(93 days)
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States. The device is intended for single use only.
JIN acupuncture needles are EtO sterilized, surgical grade stainless steel with pyrogen free for single-use only. JIN needles comply with the GMP quality and safety requirements. JIN needles use tightly secured metal handle for safe, excellent handling and are easy to use.
This document describes a 510(k) submission for JIN Acupuncture Needles, arguing for their substantial equivalence to legally marketed predicate devices. The submission does NOT contain acceptance criteria or a study proving the device meets acceptance criteria in the manner one would typically expect for an AI/software medical device.
The provided text describes a medical device (acupuncture needles), not an AI/software device. Therefore, the concepts of acceptance criteria, performance studies, expert ground truth, multi-reader multi-case studies, standalone performance, and training/test sets are not applicable in the context of AI/software for this document.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use: Identical to predicates.
- Labeling: Identical warnings and information to predicates.
- Specifications: "Very identical" in size and gauge, with minor differences due to different gauge systems.
- Materials: Similar to two predicates (surgical grade stainless steel for needle body and handle), but one predicate uses plastic for the handle.
- Historical Safety and Effectiveness: Based on over 60 years of use in Japan by the manufacturer, TAIHO.
The FDA's response confirms substantial equivalence based on the provided information, allowing the device to be marketed.
Therefore, I cannot extract the requested information as it pertains to AI/software performance studies, because the provided document is not about an AI/software 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.