(56 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The needles are sterile, for single use only. They have a stainless steel shaft and a polystyrol handles are color coded for size.
I am sorry, but the provided text does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) summary and FDA clearance letter for "Singer Acupuncture Needles" which establishes substantial equivalence to predicate devices, but it does not include details on specific acceptance criteria or performance studies. It mentions "results of bench and user testing" but provides no specifics about these tests, the data, or the metrics.
§ 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.