(28 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, intended use, or any mention of AI, ML, or related concepts.
No
The provided information does not contain any details about the device's function or intended use that would indicate it is a therapeutic device.
No
Explanation: There is no information provided in the input about the intended use or indications for use of the device, which is essential to determine if it is a diagnostic device. All fields are marked as "Not Found."
Unknown
The provided 510(k) summary is completely empty, offering no information about the device's nature, components, or function. Therefore, it's impossible to determine if it's a software-only medical device.
Based on the information provided, it is impossible to determine if this device is an IVD.
The document contains "Not Found" for all the key sections that would typically describe a medical device, including its intended use, description, and any mention of diagnostic processes.
To determine if it's an IVD, you would need information about:
- Intended Use: Does it analyze samples taken from the human body (like blood, urine, tissue)?
- Device Description: What does the device actually do?
- Any mention of diagnostic testing: Does it perform tests to diagnose diseases or conditions?
Without any of this information, we cannot classify the device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The subject of this 510k application - the Hua-Xia acupuncture needle - is a sterile, single use only acupuncture needle. The Hua-Xia acupuncture needle meets the general specifications and parameters 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
Not Found
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
LHASA MEDICAL, INC.
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters are 'K962916'. The characters are written in black ink on a white background. There is a line drawn underneath the string of characters.
234 Libbey Parkway, Weymouth, MA 02189 (617) 335-6484 (Fax: 617-335-62
July 24, 1996
SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS
In general, acupuncture needles have been used in the practice of acupuncture in the United States for now over 30+ years. Since this time, we are not aware of any serious or life threatening accidents involving acupuncture needles.
The acupuncture needles which were in commercial interstate distribution prior to May 28, 1976 were sold as a non-sterile, reusable acupuncture needle. However, the acupuncture needles which are now sold in 1996 offer greater safety since they are a sterile, single use only acupuncture needle.
The subject of this 510k application - the Hua-Xia acupuncture needle - is a sterile, single use only acupuncture needle. The Hua-Xia acupuncture needle meets the general specifications and parameters for an acupuncture needle and is effective for the practice of acupuncture.
Lhasa Medical has been selling the Hua-Xia brand acupuncture needle since 1990 as an "Investigational device, limited by U.S. law to investigational use". Since 1990, Lhasa Medical has not received any serious claims of injuries caused by the Hua-Xia acupuncture needle.
Additional information on the safety and effectiveness of the Hua-Xia acupuncture needle will be made available if it is requested.
In conclusion, based on the information provided with this 510k application, the Hua-Xia acupuncture needle meets the criteria for 510k acceptance. The Hua-Xia needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Hua-Xia needle is equivalent to other acupuncture needles which are now being sold through interstate commerce.
Not Acceptal