← Product Code FRO · K102478 # OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING (K102478) _Southwest Technologies, Inc. · FRO · Nov 3, 2010 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K102478 ## Device Facts - **Applicant:** Southwest Technologies, Inc. - **Product Code:** FRO - **Decision Date:** Nov 3, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use The OTC Manuka Honey Wound Dressing is indicated for minor cuts, minor abrasions, minor scalds and minor burns. ## Device Story OTC Elasto-Gel Manuka Honey Wound Dressing consists of amorphous gel or gel sheets containing crosslinked sodium polyacrylic acid/polyacrylamide, glycerine, honey, and water. Device functions as a protective padding and cushioning dressing for minor surface wounds. Applied topically by patients or caregivers to minor cuts, scrapes, abrasions, and burns. Gel releases honey, glycerine, and water into the wound to establish chemical equilibrium while absorbing wound fluid. Provides moist healing environment; prevents drying and adherence to wound bed; reduces pain. Supplied in various sizes and shapes. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on descriptive comparisons of technological characteristics and intended use. ## Technological Characteristics Materials: crosslinked sodium polyacrylic acid or polyacrylamide, glycerine, honey, water. Form factor: amorphous gel or soft adhesive gel sheets. Energy source: none (passive). Connectivity: none. Sterilization: sterile. Sensing/actuation: passive absorption and moisture release via chemical equilibrium. ## Predicate Devices - Elasto-Gel Occlusive Dressing ([K872165](/device/K872165.md)) - Elasto-gel Manuka Honey Wound Dressings ([K083334](/device/K083334.md)) - Derma Sciences API MEDIM Active Manuka Honey Absorbent Dressing ([K053095](/device/K053095.md)) - Derma Sciences Medihoney Primary Dressings with Active Manuka Honey ([K072956](/device/K072956.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 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. 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 5. 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 Honey
Wound Dressing | OTC API-MED
Medihoney Primary
& 100 % Honey
Dressing with
Active Manuka
Honey | API-MED™
ACTIVEMANUKA
HONEY ABSORBENT
DRESSING | Elasto-Gel™
Occlusive wound
Dressing | Derma Sciences OTC
Medihoney Dressings
with Active Manuka
Honey | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | Manufacturer | Southwest
Techologies Inc | Derma Sciences | Derma Sciences | Southwest
Technologies, 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 and
acute wounds. | with minimal to
moderate amounts
of exudate. | Of chronic and acute
wounds. | Management of
partial and full
thickness and partial
chronic and Acute
wounds. | Minor abrasions
Lacerations
Minor cuts
Minor scalds and
burns | | Material | Polyacrylamide+glyce
rine+Water + Manuka
Honey or
PolyAcrylate +
Water + Manuka
honey +glycerine | Manuka Honey
+ Alginate | Manuka Honey+
Alginate | Polyacrylamide+
glycerine + Water | Manuka Honey +
Alginate | | Honey
Source | New Zealand | ? | | NA | | | Properties of
Sheet | | | | | | | Absorbent Soft
Sheet | Yes | No | Yes | Yes | Yes | | Dissolves or
"melts" in wound
fluid | 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 --- **Source:** [https://fda.innolitics.com/device/K102478](https://fda.innolitics.com/device/K102478) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com