SEIRIN JR ACUPUNCTURE NEEDLES

K970260 · Seirin-America, Inc. · MQX · Feb 10, 1997 · General Hospital

Device Facts

• Record ID: K970260
• Device Name: SEIRIN JR ACUPUNCTURE NEEDLES
• Applicant: Seirin-America, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Seirin JR 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 JR acupuncture needle; sterile, single-use device; intended for skin penetration during acupuncture practice. Operated by qualified practitioners in clinical settings. Device design follows general acupuncture needle specifications; intended to provide safer alternative to historical reusable needles. No reported accidents or failures since 1993 introduction in US market.

Clinical Evidence

No clinical data; safety established via historical usage data since 1993 with no reported accidents or device failures.

Technological Characteristics

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

Indications for Use

Indicated for use by qualified 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.

Submission Summary (Full Text)

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K970 260

FEB 10 1997

SEIRIN-America, Inc.
230 Libbey Parkway
Weymouth, MA 02189
fax: [phone]
phone: [phone]

February 4, 1997 - Revised

# PRE-MARKET NOTIFICATION 510(k) SUMMARY

(As Required by 21 CFR 807.93)

Intended Use. Seirin JR 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 JR Acupuncture Needle - is a sterile, single use only acupuncture needle. The Seirin JR Acupuncture Needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The Seirin JR brand acupuncture needle was first manufactured in Japan in 1993 and has been imported and sold through interstate commerce in the USA since 1993 under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1993, no accidents or device failure claims have been reported as a result of using the Seirin JR brand acupuncture needle.

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

Thomas A. Riihimaki, President
2/4/97
Date

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