(470 days)
Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.
"Phoenix" Epidural and Spinal Needles.
The provided text is a 510(k) clearance letter for "Dr. Japan's Phoenix Brand Spinal and Epidural Needles" and related documentation, dated June 2, 2000. It concerns the substantial equivalence of this device to legally marketed predicate devices.
This type of document (a 510(k) clearance letter from the FDA) does not contain information about acceptance criteria, detailed study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies. It confirms that the device has been found substantially equivalent to a predicate device based on the information provided in the 510(k) submission, allowing it to be marketed.
Therefore, I cannot extract the requested details from the provided text. The document is strictly about the regulatory clearance, not the technical performance details of a new device's study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 20
Myco Medical Supplies, Inc. C/O Sam Kumar, President 113 Centre West Court Cary, NC 27513
Re : K990519 Trade Name: Dr. Japan's Phoenix Brand Spinal and Epidural Needles Requlatory Class: II Product Code: BSP Dated: March 6, 2000 Received: March 7, 2000
Dear Mr. Kumar:
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 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlations.
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Page 2 - Mr. Sam Kumar
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Mark Millikan
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________ "Phoenix" Epidural and Spinal Needles.
Indication For Use:
Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark n Milheson
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K990515
X Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use_ _________
(Optional Format 1-2-96)
OR
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).