(123 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Not Found
I am sorry, but based on the provided text, I cannot provide the requested information. The text is a letter from the FDA regarding the 510(k) premarket notification for "AcuGlide brand Acupuncture Needles." It indicates that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, the document does NOT contain:
- A table of acceptance criteria or reported device performance.
- Details of any study that proves the device meets acceptance criteria, including sample sizes, data provenance, expert information, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
- Information on training sets or how ground truth was established for any studies.
The letter is a regulatory approval document and does not delve into the technical details of performance studies.
§ 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.