KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE

K980472 · American Institute of Koryo Hand Therapy · MQX · Apr 9, 1998 · General Hospital

Device Facts

• Record ID: K980472
• Device Name: KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE
• Applicant: American Institute of Koryo Hand Therapy
• Product Code: MQX · General Hospital
• Decision Date: Apr 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Device Story

KHT Soft Needle is a sterile, silicon-coated, single-use acupuncture needle. Used by qualified acupuncture practitioners in clinical settings to pierce the skin for acupuncture therapy. Device functions as a manual instrument; no electronic or automated components. Benefits include sterility and single-use design to enhance patient safety compared to reusable needles.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and sterility specifications.

Technological Characteristics

Sterile, silicon-coated, single-use acupuncture needle. Class II device. No energy source, software, or complex connectivity.

Indications for Use

Indicated for use by qualified acupuncture practitioners to pierce the skin for the practice of acupuncture.

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

• Seirin Brand Acupuncture Needle (K963769)

Submission Summary (Full Text)

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Kg80472

APR - 9 1998

#### SOFT NEEDLES K980472

# American Institute of Koryo Hand Therapy, Inc.

3435 Wilshire Blvd., Suite 690, Los Angeles, CA 90010 Tel: [phone] Fax: [phone]

Premarket Notification (510(k) Number):

## 510(k) SUMMARY As Required by 21 CFR 807.92(c)

| Trade Name: | KHT Soft Needle |
|----------------------|------------------------------------------|
| Common Name: | Acupuncture Needles |
| Classification Name: | Class II, Single use acupuncture needles |

Legally Marketed Device to Which We Are Claiming Equivalence: Seirin Brand Acupuncture Needle 510(k) Document Number: K963769

Acupuncture needles are defined as prescription devices intended to pierce the skin In the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Acupuncture needles have been used for the general practice of acupuncture in the United States for over 30 years. Since that time, we are not aware of any serious or life threatening accidents involving acupuncture needles.

Acupuncture needles which were sold through commercial interstate distribution prior to May 28, 1976 were non-sterile, rousable acupuncture needles. Acupuncture needles which are currently being marketed through interstate distribution (i.e., 1997) offer greater safety since they are sterilized, single use only acupuncture needles.

The subject of this 510(k) Notification - the KHT Soft Needle - is a sterile, silicon coated, single use only acupuncture needle. The design, material used, sterlity and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.

In conclusion, based on the information provided with this 510(k) Notification, the KHT Soft Needle meets the criteria for 510(k) acceptance. The KHT Soft Needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the KHT Soft Needle is equivalent to other single use acupuncture needles which are currently being sold through interstate commerce.

Jin Hae Lew, Director

1-22-98 Date

Page 3 of 19

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Image /page/1/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

APR - 9 1998

American Institute of Koryo Hand Therapy, Incorporated ·C/O Mr. George Su Regulatory Consultant Crosslinks International 17870 Castleton Street, Suite 265 Industry, California 91748

Re : K980472 KHT Guam Needle, Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MQX January 22, 1998 Dated: Received: February 6, 1998

Dear Mr. Su:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Su

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone], or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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K980472

## Indications For Use

510(k) Number ( if known ) _

Device Name: KHT Soft Needle, Acupuncture Needle

Indications For Use:

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

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Concurrence of CDRH, Office of Device Evaluation ( ODE )

Petucio Cuevaste
Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

OR

510(k) Number K980422

Prescription Use

Over-The-Counter Use __

( Optional Format 1-2-96 )