HUA-XIA ACUPUNCTURE NEEDLES

K962916 · Lhasa Medical, Inc. · MQX · Aug 23, 1996 · General Hospital

Device Facts

• Record ID: K962916
• Device Name: HUA-XIA ACUPUNCTURE NEEDLES
• Applicant: Lhasa Medical, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hua-Xia acupuncture needle is a sterile, single use only acupuncture needle. The Hua-Xia acupuncture needle meets the general specifications and parameters for an acupuncture needle and is effective for the practice of acupuncture.

Device Story

Hua-Xia acupuncture needle; sterile, single-use device; intended for acupuncture practice. Device functions as a manual needle for insertion into patient tissue by licensed practitioners. Replaces older non-sterile, reusable needles to improve safety. No electronic components, software, or automated processing.

Clinical Evidence

No clinical data provided. Safety profile based on historical use of acupuncture needles and manufacturer's experience since 1990 with no reported serious injuries.

Technological Characteristics

Sterile, single-use acupuncture needle. Manual device; no energy source, connectivity, or software. Materials and dimensions consistent with general acupuncture needle specifications.

Indications for Use

Indicated for use in the practice of acupuncture. No specific patient population, age, or gender restrictions provided.

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 23 1996

LHASA MEDICAL, INC.

K962916

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

July 24, 1996

SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS

In general, acupuncture needles have been used in the practice of acupuncture in the United States for now over 30+ years. Since this time, we are not aware of any serious or life threatening accidents involving acupuncture needles.

The acupuncture needles which were in commercial interstate distribution prior to May 28, 1976 were sold as a non-sterile, reusable acupuncture needle. However, the acupuncture needles which are now sold in 1996 offer greater safety since they are a sterile, single use only acupuncture needle.

The subject of this 510k application - the Hua-Xia acupuncture needle - is a sterile, single use only acupuncture needle. The Hua-Xia acupuncture needle meets the general specifications and parameters for an acupuncture needle and is effective for the practice of acupuncture.

Lhasa Medical has been selling the Hua-Xia brand acupuncture needle since 1990 as an "Investigational device, limited by U.S. law to investigational use". Since 1990, Lhasa Medical has not received any serious claims of injuries caused by the Hua-Xia acupuncture needle.

Additional information on the safety and effectiveness of the Hua-Xia acupuncture needle will be made available if it is requested.

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

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