(62 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The subject of this 510(k) Notification - the KHT Guam Needle - is a sterile, single use only acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
The provided document for K980471 pertains to the clearance of an acupuncture needle (KHT Guam Needle). The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with acceptance criteria in the way a novel medical device or AI-driven diagnostic would require.
Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable in this context. The 510(k) process for this type of device relies on established safety and efficacy profiles of similar legally marketed devices.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: The KHT Guam Needle is substantially equivalent to a legally marketed predicate device (Seirin Brand Acupuncture Needle, K963769, and pre-amendment devices) in terms of design, materials, sterility, biocompatibility, and intended use. | The KHT Guam Needle is a sterile, single-use only acupuncture needle. The submission states that its "design, material used, sterility and biocompatibility... meet the general specifications and criteria for a single use acupuncture needle and is effective for the practice of acupuncture." The FDA's clearance letter confirms the substantial equivalence finding. |
| Safety: No serious or life-threatening accidents involving acupuncture needles known over 30 years of use. | The device is intended for the same use as acupuncture needles that have been used for over 30 years, during which no serious or life-threatening accidents were reported for the general category. The KHT_Guam Needle offers "greater safety" as it is sterilized and single-use, unlike some pre-amendment devices. |
| Effectiveness: Effective for the practice of acupuncture. | The submission states the device "is effective for the practice of acupuncture." This is implicitly accepted by the FDA's substantial equivalence finding, as the predicate devices were considered effective for this purpose. |
| Sterility: Device must be sterile. | The KHT Guam Needle is described as a "sterile, single use only acupuncture needle." (Implied by current market standards and predicate). |
| Biocompatibility: Device materials must be biocompatible. | The submission states that the "biocompatibility of this acupuncture needle meet the general specifications and criteria" for a single-use acupuncture needle. |
| Single Use: Device must be for single use only. | The KHT Guam Needle is described as a "single use only acupuncture needle." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this 510(k) submission. There was no "test set" in the sense of a clinical performance study with a specific sample size. The substantial equivalence argument relies on comparison to existing devices and general knowledge of acupuncture needle safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth was established by experts for a specific test set. The regulatory determination of "substantial equivalence" is made by the FDA based on the provided documentation and comparison to predicate devices, not on expert consensus on a new test set's ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no test set or adjudication method as typically understood in performance studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, this is not applicable. The device is an acupuncture needle, not an AI-driven diagnostic or image analysis tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, this is not applicable. The device is an acupuncture needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) process is the established safety and effectiveness of the predicate devices and the general understanding of acupuncture needles as a class of device that has been in safe use for an extended period. The FDA's determination of substantial equivalence serves as the regulatory "truth."
8. The sample size for the training set
- Not applicable. There was no "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. There was no "training set" or algorithm.
§ 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.