(78 days)
- The Perf (Ommaya Style) Reservoir is intended as a means of gaining access to the cerebral ventricles by hypodermic puncture. It may be used for ventricular drainage.
- The Perf (Ommaya Style) Reservoir may be used to access the ventricles for the administration of chemotherapeutic agents and/or radioisotopes.
Not Found
This document is a 510(k) premarket notification letter from the FDA to Phoenix Biomedical Corporation regarding their "Perf (Ommaya Style) Reservoir." It is a regulatory approval document and does not contain information about acceptance criteria, device performance, or study details.
Therefore, I cannot provide the requested information from the provided text. The document outlines the FDA's decision that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing, subject to general controls provisions of the Act.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of a stylized human figure with three profiles overlapping each other. The profiles are facing to the right and are connected to a wing-like shape above them.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UG 0 6 2002
Phoenix Biomedical Corporation Courtney Smith Regulatory Affairs Manager 2495 General Armistead Avenue, P. O. Box 80390 Valley Forge, Pennsylvania 19484
Re: K021644
Trade/Device Name: Perf (Ommaya Style) Reservoir Regulation Number: 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: May 16, 2002 Received: May 20, 2002
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. Iisting 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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Courtney Smith
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour 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 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 vours
Sincerely yours,
Mark A. Milken
Celia 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 of
510(k) NUMBER (IF KNOWN) : DEVICE NAME : INDICATIONS FOR USE:
Perf (Ommaya Style) Reservoir
Intended Use/ Indications:
- The Perf (Ommaya Style) Reservoir is intended as a means of gaining . The Pen (Onlinaya Stylo) Reber by hypodermic puncture. It may be used access to the coronal velieres of any and for ventricular drainage.
- The Perf (Ommaya Style) Reservoir may be used to access the ventricles . The Perf (Onlinaya Bryto) Resort of chemotherapeutic agents and/or radioisotopes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter-Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
for
| Mark N. Melkers | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices |
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).