ELTA ADVANCED WOUND WASH

K073610 · Swiss American Products, Inc. · FRO · Apr 23, 2008 · SU

Device Facts

• Record ID: K073610
• Device Name: ELTA ADVANCED WOUND WASH
• Applicant: Swiss American Products, Inc.
• Product Code: FRO · SU
• Decision Date: Apr 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Advanced Wound Wash is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.

Device Story

Elta Advanced Wound Wash is a topical solution used for cleansing dermal wounds. It functions by irrigating the wound site to mechanically remove foreign material, debris, and dirt. The device is intended for over-the-counter use by patients or caregivers in home or clinical settings. It aids in wound site preparation by facilitating the removal of contaminants, potentially supporting the natural healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Topical wound irrigation solution. Formulated for mechanical removal of debris from dermal wounds. Non-sterile or sterile (as per standard manufacturing practices for wound cleansers). No electronic, software, or complex mechanical components.

Indications for Use

Indicated for removal of foreign material, debris, and dirt from dermal wounds in patients requiring wound cleansing.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2008

Swiss American Products, Inc. % Eric Luo, Ph.D. 2055 Luna Road #126 Carrollton, Texas 75006

Re: K073610

Trade/Device Name: Elta Advanced Wound Wash Regulatory Class: Unclassified Product Code: FRO Dated: March 26, 2008 Received: March 27, 2008

Dear Dr. Luo:

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 r toals of a rised 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

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Page 2 – Eric Luo, Ph.D.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark N Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: Elta Advanced Wound Wash

Indications for Use: ·

Advanced Wound Wash is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use__X (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K073610