(194 days)
These devices are intended as a means of gaining access to the cerebral ventricles or cystic tumor for the short-term (less than 30 days) injection of chemotherapeutics agents and/or radioisotopes.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter for the "Phoenix Infusor Infusion Catheter System," indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
The letter discusses:
- The device name (Phoenix Infusor Infusion Catheter System)
- Regulation number and name (21 CFR 882.5550, Central nervous system fluid shunt and components)
- Regulatory class (II)
- Product code (JXG)
- The date of the letter and previous correspondence
- Details about FDA regulations and responsibilities of the manufacturer
- The "Indications for Use" statement for the device, which specifies its intended purpose: "as a means of gaining access to the cerebral ventricles or cystic tumor for the short-term (less than 30 days) injection of chemotherapeutics agents and/or radioisotopes."
There is no mention of:
- Specific acceptance criteria (e.g., performance metrics, thresholds)
- Any study design
- Sample sizes for testing or training
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Types of ground truth
- How ground truth was established
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 7 2004
Ms. Courtney Smith Regulatory Affairs Manager Phoenix Biomedical P.O. Box 80390 2495 General Armistead Avenue Valley Forge Pennsylvania 19484
Re: K033017
Trade/Device Name: Phoenix Infusor Infusion Catheter System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: December 18, 2003 Received: January 8, 2004
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 complics 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), 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). You may obtain other general information on your responsibilities under the Act 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,
Sincerely yours,
Mark A. Mulkerson
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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Indications for Use
510(k) Number (if known): K033017
Phoenix Infusor Infusion Catheter System Device Name:
Indications For Use:
These devices are intended as a means of gaining access to the cerebral ventricles or cystic tumor for the short-term (less than 30 days) injection of chemotherapeutics agents and/or radioisotopes.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- Office of Dorico Evaluation err
Division of General, Restorative, and Neurological Devices
510(k) Number K033017
Page 1 of
§ 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).