Elasto-gel Manuka Honey wound Dressings are indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers, (stages 1 -IV) venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds, and surgical wounds

Device Description

Elasto-Gel Manuka dressings are supplied as a gel(amorphous) or gel sheet. Elasto-Gel Manuka Honey sheet dressing is a sterile primary single use dressing comprised of aninsoluble polyacrylamide polymer matrix in the form of a continuous sheet with plasticizer of glycerine, honey, and water. The dressings will be supplied in many sizes, for example: 2x3", 4x4,6x8, and possibly other additional 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 film to capit establish a chemical equilibrium. The Elasto-Gel Manica Honory and Match Houng Informulated to produce a high viscosity fluid mixture suitable for filling wound cavities. 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.

AI/ML Overview

The provided text describes a medical device, the "Elasto-Gel Manuka Honey Wound Dressing," and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

This document is a 510(k) premarket notification for a wound dressing, which relies on demonstrating substantial equivalence to existing legally marketed devices. The "Performance Testing" section simply states: "The biocompatibility testing and case studies demonstrates that these dressings are safe for then immediation [sic]" (Page 3, Section 7). This implies general safety and efficacy based on established methods for wound dressings, rather than specific performance metrics and a dedicated study to meet those metrics.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC) or standalone performance is not applicable or not present in the provided text for this specific device.

However, I can extract what limited information is available and explain why other sections are not covered by the text.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of specific performance metrics for an AI/ML device. The document focuses on demonstrating substantial equivalence in terms of indications, materials, and general properties, rather than quantifiable performance criteria like sensitivity, specificity, or image analysis metrics. The "Performance Testing" section (Page 3, Section 7) broadly states that "biocompatibility testing and case studies demonstrates that these dressings are safe."

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

Not applicable. No "test set" in the context of an AI/ML algorithm is described. "Case studies" are mentioned, but no specifics on their size, nature (retrospective/prospective), or data provenance (country of origin) are provided.

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

Not applicable. No "ground truth" establishment by experts for a test set is described.

4. Adjudication method for the test set

Not applicable. No adjudication method is described.

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 device is a wound dressing, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison is relevant.

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

Not applicable. This device is a wound dressing, not an algorithm.

7. The type of ground truth used

Not applicable for an AI/ML context. For a wound dressing, ground truth would typically relate to clinical outcomes (healing, infection rates, pain reduction), which are generally assessed in clinical trials or case studies. The document only vaguely refers to "case studies" and "biocompatibility testing."

8. The sample size for the training set

Not applicable. This device is a wound dressing, not an AI/ML model requiring a training set.

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

Not applicable. This device is a wound dressing, not an AI/ML model requiring a training set with ground truth.

Summary

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

southwest technologies inc. Treating the world wish ELASTO-GEL MANUKA HON WOUND DRESSING 1. Sponsor: Southwest Technologies. Inc 1746 Levee Road N. Kansas City, MO 64116 Edward Stout, CEO Contact Person: Southwest Technologies 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 Ma Elasto-Gel Manuka Honey Wound Dress Common Name:

Device Description

Classification Name:

Legally marketed devices

(K072956)

Substantial Equivalence Claim- Predicate Devices

Dressing (Product code KMF? FRO??

Derma Sciences ABI MED Active Manuka Honey Absorbent Dressing by Derma Sciences

Derma Sciences Medinoney Primary Dressings with Active Manuka Honey by Derma Sciences

Wound Dressing

Classification: To my knowledge, FDA has not classified this device

Elasto-Gel Occlusive Dressing by Southwest Technologies(K872165)

Canada, Inc (K053095) Product Code FRO

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 products will help provide a moist healing environment and will absorb excess wound exudate. ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ

"rutch-Mate" A Gold Dust" A Stimulen

1746 Levee Road, North Kansas City, MO. 64116 (S)ph: (800) 247-9951 ph: (816) 221-395 (S) www.elastogel.com

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

southwest technologies inc.
"Treating the world well" Ⓡ

Intended Use
These products are suitable for:

full and partial thickness wounds,
pressure ulcers (stages I-IV)
venous stasis ulcers
diabetic ulcers
partial thickness burns
acute wounds
abrasions
traumatic wounds healing by secondary intention
donor sites and other surface wounds
surgical wounds

K083334
Page 2 of 3

E-2

Elasto-Gel™ Toe Comfort® Finger Bobs™ Crutch-Mate™ Gold Dust™ Stimulen
Aid

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

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

Image /page/2/Picture/0 description: The image is a black and white logo. The logo is a circle with a thick black border. Inside the circle is a large letter "S" in black, with a white conical flask in the center of the "S". The flask is oriented vertically, with the wide base at the bottom and the narrow neck at the top.

southwest technologies inc. "Treating the world well" ®

K08 3334
page 3 of 3

6. Technological Characteristics and Substantial Equivalence Comparison to Predicate Devices

Device Name	Elasto-Gel™Manuka HoneyWound Dressing	Medihoney PrimaryDressing	API-MED™ACTIVEMANUKAHONEY ABSORBENTDRESSING	Elasto-Gel™Occlusive woundDressing
Manufacturer	SouthwestTechologies Inc	Derma Sciences	Derma Sciences	SouthwestTechnologies, Inc
Indications	Prolonged use in	Used to manage	Used in the	Used in the
For use	Full and partial thick-ness chronic andacute wounds.	with minimal tomoderate amountsof exudate.	ManagementOf chronic and acutewounds:	Management ofpartial and fullthickness and partialchronic and Acutewounds.
Material	Polyacrylamide+glycerine+Water + ManukaHoney orPolyAcrylate +Water + Manukahoney +glycerine	Manuka Honey+ Alginate	Manuka Honey+Alginate	Polyacrylamide+glycerine + Water
HoneySource	New Zealand	?		NA
Properties ofSheetAbsorbent SoftSheet	Yes	Yes	Yes	Yes
Disolves or"melts" in woundfluid	No	Yes	Yes	No
Bio-Compatibility	Yes	Yes	Yes	Yes
Sterile	Yes	Yes	Yes	Yes

7. Performance Testing

The biocompatibility testing and case studies demonstrates that these dressings are sale for then immediation

Elasto-Ge/TM Tochi™ Comfort® Finger Bobs Crutch-Mate™ Gold Dust™ Stimuler
id
E-3

1746 Levee Road, North Kansas City, MO. 64116 (3)ph:(816) 221-2442 fax:(816) 221-3995 (3) www.elastogel.com

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

Image /page/3/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains an image of an abstract eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2009

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

Re: K083334

Trade/Device Name: Elasto-Gel Manuka Honey Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 22, 2009 Received: June 23, 2009

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.

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.

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

Page 2 - Mr. Edward I. Stout

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/CDRHOffices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

incerely yours,

ark N. Mellekerson

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

Enclosure

{5}------------------------------------------------

Indications for Use

510 (k) Number (If Known): K083334

Device Name: Elasto-Gel Manuka Honey Wound Dressing

Indications For Use:

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

Over-the-Counter (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)

Daniel Krone for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083334

Page 1 of 1

Regulation Number and Section

N/A