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 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.

AI/ML Overview

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)	<50% expected	<50% (Testing of eight shunt valves)
Impact on shunt valve function (damage to valve/backflow)	0% expected	0% (Testing of eight shunt valves)
Impact on programmable valve settings	0% change expected	0% (Testing of 5 programmable valves)
Detect flow generated by Micro-Pumper (occluded shunt)	0% detection expected	0% detection
Detect flow generated by Micro-Pumper (patent, non-flowing shunt with 15-100 ml/hr flow)	100% detection expected	100% detection
Detect flow generated by Micro-Pumper (patent flowing shunt with 15-200 ml/hr flow)	100% detection expected	100% detection
Clinical Testing (Safety)	Zero adverse events or safety issues	Zero Adverse Events or safety issues were recorded
Clinical Testing (Accuracy without Micro-Pumper)	Flow Confirmed results in asymptomatic patients (shunts expected patent)	15 of 38 or 39%
Clinical Testing (Accuracy with proposed Micro-Pumper)	Flow Confirmed results in asymptomatic/functioning patients (expected patent)	9 of 12 or 75%
	Flow Not Confirmed in confirmed obstructed shunts (expected occluded)	4 of 4 or 100%

2. Sample Size Used for the Test Set and the Data Provenance

Bench Testing (without Micro-Pumper): The sample size for simulating flow detection (10 ml/hr and 0 ml/hr, threshold, and misalignment) is not explicitly stated as a number of tests or runs. It mentions "bench testing was conducted" and "the ShuntCheck test is conducted normally."
Bench Testing (with Micro-Pumper):
- Shunt flow generation and impact on valve function: Testing of eight shunt valves and 5 programmable valves.
- ShuntCheck's ability to detect flow generated by Micro-Pumper: Not explicitly stated as a number of tests or runs.
Clinical Testing:
- 38 asymptomatic patients for testing ShuntCheck without Micro-Pumper.
- 12 patients (asymptomatic or confirmed functioning shunts) for testing with the proposed Micro-Pumper.
- 4 patients with confirmed obstructed shunts for testing with the proposed Micro-Pumper.
Data Provenance: The clinical testing was conducted at Boston Children's Hospital, indicating US-based, prospective clinical data collection for the clinical testing aspects. The bench testing would be lab-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

For the clinical testing, the ground truth for "shunt function or malfunction" was confirmed via MRI imaging.
The clinical diagnosis of CSF shunt function or malfunction, incorporating flow information, "should be made only by a qualified neurosurgeon." This implies that a qualified neurosurgeon ultimately interpreted the MRI imaging to establish the ground truth for shunt status in the clinical study. The exact number of neurosurgeons involved in ground truth establishment is not specified. Their qualifications are stated as "qualified neurosurgeon."

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the ground truth (e.g., 2+1 reads, consensus panel). It states that shunt function or malfunction was "confirmed via MRI imaging," implying a standard diagnostic process overseen by medical professionals (qualified neurosurgeons).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is not an AI-assisted diagnostic tool for human readers; it's a standalone device outputting a "Flow Confirmed" or "Flow Not Confirmed" result. The clinical study evaluated the device's accuracy in detecting flow in relation to a patient's shunt status and the impact of the Micro-Pumper component.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done through both bench testing and clinical testing. The device's software algorithm provides the "Flow Confirmed" or "Flow Not Confirmed" result based on its sensor data, independent of human interpretation of raw data. The "Accuracy without Micro-Pumper" and "Accuracy with proposed Micro-Pumper" in the clinical study table directly reflect the standalone performance against the ground truth.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Bench Testing: The ground truth was established by precisely controlled flow rates (e.g., 10 ml/hr, 0 ml/hr) in a simulated environment using infusion pumps and drop counters.
Clinical Testing: The ground truth for shunt function or malfunction was established by MRI imaging.

8. The Sample Size for the Training Set

The document describes a 510(k) submission for a device, not an AI/ML algorithm that typically requires a large, explicitly defined "training set." The device relies on a validated algorithm for detecting flow. The development of this algorithm would have involved various bench and potentially early clinical data, but a specific "training set size" in the context of an AI/ML model is not provided or applicable in the way it's usually understood for deep learning. The testing described serves as validation and verification of the final algorithm's performance.

