(265 days)
Not Found
No
The description focuses on a chemical solution for wound cleansing and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
Explanation: This device is for mechanical cleansing and debridement of wounds, which is a supportive rather than a direct therapeutic function. Therapeutic devices typically imply an action that heals, cures, or mitigates a disease or condition through biological, chemical, or physical means beyond just cleaning.
No
The device is described as a solution for "mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds," indicating its role in wound care and debridement, not diagnosis. The "Intended Use / Indications for Use" section also confirms it's for "debridement and the removal of foreign material and debris," which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a "solution" supplied in "bottles" and a "pump-spray," indicating it is a physical product (liquid and container) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical cleansing of wounds and skin. This is a physical action performed on the body's surface, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a solution used for cleansing. This aligns with a topical or external application, not an in vitro test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies mentioned are "non-clinical in-vitro testing" for biocompatibility and shelf-life, which are standard tests for medical devices, but not indicative of an IVD's diagnostic performance.
- Predicate Devices: The predicate devices listed are also wound cleansers, which are not IVDs.
In summary, the device's function is to physically clean wounds and skin, which falls under the category of a medical device for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For debridement and the removal of foreign material and debris from exudating and/or dirty wounds, abrasions and minor irritations, cuts, exit sites, and intact skin.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
ExSept WC 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 a 100 ml, 250 ml, and 500 ml pour white, opaque, bottles. ExSept WC has a shelf-life of 30 months.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidermal and dermal wounds, post-surgical wounds, abrasions and minor irritations, cuts, exit sites, other minor wounds, and intact skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical in-vitro testing was performed to demonstrate the biocompatibility of ExSept WC for it's intended purpose and to support the 30 month shelf-life for the product. Conclusion: Based upon the information in the 510(k) submission, ExSept WC will perform as intended as a wound cleanser, and is substantially equivalent in its actions and functions as the marketed devices Allclenz, CarraKlenz, and Dermacyn.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
510(k) Summary
-
Sponsor: Alcavis International 8322 Helgerman Court Gaithersburg, MD 20877
FEB 1 5 2007 -
Contact Person: Gary J. Mishkin Vice President, Research and Development Tele: (301) 330-7597 Fax: (301) 330-6432
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Date Prepared: May 4, 2006
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Device Name: Proprietary Name: ExSept WC Common Name: Wound Cleanser Classification Name: Liquid Bandage (21CFR 880.5090)
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Predicate Devices: Allclenz Wound Cleaner, K965120 CarraKlenz Wound Cleanser, K022670 Dermacyn Wound Cleanser, K042729
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Device Description: ExSept WC 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 a 100 ml, 250 ml, and 500 ml pour white, opaque, bottles. ExSept WC has a shelf-life of 30 months.
-
Indications for Use: For debridement and the removal of foreign material and debris from exudating and/or dirty wounds, abrasions and minor irritations, cuts, exit sites, and intact skin.
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Intended Use: For the flushing and mechanical cleansing of dirt and debris from epidermal and dermal wounds, post-surgical wounds, abrasions and minor irritations, cuts, exit sites, other minor wounds, and intact skin,
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Substantial Equivalence: ExSept WC is substantially equivalent in the cleansing functions and intended uses to the predicate devices Allclenz, CarraKlenz, and Dermacyn. All predicate devices use a flushing action to remove foreign material and other debris from the wounds and surrounding skin.
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- Testing: Non-clinical in-vitro testing was performed to demonstrate the biocompatibility of ExSept WC for it's intended purpose and to support the 30 month shelf-life for the product.
Conclusion: Based upon the information in the 510(k) submission, ExSept WC will perform as intended as a wound cleanser, and is substantially equivalent in its actions and functions as the marketed devices Allclenz, CarraKlenz, and Dermacyn.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alcavis International, Inc. % Mr. Gary J. Mishkin, M.S. VP, Research and Development 8322 Helgerman Court Gaithersburg, Maryland 20877
FEB 1 5 2007
Re: K061467
Trade/Device Name: ExSept WC Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: December 22, 2006 Received: December 26, 2006
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 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 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); 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.
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Page 2 - Mr. Gary J. Mishkin, M.S.
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 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
:1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device Name: ExSept WC Wound Cleanser
Indications For Use:
For debridement and the removal of foreign material and debris from exudating and/or dirty wounds, abrasions and minor irritations, cuts, exit sites, and intact skin.
| Prescription Use | X
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use | (21 CFR 801 Subpart C) |
| ------------------ | ---------------------------------- | -------- | ---------------------- | ------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | 15061467 |
|---|---|
| --------------- | ---------- |
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