(61 days)
Jia Chen Acupuncture Needle will be used for "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."
The Jia Chen Acupuncture Needles are defined as prescription devices intended to pierce the skin in the practice of acupuncture as determined by the States. The device consists of a solid stainless steel needle with handle attached to the needle to facilitate the delivery of acupuncture treatment. The material for Jia Chen Acupuncture needles is Austenitic stainless steel wire of ASMTF 899-94, type 304. The needle body is vacuum melted high purity stainless steel, with a good body tensile and spring, and the body surface finish has no visible defects under 100X magnifications. Jia Chen Acupuncture needle handles come in many different materials including copper, silver, plastic, steel tube and all stainless steel. The needle to handle bond strength is of at least 1 kilogram. The each single acupuncture needle is packed in plastic guide (insertion) tube. Jia Chen Acupuncture needles are sterilized with Ethylene Oxide GB 13098-98 and device sterility level (SAL) is at least 106. The ethylene oxide residue level in finished devices does not exceed EtO 25 ppm, Ethylene glycol 250 ppm, and ethylene chlorohydrin 25 ppm. Jia Chen Acupuncture needles are sterile, and for single use only.
This is a 510(k) premarket notification for an acupuncture needle, which is a medical device. The document describes how the device is substantially equivalent to legally marketed predicate devices, rather than providing a study proving performance against acceptance criteria in the context of an AI/software device.
Acupuncture needles, as medical devices, generally have acceptance criteria related to material composition, sterility, biocompatibility, and physical properties (e.g., tensile strength, handle bond strength). The study described in this document is a demonstration of substantial equivalence to existing predicate devices, which is the regulatory pathway for this type of Class II medical device. It does not involve AI or software, and therefore, many of the requested points are not applicable.
Here's how the provided information relates to your questions, with N/A for non-applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document refers to "general specifications and criteria for single use acupuncture needle" rather than explicit numeric acceptance criteria in a table format. The performance is demonstrated through compliance with manufacturing standards and material specifications.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance |
|---|---|---|
| Material | Austenitic stainless steel wire of ASMTF 899-94, type 304. | "Austenitic stainless steel wire of ASMTF 899-94, type 304, which holds Certificate of Quality Control Approvals issued by China Quality Certification Center for Import and Export Commodities and holds the Mill Certificate of Chemical Composition and Physical Properties of needle material." "The needle body is vacuum melted high purity stainless steel, with a good body tensile and spring, and the body surface finish has no visible defects under 100X magnifications." |
| Physical Properties | Needle to handle bond strength. | "The needle to handle bond strength is of at least 1 kilogram." |
| Sterility | Sterilized with Ethylene Oxide GB 13098-98; Sterility Assurance Level (SAL) at least 10-6; Ethylene oxide residue levels. | "Jia Chen Acupuncture needles are sterilized with Ethylene Oxide GB 13098-98 and device sterility level (SAL) is at least 10-6." "The ethylene oxide residue level in finished devices does not exceed EtO 25 ppm, Ethylene glycol 250 ppm, and ethylene chlorohydrin 25 ppm." |
| Biocompatibility | Meet general specifications and criteria for single use acupuncture needle. | "The material, sterility, and the biocompatibility of these acupuncture needles meet the general specifications and the criteria for single use acupuncture needle." |
| Intended Use | "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States." "Sterile Acupuncture needles for single use only." "Federal Law restricts this device to sell by or on the order of a qualified practitioner of acupuncture as determined by the States." | The device is labeled for this intended use and is designed to be compatible with existing acupuncture needles. |
| Safety Record | No serious life-threatening accidents involving acupuncture needles (as per previous 510(k) approvals and market history). | "We have searched the Federal Consumer Information Center official website... and the U.S. Consumer Product Safety Commission official website... and have found no serious life threatening accidents involving acupuncture needles." (Referring to the class of device, not specifically this brand). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission is for a medical device (acupuncture needle), not a software/AI device. The "study" is a demonstration of substantial equivalence based on material specifications, manufacturing processes, and adherence to established standards for similar devices. There is no "test set" in the context of an algorithm's performance. The provenance of material quality control is from China (manufacturer Wujiang Jia Chen Acupuncture Devices Co., Ltd.).
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)
- N/A. Ground truth in the context of expert consensus for AI/software is not relevant here. The ground truth for device safety and effectiveness relies on established engineering standards for medical devices (e.g., ASTM standards for materials, ISO/GB standards for sterilization, biocompatibility testing in accordance with general medical device requirements).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable for a physical medical device submission demonstrating substantial equivalence.
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
- N/A. This is not an AI/software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/software device. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness is based on:
- Adherence to recognized standards: e.g., ASMTF 899-94 for stainless steel, GB 13098-98 for Ethylene Oxide sterilization.
- Biocompatibility testing: General medical device requirements for materials that contact the human body.
- Mechanical property testing: Such as bond strength.
- Clinical history of predicate devices: The fact that similar acupuncture needles have been safely marketed and used for decades without serious adverse events provides historical evidence of the device type's general safety and effectiveness.
8. The sample size for the training set
- N/A. This is not an AI/software device. There is no training set.
9. How the ground truth for the training set was established
- N/A. This is not an AI/software device. There is no training set and thus no ground truth established for one.
§ 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.