ACUMASTER BRAND ACUPUNCTURE NEEDLE

K991508 · Helio Medical Supplies, Inc. · MQX · Aug 27, 1999 · General Hospital

Device Facts

• Record ID: K991508
• Device Name: ACUMASTER BRAND ACUPUNCTURE NEEDLE
• Applicant: Helio Medical Supplies, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Aug 27, 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 states.

Device Story

AcuMaster Brand Acupuncture Needle; sterile, single-use device; used by qualified acupuncture practitioners to pierce skin for therapeutic acupuncture; manual operation; provides mechanical stimulation at acupuncture points; benefits include standardized, safe, and effective needle delivery for patient treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acupuncture needle; sterile; single-use; manual operation.

Indications for Use

Indicated for use by state-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

AUG 27 1999

Ms. Yi-Fen Chanq Ouality System Manager Helio Medical Supplies, Incorporated 2080A Walsh Avenue Santa Clara, Caliornia 95050

Re: K991508 AcuMaster Brand Acupuncture Needle Trade Name: Requlatory Class: II Product Code: MQX Dated: June 9, 1999 Received: June 28, 1999

Dear Ms. Yi-Fen Chang

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

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Page 2 - Ms. Yi-Fen Chang

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 finding 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 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K991508

K991508 510(k) Number AcuMaster Brand Acupuncture Needle Device Name:

## Indication for Use:

To pierce the skin 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 Cuccenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 991508

510(k) Number.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use

(Optional Format 1-2-96)