(8 days)
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No
The summary describes a simple, sterile acupuncture needle and makes no mention of AI or ML technology.
Yes
The device is described as an "acupuncture needle" intended for the "practice of acupuncture," which is a therapeutic modality.
No
Explanation: The device, an acupuncture needle, is described as being used for the practice of acupuncture by piercing the skin, not for diagnosing conditions.
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 physical medical device used for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Ito acupuncture needle, as described, is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
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Device Description
The subject of this 510(k) application - the Ito acupuncture needle - is a sterile, single use only acupuncture needle. The Ito acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified practitioners of acupuncture
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows a stamp with the text "AUG 23" on the top line. The year is unreadable due to ink smudging. The bottom line shows the letters "OMS" in a large, bold font. The letters are evenly spaced and take up most of the image.
OMS Medical Supplies. Inc. 230 Libbey Parkway Weymouth, MA 02189
phone: (617) 331 1-800-323-1839 fax: 617-335-5779
August 14, 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 Ito acupuncture needle - is a sterile, single use only acupuncture needle. The Ito acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The Ito brand acupuncture needle was first manufactured in Japan in 1984 and has been imported and sold through interstate commerce in the USA since 1984 under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1984, no accidents or device failure claims have been reported as a result of using the Ito brand acupuncture needle.
In conclusion, based on the information provided with this 510(k) application, the Ito acupuncture needle meets the criteria for 510(k) acceptance. The Ito needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Ito needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce.
Thomas A. Rihmch
Thomas A. Riihimaki, President
Premarket Notification (510(k) Number):
- 14-96
Date
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