(80 days)
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No
The device description and performance studies focus on the physical properties and performance of a hydrocolloid dressing, with no mention of AI or ML. The "visible change indicator" is a printed guide, not an AI-driven feature.
Yes
The device is described as a hydrocolloid dressing intended for the treatment and management of various chronic and acute wounds, which falls under the definition of a therapeutic device designed to aid in the healing process.
No
The device description indicates that SignaDRESS is a hydrocolloid dressing used for wound care, providing a barrier against bacteria and external contamination. Its purpose is therapeutic and protective, not diagnostic.
No
The device description clearly states that SignaDRESS is a hydrocolloid dressing, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SignaDRESS is a wound dressing for various types of chronic and acute wounds. This is a topical application for wound management, not a diagnostic test performed on samples from the body.
- Device Description: The description details the physical components of a wound dressing (hydrocolloids, adhesive, backing film) and its function as a barrier and absorbent material. It does not describe any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting specific analytes, biomarkers, or pathogens. The device's function is entirely external and related to wound care.
Therefore, SignaDRESS falls under the category of a wound dressing, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SignaDRESS is intended for chronic wounds-pressure ulcers (Stage I-IV) and leg ulcers. SignaDRESS is also indicated for use on acute wounds-surgical wounds (post-operative wounds and donor sites), traumatic wounds (minor abrasions and lacerations), burns (first and second degree), and dermatological excisions.
Product codes
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Device Description
The purpose of this 510(k) Premarket Notification is to request clearance to market SignaDRESS Hydrocolloid Dressing.
SignaDRESS is a hydrocolloid dressing consisting of an inner (wound contact) layer of hydrocolloids contained within an adhesive polymer matrix and an outer layer of polyurethane backing film. The dressing also has a product identification mark (ConvaTec registered tear drop trademark) and a visible (SignaDRESS) change indicator guide printed on the film backing.
The dressing adheres to dry and moist tissue and provides a barrier against bacteria and other external contamination as long as the dressing is intact. SignaDRESS is featured with a delivery system that allows clinicians to apply the dressing without touching the adhesive mass. This feature is especially beneficial when gloves are worn to apply the dressing; it minimizes the chance of the gloves sticking to the adhesive mass. A visible change indicator printed on the polyurethane backing film helps simplify wound dressing management for the care giver.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative bench testing was conducted to determine the performance of SignaDRESS and Comfeel Plus Ulcer Dressing. The dressings performed essentially the same with regards to coefficient of friction, absorbency, peel adhesion, and bacterial barrier testing. A summary of the tests and corresponding reports are included in section 5a of this application.
SignaDRESS Hydrocolloid Dressing has been subjected to biocompatibility testing utilizing the ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995). The results of this testing demonstrate that SigmaDRESS is considered to be non-toxic, non-cytotoxic, and a negligible irritant. Test reports appear in Item 5 of this application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
Item 8: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510(k) Premarket Notification is to request clearance to market SignaDRESS Hydrocolloid Dressing.
SignaDRESS is a hydrocolloid dressing consisting of an inner (wound contact) layer of hydrocolloids contained within an adhesive polymer matrix and an outer layer of polyurethane backing film. The dressing also has a product identification mark (ConvaTec registered tear drop trademark) and a visible (SignaDRESS) change indicator guide printed on the film backing.
The dressing adheres to dry and moist tissue and provides a barrier against bacteria and other external contamination as long as the dressing is intact. SignaDRESS is featured with a delivery system that allows clinicians to apply the dressing without touching the adhesive mass. This feature is especially beneficial when gloves are worn to apply the dressing; it minimizes the chance of the gloves sticking to the adhesive mass. A visible change indicator printed on the polyurethane backing film helps simplify wound dressing management for the care giver.
SignaDRESS is intended for chronic wounds-pressure ulcers (Stage I-IV) and leg ulcers. SignaDRESS is also indicated for use on acute wounds-surgical wounds (post-operative wounds and donor sites), traumatic wounds (minor abrasions and lacerations), burns (first and second degree), and dermatological excisions.
SignaDRESS Hydrocolloid Dressing is contraindicated for use on individuals with known sensitivity to the dressing or its components.
SignaDRESS is substantially equivalent to Coloplast's Comfeel Plus Ulcer Dressing. Both dressings have essentially the same intended uses, contraindications, precautions, and observations. SignaDRESS is similar in construction and design to Comfeel Plus Ulcer Dressing whereby both dressings consist of a polyurethane backing film printed with a change indicator or measurement grid. Also both dressings are comprised of a hydrocolloid adhesive wound contact layer. Both devices are regulated by the same classification panel. Further classification is located in Item Id of this application.
Comparative bench testing was conducted to determine the performance of SignaDRESS and Comfeel Plus Ulcer Dressing. The dressings performed essentially the same with regards to coefficient of friction, absorbency, peel adhesion, and bacterial barrier testing. A summary of the tests and corresponding reports are included in section 5a of this application.
SignaDRESS Hydrocolloid Dressing has been subjected to biocompatibility testing utilizing the ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995). The results of this testing demonstrate that SigmaDRESS is considered to be non-toxic, non-cytotoxic, and a negligible irritant. Test reports appear in Item 5 of this application.
000129
ConvaTec, A Division of E.R. Squibb & Sons, Inc. SignaDRESS™ - A trademark of E.R. Squibb & Sons, Inc Comfeel® - A registered trademark of Coloplast