(76 days)
Not Found
No
The summary describes a simple mechanical device (acupuncture needle) with no mention of software, data processing, or AI/ML terms.
Yes
The device is used in the practice of acupuncture, which is a therapeutic treatment.
No
The intended use states the device is "intended to pierce the skin in the practice of acupuncture," which is a treatment modality, not a diagnostic one. There is no mention of analysis, measurement, or detection of a condition.
No
The device description clearly states it is a solid, stainless steel needle, which is a physical hardware component.
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 direct therapeutic intervention on the patient's body.
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease or conditions.
- Device Description: The device is a solid needle for piercing the skin, not for analyzing biological samples.
The description clearly indicates a device used for a therapeutic procedure performed directly on the patient, not for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The 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 re-enforcement handle attached to the needle shaft. For single use.
Product codes
MQX
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2005
Maanshan Medical Instruments Company Limited C/O Mr. Kevin Walls Principal Consultant Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K052846
K032640
Trade/Device Name: TeWa CJ-Type, PJ-Type, CB-Type and PB-Type Acupuncture Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: October 6, 2005 Received: October 11, 2005
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your because 31 (t) processor is substantially equivalent (for the referenced above and have determined and as neally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to reay 20, 1978, and entile in accordance with the provisions of Amendments, of to devices that have book formes and require approval of a premarket the Federal Food, Drug, and Cosmene Act (110) annual the device, subject to the general approval application (1 Miry). I The general controls provisions of the Act include controls provisions of the ret. "The genical of devices, good manufacturing practice, requirements for anilaar saagainst misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III If your device is classified (see above) into examines. Existing major regulations affecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In the Cook your device can be found in the Code of Peacharter.
addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Walls
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s issuance of a substant requires with other requirements
mean that FDA has made a determination that your devices Foderal acencies mean that FDA nas made a decemmanent that Jour ministered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by paignited to paigning of the Act of any rederal statues and regulations, but not limited to: registration in the propotion You must comply with an the Act 3 requirements) and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFK Fall 807), laocing (21 CFR areas); } // CFR Pat 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Pat 820); at the Ad requirements as set form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin matically your equivalence of your device to a premarket notification. The I DA miding of backing of backed on 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), a If you desire specific advice for your device of the Also, please note the regulation please contact the Othec or Comphanoe at (210) = 110 = 11 Part 807.97). You entified, "Misbranding by reference to premation on your responsibilities under the Act from the may obtain other general mionnation on your a sistemer Assistance at its toll-free DIVIsion of Binals 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suttie H. Michie, Dms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K052846
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
TeWa CJ-Type, PJ-Type, CB-Type, PB-Type Acupuncture Needles Device Name: for Single Use.
Indications for Use: The acupuncture needle is a device intended to pierce the skin in
ternations for the same in and secure of seununcture. The device consists of a solid, s The acupuncture needle is a trevice consists of a solid, stainless
the practice of acupuncture. The device consists of a solid, stainless the practice of acupunedite. The donos odle attached to the needle
steel needle. The device may have a reastment steel needle. The dovice may of acupuncture treatment.
Over-The-Counter Use Prescription Use _ × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED NOT WRITE BELOW THIS LINE-CONTINUE ON NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Inthan V. hur
11.65
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