(83 days)
Not Found
Not Found
No
The summary describes acupuncture needles, a traditional medical device, and contains no mention of AI, ML, image processing, or data analysis related to AI/ML.
Yes
The device, acupuncture needles, is used in the practice of acupuncture by qualified practitioners, which is a therapeutic intervention aimed at treating medical conditions or promoting well-being.
No
Explanation: The device is described as acupuncture needles used to pierce skin for the practice of acupuncture. This is a treatment modality, not a diagnostic one.
No
The device is described as acupuncture needles, which are physical objects and therefore hardware, not software.
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 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: While the description is "Not Found," the intended use clearly points away from diagnostic testing.
- No mention of samples or analysis: The description doesn't mention collecting or analyzing any biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Acupuncture needles do not fit this description.
N/A
Intended Use / Indications for Use
HWATO and HUAXIA acupuncture needles are used to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Product codes
MOX
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified practitioners of acupuncture as determined by the States.
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.
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1998
Henry Woo, Ph.D. Scientific Health Care, Incorporated 1491 Baker Street, Suite 1 Costa Mesa, California 92626
Re : K974122 Trade Name: Acupuncture Needle Under The Brand Name Hwato and Huaxia Regulatory Class: II Product Code: MOX Dated: December 8, 1997 Received: December 11, 1997
Dear Dr. Woo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಳ substantially equivalent determination assumes compliance with ---the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Paqe 2 - Dr. Woo
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdg.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulazowski
Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
510(k) Number (if known)_ K974122 acupuncture needle under the brand names HWATO Device Name: દ્વ HUAXIA Indications For Use: HWATO & HUAXIA two brand names --
HWATO and HUAXIA acupuncture needles are used to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
.. .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricin Caccende
(Division Sion-Off) Division of Dental, Info lon Control. and General Hos 510(k) Number
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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