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K Number
K031250
Device Name
DBC PRESS ACUPUNCTURE NEEDLES
Manufacturer
LHASA MEDICAL, INC.
Date Cleared
2003-07-15

(87 days)

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

These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Device Description

DBC Press Acupuncture Needles are small, sterile disposable, surgical s/steel, press type acupuncture needles. The 2.0 mm dia ring handle is continous with the 1.0 mm or 1.5 mm long needle body. These needles are supplied in sealed packages on polystyrene plastic holders.

AI/ML Overview

The provided documentation for Lhasa Medical, Inc.'s DBC Press Acupuncture Needles (K031250) states that substantial equivalence is NOT based on an assessment of performance data.

Therefore, the following information cannot be extracted from the given text:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and qualifications
  4. Adjudication method for the test set
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, or its effect size
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

Explanation:

The 510(k) summary explicitly states under section (b)(1)(2)(3) on page 6b: "Substantial equivalence is not based on an assessment of performance data."

Instead, the submission for the DBC Press Acupuncture Needles primarily relies on proving substantial equivalence in design and technological characteristics to predicate devices that were in commercial distribution prior to May 28, 1976, or that have previously received 510(k) approval (e.g., SEIRIN Pyonex Press Acupuncture Needles K-970254). The document indicates that the new device has "the same technological characteristics as the predicate device(s) identified in paragraph (a)(3). These needles use the same needle body lengths and gauges (needle thickness); handle design; method of insertion; and use the same packaging methods as these predicate devices."

This type of 510(k) submission does not typically involve the kind of performance studies or acceptance criteria that would be relevant for an AI/ML device or a device where performance claims are central to its safety and effectiveness.

§ 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.