9. How the Ground Truth for the Training Set Was Established

Given that this is not an AI/ML device with an explicit training set in the modern sense, the concept of "ground truth for the training set" as it relates to machine learning is not directly applicable. The algorithm's development (and thus its "training" or optimization) would have been based on principles of thermal dilution and fluid dynamics, likely informed by experimental data from bench models. The document refers to the algorithm as a "validated algorithm."

Summary

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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 PA19020
Contact:	Frederick J. Fritz, CEO, 609-865-4426 (telephone) 215-645-1268(fax)
Date Prepared:	October 2, 2012
Trade Name:	ShuntCheck
Classification:	Class IICentral Nervous System Fluid Shunt and Components21 CFR 882.5550
Product Code:	JXG
PredicateDevice(s):	The subject device is equivalent to the following devices:ShuntCheck (version 2.2) (K080168)
DeviceDescription:	ShuntCheck is a non-invasive device which detects flow in a CSF shunt viatranscutaneous thermal dilution. The device consists of a single usedisposable thermosensor array patch which is connected to a dataacquisition unit (a DAQ) which is connected to a laptop or tablet computer.The device also includes a Micro-Pumper which vibrates the shunt valveduring the test procedure to generate a temporary increase in flow in patentbut temporarily non-flowing shunts. The shunt is cooled transcutaneouslyby 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 theshunt as cooled fluid flows downstream and also at a two nearby controllocations. Data is transferred through the DAQ and captured in thecomputer. If the device detects a characteristic downstreamtranscutaneous temperature dip, the computer reports "flow confirmed" andpresents a time-temperature graph of test data. If no temperature dip isdetected, the unit reports "flow not confirmed" and presents a time-temperature graph.
	ShuntCheck III	ShuntCheck v2.2
Indications forUse:	ShuntCheck® is an aid to thedetection of flow in implantedcerebrospinal fluid (CSF) shunts.ShuntCheck includes Micro-Pumper,a component which may be used togenerate flow in suspectedtemporarily non-flowing, patentshunts during the ShuntCheck test.ShuntCheck cannot alone diagnoseCSF shunt function or malfunction.The clinical diagnosis of CSF shuntfunction or malfunction, incorporatingthe flow information fromShuntCheck, should be made onlyby a qualified neurosurgeon.	ShuntCheck is an aid to thedetection of flow in implantedcerebrospinal fluid (CSF) shunts.ShuntCheck cannot alone diagnoseCSF shunt function or malfunction.The clinical diagnosis of CSF shuntfunction or malfunction,incorporating the flow informationfrom ShuntCheck, should be madeonly by a qualified neurosurgeon.
Contraindications	The Micro-Pumper should not be used when conducting ShuntCheck testson patients under the age of five, patients with small or slit ventricles or
	where the ventricular catheter tip is within the brain parenchyma.
SubstantialEquivalence ofTechnologicalCharacteristics	ShuntCheck III and its predicate ShuntCheck v2.2 detect flow through CSFshunts via transcutaneous thermal dilution.Both utilize an external cooling source to cool the skin over the shunt. Bothutilize a single use disposable thermosensor patch comprised of multiplethermistors which adheres to the patient's skin via medical grade adhesiveto monitor skin temperature directly over the shunt and at separate controlskin locations.Both employ an electronic unit which conditions, amplifies and converts thethermosensor 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 (FlowConfirmed or Flow Not Confirmed plus a time-temperature graph).ShuntCheck III utilizes a tablet or laptop computer while the predicate useda 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 IIIversus its predicate, ShuntCheck v2.2, follows
	ShuntCheck III	ShuntCheck v2.2
Anatomical Sites	Thermosensor on clavicleIce above sensorMicro-Pumping on shunt valve (onscalp)	SameSameIf manual pumping is conducted,same
Where Used	Neurosurgery clinic, hospitalemergency department	Same
Energy Used orDelivered	None	Same
Thermosensor	Single use only	Same
ThermosensorThermistorMaterials	Three fast response GE thermistorsin Lexan cradles.	Same thermistorsThermistors adhered to patch
ThermosensorPatch Materials	Avery Medical grade adhesive &EVA foam	3M medical grade adhesive &Rogers medical grade Poron foam
ThermosensorCable & Connector	Insulated wire, molded plasticconnection box, RJ45 connector	Same
ThermistorOrientation	Single Test thermistor placed directlyover the subcutaneous shunt flankedby two control thermistors whichrecord ambient skin temperature:IceTest ControlControl Test(Shunt)	Two test thermistors which overlythe subcutaneous shunt. Singlecontrol thermistor which flanks theproximal test thermistor:IceTest ControlTest(Shunt)
Thermosensororientation	Single array patch indicates correctorientation	Same
Ice placement	Array patch indicates correct iceposition	Same
Ice-to-thermistordistance	28 mm	16 mm

