FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES

K990729 · Acc Intl. · MQX · May 13, 1999 · General Hospital

Device Facts

• Record ID: K990729
• Device Name: FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES
• Applicant: Acc Intl.
• Product Code: MQX · General Hospital
• Decision Date: May 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the State.

Device Story

Famous Physicians Brand Disposable Acupuncture Needles are sterile, single-use devices used by qualified acupuncture practitioners to pierce the skin during acupuncture therapy. The needles are intended to facilitate the practice of acupuncture as determined by state regulations. As a manual, non-powered device, it functions through physical insertion into the patient's skin. The device is provided as a disposable, single-use product to ensure sterility and prevent cross-contamination.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, single-use acupuncture needles. Manual insertion mechanism. No energy source or software components.

Indications for Use

Indicated for use by qualified acupuncture practitioners to pierce the skin for acupuncture therapy.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1999

Acc International C/O Mr. Arthur King Kwok Ma Key Contact for ACC International D & R Marketing Firm 108 North Ynez, Avenue, Suite 128 Monterey Park, California 91754

K990729 Re : Famous Physicians Brand Disposable Trade Name: Acupuncture Needles Regulatory Class: II Product Code: MQX Dated: April 14, 1999 Received: April 19, 1999

Dear Mr. King Kwok Ma:

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) regulation (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Kinq Kwok Ma

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

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):

K 990729

DEVICE NAME:

Famous Physicians Brand™ Disposable Acupuncture Needles

INDICATION FOR USE:

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the State.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)

Concurrence of CDEH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter-Use (Optional Format 1-2-96)

Pallozza Crescenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K990722