MARKNEW PRODUCTS ACUPUNCTURE NEEDLES

K020880 · Marknew Products · MQX · Jun 10, 2002 · General Hospital

Device Facts

• Record ID: K020880
• Device Name: MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
• Applicant: Marknew Products
• Product Code: MQX · General Hospital
• Decision Date: Jun 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States

Device Story

Marknew Products Acupuncture Needles are single-use, sterile devices designed for skin penetration during acupuncture therapy. Operated by qualified practitioners, the needles are inserted into specific anatomical points to facilitate treatment. The device functions as a mechanical tool for acupuncture practice. No electronic, software, or automated components are involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use acupuncture needle. Class II device (21 CFR 880.5580). Product code MQX. Sterile, manual instrument.

Indications for Use

Indicated for use by qualified practitioners, as determined by individual States, to pierce the skin 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)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 0 2002

Marknew Products C/O Mr. Greg Holland Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606

Re: K020880

Trade/Device Name: Marknew Products Acupuncture Needles Regulation Number: 880.5580 Regulation Name: Acupuncture Needle, Single Use Regulatory Class: II Product Code: MQX Dated: May 10, 2002 Received: May 13, 2002

Dear Mr. Holland:

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.

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.

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

## Page 2 - Mr. Greg Holland

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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

ho Celalrist

Timot hy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use Statement

020810 510(k) Number (if known):_

Device Name: Marknew Products Acupuncture Needles

Indications For Use:

To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Cincotta

ion Sign-Off) on of Dental, Infection Control, eral Hospital Devic mber

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)