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Ice	Commercially available 4½" x 6"instant cold pack	Commercially available water-filled1" plastic ice cube
Device Hardware	NeuroDx supplied Data AcquisitionUnit (signal conditioning and A to Dconverter - called "DAQ") whichattaches by wire to a NeuroDxsupplied CyberMed T10 tabletcomputer or a user suppliedWindows 7 laptop or tablet.Handheld Micro-Pumper which isheld against and vibrates the shuntvalve to generate a temporaryincrease in shunt flow	BioDisplay Unit (a Dell Axim PDAwith application software packedinto an off-the-shelf robust case) isa single hand-held device forcollecting and integrating data
Displayed Results	Computer displays "Flow Confirmed"or "Flow not Confirmed", time-temperature graph and temperaturedecrease (amplitude) on a singleresults screen. PDF of resultsscreen is available for printing orsaving.	BioDisplay Unit displays "FlowConfirmed" or "Flow not Confirmed".Time-temperature graph isaccessed on subsequent displayscreen. Temperature decrease(amplitude) is determined byinterpreting the time-temperaturegraph. Results cannot bedownloaded or printed.
Display DeviceMaterials	NeuroDx supplied tablet is inruggedized 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 heldagainst and vibrates the shunt valvefor 60 seconds, generating atemporary increase in shunt flow inpatent shunts. This temporaryincrease can be detected thermallyby ShuntCheck. Micro-Pumpingtherefore allows ShuntCheck todetect flow in temporarily non-flowingpatent shunts.	Patent shunts flow intermittently.To differentiate temporarily non-flowing patent shunts from occludedshunts, ShuntCheck users haveinduced flow by changing patientposition (supine to sitting) or viamanual shunt pumping. In manualpumping, the valve dome (orreservoir) is depressed andreleased, creating a surge of CSFflow.
Micro-Pumper Size& Materials	Oval cylinder Length 3.5" x Width2.5" x Height 3.25"Polyurethane plastic	N/A
PerformanceSpecifications	Repeatability 0.03Accuracy $\pm$ 0.3°CSampling Rate	Repeatability 0.06SameSame
ApplicationSoftware	Windows 7 based software programis preloaded onto the NeuroDxsupplied tablet PC or supplied toend-user for installation onto theirPC	Windows Mobile based softwarepreloaded onto the PDA-basedBioDisplay
Pre-test ErrorChecks	Software checks that the computer isoperating on battery power (notplugged into AC power), that thethermosensor and DAQ areconnected and that thermosensorreadings are in biological range.	Software checks that BioDisplay isoperating on battery power (notplugged into AC power), that thethermosensor is connected and thatthermosensor readings are inbiological range.
	Additionally checks for temperature fluctuations indicating inadequate sensor to skin contact and alerts user correct contact.
Post-Test ErrorChecks	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 DataOutput	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 adhesiveMicro-Pumper generates less ventricular suction than manual shunt pumping, no valve damage or alteration	SameIf 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 andSafety 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:
ShuntCheckBench Testingwithout 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 10ml/hr	100% (100% accurate)	100% (100% accurate)
Detect flow of 0ml/hr	0% (100% accurate)	0% (100% accurate)
Threshold ofdetection	Between 3.5 and 5 ml/hr	Between 5 and 7.5 ml/hr
Detect 10 ml/hrflow with sensormisalignment	100% at 20° rotation100% at 4mm lateral misplacement	0% at 20° rotation0% at 4mm lateral misplacement
ShuntCheckBench Testingwith Micro-Pumper	Micro-Pumper bench testing employs a vertical bench where shunt valvesare 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 shuntsystem. At the distal end of the shunt catheter is a drop counter whichmeasure the fluid flow rate. The Micro-Pumper vibrates the shunt valve for60 seconds while flow rate is recorded.The test of ShuntCheck's ability to detect Micro-Pumper-generated flowemployed the thermal bench described above.
