(80 days)
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No
The device description and intended use are for a nonwoven synthetic sponge dressing, and there is no mention of AI or ML technology in the provided text.
No.
The device is a nonwoven synthetic sponge used as a dressing, similar to traditional cotton gauze, and does not provide therapeutic treatment.
No
The provided text states that the device is intended as a dressing and for other general medical and dental purposes, similar to cotton gauze. It focuses on physical properties like absorbency and softness, not on diagnosing medical conditions.
No
The device description clearly states it is a nonwoven synthetic sponge, which is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "dressing and for other general medical and dental purposes for which cotton gauze has traditionally been used." This describes a topical application for wound care and general medical procedures, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description focuses on the physical characteristics of the product (nonwoven synthetic sponge, made of rayon and polyester fibers, sterilized) and its equivalence to traditional gauze and predicate devices used for wound dressing. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not contain any of the typical indicators of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims
- Use in a laboratory setting
Therefore, the CODI products described are medical devices intended for external use as dressings and for general medical purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
It is intended that the CODI products will be used as a dressing 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 CODI International BV are non-sterile and sterile versions of a nonwoven synthetic sponge that is substantially equivalent to the product currently marketed by Johnson & Johnson Medical, Inc. and known as Nu Gauze and the product currently marketed by Kendall Co. and known as Versalon. The CODI products do not have a different intended use or different technological characteristics than Johnson's Nu Gauze or Kendall's Versalon. The CODI products 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): 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).
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N/A
0
510K SUMMARY
CODI International BV Turbinestraat 13-19 3903 LV VEENENDAAL The Netherlands
JUN - 6 1996
Telephone: 00 31 318 564811 Facsimile: 00 31 318 521187
Contact person: Mr. C. van Zwetselaar, Manager of Quality Assurance
March 0 | , 1996
Trade name of Device: | None (to be produced for multiple private labels) |
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Common Name: | General Use 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 sponge that is substantially equivalent to the product currently marketed by Johnson & Johnson Medical, Inc. and known as Nu Gauze and the product currently marketed by Kendall Co. and known as Versalon. The CODI products do not have a different intended use or different technological characteristics than Johnson's Nu Gauze or Kendall's Versalon. The CODI products 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 CODI products will be used as a dressing and for other general medical and dental purposes for which cotton gauze has traditionally been used.