ASAP OTC™ Wound Dressing Gel is indicated for the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.

Device Description

ASAP OTC™ Wound Dressing Gel is a water based gel wound dressing 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 OTC™ Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene lined metal tube, sealed on one end and fitted with a popopen screw cap on the other end).

AI/ML Overview

The provided document is a 510(k) summary for a medical device called ASAP OTC™ Wound Dressing Gel. It details the device's characteristics, its intended use, and how it compares to a predicate device to establish substantial equivalence. However, it does not describe a study involving acceptance criteria and a detailed statistical analysis of device performance in the context of typical AI/ML device evaluations.

Instead, this document focuses on biocompatibility testing and antimicrobial effectiveness testing to establish the safety and basic functionality of the wound dressing gel. The "acceptance criteria" here are implied by meeting the standards of ISO 10993 for biocompatibility and USP <51> for antimicrobial effectiveness.

Therefore, many of the requested specific points regarding sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are common for AI/ML device evaluations, are not applicable to this type of device submission.

Here's an analysis based on the information provided, highlighting the differences in evaluation methodology:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with numerical targets as one might see in an AI/ML clinical study. Instead, performance is demonstrated by conformance to recognized standards and by comparison to a predicate device.

Acceptance Criteria (Implied by Standards/Demonstration)	Reported Device Performance
Biocompatibility: Conformance to ISO 10993	Found to be acceptable
Antimicrobial Effectiveness: Conformance to USP <51>	Inhibited growth of: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, MRSA, VRE, Candida albicans, Aspergillus niger
Physical/Chemical Specifications (Comparative):
- Appearance	Clear to golden yellow translucent gel (matches predicate)
- Odor	Odorless (matches predicate)
- Specific Gravity	1.01 (predicate: 1.02)
- Flowability	At 45° & 90° - more than 5 min. to travel 1 inch from origin (matches predicate)
- Feel/Tackiness	1 - smooth (matches predicate)
- Viscosity RT 30°	25,000 - 60,000 (matches predicate)
- pH	6.5 to 8.0 (matches predicate)
- Light Exposure	No further discoloration (matches predicate)
- Compatibility	No discoloration of product / reaction with containers (matches predicate)
- Moisture Donation	Greater than 5% (matches predicate)
- Moisture Uptake	Greater than 5% (matches predicate)

Study Information (Based on available document):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical data for AI/ML. For biocompatibility and antimicrobial testing, the sample sizes would be determined by the respective standards (ISO 10993 and USP <51>). These are laboratory-based tests, not human subject studies.
- Data Provenance: The studies are laboratory-based (biocompatibility and antimicrobial effectiveness). This is not retrospective or prospective human clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this type of device evaluation. Ground truth for biocompatibility and antimicrobial effectiveness is established by the methods and criteria defined in the specific standards (ISO 10993, USP <51>).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring human expert adjudication of clinical findings.
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. This device is a wound dressing gel, not an AI/ML diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. The "performance" is the inherent physical, chemical, and biological properties of the gel.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility, the "ground truth" is adherence to established biological safety criteria as defined by ISO 10993, assessed through various biological reactivity tests (e.g., cytotoxicity, sensitization, irritation).
- For antimicrobial effectiveness, the "ground truth" is defined by the inhibition of specified microbial growth according to the quantitative criteria of USP <51>. This is a direct microbiologic assessment.
The sample size for the training set:
- Not applicable. This device does not use an AI/ML algorithm that requires training data. Device formulation and manufacturing processes are developed through R&D, not a "training set" in the AI sense.
How the ground truth for the training set was established:
- Not applicable as there is no "training set" in the AI/ML context.

Summary

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MAY 2 0 2014

510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the ASAP OTCTM Wound Dressing Gel is provided below.

Device Common Name:	Wound Dressing
Device Proprietary Name:	ASAP OTC™ Wound Dressing Gel
Submitter:	ABL Medical, LLC705 E 50 SAmerican Fork, UT 84003
Contact:	Calley HerzogConsultantBiologics Consulting Group, Inc.400 N. Washington St., Suite 100Email: cherzog@bcg-usa.comPhone: 720-883-3633Fax: 703-548-7457
Date Prepared:	May 16, 2014
Classification Regulation:	Unclassified
Panel:	General & Plastic Surgery
Product Code:	FRO
Predicate Device:	K082333. ASAP Wound Dressing Gel

Indication for Use:

ASAP OTC™ Wound Dressing Gel is indicated for the topical management of minor cuts, lacerations, abrasions, 15t and 2nd degree burns, and skin irritations.

