(83 days)
The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.
The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds;
- Pressure Ulcers
- · Diabetic/Neuropathic Ulcers
- Venous Insufficiency Ulcers
- · Traumatic Wounds
- · Post-Operative and Dehisced Surgical Wounds
- · Skin Flap and Grafts
The Theia NPWT Foam Wound Dressing Kit without the pump includes a foam dressing composed of a reticulated flexible polyether based polyurethane hydrophobic foam material, an occlusive drape and silicon suction dome with negative pressure tubing. Theia NPWT Foam Wound Dressing Kits are available in three sizes; 1) small, 2) medium and 3) large.
The provided text is a 510(k) Summary for the Theia NPWT Foam Wound Dressing Kit. It describes the device and its claimed substantial equivalence to a predicate device, the UNI NPWT Foam Wound Dressing Kit (K133333).
Based on the document, the following can be extracted:
- A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a direct performance table for the Theia NPWT Foam Wound Dressing Kit against such criteria. Instead, it relies on substantial equivalence to a predicate device. The "Technical Characteristics: Feature Comparison Chart" (page 4) lists features of both the proposed device and the predicate device, showing identical characteristics across all listed categories. This implies that the 'acceptance criteria' are met by demonstrating that the device is identical in all relevant technical characteristics to the legally marketed predicate device.
| Feature / Acceptance Criteria (implied by predicate) | Theia NPWT Foam Wound Dressing Kit Performance (Reported) |
|---|---|
| Product Code: OMP | OMP |
| Technology/Function | Identical to predicate |
| Foam Dressing Material | Flexible Polyether Polyurethane Foam |
| Hydrophobic | Yes |
| Dome Assembly Components | Dome, Skirt, and Tubing |
| Dome Material | Thermoplastic Elastomer |
| Skirt Material | Polyurethane Medical Tape with Adhesive Backing |
| Tubing Material | PVC |
| Occlusive Drape Material | Semipermeable, polyurethane (polymeric) transparent film |
| Foam Dressing Dimensions (Small) | 10 x 8 x 3 cm |
| Foam Dressing Dimensions (Medium) | 20 x 13 x 3 cm |
| Foam Dressing Dimensions (Large) | 25 x 16 x 3 cm |
| Used in conjunction with NPWT pumps | For use with Simex NPWT Pumps (K113291) |
| NPWT pump provided with Dressing Kit | No |
| Provided Sterile | Yes |
| Single Use Only | Yes |
| Biocompatible | Yes |
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study was conducted" (page 5). Therefore, there is no test set, no sample size, and no data provenance from clinical data for this specific device. The device's safety and effectiveness are established through non-clinical testing and comparison to a predicate device. The non-clinical testing for the Theia NPWT Foam Wound Dressing Kit is stated to be "identical to the testing conducted in K133333 for the predicate device." However, the results or details of that non-clinical testing (including sample sizes, if applicable) are not provided in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study with a test set was conducted.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set was conducted.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (wound dressing kit) and not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (wound dressing kit) and not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Given that no clinical study was conducted, there is no ground truth established from clinical data for this device. The basis for acceptance is substantial equivalence to a legally marketed predicate device, meaning the 'ground truth' for its performance and safety is implicitly derived from the predicate's regulatory clearance and presumed safe and effective use. The non-clinical testing for the predicate is stated to be the basis for this device.
- The sample size for the training set
Not applicable, as no clinical study was conducted and there is no AI component requiring a training set.
- How the ground truth for the training set was established
Not applicable, as no clinical study was conducted and there is no AI component requiring a training set.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.