ELASTO-GEL MANUKA HONEY WOUND DRESSING

K083334 · Southwest Technologies, Inc. · FRO · Jul 30, 2009 · SU

Device Facts

• Record ID: K083334
• Device Name: ELASTO-GEL MANUKA HONEY WOUND DRESSING
• Applicant: Southwest Technologies, Inc.
• Product Code: FRO · SU
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

Elasto-Gel Manuka Honey Wound Dressing is a sterile, single-use primary dressing available as an amorphous gel or a gel sheet. The sheet consists of an insoluble polyacrylamide polymer matrix containing glycerine, honey, and water; the amorphous gel uses a super-absorbent crosslinked sodium polyacrylic acid base. The device functions by absorbing excess wound exudate while releasing honey, glycerine, and water into the wound to establish chemical equilibrium. The gel sheet provides protective padding and cushioning, reducing shear friction and pressure. It is intended for use by healthcare professionals or patients in clinical or home settings to maintain a moist healing environment. The dressing does not dissolve or melt in wound fluid, preventing it from sticking to the wound bed. By protecting the wound and managing exudate, the device aims to facilitate healing and reduce pain levels.

Clinical Evidence

No clinical trial data provided. Evidence consists of biocompatibility testing and case studies demonstrating safety and performance for the intended wound management applications.

Technological Characteristics

Materials: Polyacrylamide or polyacrylate polymer matrix, glycerine, water, and Manuka honey. Form factor: Amorphous gel or continuous soft gel sheet. Energy source: None (passive). Connectivity: None. Sterilization: Sterile. Sensing/Actuation: Passive absorption of exudate and release of honey/glycerine/water via chemical equilibrium.

Indications for Use

Indicated for management of full and partial thickness wounds, including 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 surgical wounds.

Predicate Devices

• Medihoney Primary Dressing (K072956)
• API-MED Active Manuka Honey Absorbent Dressing (K053095)
• Elasto-Gel Occlusive Dressing (K872165)

Submission Summary (Full Text)

{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: [phone] Fax: [phone] email: swtech @birch.net 2. Device Name and Classification Proprietary Name Ma Elasto-Gel Manuka Honey Wound Dress Common Name:

4. Device Description

Classification Name:

Legally marketed devices

(K072956)

3. Substantial Equivalence Claim- Predicate Devices

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.

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: [phone] ph: (816) 221-395 (S) www.elastogel.com

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

southwest technologies inc.
"Treating the world well" Ⓡ

5. 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:[phone] ph:[phone] (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

R

| Device Name | Elasto-Gel™<br>Manuka Honey<br>Wound Dressing | Medihoney Primary<br>Dressing | API-MED™<br>ACTIVEMANUKA<br>HONEY ABSORBENT<br>DRESSING | Elasto-Gel™<br>Occlusive wound<br>Dressing |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Manufacturer | Southwest<br>Techologies Inc | Derma Sciences | Derma Sciences | Southwest<br>Technologies, Inc |
| Indications | Prolonged use in | Used to manage | Used in the | Used in the |
| For use | Full and partial thick-<br>ness chronic and<br>acute wounds. | with minimal to<br>moderate amounts<br>of exudate. | Management<br>Of chronic and acute<br>wounds: | Management of<br>partial and full<br>thickness and partial<br>chronic and Acute<br>wounds. |
| Material | Polyacrylamide+glyce<br>rine+Water + Manuka<br>Honey or<br>PolyAcrylate +<br>Water + Manuka<br>honey +glycerine | Manuka Honey<br>+ Alginate | Manuka Honey+<br>Alginate | Polyacrylamide+<br>glycerine + Water |
| Honey<br>Source | New Zealand | ? | | NA |
| Properties of<br>Sheet<br>Absorbent Soft<br>Sheet | Yes | Yes | Yes | Yes |
| Disolves or<br>"melts" in wound<br>fluid | No | Yes | Yes | No |
| Bio-<br>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:[phone] fax:[phone] (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 [phone] or [phone] 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:

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

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