SONIK LDI 20 AIR by EVIT LABS, INC.

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The provided text is an FDA 510(k) clearance letter for the Sonik LDI 20 Air Nebulizer, confirming its substantial equivalence to a predicate device.

The letter discusses:

The device trade name and regulation number.
The FDA's determination of substantial equivalence.
Regulatory requirements and general controls for the device.
Contact information for further guidance.
An "Indications for Use" statement for the device.

It does not include:

A table of acceptance criteria and reported device performance.
Details of a study conducted to demonstrate performance against specific criteria.
Information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping lines that resemble an abstract bird or a symbol representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2003

Mr. S. David Piper, P.E. President Evit Labs, Incorporated 4843 46th Street, Building 351 McClellan, California 95652

Re: K030374

Trade/Device Name: Sonik LDI 20 Air Regulation Number: 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: II Product Code: CAF Dated: May 28, 2003 Received: May 29, 2003

Dear Mr. Piper:

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. S. David Piper, P.E.

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 vour 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) 594-4646. 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 Penner

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

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Page 1 of 1

510(k) Number (if known):	K030374
Device Name:	Sonik LDI 20 AIR™

Indication for Use:

To be used to convert liquid medication into aerosol for inhalation by patient.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use : (Per 21 CFR 810.109) Over-the-Counter Use

signature

(Division Sign-O
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
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510(k) Number:__

(Optional Format 1-2-96)

INTNDUSE.DOC

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).