(37 days)
The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
asia-med acupuncture needles (Special+, s-needle B-Type and s-needle J-Type) for single use.
The provided text is a 510(k) Premarket Notification letter from the FDA to Asia-Med GmbH and CO KG regarding their acupuncture needles. It is a regulatory document confirming that the device has been found substantially equivalent to a legally marketed predicate device.
This document DOES NOT contain information about acceptance criteria, device performance studies, or clinical trial data. It is purely a regulatory approval notice. Therefore, I cannot extract the requested information regarding acceptance criteria and studies from this text.
The information you are asking for (acceptance criteria, sample sizes, expert qualifications, study types, etc.) would typically be found in the 510(k) submission itself, or in supporting documentation such as a clinical study report or a validation report, which are not part of this FDA clearance letter.
§ 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.