SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES

K963769 · Seirin-America, Inc. · MQX · Oct 16, 1996 · General Hospital

Device Facts

• Record ID: K963769
• Device Name: SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES
• Applicant: Seirin-America, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Oct 16, 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

Seirin Spinex acupuncture needle; sterile, single-use device; intended for skin piercing during acupuncture practice. Manufactured in Japan since 1978; imported/sold in USA since 1983. Device functions as standard acupuncture needle; used by qualified practitioners. No reported accidents or failures since 1983. Provides safety improvement over pre-1976 non-sterile, reusable needles.

Clinical Evidence

No clinical data; historical usage since 1978 in Japan and 1983 in USA cited as evidence of safety and effectiveness.

Technological Characteristics

Sterile, single-use acupuncture needle. 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 96-3769
SEIRIN-America, Inc.
230 Libbey Parkway
Weymouth, MA 02189
OCT 16 1996
fax: [phone]
phone: [phone]

September 18, 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 Seirin Spinex acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin Spinex acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The Seirin Spinex brand acupuncture needle was first manufactured in Japan in 1978 and has been imported and sold through interstate commerce in the USA since 1983 under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1983, no accidents or device failure claims have been reported as a result of using the Seirin Spinex brand acupuncture needle.

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

Thomas A. Riihimaki, President
Date: 9-18-96
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