(29 days)
Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
The subject of this 510(k) application - the Seirin acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The provided document is a 510(k) summary for acupuncture needles and does not contain the kind of information requested regarding acceptance criteria, study details, and performance metrics typically associated with modern AI/ML medical devices.
Therefore, I cannot answer your request based on the input document. The document describes a traditional medical device (acupuncture needles) and focuses on demonstrating substantial equivalence to previously marketed devices, rather than providing performance data for a new AI-powered diagnostic or therapeutic tool.
§ 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.