Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles

K142760 · K.S. Choi Corporation · MQX · Aug 25, 2015 · General Hospital

Device Facts

• Record ID: K142760
• Device Name: Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
• Applicant: K.S. Choi Corporation
• Product Code: MQX · General Hospital
• Decision Date: Aug 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Our acupuncture needles are devices used by licensed practitioners and are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Device Story

Acupuncture needles; sterile, thin, surgical stainless steel; used by licensed practitioners to pierce skin at specific acupuncture points. Manual manipulation (spinning, flicking, moving) performed by practitioner. Available in various diameters (0.12-0.35mm) and lengths (15-60mm); some include plastic guide tubes or micropore tape for press tack/intradermal applications. Device facilitates acupuncture therapy; intended to provide stimulation to specific body points. Used in clinical settings by qualified professionals.

Clinical Evidence

No clinical data. Bench testing only: dimensional conformance, visual inspection, biocompatibility (ISO 10993 series), material-mediated pyrogen testing (ISO 10993-11), EO/ECH residuals (ISO 10993-7), sterility, bacterial endotoxin, and long-term stability testing.

Technological Characteristics

Materials: surgical stainless steel, copper, aluminum. Sterilization: ethylene oxide gas. Form factor: needles with various diameters (0.12-0.35mm) and lengths (15-60mm), some with plastic guide tubes or tape. No software or electronic components.

Indications for Use

Indicated for use by licensed 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 Special + Needle (K031716)
• Asia-med Press Tack (K042063)

Submission Summary (Full Text)

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

August 25, 2015

K. S. Choi Corporation Mr. Kak Soo Choi President 179 W 39th Street Los Angeles, California 90037-1015

Re: K142760

Trade/Device Name: AcuZone Acupuncture Needles, KSC DB Plus Acupuncture Needles, AcuZone Press Tack Needles, and AcuZone Intradermal Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture needle Regulatory Class: II Product Code: MQX Dated: May 8, 2015 Received: July 20, 2015

Dear Mr. Choi:

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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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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K142760

#### Device Name

AcuZone Acupuncture Needles, KSC DB Plus Acupuncture Needles, AcuZone Press Tack Needles, and AcuZone Intradermal Needles

#### Indications for Use (Describe)

Our acupuncture needles are devices used by licensed practitioners and are 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)

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# 510(k) SUMMARY Traditional 510(k) (As required by 21CFR 807.92)

August 24, 2015

## Applicant: 807.92(a)

K. S. Choi Corporation 179 W. 39th St. Los Angeles, CA 90037 Phone: [phone] Fax: [phone] Contact: Kak Soo Choi

Date Prepared: August 24, 2015

Device Name: AcuZone Acupuncture Needles. KSC DB Plus Acupuncture Needles. AcuZone Press Tack Needles, and AcuZone Intradermal Needles Common Name: Acupuncture Needle Classification Name: Acupuncture needle, Single Use Product Code: MQX Medical Specialty: General Hospital Device Class: II 510(k) Number: K142760 Regulation Number: 880.5580

## Predicate Device: 807.92(a)

The summary identifies the legally marketed device to which your firm is claiming equivalence: (1) Asia-med : Asia-med Special + Needle (K031716) and (K042063)

## Description of the Device 807.92(a) :

The acupuncture needles are sterile, 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 ethylene oxide gas. Acupuncture is the stimulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles. The skin is sterilized, such as with alcohol, and the needles are inserted, frequently with a plastic guide tube for the user. Needles may be manipulated in various ways including spinning, flicking, or moving up and down relative to the skin. The Acuzone Acupuncture Needles and KSC DB Plus Acupuncture Needles are made of surgical stainless steel, a handle consisting of a flexible coiled copper handle with nickel plated for protection, or a surgical stainless steel or aluminum tube handle and may be provided with a plastic guide tube. (10pcs/pack, 1000pcs/box).

Acuzone press tack needles (with micropore tape) are made with surgical stainless steel (10pcs/ pack, 100pcs/box). AcuZone Intradermal Needles are made with surgical stainless steel (5pcs/pack, 100pcs/box).

Press tack and intradermal needles have same purpose for ear acupuncture point.

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The Acupuncture needles are available in nine diameters (0.12 ~ 0.35mm), five needle lengths (15 ~ 60mm), and tube lengths (30mm, 45mm, 55mm, 65mm and 75mm).

| Gauge | Diameter | Lengths | | | | |
|-------|----------|---------|------|------|------|------|
| (#) | | | | | | |
| 44 | .12mm | 15mm | 30mm | 40mm | | |
| 42 | .14mm | 15mm | 30mm | 40mm | | |
| 40 | .16mm | 15mm | 30mm | 40mm | | |
| 38 | .18mm | 15mm | 30mm | 40mm | 50mm | |
| 36 | .20mm | 15mm | 30mm | 40mm | 50mm | 60mm |
| 34 | .22mm | 15mm | 30mm | 40mm | 50mm | 60mm |
| 32 | .25mm | 15mm | 30mm | 40mm | 50mm | 60mm |
| 30 | .30mm | 15mm | 30mm | 40mm | 50mm | 60mm |
| 28 | .35mm | 15mm | 30mm | 40mm | 50mm | 60mm |

Acuzone press tack needle is available in one diameter (0.20mm x 2mm x length (1mm). AcuZone Intradermal Needles is available in one diameter (0.12mm), one length (5mm).

