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Double-Holed Pencil Point Spinal Needle (DHPP)
This is an FDA premarket notification (510(k)) letter for a medical device. This type of document is a clearance letter, not a study report or a detailed description of device performance or clinical trials. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document.
This letter only states that the device, a "Double-Holed Pencil Point Spinal Needle (DHPP)," has been found "substantially equivalent" to legally marketed predicate devices. It does not contain details about specific acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.
To answer your questions, one would need access to the 510(k) submission document itself, which would include the performance data and the comparison to the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 30 1997
Ms.. Rochelle Froloff CSEN Ltd. ... c/o Alexander Medical 9055 Northwest 13th Court Coral Springs, Florida 33071
K951928 Re: Double-Holed Pencil Point Spinal Needle (DHPP) Regulatory Class: II (two) Product Code: 73 BSP Dated: March 1, 1997 Received: March 3, 1997
Dear Ms. Froloff:
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 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 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 regulations.
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Page 2 - Ms. Rochelle Froloff
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 diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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
sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
§ 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).