(31 days)
This device is intended to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Carbo/Optimed brand acupuncture needles are sterile disposable needle for one time use only. The needle shaft/body is made of surgical grade stainless steel (as per ASTM specifications) and is used for the practice of acupuncture as determined by state. The handle is made of aluminium alloy, which does not enter the human body, but is used to control the insertion of the needle.
The provided text is a 510(k) premarket notification summary for an acupuncture needle. It explicitly states that "Substantial equivalence is not based on an assessment of performance data."
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, and comparative effectiveness studies is not available in this document.
The submission focuses on demonstrating substantial equivalence to predicate devices (Tai-Chi Acupuncture needles K003760 and Addiquip Acupuncture needles K981272) based on design, intended use, and technological characteristics (sterile disposable, surgical grade stainless steel shaft, aluminum alloy handle). No clinical studies or performance data are presented to establish acceptance criteria or prove that the device meets them.
§ 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.