(94 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The Dong Bang acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Dong Bang acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The provided document is a 510(k) summary for the Dong Bang Acupuncture Needle and a subsequent FDA clearance letter. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to existing legally marketed devices, which is the basis for 510(k) clearance. The crucial aspects for your request are missing.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth, or training set information.
The only relevant statements from the document are:
- "The Dong Bang acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture." (This is a general claim, not supported by data in this document).
- "Since 1992, no accident or device failure claims have been reported as a result of using the Dong Bang acupuncture needle." (This is a safety claim based on past performance, not a study against specific acceptance criteria).
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Premarket Notification 510(k) Summary
OCT 1 1997
Submitted by:
Device Trade Name:
Classification:
Product Code:
Device Generic Name:
Sue Kim ( General manager) Dong Bang USA 13640 Imperial Hwy #01 Santa Fe Spring, CA 90670 Office: 562-407-7435 Fax: 310-407-7436
Dong Bang Acupuncture Needle Acupuncture Needle Class II. MOX
Device Description: The Dong Bang acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Dong Bang acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The Dong Bang acupuncture needle was first manufactured in and China in 1992 by the Dong Bang Medical Instrument Co., LTD and has been imported and sold through interstate commerce in the USA since 1992 under the FDA labeling restrictions , that states: "Caution: Investigational device limited by U.S. Law to investigational use". Since 1992, no accident or device failure claims have been reported as a result of using the Dong Bang acupuncture needle.
Intended Use: Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Image /page/0/Picture/10 description: The image shows the logo for MAGI, which stands for "The Future Biotech". The logo is in black and white, with the word "MAGI" in large, bold letters. There is a black brush stroke above the "I" in MAGI. The words "THE FUTURE BIOTECH" are in smaller letters below the word "MAGI".
Substantial Equivalence: Dong Bang acupuncture needles are currently sold in the USA under numerous propriety names by other medical device companies. Also, the Dong Bang needle is equivalent to other legally marketed acupuncture needles which are currently being sold through interstate commerce.
Su Kim General Manager
Sue Kime General Manager
7-8-97
Date
Medical, Acupuncture, Dental Health Food, Herbal Formulas Export/Import/Distribute
13640-01 Imperial Hwy. Santa Fe Springs, CA 90670 (310) 407-7433 (310) 407-7436 Fax
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 17 1997
Ms. Sue Kim General Manager Dong Bang, U.S.A. 13640 East Imperial Highway, #1 Santa Fe Springs, California 90670
Re: K972659 Dong Banq Acupuncture Needles Trade Name: Regulatory Class: II Product Code: MOX September 2, 1997 Dated: Received: September 9, 1997
Dear Ms. Kim:
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, Druq, 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, labelinq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Paqe 2 - Ms. Kim
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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) 594-4618. 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.fdaa.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot Hv A Ulatowski 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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R972659
510(k) Number (if known):
Device Name:
Dong Bang Acupuncture Needles
9/02/97
Indications For Use:
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Hubbard for Patricia Cricente
(Division S Division of Dental, In and General Hos 510(k) Numb
Prescription Use_x (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.