ACUPUNCTURE NEEDLES

K092240 · Haenglim Seowon Medical Co. · MQX · Apr 21, 2010 · General Hospital

Device Facts

• Record ID: K092240
• Device Name: ACUPUNCTURE NEEDLES
• Applicant: Haenglim Seowon Medical Co.
• Product Code: MQX · General Hospital
• Decision Date: Apr 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Sterile, hair-thin stainless steel needles; inserted into specific acupuncture points on skin. Used by qualified acupuncture practitioners in clinical settings. Device facilitates acupuncture practice; provides mechanical skin penetration. No electronic or automated components.

Clinical Evidence

Bench testing only. Microscopic examination at 200-300X magnification and mechanical testing (pull-out force, elasticity) performed to compare subject device against predicates.

Technological Characteristics

Material: stainless steel. Sterilization: gamma irradiation. Dimensions: 0.14-0.50 mm diameter; 15-60 mm needle length; 20-30 mm stick length; 30-145 mm tube length. Mechanical properties: pull-out force and elasticity equivalent to predicates.

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

• Dong Bang Acupuncture Needle (K972659)
• C & G Acupuncture Needle (K043277)
• Kangsheng Brand/Kangnian Brand/Unilink Brand /Huazhong Brand Acupuncture Needle (K052731)

Submission Summary (Full Text)

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KOS2240

# 510(k) Summary (per 21 CFR 807.92(c))

# 1. Applicant

APR 2 1 2010

HaengLim SeoWon Medical Co. #954-30, Gwanyang Dong, Dongan-Ku Anyang-City, Kyonggi-Do Korea (431-060)

Sang Don Kim, Director Tel: [phone] Fax: [phone] E-mail: [e-mail]

Date Prepared: April 13, 2010

- 2. Device Name
Acupuncture needle Trade Name: Common/ Usual Name: needle, acupuncture, single use Acupuncture needle Classification Name: Regulation Number: 880.5580 MQX Product Code: Classification: ll Panel: General Hospital

### 3. Predicate Devices

The Acupuncture Needle is substantially equivalent to the following devices:

| 510(k)<br>Number | Device | Applicant |
|------------------|------------------------------------------------------------------------------------|-----------------------------------------|
| K972659 | Dong Bang Acupuncture Needle | Dong Bang, U.S.A. |
| K043277 | C & G Acupuncture Needle | Helio Medical Supplies,<br>Incorporated |
| K052731 | Kangsheng Brand/Kangnian Brand/Unilink<br>Brand /Huazhong Brand Acupuncture Needle | Daxin Li<br>c/o<br>Lee & Xiao Attorneys |

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## 4. Intended Use

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

## 5. Description of the Device

The Acupuncture Needles are sterile, hair thin needles 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 eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm).

#### Summary of the Technical Characteristics 6.

The Acupuncture Needle, as well as two of the predicate devices (Dong Bang Acupuncture Needle, K972659 and C & G Acupuncture Needle, K043277), were 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 two predicate devices, as after cantilever-type loading all three devices returned to their original shape showing no permanent deformation.

#### 7. 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Haenglim Seowon Medical Company C/O Ms. Jean Asquith APR 2 1 2010 Senior Regulatory Affairs Consultant Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746

Re: K092240

Trade/Device Name: Acupuncture Needles Regulation Number: 21CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: March 31, 2010 Received: April 2, 2010

Dear Ms. Asquith:

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.

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### Page 2- Ms. Asquith

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/ucm115809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony 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

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# Indications for Use

510(k) Number (if known):

Device Name: Acupuncture Needles

Indications for Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k092240