br>100% at 4mm lateral misplacement | 0% at 20° rotation<br>0% at 4mm lateral misplacement |
| ShuntCheck<br>Bench Testing<br>with Micro-<br>Pumper | Micro-Pumper bench testing employs a vertical bench where shunt valves<br>are mounted under artificial skin to simulate the implanted shunt valve.<br>Shunt tubing is connected at the proximal and distal end to height-<br>adjustable fluid reservoirs to simulate pressure changes within the shunt<br>system. At the distal end of the shunt catheter is a drop counter which<br>measure the fluid flow rate. The Micro-Pumper vibrates the shunt valve for<br>60 seconds while flow rate is recorded.<br>The test of ShuntCheck's ability to detect Micro-Pumper-generated flow<br>employed the thermal bench described above. | |
| Shunt flow<br>generated by 60<br>second Micro-<br>Pumper<br>application | Testing of eight shunt valves:<br>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-<br>flowing shunts but does not generate flow in occluded shunts. It does not<br>generate sufficient flow to cause overdrainage | |
| Micro-Pumper<br>Impact on shunt<br>valve function | Testing of eight shunt valves<br>Change…