Search Results

The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage 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 Kits are sterile, single use, disposable dressings for use with the CCT Mini or CCT1 Negative Pressure Wound Drainage pumps for the application of negative pressure wound therapy (NPWT) to the wound. The kits include a foam dressing made of black reticular polyether based polyurethane hydrophobic foam material, occlusive drape(s), and a dome assembly consisting of a single lumen dome, dome skirt, and drainage tubing with clamp and female luer lock connector. The foam dressing covers the wound and the transparent occlusive drape covers the foam dressing and creates a seal around the wound. The drainage tubing connects to the exudate canister of the negative pressure pump. The powered negative pressure pump delivers negative pressure to the dressing to suction wound exudate into the exudate canister of the pump. The dressing kits are available in three sizes (small, medium, large) based on foam dressing size (length x width) and in two foam dressing thicknesses (1.5 and 3.0 cm), for a total of six dressing kits.

The provided text describes a 510(k) premarket notification for a medical device called "Theia NPWT Foam Wound Dressing Kit." This notification aims to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The core of the submission is to demonstrate substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The acceptance criteria are implicitly met by comparing the subject device's features and performance to those of the predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness.

The document directly compares the subject device (K211277) to its predicate (K161570) in Table 1: Subject vs. Predicate Theia NPWT Foam Wound Dressing Kit Comparison (pages 5-6).

Here's a summary of the key comparison points relevant to "acceptance criteria" for substantial equivalence:

Note: The primary differences are the foam thickness and the specified compatible NPWT pumps. The manufacturer's rationale for substantial equivalence (page 7) states: "The subject and predicate Theia NPWT Foam Wound Dressing Kits have the same Intended Use. The technological characteristics comparison and results of the verification testing provide evidence that the subject Theia NPWT Foam Wound Dressing Kits are substantially equivalent to the predicate Theia NPWT Foam Wound Dressing Kits (K161570), and the performance of these dressing kits when used in conjunction with CCT pumps (K082311) is substantially equivalent to the performance of the predicate dressing kits used in conjunction with SIMEX pumps (K113291)." This implies that despite the differences in foam thickness and compatible pump, the performance in terms of suction and fluid removal is deemed equivalent.

Study Information

The document describes the performance data provided to support the substantial equivalence claim.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of specific "samples" or "cases" for what one might typically refer to as a clinical "test set" in an AI context. The testing described is bench testing, which likely involves multiple repetitions or configurations, but a specific "sample size" is not provided in numerical terms.
   • Data Provenance: The studies are bench performance testing. This means the data was generated in a lab setting, not from human or animal subjects. Therefore, there is no country of origin for clinical data. The studies are not retrospective or prospective in the clinical sense, as they are non-clinical bench tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" here is based on engineering specifications and physical measurements in a bench test environment (e.g., demonstrating uniform pressure delivery, effective fluid removal). There is no mention of human experts establishing a "ground truth" in the way one would for diagnostic imaging.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This concept typically applies to clinical studies where experts review cases for ground truth establishment. For bench testing, results are typically determined by measurement against predefined engineering or performance criteria.

4. 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:

   • No. This device is a passive foam wound dressing kit used in conjunction with a negative pressure pump, and is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or reported.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, in the context of bench testing. The "Bench Performance Testing" evaluates the device's physical performance (e.g., fluid removal, pressure maintenance) in a controlled, simulated environment, without direct human intervention as part of the performance measurement. The "algorithm" here is the physical design and function of the device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Engineering specifications and physical measurements. For example, the "ground truth" for "effectively removing wound fluids" would be a measurable volume of fluid removed over time, and for "pressure is delivered uniformly," it would involve pressure mapping and measurement against specified pressure ranges.

7. The sample size for the training set:

   • Not applicable. This device does not involve an AI algorithm that requires a "training set" in the computational learning sense. The design and manufacturing processes are likely informed by engineering principles and possibly prior iterations, but not a data training set for an AI model.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no AI algorithm training set, there is no ground truth establishment for it.

In summary:

The submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics and bench performance testing. No clinical studies, animal studies, or AI-related performance studies (such as MRMC or standalone AI performance) were conducted or are relevant for this type of medical device as presented in this document. The "acceptance criteria" are implicitly met by showing the subject device's equivalence to the predicate in terms of intended use, indications for use, and physical performance under simulated conditions, despite minor differences in foam thickness and compatible pumps.

Ask a specific question about this device