(94 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The Magi acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Magi acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The provided text is a 510(k) summary for a medical device (Magi Acupuncture Needle) seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies.
Instead, the document asserts:
- Substantial Equivalence: The Magi acupuncture needles are "substantially equivalent" to other legally marketed acupuncture needles.
- Safety Record: Since 1992, "no accident or device failure claims have been reported as a result of using the Magi 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."
Without a performance study, I cannot fill out the requested table or specify details about test sets, ground truth establishment, or statistical analysis.
{0}------------------------------------------------
OCT 17 1997
Dong Bang, U.S.A
Premarket Notification 510(k) Summary
Sue Kim ( General manager) Dong Bang USA 13640 Imperial Hwy #01 Santa Fe Spring, CA 90670 Office: 562-407-7435 Fax: 310-407-7436
Magi Acupuncture Needle Acupuncture Needle Class II. MQX
Device Generic Name: Classification: Product Code:
Device Trade Name:
Submitted by:
Device Description: The Magi acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Magi acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The Magi acupuncture needle was first manufactured in 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 Magi 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.
Substantial Equivalence: Magi 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.
Sue Kim General Manager
Sue Kim General Manager -11-97 Date
Image /page/0/Picture/13 description: The image shows the logo for MAGI, which is written in a bold, sans-serif font. The words "THE FUTURE BIOTECH" are written in a smaller, sans-serif font below the logo. There is a black brush stroke above the "I" in MAGI. The logo is black and the background is white.
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
{1}------------------------------------------------
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 with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird. The logo is simple and recognizable, representing the department's role in public health and human services.
OCT 1 7 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Sue Kim General Manager Donq Banq, U.S.A. 13640 East Imperial Highway, #1 Santa Fe Springs, California 90670
K972658 Re: Magi Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MQX September 2, 1997 Dated: September 9, 1997 Received:
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, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਮੁ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (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 regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obliqation you might have under sections 531
{2}------------------------------------------------
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 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) 594-4618. 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.fdaggov/cdrh/dsmamain.html".
Sincerely yours,
Willardrs
Timo A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
{3}------------------------------------------------
| 510(k) Number (if known): _ | |
|---|---|
| designation of the complete of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of |
Device Name:
Magi 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)
Vole Richard La Patricia Oriente
(Division Sign-Off Division of Dental, and Ge 510(k) Nu
Prescription Use × (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.