(301 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
ShuntCheck is indicated for the detection of flow, which is a diagnostic function, not a therapeutic one. The description explicitly states it "cannot, alone diagnose CSF shunt function or malfunction," and the diagnosis should be made by a neurosurgeon incorporating this information.
No
The device aids in the detection of flow in CSF shunts but explicitly states it "cannot, alone diagnose CSF shunt function or malfunction." The clinical diagnosis is made by a neurosurgeon incorporating the flow information.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The intended use describes a physical action ("detection of flow in implanted silastic cerebrospinal fluid (CSF) shunts"), implying a hardware component is likely involved in the detection process. Without a device description, it's impossible to confirm if this detection is purely software-based or requires a physical sensor or other hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ShuntCheck is for the "detection of flow in implanted silastic cerebrospinal fluid (CSF) shunts." This involves interacting with an implanted device within the body, not analyzing samples taken from the body (like blood, urine, or tissue) in a laboratory setting.
- Mechanism: While the "Device Description" is not found, the intended use describes detecting flow in a shunt. This suggests a physical or physiological measurement related to the implanted device, not a chemical, immunological, or molecular analysis of a biological sample.
- IVD Definition: IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This is done by examining specimens derived from the human body. ShuntCheck does not fit this definition.
Therefore, ShuntCheck is a medical device, but it falls outside the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ShuntCheck is indicated for the detection of flow in implanted silastic cerebrospinal Shuid (CSF) shunts. ShuntCheck must be used by a qualified neurosurgeon according to instructions. 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
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified neurosurgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2004
Samuel Neff, M.D. Compliance Officer NeuroDiagnostic Devices 17 White Horse Pike, Suite 3 Haddon Heights, New Jersey 08035-1299
Re: K040021
Trade/Device Name: ShuntCheck Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: October 11, 2004 Received: October 14, 2004
Dear Dr. Neff:
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 - Samuel Neff, M.D.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 2 - Indication for use statement:
Indications for Use
510(k) Number (if known): K040021 Device Name: ShuntCheck Indications for Use:
ShuntCheck is indicated for the detection of flow in implanted silastic cerebrospinal Shuid (CSF) shunts. ShuntCheck must be used by a qualified neurosurgeon according to instructions. 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.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use __ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________