(90 days)
Not Found
Not Found
No
The summary describes a mechanical shunt system for CSF drainage and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is used in the treatment of hydrocephalic patients to shunt cerebrospinal fluid, directly addressing a medical condition.
No
The provided text describes the device as a shunt system used to treat hydrocephalus by draining cerebrospinal fluid. Its function is therapeutic (treatment), not diagnostic (identifying a disease or condition).
No
The device description is not found, but the intended use clearly describes a "Shunt System" which is a physical device used to shunt cerebrospinal fluid. This indicates a hardware component is involved.
Based on the provided information, the Maurice Worldwide Shunt System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to shunt cerebrospinal fluid within the patient's body (from the brain to the peritoneal cavity). This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: While the description is "Not Found," the intended use clearly describes a surgical implant for fluid management within the body.
- Lack of Diagnostic Function: The description does not mention any function related to analyzing samples (like blood, urine, or CSF) to diagnose a condition. Its purpose is purely therapeutic (managing fluid flow).
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Maurice Worldwide Shunt System does not fit this definition.
N/A
Intended Use / Indications for Use
The Maurice Worldwide Shunt System is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneal cavity.
This device should only be used by a physician or qualified personnel under the direction of a physician.
Care must be taken to ensure compliance with the manufacturer's instructions for use.
Product codes
JXG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain, peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or qualified personnel under the direction of a physician.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori L. Havs. MT(ASCP) Regulatory Submissions Specialist NeuroCare Group™ 8401 102nd Street, Suite 200, PO Box 390 Pleasant Prairie, Wisconsin 53158-0390
DEC I 6 1997
Re: K973525
Trade Name: Maurice Worldwide Shunt System Regulatory Class: II Product Code: JXG Dated: September 15, 1997 Received: September 17, 1997
Dear Ms. Hays:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
1
Page 2 - Ms. Lori L. Hays, MT(ASCP)
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
tcoees
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori L. Havs. MT(ASCP) Regulatory Submissions Specialist NeuroCare Group™ 8401 102nd Street, Suite 200, PO Box 390 Pleasant Prairie, Wisconsin 53158-0390
DEC I 6 1997
Re: K973525
Trade Name: Maurice Worldwide Shunt System Regulatory Class: II Product Code: JXG Dated: September 15, 1997 Received: September 17, 1997
Dear Ms. Hays:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
3
Page 2 - Ms. Lori L. Hays, MT(ASCP)
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
tcoees
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right and appears to be in flight. The logo is simple and clean, with a focus on the eagle as a symbol of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori L. Havs. MT(ASCP) Regulatory Submissions Specialist NeuroCare Group™ 8401 102nd Street, Suite 200, PO Box 390 Pleasant Prairie, Wisconsin 53158-0390
DEC I 6 1997
Re: K973525
Trade Name: Maurice Worldwide Shunt System Regulatory Class: II Product Code: JXG Dated: September 15, 1997 Received: September 17, 1997
Dear Ms. Hays:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
5
Page 2 - Ms. Lori L. Hays, MT(ASCP)
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
tcoees
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 8 - DEVICE INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Maurice Worldwide Shunt System
Indications for Use: The Maurice Worldwide Shunt System is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneal cavity.
This device should only be used by a physician or qualified personnel under the direction of a physician.
Care must be taken to ensure compliance with the manufacturer's instructions for use.
Prescription Use Only
(Per 21 CFR 801.109)
boole
Sign-Off) of General Restorative Devic