(85 days)
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No
The summary describes a standard wound dressing made of a hydrophilic polyurethane polymer and does not mention any AI or ML capabilities.
No
The device, a wound dressing, is used for the management of wounds. While it aids in the healing process, it does not directly treat a disease or condition in a therapeutic manner such as a drug or medical procedure would.
No
The device, TIELLE Dressing, is indicated for the management of wounds, which describes a therapeutic rather than a diagnostic function. There is no mention of it being used to identify or determine a medical condition.
No
The device description clearly states it is a "Hydropolymer Foam Dressing made from a hydrophilic polyurethane polymer," indicating it is a physical dressing, 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 the TIELLE Dressing is for the management of wounds. This is a topical application for treating the body directly.
- Device Description: The description details a hydropolymer foam dressing made from a polyurethane polymer. This is a physical material applied to the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples from the body. This device is applied to the body to treat a wound.
N/A
Intended Use / Indications for Use
TIELLE Dressing is indicated for the management of both chronic and superficial, moderate to heavily exudating wounds, including the following: Pressure sores (all stages) Venous ulcers Skin tears Second degree burns Donor and graft sites Acute wounds healing by secondary or primary intention Surgically debrided wounds
Product codes
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Device Description
TIELLE * Hydropolymer Foam Dressing is made from a hydrophilic polyurethane polymer.
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
510(k) SUMMARY
DEC 31 1996
TIELLE* Hydropolymer Foam Dressing
DATE PREPARED 1.
December 24, 1996
2. SUBMITTER
Johnson & Johnson Medical, Inc. 2500 Arbrook Boulevard, P.O. Box 90130 Arlington, Texas 76004-3130
3. CONTACT
Ralph H. Larsen., (817)784-4993 Sr. Project Manager, Regulatory Affairs
4 NAME OF THE MEDICAL DEVICE
Classification name: Dressing, wound Topical wound dressing Common/usual name: Proprietary name: TIELLE* Hydropolymer Foam Dressing
DEVICE CLASSINGATION ર્ડ
Classification for topical wound dressings has not yet been finalized by the Division of Surgical and Rehabilitation Devices. These devices are classified into Class I (General Controls).
STATEMENT OF SUBSTANTIAL EQUIVALENCE ર.
TTELLE® Hydropolymer Foam Dressing is substantially equivalent and identical in function to Allevyn Hydrophilic Polyurethane Dressing marketed by Smith & Nephew.
7. INDICATIONS FOR USE
TIELLE Dressing is indicated for the management of both chronic and superficial, moderate to heavily exudating wounds, including the following: Pressure sores (all stages) Venous ulcers Skin tears Second degree burns Donor and graft sites Acute wounds healing by secondary or primary intention Surgically debrided wounds
PHYSICAL DESCRIPTION 8.
TIELLE * Hydropolymer Foam Dressing is made from a hydrophilic polyurethane polymer.
9. BIOCOMPATIBILITY
1
. ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
Safety tests demonstrate that TIELLE* Hydropolymer Foam Dressing is non-sensitizing, and nonirritating and suitable for its intended use.