(240 days)
Not Found
No
The device description and intended use clearly indicate it is a liquid solution for mechanical cleansing, with no mention of AI/ML or related concepts.
No.
The device is a wound cleanser, intended for cleansing and removal of dirt, debris, and foreign material from wounds. While it aids in wound care, it does not directly treat or cure the underlying condition, which is the primary function of a therapeutic device. It is a cleaning agent, not a healing agent.
No
This device is a skin and wound cleanser, intended for mechanical cleansing and removal of foreign material and debris from wounds, not for diagnosis.
No
The device description clearly states it is a "solution" supplied in "pump-spray and pour bottles," indicating it is a physical liquid product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ExSept WC Skin and Wound Cleanser is for the cleansing and removal of dirt, debris, and foreign material from wounds and skin. This is a physical action applied to the body or a wound on the body.
- Device Description: The description reinforces that it is a solution for mechanical cleansing of wounds.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples taken from the body (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are used to perform tests in vitro (outside the body) on these types of samples.
The device is a topical wound cleanser, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes
FQH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC: Users can be lay persons.
Professional Use: healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ExSept WC Wound Cleaner, K061467, SilvaKlenz Skin and Wound Cleanser, K063069, Dermacyn Wound Cleanser, K042729, Anasept Animicrobial Skin and Wound Cleanser, K073547
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5475 Jet lavage.
(a)
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.(b)
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.
0
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K082858 ExSept WC Skin and Wound Cleanser
510(k) Summary
27 2009 MAY
| Sponsor: | Alcavis International
8322 Helgerman Court
Gaithersburg, MD 20877 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary J. Mishkin
Vice President, Research and Development
Tele: (301) 330-7597
Fax: (301) 330-6432 |
| Date Prepared: | September 25, 2008 |
| Device Name: | Proprietary Name: ExSept WC 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
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
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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
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