(76 days)
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No
The description focuses on the material and physical characteristics of a drain/slit sponge, with no mention of AI or ML technology.
No
The device is described as a nonwoven synthetic drain/slit sponge intended as a dressing around tubes and needles, and for general medical and dental purposes where cotton gauze has traditionally been used. Its function is to absorb and protect, not to treat a disease or condition.
No
The device is a dressing (drain/slit sponge) for tubes and needles, and other general medical and dental purposes, not for diagnosing conditions.
No
The device described is a physical medical device (drain/slit sponges) made of rayon and polyester fibers, not a software-only device.
Based on the provided information, 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 and absorbent material used externally on the body, not a device used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description focuses on the material composition (rayon and polyester), manufacturing process (non-sterile and sterile versions, slit cut), and physical properties (softer, more absorbent, minimal linting, wound adhesion). These are characteristics of a medical dressing, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the device described is a medical dressing, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 CODI 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.
Product codes
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Device Description
The products to be manufactured by CODI International BV 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 CODI International BV for multiple private labels. For other substantially equivalent devices, see general use sponges marketed by 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 CODI 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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
510K SUMMARY
CODI International BV Turbinestraat 13-19 3903 LV VEENENDAAL The Netherlands
Telephone: 00 31 318 564811 Facsimile: 00 31 318 521187
Contact person: Mr. C. van Zwetselaar, Manager of Quality Assurance
August 05 , 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 CODI International BV 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 CODI International BV for multiple private labels. For other substantially equivalent devices, see general use sponges marketed by 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 CODI 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.