(70 days)
The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states. The device consists of a solid, titanium needle.
The device consists of a solid, titanium needle.
This document is an FDA 510(k) clearance letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
Therefore, I cannot provide the requested information based on the given input. The categories in your request are relevant to the evaluation of AI/ML-driven medical devices, which this document is not about.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2006
Sedatelec C/O Mr. Kevin Walls Principal Consultant Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K060392
Trade/Device Name: ASP TITANIUM Acupuncture Needles for Single Use Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: March 23, 2006 Received: March 27, 2006
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. Kevin 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D 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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Indications for Use
510(k) Number (if known): K060392
Device Name: ASP TITANIUM Acupuncture Needles 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 as determined by the states. The device consists of a solid, titanium needle.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ാന്തര വിശ്വാത്തിരും, General Hospital, Truchio! Dental Devices
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§ 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.