(331 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the gel, its antimicrobial barrier function, and biocompatibility. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is indicated for the management of various types of wounds, including pressure ulcers, burns, diabetic foot ulcers, and surgical incision wounds, with the goal of promoting healing. This aligns with the definition of a therapeutic device which aims to treat or alleviate a medical condition.
No
This device is a wound care gel intended for management and healing of wounds, not for diagnosing conditions.
No
The device description clearly states it is a gel supplied in a bottle, indicating it is a physical product, 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 for the management of wounds and irritated skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a gel applied topically to wounds to manage moisture and provide an antimicrobial barrier. This is a physical/chemical interaction with the wound itself, not a test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
- Performance Studies: The performance studies focus on antimicrobial efficacy and biocompatibility, which are relevant to a topical wound treatment, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
MendaSil™-TWG Gel Skin and Wound Gel is indicated for use under the 'supervision of a healthcare professional for management of partial to full thickness wounds from mild to moderate exudate such as Stage I-IV Pressure Ulcers, Partial and Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot Ulcers, Venous Stasis Ulcers and Surgical Incision Wounds. The Gel can also be used for management of minor cuts, scrapes/abrasions, and irritated skin.
Product codes (comma separated list FDA assigned to the subject device)
FRO, MEQ
Device Description
MendaSil™ TWG Skin and Wound Gel is an amorphous wound moisture management gel that helps maintain a moist wound environment that is conducive to healing by either absorbing the wound exudates or donating the moisture. The Gel contains a silver compound that is an effective barrier to bacterial penetration by inhibiting the growth of a broad spectrum of microorganisms which come into contact with the gel. MendaSil™-TWG Skin and Wound Gel will be supplied in conventional HDPE bottles fitted with a "flip top" dispenser closure. This bottle will be placed in a chipboard dispenser box with a package insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin/Dermal wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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)
USP Preservative Efficacy and Kirby Bauer Zone Inhibition Testing were performed to establish that MendaSil™ TWG Skin and Wound Gel is an effective antimicrobial barrier. The tests were performed using the test organisms in accordance with USP and some additional; bacterial strains. Biocompatibility has been assessed according to the Standard (Biological Evaluation of Medical Devices) [Cytotoxicity, Sensitization]; The cytonicity was between none and sijeht. There was no irritation or sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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510(K) SUMMARY
| Company: | ConSeal International, Inc. |
|---|---|
| 90 Kerry Place, Suite 2 | |
| Norwood, MA 02062 | |
| JAN - 7 2010 | |
| Contact: | Stephen C. Perry, President |
| Telephone: 781-278-0010 / Facsimile: 781-278-0028 | |
| Email: sperry@consealint.com | |
| Date of Preparation: | January 5, 2010 |
| Device Name (proprietary): | MendaSil™ TWG Skin and Wound Gel |
| Common Name: | Moist Wound Filler OR |
| Amorphous Hydrogel Wound Dressing | |
| 10:9130184781:3 | |
| Classification Name: | Dressing, wound and burn, hydrogel w/drug and/or biologic |
| Classification: | Unclassified |
| STJ(K) SUMMARY | |
| Product Code: | FRO, MEQ |
Legally Marketed Devices for substantial equivalence comparison:
MendaSil™-TWG Skin and Wound Gel is substantially equivalent to:
| SilvaSorb Silver Antimicrobial Wound Gel | 781-278-0010 / Facsimile: 781-278-0028 K011994 |
|---|---|
| AcryDerm Silver Antimicrobial Wound Gel (AcryMed, Inc., OR) | K011994 |
| Silver Shield Antimicrobial Skin and Wound Gel (Anacapa Tech., Inc., CA) | K062212 |
| uary 5 2010 | |
| Description of Device: | |
| MendaSil™ TWG Skin and Wound Gel is an amorphous wound moisture management gel that helps maintain a moist wound environment that is conducive to healing by either absorbing the wound exudates or donating the moisture. The Gel contains a silver compound that is an effective barrier to bacterial penetration by inhibiting the growth of a broad spectrum of microorganisms which come into contact with the gel. MendaSil™-TWG Skin and Wound Gel will be supplied in conventional HDPE bottles fitted with a "flip top" dispenser closure. This bottle will be placed in a chipboard dispenser box with a package insert. |
Intended Use of the Device:
MendaSil™-TWG Gel Skin and Wound Gel is indicated for use under the 'supervision of a healthcare
professional for management of partial to full thickness wounds from mild to moderate exudate such as
Stage I-IV Pressure Ulcers, Partial and Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot
Ulcers, Venous Stasis Ulcers and Surgical Incision Wounds. The Gel can also be used for management
of minor cuts, scrapes/abrasions, and irritated skin.
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Device Technological Characteristics:
MendaSil™-TWG Skin and Wound Gel exhibits the capacity to absorb moistire and control light wound exudates. The Gel contains a silver compound that acts as an effective barrier to a wide spectrum of bacteria which come into contact with the gel. Hydrogel characteristics are imparted by an inert viscosity enhancing agent as contained in the predicate device (AcryDerm Silver Antimicrobial Wound Gel, Acrymed, Inc., OR aka Silvasorb™ Antimicrobial Wound. Gel, #K011994, and Silvershield™ Antimicrobial Skin and Wound Gel #K062212.) MendaSil™-TWG Skin and Wound Gel represents substantial equivalence to the predicate devices.
Manufacturing:
MendaSil™ TWG Skin and Wound Gel will be manufactured according to product specifications and under the guidelines of Good Manufacturing Practices (GMP). Risk analysis has been performed to identify possible failure mode during manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode. All established GMPs will assure that the device manufactured meets all the established specifications prior to release and is safe and effective for its intended use.
Performance Testing:
USP Preservative Efficacy and Kirby Bauer Zone Inhibition Testing were performed to establish that MendaSil™ TWG Skin and Wound Gel is an effective antimicrobial barrier. The tests were performed using the test organisms in accordance with USP and some additional; bacterial strains. Biocompatibility has been assessed according to fatt 1 . 0 . the . Sondard ( Biological Evaluation of Medical . Devices) [Cytotoxicity, Sensitization]; The cytonicity was between none and sijeht. .. There, was no irritation or sensitization. In we | edicate device (AcryD. m Silver Antimierobial Wow 1 Grel 1. tha Silvenorbild Antinicrobial Wound Gel, 14 KO 1924, and Shownan.
Substantial Equivalence Discussionsik (622). \ MendaSilTM-TWG Skin and Wor ... MendaSil™-TWG Skin and Wound Gel is a combination product within the meaning of section 503(g) of the Federal Food, Drug, and Cosmetic Act (Act) and Title 21 of the Code of Federal Regulations (CFR) section 3.2(e)(1) and (2). In accordance with section 503(g)(1) of the Act and 21 CFR section 3.4, MendaSil™-TWG Skin and Wound Gel has two modes offaction of the product is the device omponents' action to provide moisture to demal. wounds and inflamed sking Another model of action of the product is that of the silver contained in the hydroge which acts as a bacterial penetration by inhibiting the growth ; of .a . encad spectrum of mist come . into ; contact .with the hydrogel. This latter barrier action of silver is limited to within the hydrogel. The primary mode of action of the combination product is attributable to the device components' action to provide moisture to dermal wounds and inflamed skin.
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