(18 days)
Seirin JR 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 Seirin JR Acupuncture Needle - is a sterile, single use only acupuncture needle. The Seirin JR Acupuncture Needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
I am sorry, but the provided text is a 510(k) summary for an acupuncture needle. It describes the intended use, safety, and equivalence of the Seirin JR Acupuncture Needle to existing devices. However, it does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML powered medical device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is for a traditional medical device (acupuncture needle) and not an AI/ML powered device.
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K970 260
SEIRIN-America, Inc. 230 Libbey Parkway
FEB 1 0 1997
February 4, 1997 - Revised
ﺮ ﺍﻟﻌﻀﻠﺔ
fax: 617-335-5779 phone: (617) 340-1827
Weymouth, MA 02189
PRE-MARKET NOTIFICATION 510(k) SUMMARY (As Required by 21 CFR 807.93)
Intended Use. Seirin JR 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 Seirin JR Acupuncture Needle - is a sterile, single use only acupuncture needle. The Seirin JR Acupuncture Needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The Seirin JR brand acupuncture needle was first manufactured in Japan in 1993 and has been imported and sold through interstate commerce in the USA since 1993 under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1993, no accidents or device failure claims have been reported as a result of using the Seirin JR brand acupuncture needle.
In conclusion, based on the information provided with this 510(k) application, the Seirin JR Acupuncture Needle meets the criteria for 510(k) acceptance. The Seirin JR needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Seirin JR needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce.
Thomer A. Sutkin
2/4/97
Thomas A. Riihimaki, President
Date
§ 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.