OTC Elasto-Gel Manuka dressings are supplied as a gel (amorphous) a thickened viscosity honey or a gel sheet. OTC Elasto-Gel Manuka Honey sheet dressing is the same composition and identical to the Parent Product . The dressings will be supplied in many sizes, for example: 2x3, 4x4, 6x8, and possibly other additions sizes and shapes.

The amorphous gel is a mixture of a super absorbent crosslinked sodium polyacrylic acid, glycerine, honey and water. The crosslinked polyacrylamide polymer is insoluble in the wound fluid but has a relatively high capacity for absorption of the wound fluid, while releasing the glycerine, honey, and water into the wound fluid to establish a chemical equilibrium. The OTC Elasto-Gel Manuka Honey Amorphous gel dressing, is formulated to produce a high viscosity fluid mixture suitable for surface wounds cuts, scrapes and abrasions. The gel sheet is a moderately adhesive soft gel sheet that will protect the wound from shear, friction and pressure, suitable as a protective padding and cushioning device as well as functioning as a dressing. The OTC Elasto-Gel with Manuka Honey are limited to a slight change in indications and over the counter use.

The products will not dry out or become stuck to the wound. In most cases soon after application to the wound the pain level will be diminished . The provide a moist healing environment and will aid in the healing process.

AI/ML Overview

This document is a 510(k) summary for the ELASTO-GEL OTC MANUKA HONEY WOUND DRESSING. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided document, here's an analysis of the acceptance criteria and supporting study information:

Analysis of Acceptance Criteria and Study Information:

The provided document is a 510(k) submission summary to the FDA. For medical devices, particularly those seeking substantial equivalence, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally demonstrated through a rigorous comparison to legally marketed predicate devices, along with performance testing to show that differences do not raise new questions of safety or effectiveness.

In this case, the acceptance criteria are not explicitly stated in a quantitative manner as one might find for a software algorithm, but are implicitly met by demonstrating substantial equivalence to existing predicate devices for the intended use. This is common for wound dressings, where the focus is on material properties, biocompatibility, and intended use as compared to similar, already approved products.

The "study" proving the device meets these criteria is primarily the comparison to predicate devices presented in the table and the stated information that the "OTC Elasto-Gel Manuka Honey sheet dressing is the same composition and identical to the Parent Product."

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence claim for a wound dressing, the "acceptance criteria" are not numerical performance metrics like sensitivity/specificity. Instead, the acceptance criteria are linked to the properties and intended use of the legally marketed predicate devices. The "reported device performance" is the description of the new device that aligns with these criteria.

Acceptance Criteria (based on Predicate Devices)	Reported Device Performance (OTC Elasto-Gel Manuka Honey Wound Dressing)
Intended Use: Similar indications for use (Wound management)	Intended Use: Minor Cuts & Abrasions, Scrapes, Surface Wounds, Minor Scalds and Burns. (This is a slight change in indications from the parent product, focusing on OTC use and specific minor wound types, but consistent with the general category of wound management of predicates.)
Materials: Composition suitable for wound care, often including polyacrylamide, glycerine, water, and Manuka honey.	Materials: Polyacrylamide+glycerine+Water + Manuka Honey or PolyAcrylate + Water + Manuka honey +glycerine (For gel sheet: same composition as Parent Product). Amorphous gel is a mixture of super absorbent crosslinked sodium polyacrylic acid, glycerine, honey and water.
Properties: e.g., Absorbent, Soft Sheet, Biocompatible, Sterile, Does not dry out or stick to wound, Provides moist healing environment.	Properties: Absorbent Soft Sheet: Yes. Bio-Compatibility: Yes. Sterile: Yes. Products will not dry out or become stuck to the wound. In most cases soon after application to the wound the pain level will be diminished. They provide a moist healing environment and will aid in the healing process. (The comparison table also explicitly states "No" for "Dissolves or 'melts' in wound fluid," distinguishing it from some predicates but implying this difference does not raise new questions of safety/effectiveness).
Similar Mechanism of Action: E.g., providing a moist healing environment, managing exudate.	Mechanism: Absorbs wound fluid while releasing glycerine, honey, and water to establish chemical equilibrium, providing a moist healing environment, protecting from shear, friction, and pressure.
Safety: No new safety concerns raised by the device.	(Implicitly demonstrated through substantial equivalence to legally marketed devices and material compatibility).
Effectiveness: Similar effectiveness to predicate devices for the stated intended use.	(Implicitly demonstrated through substantial equivalence and the claim that it will "aid in the healing process").

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

None provided. The document is a 510(k) summary for a wound dressing, which typically relies on material characterization and comparison to predicate devices rather than clinical "test sets" in the manner of diagnostic algorithms. Data provenance is not applicable here as it's not a study involving patient data.

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

Not applicable. There is no "test set" in the context of expert-adjudicated ground truth for a wound dressing 510(k) submission.

