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.

Device Description

ShuntCheck is a non-invasive device which detects flow in a CSF shunt via transcutaneous thermal convection. The device consists of a single use disposable thermosensor array patch which is connected to a handheld "biodisplay" unit. The shunt is cooled transcutaneously by placing ice 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 nearby control location. Data is captured in the biodisplay unit. If the device detects a characteristic downstream transcutaneous temperature dip, the biodisplay reports "flow confirmed". If no temperature dip is detected, the unit reports "flow not confirmed"

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics to fully answer all aspects of the request. The document is primarily a 510(k) summary and an FDA clearance letter for the ShuntCheck device, which is an aid to detect flow in CSF shunts. It mentions functional and safety testing, and animal studies, but does not provide quantitative acceptance criteria or detailed results of a clinical study that would demonstrate performance.

However, based on the available information, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy thresholds) or provide reported device performance metrics in a clinical context. It mentions:

Acceptance Criteria (Implied)	Reported Device Performance (Implied from testing)
Accuracy of resistance readings/temperature output	Confirmed accurate when reading resistances (thermistor input simulation) and displaying expected temperature output.
Functionality in detecting flow	Device was able to detect flow rates (ml/hr) in animal studies. Found substantially equivalent to predicate device (ShuntCheck version 1.1) in animal studies.
Safety requirements compliance	Meets IEC 60601-1, IEC 60601-1-4, and IEC 60601-1-2 standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated for any clinical or animal studies. The text mentions "three animal studies" and "a representative sample of the device" for safety testing. This suggests multiple animals were used, but the exact number is not provided.
Data Provenance:
- Type: Primarily animal studies and bench testing. There is no mention of human clinical trial data for performance evaluation in this summary.
- Country of origin: Not specified.
- Retrospective or Prospective: Animal studies and bench testing are generally prospective in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The primary performance evaluation described was in animal studies and bench testing; there's no indication of human expert involvement for ground truth establishment in a test set. The intended use states that "The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheck, should be made only by a qualified neurosurgeon," implying neurosurgeons are the experts who would ultimately interpret the device's output in a clinical setting, but not for establishing ground truth in a validation study described here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As no human expert-adjudicated test set is described, there is no mention of an adjudication method.

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

Not performed. The ShuntCheck is a non-invasive thermal convection device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device. The device provides "flow confirmed" or "flow not confirmed" output.

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

This is not a software-only "algorithm." It is a physical device (thermosensor array patch connected to a handheld "biodisplay" unit) that detects temperature changes to infer flow. The device itself provides a "flow confirmed" or "flow not confirmed" output, which can be considered its "standalone" output. The studies mentioned (bench testing, animal studies) assessed this device's ability to accurately provide this output. However, it's explicitly stated that "ShuntCheck cannot alone diagnose CSF shunt function or malfunction," and its output must be interpreted by a neurosurgeon.

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

The document implies that the ground truth for the animal studies was based on known flow rates (ml/hr) or the functional state of the shunt (e.g., presence or absence of flow) as established by experimental conditions in the animal models. For bench testing, the ground truth was related to known electrical resistances and expected temperature outputs.

8. The sample size for the training set

The device is not AI/machine learning based and therefore does not have a "training set" in the conventional sense of data used to train an algorithm. The development cycle would involve engineering design, prototyping, and testing, but not and algorithmic training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI algorithm.

Summary

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Ko80168

MAY 1 6 2008

510(k) Summary 5.0

Submitter:	Neuro Diagnostic Devices, Inc.
Contact Person:	Frederick J. Fritz, CEO, 215-966-6104 (telephone) 215-966-6001(fax)
Date Prepared:	01/18/2008
Trade Name:	ShuntCheck
Classification:	Class IICentral Nervous System Fluid Shunt and Components21 CFR 882,5550
Product Code:	JXG
Predicate Device(s):	The subject device is equivalent to the following devices:ShuntCheck (version 1.1) (K040021)
Device Description:	ShuntCheck is a non-invasive device which detects flow in a CSFshunt via transcutaneous thermal convection. The device consists ofa single use disposable thermosensor array patch which is connectedto a handheld "biodisplay" unit. The shunt is cooled transcutaneouslyby placing ice over the shunt cephalic to the thermosensor. Thethermosensor array patch, which is placed on the skin over the shunt"downstream" of the ice, reads the change in skin temperature overthe shunt as cooled fluid flows downstream and also at a nearbycontrol location. Data is captured in the biodisplay unit. If the devicedetects a characteristic downstream transcutaneous temperature dip,the biodisplay reports "flow confirmed". If no temperature dip isdetected, the unit reports "flow not confirmed"
Intended Use:	ShuntCheck is an aid to the detection 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 information fromShuntCheck, should be made only by a qualified neurosurgeon.
Functional and SafetyTesting:	To verify that device design meets the functional and performancerequirements, each device was submitted to bench testing andperformance verification to confirm accuracy when reading resistances(thermistor input simulation) and the expected temperature outputdisplayed by the device software.To verify the functionality of the device, three animal studies wereconducted. In the first study, the device was found to be substantiallyequivalent to the predicate device, the second study, the device wasable to detect flow rates (ml/hr), and the third study supported theindication for use change.To verify that device design meets its safety requirements, arepresentative sample of the device has been subjected safety testing iin accordance with IEC 60601-1, IEC 60601-1-4, and IEC 60601-1-2. `
Conclusion:	Neuro Diagnostic Devices, Inc. believes the ShuntCheck v2.2 to besubstantially equivalent to the predicate device ShuntCheck (v1.0).This conclusion is based upon the both devices'similarities inprinciples of operation, technology, materials, and indications for use.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the top half of the circle. The bottom half of the circle contains an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neuro Diagnostic Devices % Mr. Frederick J. Fritz CEO 1 Interplex Drive, Suite 300 Trevose, Pennsylvania 19053

MAY 1 6 2008

Re: K080168

Trade/Device Name: ShuntCheck-CSF Shunt Flow Detector Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: May 8, 2008 Received: May 12, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); 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.

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Page 2 - Mr. Frederick J. Fritz

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Koso168

Indications for Use Statement 4.0

Device Name: ShuntCheck—CSF Shunt Flow Detector

ShuntCheck is an aid to the detection of flow in implanted cerebrospinal fluid (CSF) a Shunts. ShuntCheck cannot alone diagnose CSF shunt function or malfunction. The shunts. "Shunt function cannot alono diagnoso stunction, incorporating the flow information clinical diagnoolo of OGT themade only by a qualified neurosurgeon.

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)
Signature
for
MXM
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K080168
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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).