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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 CODI products will be used as a dressing 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 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.

This 510(k) summary describes a General Use Sponge, not a device that utilizes AI or complex algorithms requiring extensive performance studies with ground truth establishment. Therefore, the requested information categories regarding acceptance criteria, expert adjudication, MRMC studies, standalone performance, and ground truth methodologies are not applicable to this type of medical device submission.

Here's why and what information can be extracted or inferred:

• Device Type: The device is a "General Use Sponge (Non-Sterile and Sterile)" made of rayon and polyester fibers. It's a physical, low-risk, predicate-based device.
• Predicate Devices: The submission explicitly states the product 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."

For a device like this, the "acceptance criteria" and "study" proving it meets them are typically focused on material equivalence, functional equivalence, and safety characteristics compared to the predicate devices. These criteria are established through:

• Material Composition: Verifying the rayon and polyester fibers meet industry standards and are the same as or comparable to predicate devices.
• Physical Properties: Testing characteristics like absorbency, softness, linting, and wound adhesion to ensure they are equivalent or superior to predicate devices.
• Biocompatibility: Ensuring the materials are non-toxic and do not cause irritation or sensitization.
• Sterilization Validation: If sterile, demonstrating that the chosen sterilization methods (radiation or ethylene oxide) effectively sterilize the product and maintain its integrity.
• Manufacturing Quality Control: Ensuring consistent production according to good manufacturing practices (GMP).

Since the 510(k) summary only provides basic device information and predicate comparisons, it does not contain the level of detail requested for AI-powered devices.

To illustrate, if this were a complex AI device, the table would look like this, but for this sponge, these fields are irrelevant:

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