(63 days)
No
The document describes a wound care gel and powder, focusing on their physical properties and intended use for creating a protective and moist wound environment. There is no mention of AI or ML technology in the description, intended use, or performance studies.
Yes
The device is used to provide a protective film and a moist wound environment conducive to healing in chronic, non-healing wounds, ulcers, and burns, which are therapeutic functions.
No
The device is a wound dressing designed to provide a protective film and a moist wound environment for healing, not to diagnose a condition.
No
The device description clearly states it is a gel, which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a protective film and a moist wound environment for chronic, non-healing wounds, ulcers, and burns. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties and materials of the gel, and its function in wound care. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: The description does not mention any components or processes related to detecting, measuring, or analyzing substances in the body or in vitro samples for diagnostic purposes.
- Predicate Devices: The predicate devices listed are wound care products (Multidex® Gel, Multidex® Plus Powder, Elasto-gel), further supporting that this device falls under the category of wound dressings or topical treatments, not IVDs.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to directly interact with the wound to promote healing, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The DeRoyal Industries. Inc. Multider "Plus Oel in chronic, non-healing wounds, ulcers, and over burns to provide a procecive film and a moist wound environment conducive to healing.
Product codes
Not Found
Device Description
The DeRoy I Industrics, In Multidex "Plus Gel is the same as Multidex" Plus Powder in the same manner as Multider " Plus Powder, it is used in case of thoric, nombaling would, ut car, and over burn as a protection in the same in the same prodicate devices, the plater, in the strong nonealing would , ulces, ac over buns as a pocecive film. Like that for the devices is used o cover wouds and a provide a moist the basis for the device is a bot the proces and in provide a most environment conductive on healing concept of the bacesing be the form the basis for the decise in that the.
Device DesignMaterials UsedPhysical Propries: The proposed DeRoyal Industries, Inc. Multics I Plus Gr. Includes the same materials as the same of the country stour riop. The proposed Dekoyal Industries, Inc. Multies." Plus Colincludes the same Multidex Plus Powder. The concept of use is that it can be easi
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DeRoyal Industries, Inc. DEROYAL INDUSTRIES, INC., MULTIDEX® PLUS GEL
SARAH COUGHLIN
510(k) Sumwary
MAY 21
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
| NAME: | DeRoyal Industries, Inc. | TELEPHONE: | (423) 938-7828 |
|---|---|---|---|
| ADDRESS: | 200 DeBusk Lane | CONTACT: | Debra F. Manning |
| ADDRESS: | Powell, TN 37849 | DATE OF PREPARATION: | May 2, 1996 |
DEVICE NAMES
NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known):
DeRoyal Industries, Inc., Multidex® Plus Gel Multidex® Plus Gel Unclassified
PREDICATE OR LEGALLY MARKETED DEVICES
DeRoyal Industries, Inc., Multidex® Gel Lange, Multidex® Plus Powder
DEVICE DESCRIPTION
The same and a seen.
The DeRoy I Industrics, In Multidex "Plus Gel is the same as Multidex" Plus Powder in the same manner as Multider " Plus Powder, it is used in case of thoric, nombaling would, ut car, and over burn as a protection in the same in the same prodicate devices, the plater, in the strong nonealing would , ulces, ac over buns as a pocecive film. Like
that for the devices is used o cover wouds and a provide a moist the basis for the device is a bot the proces and in provide a most environment conductive on healing concept of the bacesing be
the form the basis for the decise in that the
Device DesignMaterials UsedPhysical Propries: The proposed DeRoyal Industries, Inc. Multics I Plus Gr. Includes the same materials as the same of the country stour riop. The proposed Dekoyal Industries, Inc. Multies." Plus Colincludes the same
Multidex Plus Powder. The concept of use is that it can be easi
DEVICE INTENDED USE
The DeRoyal Industries. Inc. Multider "Plus Oel in chronic, non-healing wounds, ulcers, and over burns to provide a procecive film and a moist wound environment conducive to healing.
| Characteristics | Multidex® Plus Powder | Multidex® Plus Gel | Rationale |
|---|---|---|---|
| Form | Powder | Gel | The gel allows easier application to difficult to reach areas. |
| Also, see explanation below. |
TECHNOLOGICAL COMPARISON WITH MULTIDEX® P
The combination of glycein with Multidex Plus Powder allows a more soluble, elastic and flexible dessing the micro beter with wound and ulcer
Glycerin has been known since 600 AD, but was not check until 174 by Scheel. It is a non-toxic, non-anigenic, non-aliergie substance inti is not rejected by human tissues and does not produce inflammatory responses or scarting responses or scarting resctions.
The Merce Manual (I In ed, 1988) list the properties of shistical platfort, humcoan, plasticaz, and mollier, . I herican continuel has and in all be security all the minister of the rest, not hos as postition in the chemical platfield, that in the clipsel in also assession in allo nec in also assession in all used in all human issus s
Additionally, as previously indicated, glycerin is used by other manufactures of gel devices, including Southwest Technologics, in their Elasto-gel.