(181 days)
The PREVENT™ Kit is intended to be used as an alternative to foam and other negative pressure wound therapy dressings when used in conjunction with the CCT1 and CCT Mini Negative Pressure Wound Drainage Pumps (K082311) for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT1 or CCT Mini Negative Pressure Wound Drainage Pumps, the PREVENT™ Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudate, infectious material and tissue debris.
The PREVENT™ 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 Flaps and Grafts
The system is for prescription use only.
The PREVENT™ Kits are composed of sterile, single-use, disposable components that are designed to be used with a pump to deliver NPWT to a wound surface as part of a negative pressure wound therapy (NPWT) system.
The dressing kit includes 1) a thermoplastic elastomer (TPE) dressing (Prevent™ barrier) used to contact the wound bed and allow the application of NPWT to the wound and to provide flow pathways for the removal of exudate, 2) occlusive drape(s) to create a seal around the wound, and 3) a dome assembly with drainage tubing that is connected to the suction tubing of the disposable canister of the negative pressure pump to create a closed system.
The negative pressure pump creates a vacuum that provides the suction needed to remove wound exudate from the wound surface to the collection canister.
The wound contact layer is provided in a single size and thickness, so the kits are provided in a single size.
This FDA 510(k) summary describes the PREVENT™ Kit, a negative pressure wound therapy (NPWT) dressing. The primary focus of the provided text is on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a diagnostic study for an AI/ML powered device. As such, information regarding AI/ML specific aspects like acceptance criteria for algorithmic performance, independent test sets, expert ground truth establishment, MRMC studies, or training set details for AI are not present in this document.
The document discusses various performance and safety tests for the PREVENT™ Kit, which is a physical medical device, not an AI/ML algorithm.
Here's an attempt to answer the questions based on the provided text, highlighting what is not applicable or not provided for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
The document states acceptance criteria were "pre-determined" and that the device "met the pre-determined acceptance criteria" for various tests. However, it does not provide specific numerical acceptance criteria for most tests, nor does it provide the exact numerical performance results beyond general statements of success.
| Acceptance Criteria Category (General Statement) | Reported Device Performance (General Statement) |
|---|---|
| Bench Testing (e.g., 7-day Glass Top Simulated Use, Tensile Testing, Seal Strength, Bubble Emission, System Alarm Functionality) | "All tests of the device met the pre-determined acceptance criteria." |
| Shelf-Life (Accelerated Aging, Real-time Long-term) | "The data from all three sets of accelerated aging tests confirm that the PREVENT™ Kit device meets the requirements as tested and reported within the document series. Real-time, long-term shelf life testing on the PREVENT™ Kit was completed for one year and confirmed the acceptable results of one year accelerated aging. Real-time testing will continue to a minimum of two years to confirm acceptable results to support the targeted two-year shelf-life." |
| Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Systemic Toxicity, Implantation, EO residuals, Bacterial Endotoxin) | "All tests of the device met the pre-determined acceptance criteria." |
| GLP Animal Testing (Animal health, wound healing, local histological effects compared to control) | "All endpoints were evaluated per protocol for this study and met the pre-determined acceptance criteria. Based on evaluation of overall animal healing performance and local tissue response to the study articles, there were no concerns identified regarding the safety and effectiveness of CCT PREVENT™ Kit." |
| Usability Testing (Successful completion of subtasks, absence of harmful use errors) | "Only 10 use errors were observed and none of these would cause harm of a serious nature." (Out of 272 individual subtasks, 249 were successful without UEs, difficulties, or close calls.) |
2. Sample size(s) used for the test set and the data provenance
- Bench Testing: Sample sizes are not explicitly stated for individual bench tests.
- Shelf-Life: Not specified.
- Biocompatibility Testing: Not specified.
- GLP Animal Testing: Sample size is not explicitly stated. The study involved swine.
- Usability Testing: 15 participants. Data provenance is implied to be from a controlled, prospective validation study conducted to ISO/IEC 62366-1:2015 standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes a physical medical device approval, not an AI/ML diagnostic algorithm. The "ground truth" equivalent here would be the physical and biological test results, which are objectively measured/observed, not established by expert consensus. For usability testing, the "truth" is the observed performance of the participants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no diagnostic image interpretation or similar expert-driven assessment described.
5. 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
This is not applicable. This document details the clearance of a negative pressure wound therapy kit, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as it is not an algorithm. The device's performance is inherently "standalone" in mechanical/biological terms (e.g., flow rate, seal integrity, biocompatibility, wound healing in animals).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Mechanical measurements, physical properties, alarm function validation.
- Shelf-Life: Stability data (e.g., material degradation, sterility maintenance).
- Biocompatibility Testing: Lab results from standardized tests (e.g., cytotoxicity assays, irritation tests, analytical chemistry for residuals, LAL test for endotoxins).
- GLP Animal Testing: Direct observation of animal health, gross and histological evaluation of wound healing and tissue response (e.g., pathology findings). This is a form of outcomes data in a controlled animal model.
- Usability Testing: Observed user performance against pre-defined task success criteria and identification of use errors.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device.
§ 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.