K962809 · Seirin-America, Inc. · MQX · Aug 16, 1996 · General Hospital
Device Facts
Record ID
K962809
Device Name
SEIRIN ACUPUNCTURE NEEDLES
Applicant
Seirin-America, Inc.
Product Code
MQX · General Hospital
Decision Date
Aug 16, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5580
Device Class
Class 2
Attributes
Therapeutic
Indications for 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 acupuncture needle; sterile, single-use device; intended for skin piercing during acupuncture practice. Operated by qualified practitioners in clinical settings. Device design follows general acupuncture needle specifications. Benefits include enhanced safety compared to historical reusable needles due to sterile, single-use nature. No reported accidents or failures since 1983.
Clinical Evidence
No clinical data provided; safety established through historical usage data since 1978 in Japan and 1983 in the USA with no reported accidents or device failures.
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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AUG-12 96 15:37 FROM:OMS MEDICAL 617-335-5779 TO:301 480 3002 PAGE:05
AUG 16 1996 K962809
SEIRIN-America, Inc.
230 Libbey Parkway, Weymouth, MA 02189 (617) 340-1827 (fax: 617-335-5779)
August 12, 1996
PRE-MARKET NOTIFICATION
510(k) SUMMARY - K-96-2809
(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 acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
The Seirin 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 brand acupuncture needle.
In conclusion, based on the information provided with this 510(k) application, the Seirin acupuncture needle meets the criteria for 510(k) acceptance. The Seirin needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Seirin needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce.
Thomas A. Riihimäki, President
Premarket Notification (510(k) Number): K-96-2809
Date: 8-12-96
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