## Intended Use of Device 807.92(a) :

Our acupuncture needles are devices used by licensed practitioners and are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

# Summary of the technological characteristics of the device compared to the predicate devices 807.92(a)

The acupuncture needle, as well as two predicate devices, Asia-med Special + Needle (K031716) and Asia-med Press Tack (K042063), 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 100X or higher magnification. Also the pull-out force of 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 devices returned to their original shape showing no permanent deformation.

Table 1: Comparison of Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needle, and Asia-med Special + Needle (K031716)

| Device | AcuZone and KSC DB Plus<br>Acupuncture Needle | Asia-med Special + Needle<br>510(k) #K031716 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Indication<br>for use | Intended to pierce the skin in the<br>practice of acupuncture by qualified<br>practitioners of acupuncture as<br>determined by the states. | Intended to pierce the skin in the<br>practice of acupuncture by qualified<br>practitioners of acupuncture as<br>determined by the states. |
| Needle tip<br>shape | Arrow | Arrow |

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| Design | Stainless steel needle with a steel,<br>aluminum or copper handle and a<br>plastic guide tube for user | Stainless steel needle (+ silicon<br>layer) with a copper handle and a<br>copolymer (PET) guide tube. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Needle: surgical stainless steel<br>Handle: metal (steel or aluminum<br>tube or copper wire) | Needle: surgical stainless steel (+<br>silicon layer)<br>Handle: copper |
| Sterility | Sterilized with ethylene oxide gas<br>with residuals at a validated dose<br>level | Sterilized with radiation at a<br>validated dose level. |
| Needle<br>(invasive) | Surgical stainless steel | Surgical stainless steel |
| Guide tube<br>(non-invasiv<br>e) | Polypropylene or PROVISTATM<br>Copolymer (PET) | PROVISTA™ Copolymer (PET) |
| Labeling | • Indication for use<br>• Manufactured for or Distributed<br>by<br>• Product name<br>• Acupuncture needles<br>• Quantity<br>• Size<br>• Lot number<br>• Expiration date<br>• "Sterilized by ethylene oxide<br>gas"<br>• "For single use"<br>• Discard any unused needle in the<br>package after treatment session<br>is completed.<br>• "Made in China" | • Manufacturer's name and address<br>• Product name<br>• Acupuncture needles<br>• Quantity<br>• Size<br>• Lot number<br>• "Sterile"<br>• Expiration date<br>• "Sterilized by gamma radiation"<br>• "For single use"<br>• Rx statement<br>• "Do not store at extreme<br>temperatures and humidity"<br>• "Do not use if package is previously<br>opened or damaged"<br>• "Made in Germany" |
| Available in<br>Needle<br>Diameters | 0.12 mm, 0.14 mm, 0.16 mm,<br>0.18 mm, 0.20 mm, 0.22 mm, 0.25<br>mm, 0.30 mm, and 0.35 mm | 0.20 mm, 0.25 mm, and 0.30 mm |
| Available in<br>Needle<br>Lengths | 15 mm, 30 mm, 40 mm, 50 mm,<br>and 60 mm | 15 mm, 30 mm, and 40 mm |

Table 2: Comparison of AcuZone Press Tack Needles, AcuZone Intradermal Needles, and Asia-med Press Tack (K042063)

| Device | AcuZone Press Tack Needles<br>and AcuZone Intradermal<br>Needles K142760 | Asia-med Press Tack<br>K042063 |
|--------|--------------------------------------------------------------------------|--------------------------------|
|--------|--------------------------------------------------------------------------|--------------------------------|

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| Indication for<br>use | Intended to pierce the skin in the<br>practice of acupuncture by<br>qualified practitioners of<br>acupuncture as determined by the<br>states. | Intended to pierce the skin in the<br>practice of acupuncture by qualified<br>practitioners of acupuncture as<br>determined by the states. |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Needle tip shape | Arrow | Arrow |
| Design | Image: acupuncture needles<br>With or without tape for user | Image: acupuncture needles |
| Materials | Surgical stainless steel | Surgical stainless steel |
| Sterility | Sterilized | Sterilized |
| Available in<br>Needle<br>Diameters | Intradermal: 0.12 mm<br>Press Tack: 0.20 mm | 0.22 ~ 0.26 mm |
| Available in<br>Needle Lengths | Intradermal: 5 mm<br>Press Tack: 1 mm | 1.6 ~ 1.8 mm |

Our acupuncture needles are as safe and effective as the predicate, and are 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. The only difference is the quality of the product; for instance, the sharpness and the smoothness of the needle. Any differences in technological characteristics between the acupuncture needle and the predicate devices do not raise new issues of safety and effectiveness.

## Non-clinical Performance Data 807.92(b)

Performance testing was conducted to evaluate and characterize the performance of the Acuzone and KSC DB Plus. Non-clinical data included dimensional conformance evaluation, visual inspections, and design verification to confirm biocompatibility testing based on the applicable elements of ISO 10993 series, which included the Material Mediated Pyrogen Testing using ISO 10993-11 and the EO and ECH Residuals Testing in accordance with ISO10993-7.

The EO Sterilization Validation, Sterility Testing, Bacterial Endotoxin Testing, Validation, and Long-Term Stability Testing were also performed.

## Clinical Data 807.92(b)

Does not apply for these devices

#### Conclusion 807.92(b)

Biocompatibility tests and performance tests show that the device meets the requirements of those standards. Comparison with the predicate device shows that the device has similar specification and performance. Thus,

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we conclude that Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles, Acuzone Press Tack Needles, and Acuzone Intradermal Needles are substantially equivalent to the predicate device.

Kakeeco cheai

08/24/15

Kak Soo Choi, President

Date