ASP TITANIUM

K060392 · Sedatelec · MQX · Apr 26, 2006 · General Hospital

Device Facts

• Record ID: K060392
• Device Name: ASP TITANIUM
• Applicant: Sedatelec
• Product Code: MQX · General Hospital
• Decision Date: Apr 26, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states. The device consists of a solid, titanium needle.

Device Story

ASP TITANIUM Acupuncture Needles are solid titanium needles designed for single-use skin piercing during acupuncture procedures. Operated by state-qualified practitioners in clinical settings, the device functions as a manual tool for acupuncture therapy. It provides a sterile, single-use instrument to facilitate treatment, aiming to ensure patient safety by preventing cross-contamination associated with reusable needles.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid titanium needle; single-use; manual operation; non-powered.

Indications for Use

Indicated for use by qualified practitioners for piercing the skin in 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2006

Sedatelec C/O Mr. Kevin Walls Principal Consultant Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127

Re: K060392

Trade/Device Name: ASP TITANIUM Acupuncture Needles for Single Use Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: March 23, 2006 Received: March 27, 2006

Dear Mr. Walls:

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. Kevin Walls

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 (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 continue 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 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D 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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Indications for Use

510(k) Number (if known): K060392

Device Name: ASP TITANIUM Acupuncture Needles for Single Use.

Indications for Use: The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states. The device consists of a solid, titanium needle.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ാന്തര വിശ്വാത്തിരും, General Hospital, Truchio! Dental Devices

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