(79 days)
Not Found
Not Found
No
The device description and intended use clearly define a physical acupuncture needle, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The intended use states the device is for the practice of acupuncture, which is a therapeutic practice.
No
The device, an acupuncture needle, is explicitly described as a tool for the practice of acupuncture, which involves piercing the skin for therapeutic purposes, not for diagnosing conditions.
No
The device description explicitly states it is a "sterile, single use only 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
IVDs are used to perform tests in vitro (outside the body) on samples to gain information about a patient's health status. Acupuncture needles are used in vivo (inside the body) for therapeutic purposes.
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 (comma separated list FDA assigned to the subject device)
Not Found
Device Description
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".
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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