(25 days)
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No
The device description and intended use clearly describe a physical dressing (sponge) with a slit, made of traditional materials, and sterilized using standard methods. There is no mention of any computational or analytical functions, let alone AI/ML.
No.
The device is described as a dressing and sponge for general medical and dental purposes, with no indication of therapeutic action or intended purpose beyond basic wound care and absorption.
No
The device is described as a dressing (drain/slit sponge) used around tubes and needles, and for general medical and dental purposes, similar to cotton gauze. Its function is to absorb and protect, not to diagnose.
No
The device is a physical medical device (sponges) and the description does not mention any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "dressing around tubes and needles and for other general medical and dental purposes for which cotton gauze has traditionally been used." This describes a physical barrier or absorbent material used externally on the body, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on the physical characteristics of the sponge (material, slit, sterilization, absorbency, linting, adhesion) and its function as a dressing. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Detecting specific analytes (e.g., glucose, antibodies, DNA).
- Providing information for diagnosis, prognosis, or treatment monitoring.
The device is clearly described as a medical dressing, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
It is intended that the drain/slit sponges will be used as a dressing around tubes and needles and for other general medical and dental purposes for which cotton gauze has traditionally been used.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The products to be manufactured by Igenics, Inc. are non-sterile and sterile versions of a nonwoven synthetic drain/slit sponge that is substantially equivalent to the general use sponges currently produced by Igenics, Inc. for multiple private labels. The drain/slit sponges do not have a different intended use or different technological characteristics than the general use sponges, except that the drain/slit sponges have a slit cut in them to accommodate a tube or needle. The drain/slit sponges are made of rayon and polyester fibers and will be sterilized by radiation or ethylene oxide methods. The finished products have a pattern similar to traditional cotton gauze, but they are softer and more absorbent. The Igenics products also have minimal linting and wound adhesion compared to traditional cotton gauze.
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)
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
SEP - 6 1996
IGENICS. INC. 3 First Avenue Peabody, MA 01960
510K SUMMARY K963134
Telephone: (508) 538-0800 Facsimile: (508) 538-0803
Contact Person: Eduard T. van Breen, President
August 2, 1996
| Trade name of Device: | None (to be produced for multiple private labels) |
|---|---|
| Common Name: | Drain/Slit Sponge (Non-Sterile and Sterile) |
| Classification Name: | Synthetic Sponge (Non-Sterile and Sterile) (21 CFR 878.4060) |
The products to be manufactured by Igenics, Inc. are non-sterile and sterile versions of a nonwoven synthetic drain/slit sponge that is substantially equivalent to the general use sponges currently produced by Igenics, Inc. for multiple private labels. For other substantially equivalent devices, see general use sponges marketed by Johnson & Johnson Medical, Inc. known as Nu Gauze and general use sponges marketed by Kendall Co. known as Versalon. The drain/slit sponges do not have a different intended use or different technological characteristics than the general use sponges, except that the drain/slit sponges have a slit cut in them to accommodate a tube or needle. The drain/slit sponges are made of rayon and polyester fibers and will be sterilized by radiation or ethylene oxide methods. The finished products have a pattern similar to traditional cotton gauze, but they are softer and more absorbent. The Igenics products also have minimal linting and wound adhesion compared to traditional cotton gauze. It is intended that the drain/slit sponges will be used as a dressing around tubes and needles and for other general medical and dental purposes for which cotton gauze has traditionally been used.