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K Number
K021904
Device Name
MAEDA SILVER ACUPUNCTURE NEEDLE
Manufacturer
MAEDA TOYOKICHI SHOTEN
Date Cleared
2002-08-14

(65 days)

Product Code
MQX,MOX
Regulation Number
880.5580
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Acupuncture Needles are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Maeda Silver Acupuncture Needle Disposable." This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as it pertains to a medical device that does not typically involve complex algorithms or performance metrics in the same way as, for example, an AI-powered diagnostic tool.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It does not include:

  1. A table of acceptance criteria and reported device performance: This is not relevant for an acupuncture needle in a 510(k) submission of this nature. Performance is generally assumed to be equivalent to existing devices.
  2. Sample size used for the test set and data provenance: No such test set is described.
  3. Number of experts used to establish ground truth and their qualifications: Not applicable.
  4. Adjudication method: Not applicable.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-powered diagnostic device.
  6. Standalone (algorithm only) performance study: Not applicable, as no algorithm is involved.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable.
  9. How ground truth for the training set was established: Not applicable.

The document primarily focuses on regulatory approval based on substantial equivalence, not on a detailed performance study as would be seen for more complex or novel medical devices, especially software as a medical device (SaMD) or AI-driven systems.

§ 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.