WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)

K111392 · Woojeon Company · MQX · Nov 4, 2011 · General Hospital

Device Facts

• Record ID: K111392
• Device Name: WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
• Applicant: Woojeon Company
• Product Code: MQX · General Hospital
• Decision Date: Nov 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states

Device Story

Woojeon Acupuncture Needles are sterile, single-use stainless steel needles designed for insertion into acupuncture points on the skin. Available in 78 variations based on diameter (0.16 to 0.40 mm) and length (8-60 mm). Operated by qualified acupuncture practitioners in clinical settings. Needles are sterilized via gamma irradiation. Device function involves manual insertion by the practitioner to perform acupuncture. Benefits include providing a sterile, mechanical tool for acupuncture practice.

Clinical Evidence

Bench testing only. Evidence includes microscopic surface inspection (200-300X magnification) to ensure smoothness and lack of defects, and mechanical testing of pull-out force and elasticity properties compared to the predicate device.

Technological Characteristics

Stainless steel acupuncture needles; available in 78 models (0.16-0.40 mm diameter; 8-60 mm length). Sterilized via gamma irradiation. Mechanical properties include pull-out force and elasticity. No software or electronic 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.

Predicate Devices

• ASIA-MED Single use, Acupuncture Needle (K052085)

Submission Summary (Full Text)

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

K111392

Woo_jeong 우정
ㄴ. 청구제

WOOJEON ACUPUNCTURE NEEDLE

# 510(k) Summary

# 1. Applicant

Wooieon Co. 364-4 Dangjeong-dong, Gunpo-si, Gyeonggi-do 435-832, Korea TEL. [phone] FAX. [phone] Date: Aug. 29th, 2011 2.Contact person

Peter Chung

–Tel [phone],Fax #: [phone] (Same with the home number)

-Mobil phone #: [phone])

-300 Atwood Street Pittsburgh, PA 15213 USA

# 3. Device Name

Trade Name: . WOOJEON ACUPUNCTURE NEEDLE

Common Name: Single use, Acupuncture Needle.

Classification Name: Single use, Acupuncture Needle.

Product Code: MOX

Requlation: 880.5580

Class of device : ClassII.

# 4. Predicate Devices

WOOJEON ACUPUNCTURE NEEDLE is similar with the legally marketed ASIA-MED Single use, Acupuncture Needle to have K052085.

#### 5. Description of the Device

The our needles are sterile which are inserted into specific points on the skin, called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation.

The Acupuncture Needles are available in 78 models as per diameters (0.16 to 0.40 mm) and 78 needle tube models as per lengths (8-60mm)

## 6. Intended Use:

WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states

# 7. Technical Characteristics

The Acupuncture Needle is examined microscopically and mechanically tested to evaluate pull-out and elasticity properties. Specifically, the surfaces of the subject and predicate devices were found to be smooth and free of visible defects at 200-300X magnification. Also, the pull-out force of the Acupuncture Needle was quantified and fell within the average values reported for the predicate devices. Finally, the elasticity properties of the subject device were found to be substantially equivalent to the predicate devices

## 8. Safety and Effectiveness

The Acupuncture Needle is a safe and effective device and is substantially equivalent to the predicate devices listed in this 510(k) submission; that is, the Acupuncture Needle has the same intended use (i.e., indications for use) and is similar, and in some cases the same, in both design (e.g., materials, sizes) and performance. Any differences in technological characteristics between the Acupuncture Needle and the predicate devices do not raise issues of safety and effectiveness.

NOV - 4 2011

11

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's emblem in the center. The emblem consists of a stylized caduceus-like symbol with three wavy lines emanating from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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

NOV - 4 2011

Woojeon Company C/O Mr. Peter Chung 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K111392

Trade/Device Name: Woojeon Acupuncture Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: September 29, 2011 Received: October 19, 2011

Dear Mr. Chung:

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.

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

Page 2- Mr. Chung

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director

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

Enclosure

{3}------------------------------------------------

# Indications For Use

510(k) Number (if known):

Device Name: Woojeon Acupuncture Needles

Indications For Use:

WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states

Prescription Use ×

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111392

Page 1 of ***_***