EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE

K111313 · Alcavis Hdc, LLC · FQH · Dec 14, 2011 · General Hospital

Device Facts

• Record ID: K111313
• Device Name: EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
• Applicant: Alcavis Hdc, LLC
• Product Code: FQH · General Hospital
• Decision Date: Dec 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OTC: ExSept Skin and Wound Cleanser with is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor skin and nail irritations, minor cuts, and intact skin. Professional Use: Under supervision of healthcare professionals, ExSept Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, ingrown toe nails, post surgical wounds, first and second degree burns, grafted and donor sites, and exit sites.

Device Story

ExSept Skin and Wound Cleanser is a clear to slight yellow solution with a slight chlorine odor; supplied in pump-spray or pour bottles. Device functions via mechanical flushing action to remove debris, foreign material, and exudate from wounds and skin. Used in clinical settings by healthcare professionals or by patients for OTC applications. Cleansing action aids in wound management and preparation. No complex electronics or software involved.

Clinical Evidence

Numerous in-vitro and in-vivo studies performed to demonstrate efficacy, safety, and biocompatibility. Stability studies confirm a 30-month shelf life at room temperature.

Technological Characteristics

Liquid solution containing a preservative; supplied in 100ml, 200ml, 250ml, and 500ml containers. Mechanical cleansing via flushing action. No electronic components or software.

Indications for Use

Indicated for OTC use on minor skin abrasions, lacerations, irritations, cuts, and intact skin. Indicated for professional use on exudating or dirty wounds including stage I-IV pressure ulcers, diabetic foot ulcers, ingrown toe nails, post-surgical wounds, first/second degree burns, grafted/donor sites, and exit sites.

Regulatory Classification

Identification

A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• ExSept WC Wound Cleaner (K061467)
• SilvaKlenz Skin and Wound Cleanser (K063069)
• Dermacyn Wound Cleanser (K042729)
• Anasept Animicrobial Skin and Wound Cleanser (K073547)
• Dakin's Wound Cleanser (K090791)

Submission Summary (Full Text)

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DEC 1 4 2011

Alcavis K111313: ExSept Skin and Wound Cleanser

## 510(k) Summary

| 8322 Helgerman Court |
|------------------------|
| Gaithersburg, MD 20877 |

| Contact Person: | Gary J. Mishkin |
|-----------------|--------------------------|
| | Chief Operations Officer |
| | Tele: [phone] |
| | Fax: [phone] |

| Date Prepared: | April 15, 2011 |
|----------------|----------------|
|----------------|----------------|

| Device Name: | |
|--------------|--------------------------------------------------|
| | Proprietary Name: ExSept Skin and Wound Cleanser |
| | Common Name: Wound Cleanser |
| | Classification Name: Dressing, Wound, Drug |

| Predicate Devices: | ExSept WC Wound Cleaner, K061467 |
|--------------------|---------------------------------------------|
| | SilvaKlenz Skin and Wound Cleanser, K063069 |
| | Dermacyn Wound Cleanser, K042729 |

Alcavis HDC LLC

,"

Sponsor:

Anasept Animicrobial Skin and Wound Cleanser, K073547

Dakin's Wound Cleanser, K090791

Device Description: ExSept Skin and Wound Cleanser is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from

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K111313
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Alcavis HDC LLC

K111313: ExSept Skin and Wound (

exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and 100 ml, 250 ml and 500 ml pour bottles. ExSept Skin and Wound Cleanser contains a preservative permitting a 30 month shelf life.

## Intended Use:

OTC: ExSept Skin and Wound Cleanser with is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor skin and nail irritations, minor cuts, and intact skin.

Professional Use: Under supervision of healthcare professionals, ExSept Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, ingrown toe nails, post surgical wounds, first and second degree burns, grafted and donor sites, and exit sites.

Substantial Equivalence: ExSept Skin and Wound Cleanser is substantially equivalent in the cleansing functions and intended uses to the predicate devices ExSept WC, SilvaKlenz, Dermacyn, Anasept, and Dakin's. All predicate devices use a flushing action to remove foreign material and other debris from the wounds and surrounding skin.

Testing: Numerous in-vitro and in-vivo studies have been performed to demonstrate the efficacy, safety and biocompatibility of the ExSept Skin and Wound Cleanser for the indications for use. Stability studies show a shelf life of 30 months, when stored at room temperature.

Conclusion: Based upon the information in the 510(k) submission,

ExSept Skin and Wound Cleanser will perform as intended as a wound cleanser. ExSept Skin and Wound Cleanser is substantially equivalent in its actions and functions as the marketed devices ExSept WC, SilvaKlenz, Dermacyn, Anasept, and Dakin's.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized bird or eagle with three wing-like shapes.

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

Alcavis HDC, LLC % Mr. Gary J. Mishkin Chief Operations Officer 8322 Helgerman Court Gaithersburg, Maryland 20877

DEC 1 4 2011

Re: K111313

Trade/Device Name: Alcavis ExSept Skin and Wound Cleanser Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: II Product Code: FQH Dated: November 3, 2011 Received: November 8, 2011

Dear Mr. Mishkin:

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. Iisting 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 vour 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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Page 2 - Mr. Gary J. Mishkin

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Erin 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): K 111313

Device Name: Alcavis ExSept Skin and Wound Cleanser

Indications For Use:

OTC: ExSept Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor skin and nail irritations, minor cuts, and intact skin.

Professional Use: Under supervision of healthcare professionals, ExSept Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, ingrown toe nails, post surgical wounds, first and second degree burns, grafted and donor sites, and exit sites.

Prescription Use __ X AND/OR Over-The-Counter Use _ X

(21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Daid Kime for MXY

Tce of CDRH, Office of Device Evaluation (ODE)

gical, Orthopedic. and Restorative Devices

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510(k) Number K111313