(302 days)
The Kendall™ Negative Pressure Wound Therapy (NPWT) Incision Management Device, when used with a Kendall™ NPWT Incision Management Dressing Kit, is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate via the application of negative pressure wound therapy. The system is intended for use in acute, extended and home care settings.
The Kendall™ Negative Pressure Wound Therapy (NPWT) Incision Management (IM) Device is a portable, single use, battery operated (lithium AA) suction pump with a canister. The device, when connected to a Kendall™ NPWT Incision Management Dressing Kit, applies negative pressure to an incision site that is closed with sutures or staples. The device can be set at negative pressures of -50mmHg to -125mmHg in 5mmHg increments. The device will stop working after 7 days and cannot be restarted. Visual and audible alerts from the device alerts the user to possible leaks, blockages, a full canister, low batteries, and therapy time out.
The provided text describes a 510(k) premarket notification for the Kendall™ NPWT Incision Management Device. It outlines comparisons to a predicate device and details various non-clinical performance data.
However, the document does not contain information related to a study that proves the device meets acceptance criteria for an AI/ML medical device, nor does it provide details about acceptance criteria for such a device in the context of device performance as one might expect for an AI/ML product.
The device described is a physical medical device (a powered suction pump for negative pressure wound therapy), not an AI/ML-driven diagnostic or prognostic tool. Therefore, the requested information (acceptance criteria table for AI/ML performance, sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details, etc.) is not applicable to this submission.
The "Performance Data" section (starting on page 6) lists the types of non-clinical testing performed, which are typical for physical medical devices:
- Sterilization and Shelf Life: Not applicable to AI/ML performance.
- Biocompatibility Testing: Relates to material safety, not AI/ML performance.
- Software: Mentions adherence to FDA guidance for software in medical devices and a "Moderate" Level of Concern. This refers to the embedded control software of the pump, not an AI/ML algorithm for analysis.
- Electromagnetic Compatibility and Electrical Safety: Relates to electrical safety and interference, not AI/ML performance.
- Non-Clinical Testing (Bench Testing): Verifies physical functionalities like pressure maintenance, occlusion detection, leak alerts, full canister alerts, multi-orientation function, and battery alerts. These are engineering specifications for the pump's operation, not AI/ML performance metrics.
- Usability Testing: Evaluates the user interface and safety in a simulated use scenario, not AI/ML performance.
In summary, there is no information in the provided document about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML-based medical device. The device is a traditional mechanical/electronic medical device, and its substantial equivalence is based on comparisons of its physical and functional characteristics to a predicate device, supported by standard engineering and biocompatibility testing.
§ 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.