H.M.T. ACUPUNCTURE NEEDLE

{0}------------------------------------------------ ## Hummingbird Medical Technolog ## 510(K) SUMMARY V. DEC 1 1 2001 ## 510(K) Summary As required by section 807.92(c) Hummingbird Medical Technology L.L.C. 1427 Greenbriar Dr. Allen, TX 75013 214-284-5433 Phone: Fax: 214-495-8888 Geoffrey Hsu (General Manager) July 4th 2001 Device Name: H.M.T. Acupuncture Needle, Signal Use Common Device Name: Acupuncture Needle, Signal Use Product Code: MOX Medical Specialty: General Hospital Device Class: II Hummingbird brand acupuncture needles are defined as prescription devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States. FDA had issued 510(K)s to 47 different signal use acupuncture needles brand and them have been used for general practice of acupuncture in the United States since 1996. We had searched Federal Consumer Information Center web site http://www.pueblo.gsa.gov and U.S. Consumer Product Safety Commission web site http://www.cpsc.gov and found no serious or life threatening accidents involving acupuncture needles. Hummingbird brand acupuncture needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture. In conclusion, based on the information provided with this 510(K) Notification, the Hummingbird acupuncture needles meet the criteria for 510(k) acceptance. The Hummingbird acupuncture needles is equivalent to other acupuncture needles which are currently being sold through interstate commerce. Greg H ## 7-29-01 Geoffrey M. C. Hsu (General Manager) Date Image /page/0/Picture/15 description: The image shows a logo with a bird-like figure in the center. The bird is surrounded by circular shapes and what appears to be plant life. The letters 'HME' are at the bottom of the logo. The letters 'TM' are in the upper right corner of the image. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized design that resembles an abstract representation of a human figure or a symbol related to health and well-being. The design is composed of curved lines and shapes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 1 2001 Mr. Geoffrey Hsu Hummingbird Medical Technology, L.L.C. 1427 Greenbriar Drive Allen, Texas 75013 Re: K012501 Trade/Device Name: H.M.T Acupuncture Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle, Single Use Regulatory Class: II Product Code: MQX Dated: October 12, 2001 Received: October 19, 2001 Dear Mr. Hsu: 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 ications 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amondinenelia, er or do active Act (Act) that do not require approval of a premarket the reachar Four (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include controls provision 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 (1 Mr), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can as publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not r lease of acrised that de a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. {2}------------------------------------------------ Page 2 - Mr. Hsu You must comply with all the Act's requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF RT rut 007), laceling (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (QS) regulation (21 CFR Part 680); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section This letter will anow you to begin maintening your of substantial equivalence of your device to 310(K) premarket nonfloated." The 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 II you desire specific ad not 2017 your and one of the vitro diagnostic devices), please contact the and additionally 21 CFR Fart 607.10 Ion in the onelly, for questions on the promotion and Office of Compliance at (301) 594-4618. Additionally, for questions on 16001 504-46 Office of Comphance at (301) 59 : The Office of Compliance at (301) 594-4639. advertising or your are more the d, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (ZTCFR Part 007.97) Online golf Small Manufacturers, International and ule Act may be obtained in its = sumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K012501 Hummingbird Medical Technology ## STATEMENT OF INDICATIONS FOR USE IV. Hummingbird brand acupuncture needles will be used for "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states." Nick Hubbard for Pat Crescent: 11/12/01 al Hospital 510(k) Number K012501