(260 days)
Not Found
No
The device description focuses on the physical and chemical properties of a wound dressing and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No.
Explanation: The device is indicated for use in the management of wounds, which implies support for healing rather than a direct therapeutic effect on a disease or condition itself. It is a dressing that helps maintain a beneficial wound environment.
No
This device is a wound dressing designed for the management and healing of wounds, not for diagnosing conditions.
No
The device description clearly describes a physical wound dressing made of a polymer matrix, glycerine, honey, and water, supplied as a gel or gel sheet. It is a tangible product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of wounds." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a wound dressing designed to absorb wound fluid, release components, and provide protection and cushioning. This aligns with a wound care product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing information for diagnosis or treatment decisions based on laboratory analysis.
The device is clearly described as a wound dressing for topical application to wounds.
N/A
Intended Use / 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
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The biocompatibility testing and case studies demonstrates that these dressings are sale for then immediation
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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
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: (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
R
| Device Name | Elasto-Gel™
Manuka Honey
Wound Dressing | Medihoney Primary
Dressing | API-MED™
ACTIVEMANUKA
HONEY ABSORBENT
DRESSING | Elasto-Gel™
Occlusive wound
Dressing |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Manufacturer | Southwest
Techologies Inc | Derma Sciences | Derma Sciences | Southwest
Technologies, Inc |
| Indications | Prolonged use in | Used to manage | Used in the | Used in the |
| For use | Full and partial thick-
ness chronic and
acute wounds. | with minimal to
moderate amounts
of exudate. | Management
Of chronic and acute
wounds: | Management of
partial and full
thickness and partial
chronic and Acute
wounds. |
| Material | Polyacrylamide+glyce
rine+Water + Manuka
Honey or
PolyAcrylate +
Water + Manuka
honey +glycerine | Manuka Honey
- Alginate | Manuka Honey+
Alginate | Polyacrylamide+
glycerine + Water |
| Honey
Source | New Zealand | ? | | NA |
| Properties of
Sheet
Absorbent Soft
Sheet | Yes | Yes | Yes | Yes |
| Disolves or
"melts" in wound
fluid | 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:
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
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