CW ACUPUNCTURE NEEDLES

K964529 · Lhasa Medical, Inc. · MQX · Jan 30, 1997 · General Hospital

Device Facts

• Record ID: K964529
• Device Name: CW ACUPUNCTURE NEEDLES
• Applicant: Lhasa Medical, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Jan 30, 1997
• 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

CW acupuncture needle; sterile, single-use device; used by qualified practitioners to pierce skin for acupuncture therapy; manufactured in Korea; imported for clinical use; provides equivalent function to pre-1976 reusable needles; enhances safety via sterile, single-use design.

Clinical Evidence

No clinical data; safety established through historical usage data since 1986 with no reported accidents or device failures.

Technological Characteristics

Sterile, single-use acupuncture needle; manufactured in Korea; 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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K964529

LHASA MEDICAL, INC.

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

November 8, 1996

JAN 30 1997

# 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 CW acupuncture needle - is a sterile, single use only acupuncture needle. The CW acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The CW brand acupuncture needle is manufactured in Korea and has been imported and sold through interstate commerce in the USA since 1986 under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1986, no accidents or device failure claims have been reported as a result of using the CW brand acupuncture needle.

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

Kyung Soon Riihimaki, President

Date: 11-8-96

Premarket Notification (510(k) Number):