Device Description:

ASAP OTC™ Wound Dressing Gel is a water based gel wound dressing that contains silver hydrosol that may inhibit the growth of microorganisms within the dressing.

Performance Data:

The device was evaluated with biocompatibility testing (ISO 10993) and was found to be acceptable. The gel contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. Antimicrobial effectiveness was established through testing in accordance

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with USP <51> and was shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, MRSA and VRE, as well as fungi such as Candida albicans and aspergillus niger.

Substantial Equivalence Summary:

The composition of ASAP OTC™ Wound Dressing Gel is similar to that of the ASAP, Wound Dressing Gel cleared in K082333. The only differences between the subject device and the predicate device are that 1) the subject device contains 24ppm silver hydrosol and the predicate device contains 32ppm silver hydrosol and 2) the subject device does not contain propylene glycol.

	Proposed Device	Predicate Device
510(k) Number	TBD	K082333
Submitter	ABL Medical, LLC	American Biotech Labs(Note: 510(k) ownership has beentransferred to ABL Medical LLC)
Classification Regulation	Unclassified	Unclassified
Product Code	FRO	FRO
Indication	ASAP OTCTM Wound DressingGel is indicated for the topicalmanagement of minor cuts,lacerations, abrasions, 1st and 2nddegree burns, and skin irritations.	For the topical management ofminor cuts, lacerations, abrasions,1st and 2nd degree burns, and skinirritations. (Over-the-Counter)
Packaging	Multi-dose gel pump or a tube(collapsible, low-densitypolyethylene lined metal tube,sealed on one end and fitted witha pop-open screw cap on the otherend)	Multi-dose gel pump or a tube(collapsible, low-densitypolyethylene lined metal tube,sealed on one end and fitted with apop-open screw cap on the otherend)
Sterilized	Not provided sterile	Not provided sterile
Shelf Life	No shelf life claimed	No shelf life claimed
Ingredients
Active & Diluent	24 ppm ASAP Solution - 98.42%	32 ppm ASAP Solution - 91%
Thickening Agent	Carbopol ETD 2020 - 0.58%	Carbopol ETD 2020 - 0.58%
Buffering Agent, PenetratingAgent	Triethanolamine (TEA) - 1%	Triethanolamine (TEA) - 1%
Humectant		Propylene Glycol - 7%

Table 1: Device Comparison Table

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	Proposed Device	Predicate Device
Specifications
Appearance	Clear to golden yellow translucentgel	Clear to golden yellow translucentgel
Odor	Odorless	Odorless
Specific Gravity	1.01	1.02
Flowability	At 45° & 90° - more than 5 min. totravel 1 inch from the origin	At 45° & 90° - more than 5 min.to travel 1 inch from the origin
Feel/Tackiness	1 - smooth	1 - smooth
Viscosity RT 30°	25,000 - 60,000	25,000 - 60,000
PH	6.5 to 8.0	6.5 to 8.0
Light Exposure	No further discoloration	No further discoloration
Compatibility	No discoloration of product /reaction with containers	No discoloration of product /reaction with containers
Moisture Donation	Greater than 5%	Greater than 5%
Moisture Uptake	Greater than 5%	Greater than 5%

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2014

ABL Medical, LLC % Ms. Calley Herzog Biologics Consulting Group Incorporated 400 North Washington Street, Suite 100 Alexandria, Virginia 22314

Re: K140483

Trade/Device Name: ASAP OTC™ Wound Dressing Gel Regulatory Class: Unclassified Product Code: FRO Dated: April 22, 2014 Received: April 24, 2014

Dear Ms. Herzog:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 (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.

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Page 2 - Ms. Calley Herzog

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices . . Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K140483

Device Name

ASAP OTCTM Wound Dressing Gel

Indications for Use (Describe)

ASAP OTC™ Wound Dressing Gel is indicated for the topical management of minor cuts, lacerations, abrasions, Ist and 2nd degree burns, and skin irritations.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Jiyoung Dar

FORM FDA 3881 (1/14)

Regulation Number and Section

N/A