(77 days)
The TeWa 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.
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This document is a 510(k) clearance letter for TeWa Acupuncture Needles and does not contain the requested information regarding acceptance criteria and performance study details. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the specific details you've asked for, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, expert qualifications, or adjudication methods for test sets.
- Information on MRMC studies or standalone algorithm performance.
- The type of ground truth used or details about training sets.
§ 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.