SHUNTCHECK - CSF SHUNT FLOW DETECTOR

K080168 · Neuro Diagnostic Devices · JXG · May 16, 2008 · Neurology

Device Facts

• Record ID: K080168
• Device Name: SHUNTCHECK - CSF SHUNT FLOW DETECTOR
• Applicant: Neuro Diagnostic Devices
• Product Code: JXG · Neurology
• Decision Date: May 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2

Intended Use

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 Story

ShuntCheck is a non-invasive device for detecting CSF shunt flow via transcutaneous thermal convection. System comprises a single-use disposable thermosensor array patch and a handheld biodisplay unit. Operation involves placing ice over the shunt cephalic to the patch; the patch is placed on the skin downstream of the ice. The device reads skin temperature changes over the shunt compared to a control location. Data is processed by the biodisplay unit to detect a characteristic downstream temperature dip. Output is binary: 'flow confirmed' or 'flow not confirmed'. Used in clinical settings by healthcare professionals to assist neurosurgeons in evaluating shunt patency. The output provides supplemental information for clinical decision-making regarding shunt function.

Clinical Evidence

Three animal studies were conducted. Study 1 confirmed substantial equivalence to the predicate. Study 2 demonstrated the device's ability to detect flow rates (ml/hr). Study 3 supported the change in indications for use. Bench testing verified device design against functional requirements, including accuracy of thermistor input simulation and software-calculated temperature output. Safety testing performed per IEC 60601-1, IEC 60601-1-4, and IEC 60601-1-2.

Technological Characteristics

Non-invasive thermal convection sensor. Components: single-use disposable thermosensor array patch, handheld biodisplay unit. Sensing principle: transcutaneous thermistor-based temperature differential detection. Energy source: battery-powered (implied by handheld unit). Safety standards: IEC 60601-1, IEC 60601-1-4, IEC 60601-1-2.

Indications for Use

Indicated for use as an aid in detecting flow in implanted cerebrospinal fluid (CSF) shunts in patients requiring assessment of shunt patency. Not for use as a standalone diagnostic tool for shunt function or malfunction.

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 1.1) (K040021)

Submission Summary (Full Text)

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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 II<br>Central Nervous System Fluid Shunt and Components<br>21 CFR 882,5550 |
| Product Code: | JXG |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>ShuntCheck (version 1.1) (K040021) |
| Device Description: | ShuntCheck is a non-invasive device which detects flow in a CSF<br>shunt via transcutaneous thermal convection. The device consists of<br>a single use disposable thermosensor array patch which is connected<br>to a handheld "biodisplay" unit. The shunt is cooled transcutaneously<br>by placing ice over the shunt cephalic to the thermosensor. The<br>thermosensor array patch, which is placed on the skin over the shunt<br>"downstream" of the ice, reads the change in skin temperature over<br>the shunt as cooled fluid flows downstream and also at a nearby<br>control location. Data is captured in the biodisplay unit. If the device<br>detects a characteristic downstream transcutaneous temperature dip,<br>the biodisplay reports "flow confirmed". If no temperature dip is<br>detected, the unit reports "flow not confirmed" |
| Intended Use: | ShuntCheck is an aid to the detection of flow in implanted<br>cerebrospinal fluid (CSF) shunts. ShuntCheck cannot alone diagnose<br>CSF shunt function or malfunction. The clinical diagnosis of CSF shunt<br>function or malfunction, incorporating the flow information from<br>ShuntCheck, should be made only by a qualified neurosurgeon. |
| Functional and Safety<br>Testing: | To verify that device design meets the functional and performance<br>requirements, each device was submitted to bench testing and<br>performance verification to confirm accuracy when reading resistances<br>(thermistor input simulation) and the expected temperature output<br>displayed by the device software.<br>To verify the functionality of the device, three animal studies were<br>conducted. In the first study, the device was found to be substantially<br>equivalent to the predicate device, the second study, the device was<br>able to detect flow rates (ml/hr), and the third study supported the<br>indication for use change.<br>To verify that device design meets its safety requirements, a<br>representative sample of the device has been subjected safety testing i<br>in 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 be<br>substantially equivalent to the predicate device ShuntCheck (v1.0).<br>This conclusion is based upon the both devices'similarities in<br>principles 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)
for
MXM
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K080168 |
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