(273 days)
Kevo NPWT- αHemo30 Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Kevo NPWT- αHemo30 Foam 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.
Kevo NPWT - αHemo30 Foam 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 Flaps and Grafts .
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
The Kevo NPWT- α.Hemo30 Foam Dressing Kit is manufactured using a reticulated flexible polyether and polyurethane hydrophobic foam material. The single-use dressing is housed in a Tyvek/Mylar Peel Pouch which is sterilized using EtO.
The Kevo NPWT- αHemo30 Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large:
Small: 100mm x 80mm x 30mm Medium: 125mm x 190mm x 30mm Large: 150mm x 250mm x 30mm
This document describes the 510(k) summary for the Kevo NPWT-αHemo30 Foam Dressing Kit. This is a medical device submission, and the "acceptance criteria" and "device performance" here refer to demonstrating substantial equivalence to a predicate device, not typical AI model performance metrics. The information is extracted and presented as requested, adapted to the nature of this submission.
Analysis of the Kevo NPWT-αHemo30 Foam Dressing Kit (K113199) Submission
The provided document describes a 510(k) submission for the Kevo NPWT-αHemo30 Foam Dressing Kit, which is a medical device and not an AI/software device. Therefore, the questions related to AI model performance, AI-assisted human reading, training sets, and expert adjudication are not directly applicable in the context of this submission.
The "acceptance criteria" and "device performance" in this context refer to demonstrating substantial equivalence to a predicate device, the Genadyne A4-XLR8 Foam Dressing Kit (K092992), through a series of bench tests and comparisons of physical and material properties.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrating Substantial Equivalence to Predicate) | Reported Device Performance (Kevo NPWT-αHemo30 Foam Dressing Kit) |
|---|---|
| Dimensions unchanged after 72 hours of suction pressure | Dressings appeared unchanged after undergoing long periods of suction pressures. |
| Variation in suction pressures to be Bacterial Endotoxins, ISO 10993 -1 Rabbit Pyrogen, ISO11137-1:2006 (Radiation Sterilization), ISO 11737-1 2006 (Microorganism Population), ANSI/AAMI/ISO 11737-2:1998 (Sterility Test), USP 32 NF Sterility Tests, ISO 17025:2005 (Testing/Calibration Labs), ASTM F1980-07 (Accelerated Aging). | |
| Foam composition | Reticulated flexible polyether-based polyurethane foam (Identical to predicate). |
| Foam code | Identical (A30M) to predicate. |
| Foam manufacturer | Crest Foam Industries (Identical to predicate). |
| Foam converter/kitter | Keystone Solutions Group (Identical to predicate). |
| Processing and Sterilization methods | Identical to predicate. |
| Hydrophobic property | Yes (Identical to predicate). |
| Sizes available | Small, Medium, Large (Identical to predicate). |
| Use with negative pressure wound therapy (NPWT) | Yes (Identical to predicate). |
| Sterility | Yes (Identical to predicate). |
| Prescription only | Yes (Identical to predicate). |
| Use environment | Acute, Extended, and Home Care Settings by Healthcare Professionals (Identical to predicate). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify a precise numerical "sample size" for the foam dressings tested in the bench studies. It refers to "3 different conditions" for the core bench tests but doesn't quantify the number of dressings per condition.
- Data Provenance: The data comes from prospective bench tests conducted specifically for this 510(k) submission. The country of origin for the data collection is implied to be within the US, given the submission is to the FDA from a US company (Ann Arbor, MI).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable as the ground truth for this medical device (a foam dressing) is established through objective physical and chemical bench testing, not expert interpretation of outputs like in AI/imaging studies. The "ground truth" is adherence to predefined engineering specifications and performance benchmarks compared to the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. As there are no human interpretations or subjective assessments requiring adjudication in these bench tests, no adjudication method was used.
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
- Not applicable. This submission is for a foam dressing, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's substantial equivalence is based on objective physical and chemical measurements from bench testing (e.g., dimensional stability, pressure variation, fluid removal rates, biocompatibility, sterilization parameters) and direct comparison of material properties and manufacturing processes to the legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for a physical device, ground truth establishment for such a set is irrelevant.
§ 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.