(272 days)
The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The Acupuncture Needles are sterile, hair thin needles which are inserted into specific points on the skin, called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation. The Acupuncture Needles are available in eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm).
Acupuncture Needles (K092240) - Acceptance Criteria and Performance Study
The K092240 submission concerns Acupuncture Needles manufactured by HaengLim SeoWon Medical Co. The primary study presented aims to demonstrate substantial equivalence to predicate devices rather than establishing novel safety and efficacy criteria through a clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (K092240) |
|---|---|
| Surface Smoothness & Freedom from Visible Defects | Surfaces found to be smooth and free of visible defects at 200-300X magnification. |
| Pull-out Force | Quantified pull-out force fell within the average values reported for the predicate devices. |
| Elasticity Properties (No Permanent Deformation after Cantilever-Type Loading) | Returned to original shape after cantilever-type loading, showing no permanent deformation, similar to predicate devices. |
| Sterility | Sterilized with gamma irradiation (implied to meet relevant standards). |
| Material Composition | Manufactured from stainless steel (consistent with predicate devices). |
| Available Sizes (Diameters, Lengths) | Available in eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm) - implies offering a comparable range to predicate devices. |
| Intended Use | Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture (identical to predicate devices). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size in terms of a "test set" in the traditional sense of a clinical or in vivo study. The evaluation appears to be a bench-top comparison between the subject device and two predicate devices.
- Test Set: The "test set" consisted of the Acupuncture Needle (subject device) and two predicate devices (Dong Bang Acupuncture Needle, K972659 and C & G Acupuncture Needle, K043277).
- Data Provenance: The study was a retrospective bench-top comparison performed on the devices themselves. No details on the origin of the specific samples (e.g., country of origin for the tested devices) are provided, beyond the manufacturing location of the subject device (Korea) and the listed applicants of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The study does not involve human observers or interpretation of medical images, thus the concept of "experts" establishing ground truth for a test set is not applicable in the traditional sense. The "ground truth" for the mechanical and microscopic properties was based on direct measurement and observation by the individuals conducting the testing. Their qualifications are not specified, but it's presumed they were technicians or engineers competent in microscopy and mechanical testing.
4. Adjudication Method for the Test Set
No adjudication method was used, as the study involved direct physical and mechanical testing rather than human interpretation requiring consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This device is an acupuncture needle, and the study focuses on its physical and mechanical properties compared to legally marketed predicate devices, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical medical instrument (acupuncture needle), not an algorithm or AI-powered system.
7. Type of Ground Truth Used
The ground truth used was based on direct physical and mechanical measurements and microscopic observations. This includes:
- Visual assessment under magnification for surface defects.
- Quantitative measurement of pull-out force.
- Qualitative assessment of elasticity (return to original shape after loading).
8. Sample Size for the Training Set
Not applicable. There was no "training set" as this was a physical device comparison study, not a machine learning or AI context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no training set, there was no ground truth for a training set to be established.
§ 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.