(80 days)
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:
| Acceptance Criteria Category | Reported Device Performance (N/A for this device) |
|---|---|
| 1. Acceptance Criteria & Performance | |
| - Primary Metric (e.g., Sensitivity, Specificity) | N/A |
| - Secondary Metrics (e.g., AUC, Precision) | N/A |
| - Safety Endpoints | N/A |
| 2. Test Set Details | |
| - Sample Size | N/A |
| - Data Provenance (Country, Retrospective/Prospective) | N/A |
| 3. Ground Truth Experts | |
| - Number of Experts | N/A |
| - Qualifications | N/A |
| 4. Adjudication Method | N/A |
| 5. MRMC Study Conducted? | No |
| - Effect Size (AI vs. No AI) | N/A |
| 6. Standalone Performance Done? | N/A |
| 7. Type of Ground Truth Used | N/A |
| 8. Training Set Sample Size | N/A |
| 9. Training Set Ground Truth Establishment | N/A |
N/A