TAKI ACUPUNCTURE NEEDLES

K964411 · Lhasa Medical, Inc. · MQX · Dec 31, 1996 · General Hospital

Device Facts

• Record ID: K964411
• Device Name: TAKI ACUPUNCTURE NEEDLES
• Applicant: Lhasa Medical, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Dec 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

TAKI acupuncture needle; sterile, single-use device; intended for skin piercing during acupuncture. Manufactured in Korea; imported for use by qualified practitioners. Device design meets general acupuncture needle specifications. Safety profile established by history of use since 1988 without reported accidents or device failures. Intended to provide equivalent performance to pre-1976 acupuncture needles and currently marketed sterile, single-use needles.

Clinical Evidence

No clinical data; bench testing only. Safety and effectiveness supported by historical usage data since 1988 with no reported accidents or device failures.

Technological Characteristics

Sterile, single-use acupuncture needle. Manufactured in Korea. Design meets general specifications for acupuncture needles.

Indications for Use

Indicated for use by qualified practitioners 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.

Submission Summary (Full Text)

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K 964411

LHASA MEDICAL, INC.

234 Libbey Parkway, Weymouth, MA 02189 [phone] (fax: [phone])

October 9, 1996

DEC 31 1996

# PRE-MARKET NOTIFICATION 510(k) SUMMARY

(As Required by 21 CFR 807.93)

Acupuncture needles are defined as 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 this 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, reusable acupuncture needles. Acupuncture needles which are currently being marketed through interstate distribution (ie, 1996) offer greater safety since they are sterile, single use only acupuncture needles.

The subject of this 510(k) application - the TAKI acupuncture needle - is a sterile, single use only acupuncture needle. The TAKI acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The TAKI brand acupuncture needle is manufactured in Korea and has been imported and sold through interstate commerce in the USA since 1988 under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1988, no accidents or device failure claims have been reported as a result of using the TAKI brand acupuncture needle.

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

Kyung Soon Riihimaki, President

Date

10-9-96

Premarket Notification (510(k) Number):