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K Number
K031060
Device Name
NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
Manufacturer
LHASA MEDICAL, INC.
Date Cleared
2003-07-11

(99 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

Nano Tech and Super Nano Acupuncture Needles are sterile disposable, surgical s/steel acupuncture needles with rigid pipe type plastic handles. These needles are supplied in individual blister or bulk packages, with or without polypropylene insertion tubes.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for acupuncture needles. It explicitly states in section (b)(1)(2)(3) on page 6b: "Substantial equivalence is not based on an assessment of performance data."

Therefore, the document does not contain information on acceptance criteria or a study proving device performance in the way typically expected for a medical device with measurable performance metrics (e.g., accuracy, sensitivity, specificity). This submission is based on substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting where information is not present:

Acceptance Criteria and Device Performance Study

  1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission explicitly states that substantial equivalence is not based on performance data.

  2. Sample Size Used for the Test Set and Data Provenance: This information is not provided. No test set or performance evaluation study (in terms of clinical or analytical performance) was conducted or reported.

  3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: This information is not provided. No test set or ground truth establishment based on expert review was conducted or reported.

  4. Adjudication Method for the Test Set: This information is not provided. No test set or adjudication process was conducted or reported.

  5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This information is not provided. No performance study involving human readers or AI assistance was conducted or reported.

  6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: This information is not provided. This device is a physical medical device (acupuncture needles), not a software algorithm, so a standalone algorithm study is not applicable.

  7. Type of Ground Truth Used: This information is not provided. No ground truth was established for a performance study.

  8. Sample Size for the Training Set: This information is not provided. The device is not an AI/ML algorithm that requires a training set.

  9. How the Ground Truth for the Training Set Was Established: This information is not provided. Not applicable as the device is not an AI/ML algorithm.

Summary of the basis for clearance:

The Nano Tech and Super Nano Acupuncture Needles were determined to be substantially equivalent to legally marketed predicate devices based on design and technological characteristics, not on performance data. The key characteristics considered were:

  • Same needle body lengths and gauges (thickness).
  • Same handle design.
  • Same packaging methods (single blister and bulk).
  • Same method of insertion (with or without guide tubes).

The predicate devices cited are:

  • DBC Acupuncture Needles (K-963300, 9/23/96)
  • SEIRIN Acupuncture Needles (K-962809, 8/16/92)

§ 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.