These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Device Description

Tai-Chi and Master acupuncture needles are sterile disposable, surgical s/steel acupuncture needles with spiral wound spring or rigid pipe type handles. These needles are supplied in individual blister or bulk packages. with or without polypropylene insertion tubes.

AI/ML Overview

The provided text describes a 510(k) pre-market notification for Tai-Chi and Master Acupuncture Needles. It explicitly states that substantial equivalence is NOT based on an assessment of performance data. Instead, the equivalence is based on the devices having the "same technological characteristics" as predicate devices already on the market (K-003760 and K-962809).

Therefore, this document does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the other requested details regarding performance studies (sample sizes, ground truth, expert adjudication, MRMC, or standalone performance).

The only relevant information that can be extracted regarding the device and its regulatory pathway is:

Device Identification:

Device Trade Name: Tai-Chi and Master Acupuncture Needles (other trade names may also be used)
Common or Usual Name: Acupuncture Needles
Device Classification Name: Needle, Acupuncture, Single Use
Classification: Class II
510(k) Number: K-023787
Indications for Use: These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Since no performance study was conducted or reported, the table of acceptance criteria and reported device performance cannot be generated. Similarly, all other requested information pertaining to study design and execution (sample sizes, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is absent from this document.

Summary

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LHASA MEDICAL, INC.

234 Libbey Parkway, Weymouth, MA 02189 (781) 340-1071 fax: 781-659-9916 (or fax: 781-335-6296)

February 13, 2003

Page 8a

PRE-MARKET NOTIFICATION 510(k) SUMMARY (As Required by 21 CFR 807.92)

(a)(1) Cubmitter

Submitter:	Lhasa Medical, Inc234 Libbey ParkwayWeymouth, MA 02189
Contact Person:	Kyung P. Riihimaki
Date Summary Prepared:	February 13, 2003
(a)(2)
Device Trade Name:	Tai-Chi and Master Acupuncture Needles(other trade names may also be used)
Common or Usual Name:	Acupuncture Needles
Device Classification Name:	Needle, Acupuncture, Single Use
Classification:	Class II
510(k) Number:	K-023787

(a)(3)

This device is substantially equivalent in design and performance to other brands of acupuncture needles which were in commercial distribution in the USA prior to May 28, 1976. These acupuncture needles are also substantially equivalent to other acupuncture needles which have received approval through the 510(k) premarket notification process.

These include the following:

Tai-Chi Acupuncture Needles	K-003760 (2/6/01)
SEIRIN Acupuncture Needles	K-962809 (8/16/92)

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LHASA MEDICAL, INC.

234 Libbey Parkway, Weymouth, MA 02189 (781) 340-1071 fax: 781-659-9916 (or fax: 781-335-6296)

November 11, 2002

Page 8b

PRE-MARKET NOTIFICATION 510(k) SUMMARY ..... continucd from previous page

(a)(4)

Description of Tai-Chi and Master Acupuncture Needles.

(a)(5)

Acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

(a)(6)

Tai-Chi and Master acupuncture needles have the same technological characteristics as the predicate devices identified in paragraph (a)(3). These needles use the same needle body lengths and gauges (needle thickness); handle length and design; and packaging methods (single blister and bulk packaging) as these predicate devices. These needles also employ the same method of insertion, with or without polypropylene guide tubes.

(b)(1)(2)(3)

Substantial equivalence is not based on an assessment of performance data.

Hyry P. Büchrich.

February 13, 2003

Date

Kyung P. Riihimaki, President Premarket Notification (510(k) Number): K-023787

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes extending upwards and to the right. Below the bird is a wavy line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2003

Mr. Kyung P. Riihimaki President Lhasa Medical, Incorporated 234 Libbey Parkway Weymouth, Massachusetts 02189

Re: K023787

Trade/Device Name: Tai-Chi and Master Acupuncture Needles Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: January 17, 2003 Received: January 22, 2003

Dear Mr. Riihimaki:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Riihimaki

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K023787

Page 6

K-023787 510(k) Number (if known):

Device Name:

Tai-Chi and Master Acupuncture Needles

Indications for Use

These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluations (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _

Patricia Cucurullo

510(k) Number. K023787

Regulation Number and Section

§ 880.5580 Acupuncture needle.

(a)
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.(b)
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.