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

Nano Tech and Super Nano Acupuncture Needles are sterile disposable, surgical s/steel acupuncture needles with rigid pipe type plastic handles. These needles are supplied in individual blister or bulk packages, with or without polypropylene insertion tubes.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for acupuncture needles. It explicitly states in section (b)(1)(2)(3) on page 6b: "Substantial equivalence is not based on an assessment of performance data."

Therefore, the document does not contain information on acceptance criteria or a study proving device performance in the way typically expected for a medical device with measurable performance metrics (e.g., accuracy, sensitivity, specificity). This submission is based on substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting where information is not present:

Acceptance Criteria and Device Performance Study

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission explicitly states that substantial equivalence is not based on performance data.
Sample Size Used for the Test Set and Data Provenance: This information is not provided. No test set or performance evaluation study (in terms of clinical or analytical performance) was conducted or reported.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: This information is not provided. No test set or ground truth establishment based on expert review was conducted or reported.
Adjudication Method for the Test Set: This information is not provided. No test set or adjudication process was conducted or reported.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This information is not provided. No performance study involving human readers or AI assistance was conducted or reported.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: This information is not provided. This device is a physical medical device (acupuncture needles), not a software algorithm, so a standalone algorithm study is not applicable.
Type of Ground Truth Used: This information is not provided. No ground truth was established for a performance study.
Sample Size for the Training Set: This information is not provided. The device is not an AI/ML algorithm that requires a training set.
How the Ground Truth for the Training Set Was Established: This information is not provided. Not applicable as the device is not an AI/ML algorithm.

Summary of the basis for clearance:

The Nano Tech and Super Nano Acupuncture Needles were determined to be substantially equivalent to legally marketed predicate devices based on design and technological characteristics, not on performance data. The key characteristics considered were:

Same needle body lengths and gauges (thickness).
Same handle design.
Same packaging methods (single blister and bulk).
Same method of insertion (with or without guide tubes).

The predicate devices cited are:

DBC Acupuncture Needles (K-963300, 9/23/96)
SEIRIN Acupuncture Needles (K-962809, 8/16/92)

Summary

{0}------------------------------------------------

JUL 1 1 2003

K031060

LHASA MEDICAL, INC.

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

April 2, 2003

Page 6a

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

(a)(1)
Submitter:	Lhasa Medical, Inc
	234 Libbey Parkway
	Weymouth, MA 02189
Contact Person:	Kyung P. Riihimaki
Date Summary Prepared:	April 2, 2003
(a)(2)
Device Trade Name:	Nano Tech and Super Nano
	Acupuncture Needles
Common or Usual Name:	Acupuncture Needles
Device Classification Name:	Needle, Acupuncture, Single Use
Classification:	Class II
510(k) Number:	K-

(a)(3) Substantially Equivalent

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:

DBC Acupuncture Needles	K-963300 (9/23/96)
SEIRIN Acupuncture Needles	K-962809 (8/16/92)

{1}------------------------------------------------

LHASA MEDICAL, INC.

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

April 2, 2003

Page 6b

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

(a)(4) Description

Description of Nano Tech and Super Nano Acupuncture Needles. Nano Tech and Super Nano Acupuncture Needles are sterile disposable, surgical s/steel acupuncture needles with rigid pipe type plastic handles. These needles are supplied in individual blister or bulk packages, with or without polypropylene insertion tubes.

(a)(5) Indications for Use

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) Technological Characteristics

Nano Tech and Super Nano 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 design; and use the same 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2003

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

Re: K031060

Trade/Device Name: Nano Tech and Super Nano Acupuncture Needles Regulation Number: 880.5580 Regulation Name: Acupuncture needle Regulatory Class: II Product Code: MQX Dated: April 2, 2003 Received: May 12, 2003

Dear Ms. 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 - Ms. 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.

Suser Ruans

Susan Runner, DD, 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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K0310600

Page 4

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

Device Name:

Nano Tech and Super Nano 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)

Patricia Ciuccute

(División Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K031060

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use

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.