(77 days)
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Not Found
No
The summary describes a simple acupuncture needle and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is used in the practice of acupuncture, which is a therapeutic modality, but the needle itself is an instrument used to pierce the skin, not a therapeutic device that delivers therapy.
No
The device is an acupuncture needle, used for piercing the skin in the practice of acupuncture. Its intended use does not involve diagnosing conditions or diseases.
No
The device is described as an "Acupuncture Needle," which is a physical, hardware device used to pierce the skin. There is no mention of software functionality or components in the provided text.
Based on the provided information, the TeWa Acupuncture Needle 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 direct therapeutic intervention on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
The TeWa Acupuncture Needle is a device used on the body for a therapeutic purpose, not for analyzing samples from the body to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The TeWa Acupuncture Needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Product codes
MQX
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
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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 (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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2013
Regulatory Insight, Incorporated C/O Mr. Kevin Walls Regulatory Affairs Consultant 33 Golden Eagle Lane Littleton, Colorado 80127
Re: K132896
Trade/Device Name: TeWa Acupuncture Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture needle Regulatory Class: Class II Product Code: MQX Dated: October 8, 2013 Received: October 9, 2013
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/6 description: The image contains the text "Kwame Ulmer-s". The text is arranged in two lines, with "Kwame" on the top line and "Ulmer-s" on the bottom line. There is a design to the right of the text.
for
Erin 1. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132896
Device Name
TeWa Acupuncture Needles
Indications for Use (Describe)
The TeWa Acupuncture Needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Type of Use (Select one or both, as applicable)
Prescription Use {Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
SERVET THE TERRENERS FOR FOR FOR FOR FOR FOR FOR FOR MARK STORE THE FOR STORE OF CONSERVED Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/2/Picture/12 description: The image shows the FDA logo. The logo is made up of the letters F, D, and A. The letters are all capitalized and in a bold, sans-serif font. The letters are arranged in a horizontal line, with the F on the left, the D in the middle, and the A on the right. The logo is black and white.
Digitally signed by Richard C. Chapman Date: 2013.11.29 12:59:17 -05'00'