NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES

K031060 · Lhasa Medical, Inc. · MQX · Jul 11, 2003 · General Hospital

Device Facts

• Record ID: K031060
• Device Name: NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
• Applicant: Lhasa Medical, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Jul 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Nano Tech and Super Nano Acupuncture Needles are sterile, single-use, surgical stainless steel needles featuring rigid plastic pipe-style handles. Supplied in individual blister or bulk packaging, they may include polypropylene insertion tubes. Used by qualified acupuncture practitioners to pierce the skin during acupuncture procedures. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data.

Technological Characteristics

Surgical stainless steel needle body; rigid plastic pipe-type handle; polypropylene guide tubes. Manual insertion method. Sterile, single-use, disposable.

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.

Predicate Devices

• DBC Acupuncture Needles (K963300)
• SEIRIN Acupuncture Needles (K962809)

Submission Summary (Full Text)

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

JUL 1 1 2003

K031060

# LHASA MEDICAL, INC.

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

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 [phone] fax: [phone] (or fax: [phone])

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.

(c) This summary includes these 2 pages in total.

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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 [phone] or [phone] 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

or

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use