SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE

K031716 · Asia-Med GmbH and CO KG · MQX · Jul 10, 2003 · General Hospital

Device Facts

• Record ID: K031716
• Device Name: SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
• Applicant: Asia-Med GmbH and CO KG
• Product Code: MQX · General Hospital
• Decision Date: Jul 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Device Story

Acupuncture needles (Special+, S-Needle B-Type, S-Needle J-Type) for single-use; sterile, invasive devices. Used by qualified acupuncture practitioners in clinical settings to pierce skin for therapeutic acupuncture. Manual operation by practitioner. Benefits include standardized, single-use sterile delivery of acupuncture therapy, reducing cross-contamination risk compared to reusable needles.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Single-use acupuncture needles. Materials and construction consistent with standard acupuncture needle specifications. Sterilized for single use. No electronic components, software, or energy sources.

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

JUL 1 0 2003

Asia-Med GmbH and CO KG C/O Mr. Kevin Walls Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127

Re: K031716

Trade/Device Name: Asia-Med Acupuncture Needles (Special+, S-Needle B-Type and S-Needle J-Type) for Single Use Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: May 23, 2003 Received: June 6, 2003

Dear Mr. Walls:

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 indications 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Walls

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runne

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko31716

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## 510(k) Number (if known):

asia-med acupuncture needles (Special+, s-needle B-Type and s-Device Name: needle J-Type) for single use.

- Indications for Use: The acupuncture needle is a device intended 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 Caccavale
(Division Sign Off)

Division of Dental. Infection Control. and General Hospital Devices 510(k) Number

Prescription Use × (Per 21 CFR 801.109)