EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER

K082858 · Alcavis International, Inc. · FQH · May 27, 2009 · General Hospital

Device Facts

• Record ID: K082858
• Device Name: EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
• Applicant: Alcavis International, Inc.
• Product Code: FQH · General Hospital
• Decision Date: May 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin. Professional Use: Under supervision of healthcare professionals, ExSept WC 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, post surgical wounds, first and second degree burns, grafted and donor sites, and catheter exit sites.

Device Story

ExSept WC Skin and Wound Cleanser is a liquid solution used for mechanical cleansing of wounds. It removes dirt, debris, and foreign material from epidermal and dermal wounds. Supplied in pump-spray or pour bottles; applied by patients (OTC) or healthcare professionals (clinical setting). The solution acts mechanically to clear wound beds and surrounding skin. Benefits include effective debridement and removal of contaminants, facilitating wound care management.

Clinical Evidence

Bench testing only. 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

Clear to slight yellow liquid solution with slight chlorine odor. Supplied in 100ml, 200ml, 250ml, and 500ml containers. Mechanical cleansing principle. No software or electronic components.

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, post-surgical wounds, first/second degree burns, grafted/donor sites, and catheter 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)

Submission Summary (Full Text)

{0}------------------------------------------------

Page 1 of 2

K082858 ExSept WC Skin and Wound Cleanser

# 510(k) Summary

27 2009 MAY

| Sponsor: | Alcavis International<br>8322 Helgerman Court<br>Gaithersburg, MD 20877 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary J. Mishkin<br>Vice President, Research and Development<br>Tele: [phone]<br>Fax: [phone] |
| Date Prepared: | September 25, 2008 |
| Device Name: | Proprietary Name: ExSept WC Skin and Wound Cleanser<br>Common Name: Wound Cleanser<br>Classification Name: Dressing, Wound, Drug |
| Predicate Devices: | ExSept WC Wound Cleaner, K061467<br>SilvaKlenz Skin and Wound Cleanser, K063069<br>Dermacyn Wound Cleanser, K042729<br>Anasept Animicrobial Skin and Wound Cleanser, K073547 |

Device Description: ExSept WC 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 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 WC Skin and Wound Cleanser has a 30 month shelf life.

### Intended Use:

1

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

Professional Use: Under supervision of healthcare professionals, ExSept WC 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, post surgical wounds, first and second degree burns, grafted and donor sites, and catheter exit sites.

- Substantial Equivalence: ExSept WC Skin and Wound Cleanser is substantially equivalent in the cleansing functions and intended uses to the predicate devices ExSept WC, SilvaKlenz, Dermacyn

{1}------------------------------------------------

K082858
Page 2 of 2

K082858 ExSept WC Skin and Wound Cleanser

and Anasept. All predicate devices use a mechanical 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 WC Skin and Wound Cleanser for the indications for use. Stability studies show a shelf life of 30 months for the ExSept WC Skin and Wound Cleanser, when stored at room temperature.
Conclusion: Based upon the information in the 510(k) submission, ExSept WC Skin and Wound Cleanser will perform as intended as a wound cleanser. ExSept WC Skin and Wound Cleanser is substantially equivalent in its actions and functions as the marketed devices ExSept WC, SilvaKlenz, Dermacyn and Anasept.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

## MAY 27 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alcavis International, Incorporated % Mr. Gary J. Mishkin Vice President, Research and Development 8322 Helgerman Court Gaithersburg, Maryland 20877

Re: K082858

Trade/Device Name: ExSept WC Skin and Wound Cleanser Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: II Product Code: FQH Dated: April 17, 2009 Received: April 20, 2009

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, 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 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

{3}------------------------------------------------

Page 2-Mr. Mishkin

(reporting of medical device-related adverse events) (21 CFR 803); 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.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.

F-R Pete D. Rummmo mfit
Mark N. Mallem O.K.

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

Enclosure

{4}------------------------------------------------

Page 1 of 1

K082858 ExSept WC Skin and Wound Cleanser

# Indications for Use

### 510(k) Number (if known):K082858

Device Name: ExSept WC Skin and Wound Cleanser

#### Indications For Use:

- OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
- Professional Use: Under supervision of healthcare professionals, ExSept WC 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, post surgical wounds, first and second degree burns, grafted and donor sites, and catheter exit sites.

Prescription Use X ( Part 21 CFR 801 Subpart D) Over-The-Counter Use _ X (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for MXM
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K062656

Page 1 of 10