(415 days)
Not Found
Not Found
No
The summary describes a mechanical valve for shunting cerebrospinal fluid and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is used in the treatment of hydrocephalic patients to shunt cerebrospinal fluid, directly addressing a medical condition.
No.
The device's intended use is to treat hydrocephalic patients by shunting cerebrospinal fluid, which is a therapeutic function and not a diagnostic one.
No
The device description clearly indicates a "Beverly Referential Valve," which is a physical component used in shunting cerebrospinal fluid. This is a hardware device, not software.
Based on the provided information, the Beverly Referential Valve is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to shunt cerebrospinal fluid from the body (lateral ventricles) into other parts of the body (peritoneum or right atrium). This is an in vivo application, meaning it is used within a living organism.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The Beverly Referential Valve does not perform any such testing on samples.
- Device Description: The description simply names the device and doesn't mention any components or functions related to laboratory testing or analysis of biological samples.
Therefore, the Beverly Referential Valve is a medical device used for surgical implantation and fluid management within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Beverly Referential Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the peritoneum or the right atrium of the heart.
The Beverly Referential Valve is intended to minimize the effect of hydrostatically induced flow when the patient is sitting, standing or semi-recumbent when compared to devices not containing an anti-siphon device.
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)
Product codes
JXG
Device Description
Beverly Referential Valve with Integral Peritoneal Catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain, peritoneum, right atrium of the heart
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces, suggesting a sense of community and care.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 1999
Ms. Lori L. Hays Regulatory Submissions Specialist Hever-Schulte Neurocare, L.P. 8401 102nd Street, Suite 200 Pleasant Prairie, Wisconsin 53158
Re: K981246 Trade Name: Beverly Referential Valve with Integral Peritoneal Catheter Regulatory Class: II Product Code: JXG Dated: February 24, 1999 Received: February 25, 1999
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 requirement, 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 -- Ms. Lori Hays
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,
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
SECTION 1 - DEVICE INDICATIONS FOR USE
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Beverly Referential Valve
Indications for Use:
The Beverly Referential Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the peritoneum or the right atrium of the heart.
The Beverly Referential Valve is intended to minimize the effect of hydrostatically induced flow when the patient is sitting, standing or semi-recumbent when compared to devices not containing an anti-siphon device.
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)
to Sollo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K981246