(174 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision Acupuncture Needles, Alpha Acupuncture Needles, Fine Point Acupuncture Needles, Chi Acupuncture Needles and Zen Acupuncture Needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture Needles meet the general specifications and criteria for an single use acupuncture Needles and is effective for the practice of acupuncture.
This 510(k) premarket notification for acupuncture needles (K061517) is a submission for a Class II medical device, and as such, it relies on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance as would be expected for novel, high-risk devices. The notification focuses on showing that the new acupuncture needles are as safe and effective as already legally marketed acupuncture needles.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the traditional sense for this 510(k). The "acceptance criteria" here are met by demonstrating the substantial equivalence of the new devices to existing, legally marketed predicate devices. The performance is therefore implicitly accepted as being equivalent to these predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Devices: | |
| Same intended use as predicate devices | Intended for the practice of acupuncture by qualified practitioners. |
| Similar technological characteristics (design, materials, sterility, biocompatibility) to legally marketed predicate acupuncture needles. | "The design, material used, sterility and biocompatibility of this acupuncture Needles meet the general specifications and criteria for a single use acupuncture Needles and is effective for the practice of acupuncture." |
| No new questions of safety or effectiveness are raised. | Search of Federal Consumer Information Center and U.S. Consumer Product Safety Commission websites found "no serious or life-threatening accidents involving acupuncture Needles." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no specific "test set" of patient data or clinical samples mentioned for evaluating the performance of the new acupuncture needles against predefined metrics. The assessment is based on a comparison of device characteristics to predicate devices and a general safety review of existing acupuncture needles.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth, in the sense of expert-validated diagnostic classifications or outcomes, is not established for this type of submission. The safety assessment relies on publicly available incident reports for similar devices.
4. Adjudication Method for the Test Set
Not applicable. No test set of data is described.
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
Not applicable. This device is an acupuncture needle, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an acupuncture needle and does not involve an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this submission is the established safety and effectiveness of legally marketed predicate acupuncture needles. This is primarily based on:
- Prior FDA 510(k) clearances: The document states, "FDA had issued 510(K)s to 47 different single use acupuncture Needless brand and them have I DA had issued 9 ro(11)3 wire in the United States since 1996." This indicates a history of regulatory acceptance for similar devices.
- Absence of reported safety issues with predicate devices: The search of consumer safety websites for adverse events ("no serious or life-threatening accidents involving acupuncture Needless") serves as a form of "negative ground truth" supporting the safety profile of the device category.
8. The Sample Size for the Training Set
Not applicable. There is no machine learning or AI component requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary of the Study (Demonstration of Substantial Equivalence):
The study presented in this 510(k) is not a traditional performance study with empirical data generated from the new devices. Instead, it is a demonstration of substantial equivalence. The manufacturer, Prime Herbs Co., is asserting that their various acupuncture needles (Precision Press Tack / Intraderm Needle, Precision Seven Star Needle, Präzision Acupuncture Needle, Alpha Acupuncture Needle, Fine Point Acupuncture Needle, Chi Acupuncture Needle, and Zen Acupuncture Needle) are as safe and effective as predicate devices already on the market.
The "study" or justification for this claim involves:
- Identification of Predicate Devices: While not explicitly named in the provided text, the submission implicitly references all existing 510(k)-cleared acupuncture needles as predicates.
- Comparison of Intended Use: The intended use of piercing the skin for acupuncture by qualified practitioners is identical to that of predicate devices.
- Comparison of Technological Characteristics: The submission asserts that the new needles' "design, material used, sterility and biocompatibility... meet the general specifications and criteria for a single use acupuncture Needles" and are "effective for the practice of acupuncture." This implies a comparison to the known characteristics of predicate devices.
- Safety Review of Device Category: The search of government consumer safety websites for adverse events associated with any acupuncture needles serves to support the general safety profile of this device type, thereby reinforcing the argument for the substantial equivalence of the new devices.
In essence, the "study" is a regulatory argument, not a scientific experiment with the new devices themselves. The FDA's letter confirms that they have reviewed this argument and determined the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market.
§ 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.