ASAP Wound Dressing Gel is an amorphous, water-based gel that contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. The high moisture content gel contains a base matrix composed of hydrophilic and buffering compounds and contains silver from American Biotech Labs' proprietary silver hydrosol suspension. ASAP Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene tube, sealed on one end and fitted with a pop-open screw cap on the other end).

AI/ML Overview

This document describes a 510(k) submission for the ASAP Wound Dressing Gel, a silver hydrosol-based wound dressing. The submission asserts substantial equivalence to predicate devices and does not contain details about acceptance criteria, a specific study proving device performance against such criteria, or the methodology typically used in AI/ML medical device studies (like sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone performance).

Here's an analysis based on the provided text, focusing on the questions that can be answered:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria as pass/fail metrics for specific performance endpoints (e.g., sensitivity, specificity, accuracy). Instead, it states that the device was evaluated through standard biological reactivity tests (ISO 10993) and antimicrobial effectiveness testing in accordance with USP <51>. The acceptance criterion essentially appears to be "found to be acceptable" for biological reactivity and "effectiveness was established" for antimicrobial properties.

Acceptance Criteria Category	Reported Device Performance
Biological Reactivity	Evaluated through standard biological reactivity tests (ISO 10993) and found to be acceptable.
Antimicrobial Effectiveness	Established through testing in accordance with USP <51>.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size for any test set or the provenance of data. The "testing" mentioned refers to laboratory standards (ISO, USP) rather than clinical or image-based studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes a wound dressing and not an AI/ML-driven diagnostic device that would typically rely on expert consensus for ground truth. The "ground truth" here would be defined by the results of the specific biological and antimicrobial assays.

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

This is not applicable for the same reasons as point 3. The document does not describe a scenario requiring expert adjudication of results.

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

An MRMC study was not conducted (and would not be relevant) as this is not an AI-assisted diagnostic device.

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

This question is not applicable as the device is a wound dressing, not an algorithm.

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

The "ground truth" for the device's claims are based on:

Biological Reactivity: Results from ISO 10993 standard tests. This would involve laboratory measurements against established biological endpoints (e.g., cytotoxicity, sensitization).
Antimicrobial Effectiveness: Results from USP <51> testing. This involves standardized microbiological assays to determine the product's ability to inhibit microbial growth.

8. The sample size for the training set

This question is not applicable as the device is a wound dressing and does not involve AI/ML models requiring a training set.

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

This question is not applicable for the same reason as point 8.

Summary

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K0γ2333

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APR - 2 2009

510(k) Summary

Submitter's Name and Address:

Contact Person:

American Biotech Labs 780 West Canyon Crest Road Alpine, UT 84004

William D. Moeller A Managing Director Phone: 801-756-1000 Fax: 801-756-5454

ASAP Wound Dressing Gel

Date of Preparation:

Professional Trade Name:

OTC Trade Name

Device Common-Usual Name:

Classification Number/Class

Unclassified

Wound Dressing Gel

March 20, 2009

This 510(k) Summary is being submitted in accordance with the requirements of 21 C.F.R. 807.92.

The assigned 510(k) Number is: K082333

Predicate Devices:

Elta Silver Antimicrobial Wound Gel Dressing, WOU (K071703) AcryDerm Silver Antimicrobial Would Gel (K011994 and K070333) Silver Shield Antimicrobial Skin and Wound Gel (K062212) Silveron® Adhesive Strip (K023609) Actisorb Silver 220 Antimicrobial Binding Dressing (K022483)

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Description of Device:

Indications for Use:

For the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations

Technological Characteristics:

ASAP Wound Dressing Gel is an amorphous, water-based, gel that contains silver hydrosol. The composition of ASAP Wound Dressing Gel is substantially equivalent to the predicate devices listed above in that silver is the antimicrobial ingredient and moisture is managed using an aqueous base combined with a proper blend of hydrophilic substances. ASAP Wound Dressing Gel contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. The product was evaluated through standard biological reactivity tests (ISO 10993) and found to be acceptable. Antimicrobial effectiveness was established through testing in accordance with USP <51>.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2009

American Biotech Labs % Swankin & Turner Mr. James S. Turner 1400 16th Street, Northwest, Suite 101 Washington, District of Columbia 20036

Re: K082333

Trade/Device Name: ASAP Wound Dressing Gel Regulatory Class: Unclassified Product Code: FRO Dated: March 24, 2009 Received: March 25, 2009

Dear Mr. Turner:

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 Fed-ral 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. James S. Turner

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

for

Mark N. Melkerson
Director
Dep Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(K) Number (if known): K082333

Device Name: ASAP Wound Dressing Gel

Over-the-Counter Indications for Use:

For the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use XX (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Keene fa mxm 4/1/2009

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082333

Regulation Number and Section

N/A