(130 days)
Not Found
Not Found
No
The 510(k) summary describes a standard acupuncture needle and makes no mention of AI or ML technology.
Yes
The device is intended to be used in the practice of acupuncture, which is a therapeutic intervention aimed at treating various conditions.
No
Explanation: The provided text explicitly states the intended use of the device is to "pierce the skin in the practice of acupuncture." There is no mention of the device being used to identify, detect, or monitor a medical condition, disease, or injury, which are characteristics of a diagnostic device.
No
The device description clearly states it is a physical acupuncture needle, which is a hardware device.
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 physical intervention on the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on the physical characteristics of the needle (sterile, single use, design, material, sterility, biocompatibility) and its function in acupuncture. There is no mention of analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical elements associated with IVDs, such as:
- Analyzing biological samples.
- Providing diagnostic, monitoring, or screening information.
- Using reagents or assays.
- Measuring analytes.
In summary, the Hummingbird brand acupuncture needles are described as a physical tool used in a therapeutic practice (acupuncture), not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Hummingbird brand acupuncture needles will be used for "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states."
Product codes
MQX, MOX
Device Description
Hummingbird brand acupuncture needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use 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
qualified practitioners of acupuncture
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
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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
Hummingbird Medical Technolog
510(K) SUMMARY V.
DEC 1 1 2001
510(K) Summary As required by section 807.92(c)
Hummingbird Medical Technology L.L.C. 1427 Greenbriar Dr. Allen, TX 75013 214-284-5433 Phone: Fax: 214-495-8888 Geoffrey Hsu (General Manager) July 4th 2001
Device Name: H.M.T. Acupuncture Needle, Signal Use Common Device Name: Acupuncture Needle, Signal Use Product Code: MOX Medical Specialty: General Hospital Device Class: II
Hummingbird brand acupuncture needles are defined as prescription devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
FDA had issued 510(K)s to 47 different signal use acupuncture needles brand and them have been used for general practice of acupuncture in the United States since 1996. We had searched Federal Consumer Information Center web site http://www.pueblo.gsa.gov and U.S. Consumer Product Safety Commission web site http://www.cpsc.gov and found no serious or life threatening accidents involving acupuncture needles.
Hummingbird brand acupuncture needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
In conclusion, based on the information provided with this 510(K) Notification, the Hummingbird acupuncture needles meet the criteria for 510(k) acceptance. The Hummingbird acupuncture needles is equivalent to other acupuncture needles which are currently being sold through interstate commerce.
Greg H
7-29-01
Geoffrey M. C. Hsu (General Manager)
Date
Image /page/0/Picture/15 description: The image shows a logo with a bird-like figure in the center. The bird is surrounded by circular shapes and what appears to be plant life. The letters 'HME' are at the bottom of the logo. The letters 'TM' are in the upper right corner of the image.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized design that resembles an abstract representation of a human figure or a symbol related to health and well-being. The design is composed of curved lines and shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2001
Mr. Geoffrey Hsu Hummingbird Medical Technology, L.L.C. 1427 Greenbriar Drive Allen, Texas 75013
Re: K012501
Trade/Device Name: H.M.T Acupuncture Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle, Single Use Regulatory Class: II Product Code: MQX Dated: October 12, 2001 Received: October 19, 2001
Dear Mr. Hsu:
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 ications 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amondinenelia, er or do active Act (Act) that do not require approval of a premarket the reachar Four (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include controls provision 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can as publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease of acrised that de a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
2
Page 2 - Mr. Hsu
You must comply with all the Act's requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF RT rut 007), laceling (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 680); and if applicable, the electronic product radiation control provisions (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 This letter will anow you to begin maintening your of substantial equivalence of your device to 310(K) premarket nonfloated." The 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 II you desire specific ad not 2017 your and one of the vitro diagnostic devices), please contact the and additionally 21 CFR Fart 607.10 Ion in the onelly, for questions on the promotion and
Office of Compliance at (301) 594-4618. Additionally, for questions on 16001 504-46 Office of Comphance at (301) 59 : The Office of Compliance at (301) 594-4639. advertising or your are more the d, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (ZTCFR Part 007.97) Online golf Small Manufacturers, International and ule Act may be obtained in its = sumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K012501
Hummingbird Medical Technology
STATEMENT OF INDICATIONS FOR USE IV.
Hummingbird brand acupuncture needles will be used for "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states."
Nick Hubbard for Pat Crescent: 11/12/01
al Hospital
510(k) Number K012501