(46 days)
The Universal Shunt System is intended for use as the principle pressure-regulating component of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.
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I am sorry, but the provided text does not contain the information requested in your prompt. The document is a clearance letter from the FDA for a device called "Phoenix Universal Shunt System" and primarily discusses regulatory matters, product classification, and general marketing stipulations.
It does not include any details about:
- Acceptance criteria or reported device performance
- Sample sizes for test sets or their data provenance
- Number or qualifications of experts for ground truth
- Adjudication methods
- Multi-reader, multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance studies
- Type of ground truth used
- Sample size for training sets
- How ground truth for training sets was established
Therefore, I cannot provide the requested table or answer the specific questions based on the input text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2003
Phoenix Biomedical Corporation Courtney Smith Regulatory Affairs Manager P. O. Box 80390 Valley Forge, Pennsylvania 19484
Re: K024101
Trade/Device Name: Phoenix Universal Shunt System Regulation Number: 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: December 20, 2002 Received: January 7, 2003
Dear Ms. Smith:
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
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Page 2 - Ms. Courtney Smith
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Muriam C. Provost
Corcelia 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
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Page_ I of I
510(k) Number (if known): KO2410 l Device Name: Phoe Indications For Use: t
Universal Shunt System
Intended Use/ Indications:
- The Universal Shunt System is intended for use as the principle pressure-● regulating component of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Muriam C. Provost
ision Sign-C Ivision of General, Restorative 1 Neurological Devices
§ 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).