(232 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding an acupuncture needle (Qizhou Acupuncture Needle, K013926). It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML-based medical device.
The document determines the device is substantially equivalent to legally marketed predicate devices, which means it doesn't require a new clinical study to establish safety and effectiveness, but rather demonstrates it's as safe and effective as a device already on the market.
Therefore, I cannot fulfill your request for the specific sections you've outlined, as they are not present in this regulatory document for a physical medical device.
§ 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.