(18 days)
Not Found
None
No
The 510(k) summary describes a simple, sterile, single-use acupuncture needle and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for descriptions of training or test sets, which are typical components of AI/ML device submissions.
Yes
The device is described as an acupuncture needle, which is used in the practice of acupuncture, a therapeutic technique.
No
Explanation: The device is an acupuncture needle, used to pierce the skin for acupuncture practice, not to diagnose a disease or condition.
No
The device description explicitly states it is a sterile, single-use acupuncture needle, which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pierce the skin in the practice of acupuncture." This is a physical intervention on the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as a "sterile, single use only acupuncture needle." This aligns with a device used for a physical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Seirin JR acupuncture needle does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified practitioners of acupuncture
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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