(37 days)
The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
asia-med acupuncture needles (Special+, s-needle B-Type and s-needle J-Type) for single use.
The provided text is a 510(k) Premarket Notification letter from the FDA to Asia-Med GmbH and CO KG regarding their acupuncture needles. It is a regulatory document confirming that the device has been found substantially equivalent to a legally marketed predicate device.
This document DOES NOT contain information about acceptance criteria, device performance studies, or clinical trial data. It is purely a regulatory approval notice. Therefore, I cannot extract the requested information regarding acceptance criteria and studies from this text.
The information you are asking for (acceptance criteria, sample sizes, expert qualifications, study types, etc.) would typically be found in the 510(k) submission itself, or in supporting documentation such as a clinical study report or a validation report, which are not part of this FDA clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2003
Asia-Med GmbH and CO KG C/O Mr. Kevin Walls Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K031716
Trade/Device Name: Asia-Med Acupuncture Needles (Special+, S-Needle B-Type and S-Needle J-Type) for Single Use Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: May 23, 2003 Received: June 6, 2003
Dear Mr. Walls:
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 indications 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Walls
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runne
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko31716
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510(k) Number (if known):
asia-med acupuncture needles (Special+, s-needle B-Type and s-Device Name: needle J-Type) for single use.
- Indications for Use: The acupuncture needle is a device intended 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)
Patricia Caccavale
(Division Sign Off)
Division of Dental. Infection Control. and General Hospital Devices 510(k) Number
Prescription Use × (Per 21 CFR 801.109)
§ 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.