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

Not applicable.

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. This document describes a wound dressing, not an AI-assisted diagnostic device.

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

Not applicable. This describes a physical medical device (wound dressing), not a software algorithm.

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

For the purpose of this 510(k), the "ground truth" is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance. The new device demonstrates "ground truth" by showing substantial equivalence to these products in terms of materials, indications, and performance characteristics.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

K10 2478
page 1 of 2

southwest technologies inc. Treating the world well ®

510(k) Summary

NOV - 3 201

ELASTO-GEL OTC MANUKA HONEY WOUND DRESSING

Southwest Technologies, Inc. 1. Sponsor: 1746 Levee Road N. Kansas City, MO 64116

Edward I. Stout, CEO Contact Person: Southwest Technologies, Inc. 1746 Levee Rd N. Kansas City, MO 64116 Telephone: (816) 221-2442 Fax: (816) 221-3995 email: swtech@birch.net

2. Device Name and Classification

Proprietary Name: OTC Elasto-Gel Manuka Honey Wound Dressing (K102478) Common Name: Wound Dressing Classification Name: Dressing Product code FRO Classification: To my knowledge, FDA has not classified this device.

3. Substantial Equivalence Claim- Predicate Devices

Legally marketed devices: Elasto-Gel Occlusive Dressing by Southwest Technologies (K872165) Elasto-gel Manuka Honey Wound Dressings (K083334) Derma Sciences API MEDIM Active Manuka Honey Absorbent Dressing by Derma Sciences Canada, Inc (K053095) Product Code FRO Derma Sciences Medihoney Primary Dressings with Active Manuka Honey by Derma Sciences (K072956)

4. Device Description

Elasto-Ge/M
TM TOCA
id
TM
TM
Comfort Finger Bobs Crutch-Mate The Gold Dust™ Stimulen

1746 Levee Road, North Kansas City, MO. 64116 (Sph:(800) 247-9951 ph:(816) 221-2442 fax:(816) 221-3995 (S) www.elastogel.com

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

K102478
Page 2 of 2

Intended Use (for OTC ) Minor Cuts & Abrasions, Scrapes
Surface Wounds, Minor Scalds and Burns

6. Technological Characteristics and Substantial Equivalence

Comparison to Predicate Devices

Device Name	Elasto-Gel™Manuka HoneyWound Dressing	OTC API-MEDMedihoney Primary& 100 % HoneyDressing withActive ManukaHoney	API-MED™ACTIVEMANUKAHONEY ABSORBENTDRESSING	Elasto-Gel™Occlusive woundDressing	Derma Sciences OTCMedihoney Dressingswith Active ManukaHoney
Manufacturer	SouthwestTechologies Inc	Derma Sciences	Derma Sciences	SouthwestTechnologies, Inc	Derma Sciences
Indications	Prolonged use in	Used to manage	Used in the	Used in the	Used for
For use	Full and partial thick-ness chronic andacute wounds.	with minimal tomoderate amountsof exudate.	Of chronic and acutewounds.	Management ofpartial and fullthickness and partialchronic and Acutewounds.	Minor abrasionsLacerationsMinor cutsMinor scalds andburns
Material	Polyacrylamide+glycerine+Water + ManukaHoney orPolyAcrylate +Water + Manukahoney +glycerine	Manuka Honey+ Alginate	Manuka Honey+Alginate	Polyacrylamide+glycerine + Water	Manuka Honey +Alginate
HoneySource	New Zealand	?		NA
Properties ofSheet
Absorbent SoftSheet	Yes	No	Yes	Yes	Yes
Dissolves or"melts" in woundfluid	No	Yes	Yes	No	No
Bio-Compatibility	Yes	Yes	Yes	Yes	Yes
Sterile	Yes	Yes	Yes	Yes	Yes

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

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

Southwest Technologies, Inc. % Mr. Edward I. Stout, CEO 1746 Levee Road North Kansas City, Missouri 64116

NOV - 3 1.0.3

Re: K102478

Trade/Device Name: OTC Elasto-Gel Manuka Honey Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 25, 2010 Received: October 13, 2010

Station Comments of Children Comments of Children

Dear Mr. Stout:

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

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

Page 2 - Mr. Edward I. Stout, CEO

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

NOV - 3 2010

510(K)Number (If Known) K102478

Device Name : OTC Elasto-Gel Manuka Honey Wound Dressing

Indications for Use: The OTC Manuka Honey Wound Dressing is indicated for minor

cuts, minor abrasions, minor scalds and minor burns.

Prescription Use_ (Part 21CFR 801Subpart D) AND/OR

Over the Counter______________________________________________________________________________________________________________________________________________________________ (Part 21CFR 801Subpart D)

Daind Kime for MXM
Division Sigr. OGS

(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102478

Regulation Number and Section

N/A