(130 days)
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.
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.
The provided document is a 510(k) Summary for the Hummingbird Medical Technology H.M.T. Acupuncture Needle. This document focuses on demonstrating substantial equivalence to previously approved devices, rather than outlining a study with specific performance acceptance criteria and a detailed study design to prove those criteria.
Therefore, many of the requested sections (e.g., specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of regulatory submission.
Here's an breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (as implied by Substantial Equivalence): The device (Hummingbird brand acupuncture needles) must meet general specifications and criteria for a single-use acupuncture needle and be effective for the practice of acupuncture, consistent with predicate devices. This includes aspects like sterility, material used, and biocompatibility. The primary acceptance criterion for 510(k) is "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states that the design, material used, sterility, and biocompatibility of the Hummingbird acupuncture needle meet the general specifications and criteria for a single-use acupuncture needle and is "effective for the practice of acupuncture." It also notes that a search of federal consumer information centers found "no serious or life-threatening accidents involving acupuncture needles," implying a safety profile consistent with predicate devices. Specific quantitative performance metrics (e.g., force to penetrate, breakage rates) are not reported.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: A dedicated "test set" with a specific sample size for performance evaluation in the way a diagnostic or AI device would have is not described. The submission relies on demonstrating equivalence through design, materials, and existing safety data for acupuncture needles in general.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: As there is no "test set" with ground truth requiring expert adjudication described for this type of device, this information is not relevant or present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided: This device is an acupuncture needle, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is an acupuncture needle, not an algorithm. Standalone performance as typically described for AI/software devices is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implicit "Ground Truth": For an acupuncture needle, "ground truth" relates to its physical properties, sterility, biocompatibility, and intended function (piercing the skin effectively and safely). This is established through engineering specifications, material standards (e.g., ISO for sterility, biocompatibility testing), and clinical experience with equivalent devices. The submission heavily relies on the fact that these types of devices have been "used for general practice... since 1996" without serious incidents.
8. The sample size for the training set
- Not Applicable / Not Provided: This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: See point 8.
In summary: The provided document is a 510(k) summary for an acupuncture needle, demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a detailed clinical or technical study as would be seen for a novel diagnostic or AI-powered device. The "study" referenced is the 510(k) submission process itself, where the manufacturer provides information to the FDA to demonstrate equivalence based on design, materials, manufacturing controls, and the established safety profile of similar devices already on the market.
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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.
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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.
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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
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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
§ 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.