(136 days)
The acupuncture needles are devices used by licensed practitioners which are intended to pierce the ski in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Acupuncture needles is defined as a device intended to pierce the skin in the practice of acupuncture by qualified practitioner of acupuncture as determined by the States. The subject of this 510(k) application - the Natural Brand acupuncture needles - is sterile, single use acupuncture needles.
This document describes the premarket notification (510(k)) for the Natural Brand acupuncture needles. However, it does not contain a study with acceptance criteria and reported device performance in the way a typical medical device validation study for a new, innovative device would.
The core of this 510(k) submission is based on substantial equivalence to devices already on the market prior to May 28, 1976, and to other currently marketed acupuncture needles. Therefore, the "acceptance criteria" and "device performance" are primarily focused on meeting the definition of an acupuncture needle and demonstrating a safe history of use, rather than detailed performance metrics from a formal study.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material/Design: Sterile, single-use acupuncture needle | The Natural Brand acupuncture needle is sterile, single-use, and meets general specifications and criteria for an acupuncture needle. |
| Intended Use: Device intended to pierce the skin in the practice of acupuncture by qualified practitioners. | The Natural Brand acupuncture needle is effective for the practice of acupuncture. |
| Safety: No serious or life-threatening accidents. | No accidents or device failure claims reported since 1985 (when sold under investigational use). Not aware of serious or life-threatening accidents with acupuncture needles used for over 30 years. |
| Substantial Equivalence: Equivalent to acupuncture needles in commercial distribution prior to May 28, 1976, and to other currently marketed acupuncture needles. | Claimed as met. The FDA letter confirms the device is substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a performance study. The "test set" here would refer to the historical use of the device and other similar devices.
- Data Provenance:
- Natural Brand: The device has been imported and sold in the USA since 1985 under "investigational use" labeling. Records of no reported accidents or device failure claims since 1985 were used. This is retrospective data from a specific device's commercial history.
- General Acupuncture Needles: General knowledge and historical data of acupuncture needles being used for over 30 years in the US without serious incidents. This is also retrospective, broad historical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as there was no formal "test set" with a ground truth established by experts in the context of a performance study. The "ground truth" here is the established safe and effective use of acupuncture needles generally, and the lack of reported issues with the Natural Brand specifically.
4. Adjudication Method for the Test Set
- Not applicable, as there was no formal "test set" requiring adjudication.
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
- No, an MRMC comparative effectiveness study was not done. This device is a simple medical instrument (acupuncture needle), not an AI-powered diagnostic or therapeutic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is based on:
- Historical Safety Data: Lack of reported accidents or device failures for the Natural Brand needle over many years of use.
- General Acceptance/Experience: Long-standing, safe use of acupuncture needles in the US for over 30 years.
- Functional Definition: The device meets the generally accepted definition and function of an acupuncture needle (to pierce the skin for acupuncture).
8. The Sample Size for the Training Set
- Not applicable, as this is not an AI/machine learning device. The "training" for the substantial equivalence argument comes from the historical use and established safety of predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no "training set" in the machine learning sense. The "ground truth" for the substantial equivalence argument relies on:
- The regulatory classification and established safety profile of acupuncture needles as a class of devices.
- The lack of adverse events reported for the specific device (Natural Brand) during its prior distribution under investigational labeling.
- The general consensus in the medical community about the safe practice of acupuncture with appropriately manufactured needles.
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3/4/99
T.C.M. Supply Corp.
12490 Central Ave., Ste.#221 Chino, CA 91710 (909)628-9698
SUMMARY
Acupuncture needles is defined as a device intended to pierce the skin in the practice of acupuncture by qualified practitioner of acupuncture as determined by the States.
Acupuncture needles have been used for the general practice of acupuncture in the United States for over 30 years. Since this time, we are not aware of any serious or life threatening accident involving acupuncture needles.
Acupuncture needles, which were sold through commercial interstate distribution prior to May 28, 1976, were non-sterile, reusable acupuncture needles. Acupuncture needles, which were currently being marketed through interstate distribution, offer greater safety since they are sterile, single use only acupuncture needles.
The subject of this 510(k) application - the Natural Brand acupuncture needles - is sterile, single use acupuncture needles. The Natural Brand acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The Natural Brand acupuncture needle was manufactured in China and has been imported and sold through interstate commerce in the USA since 1985 under the FDA labeling restriction of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1985, no accidents or device failure claims have been reported as a result of using the Natural Brand acupuncture needle.
In conclusion, based on the information provided with this 510(k) application, the Natural Brand acupuncture needle meets the criteria for 510(k) acceptance. The Natural Brand needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Natural Brand needle is equivalent to other acupuncture needles, which are currently being sold through interstate commerce.
William R
William Hung Lee, President
Date
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1999
Ms. Catherine Arquillano TCM Supply Corporation 12490 Central Avenue, Suite 221 Chino, California 91710
Re : K983671 Natural Branch Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MOX Dated: January 22, 1999 Received: January 29 1999
Dear Ms. Arquillano
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 regulation 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. Arquillano
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 ations 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) 638-20A1 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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510(k) Number (if known):_
Acupuncture Needles Device Name:
ﮧ
Indications For Use:
The acupuncture needles are devices used by licensed practitioners which are intended to pierce the ski 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 Crescenti
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Prescription Use_ V (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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.