(79 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 CW acupuncture needle - is a sterile, single use only acupuncture needle. The CW 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, not a study evaluating an AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, expert involvement, or AI performance metrics.
The document focuses on demonstrating substantial equivalence of the "CW acupuncture needle" to legally marketed devices, primarily by highlighting its sterile, single-use nature and its history of safe use. It explicitly states: "The CW acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture." However, it does not detail specific quantitative acceptance criteria or a formal study with a test set, ground truth, or expert review that would typically be associated with performance evaluation of an AI/ML device.
Therefore, I cannot provide the requested table and information as it is not present in the given text.
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LHASA MEDICAL, INC.
234 Libbey Parkway, Weymouth, MA 02189 (fax: 617-335-6296) (617) 335-6484
November 8, 1996
PRE-MARKET NOTIFICATION 510(k) SUMMARY
JAN 30 1997
(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 CW acupuncture needle - is a sterile, single use only acupuncture needle. The CW acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The CW brand acupuncture needle is manufactured in Korea and has been imported and sold through interstate commerce in the USA since 1986 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 CW brand acupuncture needle.
In conclusion, based on the information provided with this 510(k) application, the CW acupuncture needle meets the criteria for 510(k) acceptance. The CW needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the CW needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce.
Kyra Soon Richel.
Soon Riihimaki, President
Premarket Notification (510(k) Number):
11-8-96
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.