(63 days)
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.
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
This document is a 510(k) summary for the DeRoyal Industries, Inc. MULTIDEX® PLUS GEL. It describes the device and its intended use, and compares it to legally marketed predicate devices.
However, it does not contain any information about a study that tests specific acceptance criteria and reports device performance against those criteria.
The document states that "The DeRoyal Industries, Inc. Multidex® Plus Gel is the same as Multidex® Plus Powder... Like its predicate devices, the Multidex® Plus Gel is used to cover wounds and to provide a moist environment conducive to healing." It highlights the difference in form (gel vs. powder) for easier application and flexibility but doesn't present data from a clinical or performance study about this.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence based on materials, intended use, and existing knowledge of a key ingredient (glycerin), rather than providing results from a specific performance study.
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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.
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