(303 days)
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
The DN needle consists of a solid stainless steel needle with a copper wire wrapped around the stainless steel needle shaft. The copper wire acts as a handle which facilitates the delivery of acupuncture treatment by making the needles easier to manipulate and place. DN needles are sterile devices for single use only. The needles are made from 302 grade stainless steel meeting ASTM F899-84 standards. No lubricant is used on the needles.
The provided document describes a 510(k) premarket notification for the SEDATELEC DN Acupuncture Needles (K983800). This submission aims to demonstrate substantial equivalence to a predicate device, the CARBO MicroClean acupuncture needle (K961339), rather than presenting a performance study against specific acceptance criteria. Therefore, the information requested in the prompt regarding acceptance criteria, device performance, and a study proving said performance is largely not applicable in the context of this 510(k) submission.
Here's an breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in this 510(k) submission. The submission's goal is to establish substantial equivalence to a predicate device, implying that if the DN Acupuncture Needles are sufficiently similar to the legally marketed CARBO MicroClean acupuncture needle, they are presumed to be safe and effective. There are no specific performance criteria or a study demonstrating achievement of those criteria detailed in this document.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is not a performance study involving a test set. The submission relies on a comparison table of device features to demonstrate equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This device is an acupuncture needle, not an algorithm or AI system.
7. The type of ground truth used:
Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" in a 510(k) submission is effectively the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set:
Not applicable. There is no training set mentioned as this is not a study involving machine learning or similar methodologies.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set, there is no corresponding ground truth establishment process.
Summary of Relevant Information from the Document (if interpreted for "equivalence" as the "criterion"):
The submission argues for substantial equivalence to the CARBO MicroClean acupuncture needle (K961339) based on the following:
- Identical Intended Use: Both devices are "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states."
- Similar Design Features:
- Device Type: Both are considered "DN Type" (DN Equivalent for the predicate).
- Needle Tip Shape: Both are "Taper."
- Needle Shape: Both are "Stylet."
- Biocompatibility: Both use "ASTM 302 surgical stainless steel" (Standard specifications for stainless steel billet, bar, and wire for surgical instruments F899-84).
- Similar Materials: The needle material is surgical stainless steel for both. The handle material differs (copper for the SEDATELEC device vs. silver-plated metal for the CARBO device), but this difference is not presented as affecting equivalence for the intended use.
- Labeling: Both have comparable labeling requirements for identification and statements (e.g., sterile, single use, lot number, manufacturer, gauge, length, quantity).
- Sterilization: Both are sterilized devices. The SEDATELEC needles are sterilized by Gamma radiation at a validated dose level of 25kGy to achieve a sterility assurance level of 10^-6, in accordance with ISO 11737-1, EN552, and ISO 11137 standards. The predicate's sterilization method is listed as "Ethylene oxide gas sterilization" in its labeling, which is a different method but both are acceptable for sterilization.
- Dimensions: While there are differences in the range of invasive lengths (SEDATELEC: 18-47mm; CARBO: 13-75mm) and diameters (SEDATELEC: 0.25-0.40mm; CARBO: 0.20-0.30mm), these variations are considered within acceptable limits for acupuncture needles and do not preclude substantial equivalence.
Conclusion stated in the document: "Based on the design, function, intended use and materials of the DN Needles, substantial equivalence is evident. The referenced CARBO brand needles are functionally identical. The anticipated safety and effectiveness of both devices is or may be expected to be the same."
§ 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.