(114 days)
Not Found
No
The description details a device that measures temperature changes based on thermal convection and reports a binary outcome ("flow confirmed" or "flow not confirmed") based on detecting a "characteristic downstream transcutaneous temperature dip." There is no mention of algorithms that learn from data or adapt over time, which are hallmarks of AI/ML. The performance studies focus on bench testing, animal studies, and safety standards, not on training or testing AI/ML models.
No.
The device is an aid to the detection of flow in CSF shunts and cannot diagnose shunt function or malfunction on its own; a qualified neurosurgeon makes the clinical diagnosis. It provides information for diagnosis rather than directly treating a condition.
Yes
The device "aids to the detection of flow in implanted cerebrospinal fluid (CSF) shunts," providing "flow information" that helps in the "clinical diagnosis of CSF shunt function or malfunction." It identifies whether "flow is confirmed" or "flow is not confirmed," which are pieces of information used in a diagnostic process.
No
The device description explicitly states it consists of a disposable thermosensor array patch and a handheld "biodisplay" unit, which are hardware components.
Based on the provided information, ShuntCheck is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ShuntCheck's Mechanism: ShuntCheck is a non-invasive device that detects flow in an implanted shunt by measuring transcutaneous temperature changes on the skin. It does not analyze any biological specimens taken from the patient.
- Intended Use: The intended use is to aid in the detection of flow in an implanted device, not to analyze biological samples for diagnostic purposes.
Therefore, ShuntCheck falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
JXG
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"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebrospinal fluid (CSF) shunts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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 the functionality of the device, three animal studies were conducted. In the first study, the device was found to be substantially equivalent to the predicate device, the second study, the device was able to detect flow rates (ml/hr), and the third study supported the indication for use change. To verify that device design meets its safety requirements, a representative sample of the device has been subjected safety testing in accordance with IEC 60601-1, IEC 60601-1-4, and IEC 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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 |
| 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 1.1) (K040021) | |
| 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" | |
| 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. | |
| Functional and Safety | |
| 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 the functionality of the device, three animal studies were | |
| conducted. In the first study, the device was found to be substantially | |
| equivalent to the predicate device, the second study, the device was | |
| able to detect flow rates (ml/hr), and the third study supported the | |
| indication for use change. | |
| To verify that device design meets its safety requirements, a | |
| representative sample of the device has been subjected safety testing i | |
| 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 |
| substantially equivalent to the predicate device ShuntCheck (v1.0). | |
| This conclusion is based upon the both devices'similarities in | |
| principles of operation, technology, materials, and indications for use. |
1
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.
2
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
3
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)
for
MXM
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K080168 |
|---|---|
| --------------- | --------- |