Shunt flowgenerated by 60second Micro-Pumperapplication	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 notgenerate sufficient flow to cause overdrainage
Micro-PumperImpact on shuntvalve function	Testing of eight shunt valvesChange in natural flow pre vs post Micro-Pumping <50% Damage to valve (evidence of backflow) post Micro-Pumping 0% Testing of 5 programmable valve Valve settings changed by Micro-Pumping 0% These results indicate that valve performance is unaltered by Micro-Pumper
Test ofShuntCheck'sability to detectflow generated byMicro-Pumper	Test of occluded shunt (no flow) - 0% detection Test of patent, non-flowing shunt with Micro-Pumper generated flowof 15 to 100 ml/hr - 100% detection Test of patent flowing shunt with Micro-Pumper generated flow of15 to 200 ml/hr - 100% detection These results indicate that ShuntCheck can correctly detect the increasedflow generated with the Micro-Pumper application
Functional andSafety ClinicalTesting:	Human clinical testing was conducted at Boston Children's Hospital to verifythe safety and functionality of the Micro-Pumper component of the system.Pediatric hydrocephalus patients 5 years and older were tested. 38asymptomatic patients were tested with ShuntCheck without Micro-Pumper.These same patients were tested a second time with ShuntCheck plus anearlier version of Micro-Pumper. Finally, 12 patients who were eitherasymptomatic or had confirmed functioning shunts and 4 patients withconfirmed obstructed shunts were tested with ShuntCheck III including theproposed version of Micro-Pumper. (Shunt function or malfunction wasconfirmed via MRI imaging). Specific findings were:Study Results
Safety	Zero Adverse Events or safety issues were recorded
Accuracy ofShuntCheckwithout Micro-Pumper	Flow Confirmed results in 38 asymptomatic patients (shunts expected to bepatent)15 of 38 or 39%
Accuracy withproposed Micro-Pumper	Flow Confirmed results in 12 asymptomatic or confirmed functioning shuntpatients 9 of 12 or 75% Flow Not Confirmed in 4 patients with confirmed obstructed shunts 4 of 4 or 100%
	These results suggest that Micro-Pumper increases ShuntCheck's ability to detect flow in patent shunts.
Conclusion:	NeuroDx Development believes the ShuntCheck III to be substantially equivalent to the predicate device ShuntCheck (v2.2). This conclusion is based upon the both devices' similarities in principles of operation, technology, materials, and indications for use.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

March 7,2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NeuroDx Development, Inc. % Mr. Fredrick J. Fritz President and CEO 3333 Street Road, Suite 210 Bensalem, PA 19020

Re: K123554

Trade/Device Name: ShuntCheck III: Non-Invasive Transcutaneous Thermal Dilution System for Detecting Ventriculo-Peritoneal Shunt Flow Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: February 1, 2013 Received: February 4, 2013

Dear Mr. Fritz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either Class II (Special Controls) or Class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Fredrick J. Fritz

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Joyce M. Whang

for Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123554

Device Name: ShuntCheck III: Non-Invasive Transcutaneous Thermal Dilution System for Detecting Ventriculo-Peritoneal Shunt Flow

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Jovce MDWhand

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number

Page 1 of 1

Regulation Number and Section

§ 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).