EXSEPT WC WOUND CLEANSER

• K Number: K061467
• Device Name: EXSEPT WC WOUND CLEANSER
• Manufacturer: ALCAVIS INTERNATIONAL, INC.
• Date Cleared: 2007-02-15 ( 265 days)
• Product Code: FRO
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K965120 , K022670 , K042729
• Predicate For: K082858 , K111313

Intended 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.

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.

AI/ML Overview

The provided 510(k) summary is for a wound cleanser (ExSept WC), which is a medical device. Medical devices, especially wound cleansers, typically do not undergo the same type of performance studies (e.g., studies using AI, human readers, or image analysis) as diagnostic or imaging devices. The document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical in-vitro testing for biocompatibility and shelf-life, rather than clinical performance metrics in the way a diagnostic AI would.

Therefore, the requested information (acceptance criteria and study details for device performance like those used in AI/diagnostic studies) is not present in the provided text. The device approval is based on substantial equivalence to existing predicate devices (Allclenz Wound Cleaner, CarraKlenz Wound Cleanser, Dermacyn Wound Cleanser) in terms of its "cleansing functions and intended uses."

Here's a breakdown of what can be extracted or inferred based on the document, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Based on the document, the acceptance criteria are not explicitly stated in terms of performance metrics like sensitivity, specificity, accuracy, or effect size. Instead, the primary acceptance criterion appears to be demonstrating substantial equivalence to predicate devices. This equivalence is based on the device having the same intended use and similar technological characteristics (a flushing action to remove foreign material and debris from wounds).
• Reported Device Performance: The document states: "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." And the conclusion is: "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."
  • Biocompatibility: The device passed biocompatibility testing. No specific metrics are given.
  • Shelf-life: The device met the criteria for a 30-month shelf-life. No specific metrics are given.
  • Cleansing Function: The device is considered substantially equivalent in its cleansing function to predicate devices. No specific quantitative performance metrics for cleansing are provided.

Therefore, a table cannot be constructed with quantitative performance metrics for "device performance" in the way one would for an AI or diagnostic device.

2. Sample size used for the test set and the data provenance:

• Not applicable/Not provided. The testing mentioned is "non-clinical in-vitro testing" for biocompatibility and shelf-life, not clinical performance testing with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. Ground truth establishment for a diagnostic test set is not relevant for a wound cleanser's substantial equivalence determination.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. Adjudication methods are relevant for expert review of diagnostic cases, which is not part of this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable/Not done. This device is a wound cleanser, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not done. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For in-vitro biocompatibility and shelf-life testing, "ground truth" would refer to established laboratory standards and methods rather than clinical outcome data or expert consensus on patient cases.

8. The sample size for the training set:

• Not applicable. There is no AI algorithm being trained for this device.

9. How the ground truth for the training set was established:

• Not applicable. There is no AI algorithm being trained for this device.

In summary, the 510(k) summary for ExSept WC wound cleanser confirms its substantial equivalence based on non-clinical in-vitro testing for biocompatibility and shelf-life, and its similarity in function and intended use to existing predicate devices. It does not involve performance studies typically associated with AI or diagnostic imaging devices.

Summary

{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: [phone] Fax: [phone]

• Date Prepared: May 4, 2006

• Device Name: Proprietary Name: ExSept WC Common Name: Wound Cleanser Classification Name: Liquid Bandage (21CFR 880.5090)

• Predicate Devices: Allclenz Wound Cleaner, K965120 CarraKlenz Wound Cleanser, K022670 Dermacyn Wound Cleanser, K042729

• 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.

• 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,

• 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.

Page 1 of 2

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

• 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.

Page 2 of 2

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

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.

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

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 [phone]. 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 [phone] or [phone] 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}------------------------------------------------

K061467

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
---------------	----------

Page 1 of 1

Regulation Number and Section

N/A