(176 days)
The acupuncture needles devices licensed are used by practitioners which are intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
Not Found
This document is a 510(k) clearance letter from the FDA for Acupuncture Needles, allowing them to be marketed based on substantial equivalence to existing devices. As such, it does not contain the detailed information about acceptance criteria and clinical study results typically found in a Premarket Approval (PMA) application or a more extensive 510(k) submission summary.
Therefore, I cannot provide the requested information. This document primarily focuses on regulatory clearance based on substantial equivalence, rather than a performance study demonstrating acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
C.A.M. Supply, Incorporated C/O Mr. John N. Politis Politis & Politis Attorney At Law 865 South Fiqueroa Street, Suite 1388 Los Angeles, California 90017
Re : K964861 Trade Name: Acupuncture Needles Requlatory Class: II Product Code: MOX March 25, 1997 Dated: March 27, 1997 Received:
Dear Mr. Politis:
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 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 The general controls provisions of the Act 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) regulation (21 CFR Part 820) and that, through periodic GMP 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
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the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) Additionally, for questions on the promotion and 594-4692. 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 of (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Tim R. Ulatowski
Timo Director Division of Dental, Infection Control, and General Hospital 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: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE:
The acupuncture needles devices licensed are used by practitioners which are intended to pierce the skin in the practice acupuncture by qualified practitioners of of acupuncture as determined by the states.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBBED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
(Division Sign-Off)Patacia Oucenti
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K941866
Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-95)
§ 880.5580 Acupuncture needle.
(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.