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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.

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. 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.

This 510(k) summary for K963188 describes a medical device, specifically a drain/slit sponge. However, the provided text does not contain any information related to acceptance criteria, specific device performance metrics, or a study that proves the device meets such criteria.

The summary focuses entirely on:

• Identification of the manufacturer and contact person.
• Device trade name, common name, and classification.
• A substantial equivalence claim to already marketed general use sponges, highlighting that the drain/slit sponges do not have a different intended use or different technological characteristics other than the slit cut.
• Material composition (rayon and polyester fibers).
• Sterilization methods (radiation or ethylene oxide).
• Physical characteristics (pattern similar to traditional cotton gauze, softer, more absorbent, minimal linting and wound adhesion).
• Intended use (dressing around tubes and needles, general medical and dental purposes where cotton gauze is traditionally used).

Therefore, I cannot provide the requested information about acceptance criteria or a study proving performance, as it is not present in the given text. This type of information (performance data, clinical study results, etc.) is typically found in other sections of a 510(k) submission, not usually in the summary which primarily focuses on substantial equivalence.

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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.

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.

This document is a 510(k) summary for a medical device (Drain/Slit Sponge) and does not contain any information regarding acceptance criteria or a study proving device performance in the context of diagnostic accuracy, algorithm performance, or clinical effectiveness.

The document primarily focuses on establishing "substantial equivalence" to existing general-use sponges. It describes:

• Device name and classification: Drain/Slit Sponge (Non-Sterile and Sterile), classified as a Synthetic Sponge (21 CFR 878.4060).
• Manufacturer: Igenics, Inc.
• Materials: Rayon and polyester fibers.
• Sterilization methods: Radiation or ethylene oxide.
• Key features: Slit cut to accommodate a tube or needle, softer, more absorbent, minimal linting, and wound adhesion compared to traditional cotton gauze.
• Intended Use: Dressing around tubes and needles and for other general medical and dental purposes where cotton gauze is traditionally used.
• Substantial Equivalence: Claimed to be substantially equivalent to general use sponges produced by Igenics, Inc., Johnson & Johnson Medical, Inc. (Nu Gauze), and Kendall Co. (Versalon).

Therefore, I cannot provide any of the requested information about acceptance criteria or a study proving device performance because it is not present in the provided text. This type of information is typically found in clinical trial reports, validation studies, or performance testing protocols for devices with diagnostic algorithms or specific performance metrics beyond basic material properties and intended use.

Ask a specific question about this device