ELTA WOUND CLEANSER

K103713 · Swiss American Products, Inc. · FRO · Jun 16, 2011 · SU

Device Facts

• Record ID: K103713
• Device Name: ELTA WOUND CLEANSER
• Applicant: Swiss American Products, Inc.
• Product Code: FRO · SU
• Decision Date: Jun 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

Device Story

Elta Wound Cleanser is a topical solution used for cleaning dermal wounds. It functions by facilitating the removal of foreign materials, including debris and dirt, from the wound site. It is intended for over-the-counter use by patients or caregivers to assist in wound hygiene. The device is applied directly to the wound area to aid in the cleansing process, supporting proper wound care management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Topical wound cleanser solution. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for the removal of foreign material, such as debris and dirt, from dermal wounds. Available for over-the-counter use.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

JUN 16 201

Re: K103713

Trade/Device Name: Elta Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: June 2, 2011 Received: June 6, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

E. L. Keith

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

Enclosure

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## Indications for Use

510(k) Number (if known): K103713

Device Name: Elta Wound Cleanser

Indications for Use:

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

Prescription Use

AND/OR

Over-The-Counter Use X

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krome for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103713

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