(40 days)
Acupuncture needles are defined as devices intended 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) application - the Hwa-To acupuncture needle - is a sterile, single use only acupuncture needle. The Hwa-To acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The provided text is a 510(k) summary for an acupuncture needle (Hwa-To) and does not contain the detailed information required to answer the questions about acceptance criteria, study design, and performance metrics in the context of advanced AI/ML device evaluations. This document predates modern regulatory requirements for such detailed performance studies and focuses on demonstrating equivalence to predicate devices based on historical use and safety profiles.
Therefore, I cannot extract the following information from the provided text:
- Acceptance criteria and reported device performance table: The document states the device "meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture," but it does not provide specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, AUC) for the device's function as an AI/ML product.
- Sample size and data provenance for the test set: Not applicable for this type of device and submission. The "test set" in this context refers to the real-world use of acupuncture needles.
- Number of experts and qualifications for ground truth: Not applicable. Ground truth for acupuncture needles involves their physical characteristics and safety in use, not diagnostic interpretations.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
- Standalone performance: Not applicable. This is a physical medical device.
- Type of ground truth used: The ground truth for an acupuncture needle relates to its manufacturing quality, sterility, and safe function, not clinical outcomes in a specific diagnostic context.
- Sample size for the training set: Not applicable. This is not an AI/ML device that undergoes training.
- How the ground truth for the training set was established: Not applicable.
Summary of what can be inferred from the document regarding "acceptance" in its context:
The document primarily focuses on demonstrating the substantial equivalence of the Hwa-To acupuncture needle to legally marketed predicate devices, which is the core principle of a 510(k) submission for this type of medical device.
Acceptance Criteria (Implicit from the document's structure and claims):
- Sterility: The device is sterile.
- Single-Use: The device is for single use only, enhancing safety over older reusable needles.
- General Specifications and Criteria for Acupuncture Needles: The device meets these unspecified general standards.
- Effectiveness for Acupuncture Practice: The device is suitable for its intended purpose.
- Safety Profile: No serious accidents, life-threatening incidents, or device failure claims reported since 1986.
- Equivalence to Predicate Devices:
- Equivalent to pre-May 28, 1976, acupuncture needles (which were non-sterile, reusable).
- Equivalent to other sterile, single-use acupuncture needles currently on the market.
Study/Evidence that Proves the Device Meets Acceptance Criteria:
The "study" here is not a formal clinical trial with specific performance endpoints, but rather a combination of:
- Historical Data/Absence of Adverse Events: The document states, "Since 1986, no accidents or device failure claims have been reported as a result of using the Hwa-To brand acupuncture needle." It also notes no serious incidents involving acupuncture needles in general over 30 years.
- Manufacturing Standards and Controls (Implied): While not explicitly detailed, the claims of "sterile" and "single use" imply adherence to relevant manufacturing and quality control standards.
- Comparison to Predicate Devices: The core of the 510(k) is the argument that "The Hwa-To needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Hwa-To needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce." This comparison likely involves evaluating material, design, intended use, and sterility against currently marketed devices and historical practice.
The provided document is a regulatory submission from 1996 for a basic medical device (acupuncture needle), which falls under a different regulatory and evaluative framework than complex AI/ML-driven diagnostic devices.
{0}------------------------------------------------
P 3 0 1998
LHASA MEDICAL, INC.
234 Libbey Parkway, Weymouth, MA 02189 (617) 335-6484 (fax: 617-335-6296)
August 20, 1996
PRE-MARKET NOTIFICATION 510(k) SUMMARY
(As Required by 21 CFR 807.93)
Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Acupuncture needles have been used for the general practice of acupuncture in the United States for over 30 years. Since this time, we are not aware of any serious or life threatening accidents involving acupuncture needles.
Acupuncture needles which were sold through commercial interstate distribution prior to May 28, 1976 were non-sterile, reusable acupuncture needles. Acupuncture needles which are currently being marketed through interstate distribution (ie, 1996) offer greater safety since they are sterile, single use only acupuncture needles.
The subject of this 510(k) application - the Hwa-To acupuncture needle - is a sterile, single use only acupuncture needle. The Hwa-To acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The Hwa-To brand acupuncture needle was first manufactured in China in 1986 and has been imported and sold through interstate commerce in the USA under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1986, no accidents or device failure claims have been reported as a result of using the Hwa-To brand acupuncture needle.
In conclusion, based on the information provided with this 510(k) application, the Hwa-To acupuncture needle meets the criteria for 510(k) acceptance. The Hwa-To needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Hwa-To needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce.
Kyung Rihimichi
Kyung Yoon Riihimaki, President Premarket Notification (510(k) Number):
8-20-96
Date
page 7
§ 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.