(415 days)
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)
Beverly Referential Valve
The provided text is a 510(k) clearance letter from the FDA for the "Beverly Referential Valve with Integral Peritoneal Catheter." It states that the device is substantially equivalent to a predicate device but does not contain any information regarding acceptance criteria, device performance results, or details of a study.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies. The document only confirms the device's clearance for marketing.
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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.
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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
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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
§ 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).