(404 days)
This device is intended for use as the principle regulating component of a CSF ITOW and pressure regaremently, used in the treatment of hydrocephalus.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "CRX DIAMOND VALVE." It confirms that the device is substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.
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8 1998 DEC
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Courtney Smith Clinical and Requlatory Specialist Phoenix Biomedical Corporation P.O. Box 80390 19484 Vallev Forge, Pennsylvania
K974096 Re: CRX Diamond Valve Trade Name: Requlatory Class: II Product Code: JXG September 8, 1998 Dated: September 9, 1998 Received:
Dear Ms. Smith:
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 The general controls provisions of the Act 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 Requlations, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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. Courtney Smith
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 diaqnostic 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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K974096/A'
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510(k) Number (if known): K974096
Device Name: CRX DIAMOND VALJE
Indications For Use:
This device is intended for use as the principle This device is Intended For the regulating component of a CSF ITOW and pressure regaremently, used in the treatment of hydrocephalus.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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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).