(120 days)
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No
The summary describes a simple acupuncture needle and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
Therapeutic devices are typically used to treat a disease or condition, or to restore function. This device is described as piercing the skin for acupuncture, which is a traditional medical practice, but the device itself is not described as directly treating a condition or restoring function. Instead, it's a tool used in a therapeutic practice.
No
The device, an acupuncture needle, is used to pierce the skin for acupuncture practice, which is a therapeutic treatment. It is not described as being used to identify or analyze a disease or condition.
No
The device description explicitly states "Kangnian Brand Acupuncture Needle," which is a physical hardware device used for piercing the skin.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Intended Use: The intended use of the Kangnian Brand Acupuncture Needle is to "pierce the skin in the practice of acupuncture." This is a procedure performed on the body, not a test performed on a specimen taken from the body.
- Device Description: The description is simply "Kangnian Brand Acupuncture Needle," which aligns with a device used for a physical procedure, not for diagnostic testing.
Therefore, based on the provided information, the Kangnian Brand Acupuncture Needle is a device used for a therapeutic procedure (acupuncture) and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Product codes
MOX
Device Description
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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
skin
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract design of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Ms. Yi-Fen Chang Quality System Manager Helio Medical Supplies, Incorporated 2080A Walsh Avenue Santa Clara, Caliornia 95050
Re: K991507 Kangnian Brand Acupuncture Needle Trade Name: Regulatory Class: II Product Code: MOX June 10, 1999 Dated: Received: June 28, 1999
Dear Ms. Yi-Fen Chang
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 The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 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 through 542 of
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Page 2 - Ms. Yi-Fen Chang
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 legally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K 991507
K991507 Amendment, 06/10/99
| 510(k) Number | K991507 |
|---|---|
| Device Name: | Kangnian Brand Acupuncture Needle |
Indication for Use:
To pierce the 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)
Patricia Cucenti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K991507
| Prescription Use | V |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter-Use
(Optional Format 1-2-96)