CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE

K132896 · Asia-Med GmbH and CO KG · MQX · Dec 2, 2013 · General Hospital

Device Facts

• Record ID: K132896
• Device Name: CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
• Applicant: Asia-Med GmbH and CO KG
• Product Code: MQX · General Hospital
• Decision Date: Dec 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TeWa 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

TeWa Acupuncture Needles are sterile, single-use devices designed for acupuncture therapy. The device consists of a needle used by qualified practitioners to pierce the skin at specific anatomical points. Operation is manual; the practitioner inserts the needle to stimulate the site. The device is intended for professional use in clinical settings. It provides a mechanical means for acupuncture treatment, potentially benefiting patients by facilitating traditional acupuncture procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel acupuncture needle; sterile, single-use, disposable. Manual operation. No electronic components or software.

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)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 2, 2013

Regulatory Insight, Incorporated C/O Mr. Kevin Walls Regulatory Affairs Consultant 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K132896

Trade/Device Name: TeWa Acupuncture Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture needle Regulatory Class: Class II Product Code: MQX Dated: October 8, 2013 Received: October 9, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{1}------------------------------------------------

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/6 description: The image contains the text "Kwame Ulmer-s". The text is arranged in two lines, with "Kwame" on the top line and "Ulmer-s" on the bottom line. There is a design to the right of the text.

for

Erin 1. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K132896

## Device Name

TeWa Acupuncture Needles

#### Indications for Use (Describe)

The TeWa 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.

Type of Use (Select one or both, as applicable)

> Prescription Use {Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

SERVET THE TERRENERS FOR FOR FOR FOR FOR FOR FOR FOR MARK STORE THE FOR STORE OF CONSERVED Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/2/Picture/12 description: The image shows the FDA logo. The logo is made up of the letters F, D, and A. The letters are all capitalized and in a bold, sans-serif font. The letters are arranged in a horizontal line, with the F on the left, the D in the middle, and the A on the right. The logo is black and white.

Digitally signed by Richard C. Chapman Date: 2013.11.29 12:59:17 -05'00'