(122 days)
The Cardinal Health NPWT device is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy. The system may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings.
The Cardinal Health NPWT system consists of a powered suction pump device that provides continuous or intermittent negative pressure (SVED – K142916, PRO/PRO to GO/PRO at HOME – K143016, PRO HC – K150124) with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressing, canister tubing with clamps and connectors, polyurethane drape with adhesive, and fluid collection canisters. The pump devices are AC-powered, portable suction devices with battery backup that provide localized negative pressure to remove fluids and infectious materials from the wound. The devices must be used with the Cardinal Health NPWT dressing kits, which are available in various foam sizes. Each Cardinal Health NPWT dressing kit contains an occlusion detection tubing set. various sizes of polyurethane foam, and a polyurethane drape with adhesive.
The purpose of this submission is to modify 1) the tubing in the dressing kits and 2) the disposable fluid collection canister to allow detection of blockage or an occlusion that may occur in the dressing or within the tubing, which in turn triggers an alarm on the pump. The modification consists of a dual lumen tubing set with a twist and lock port that attaches to a disposable fluid collection canister. The canister is modified with three ports in the cap of the canister. One port accepts the twist and lock end of the tubing set for collection of exudate from the wound, and two ports connects to sensors within the pump device. The modifications to the tubing set and the fluid collection canister cap do not require any software or hardware changes to the NPWT pump devices. There are no changes to the Indications for Use for any of the NPWT devices.
This document is a 510(k) premarket notification for a medical device modification, not a study report detailing performance of an AI/ML algorithm. Therefore, many of the requested criteria regarding AI model performance, training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable.
However, I can extract the relevant information from the provided text regarding the device modification and its acceptance criteria as presented in a regulatory context.
The device in question is a Cardinal Health NPWT Occlusion Detection Dressing Kit and Canister, a modification of an existing Negative Pressure Wound Therapy (NPWT) system. The modification aims to allow the detection of blockages or occlusions in the dressing or tubing, triggering an alarm on the NPWT pump.
Here's a breakdown of the information based on your request, focusing on what can be gleaned from a 510(k) submission for a physical device modification:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like a typical AI/ML study would. Instead, it lists the types of bench testing conducted to verify the intended performance of the physical modifications. The "acceptance criteria" are implied to be "proper functioning as intended" for each test.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Proper functioning of device features and alarms | Verified to function as intended (Conclusion Statement) |
| Pressure stability | Verified to function as intended (Conclusion Statement) |
| Exudate removal | Verified to function as intended (Conclusion Statement) |
| Usability | Verified to function as intended (Conclusion Statement) |
| Detection of blockage or occlusion leading to alarm | Verified to function as intended (Conclusion Statement) |
| No change in safety or effectiveness of the system | Verified, leading to substantial equivalence determination (Conclusion Statement) |
2. Sample sized used for the test set and the data provenance
- Sample Size: The document refers to "Bench Testing" but does not specify the sample sizes (e.g., number of dressing kits, canisters, or test runs) for each type of test.
- Data Provenance: The document does not provide details on data provenance like country of origin or whether the data was retrospective or prospective. Given it's bench testing for a physical device, this level of detail is typically not reported in a 510(k) summary for such modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device modification, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for these tests would be the controlled experimental conditions and the direct measurement of the device's functional response.
4. Adjudication method for the test set
Not applicable. As this is not a study requiring human interpretation or labeling, there would be no adjudication method.
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 is not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The device itself (the tubing and canister modification) performs the "detection" of the occlusion, which then triggers an existing alarm system on the pump. It's a mechanical/sensor-based function, not an algorithm.
7. The type of ground truth used
For this physical device modification, the "ground truth" for the bench testing would be the controlled experimental conditions designed to simulate blockages, measure pressure, and evaluate exudate removal. The success or failure is determined by whether the device functions within pre-defined engineering specifications for detecting blockages and triggering alarms, maintaining pressure, and removing exudate. This is not established by expert consensus, pathology, or outcomes data in the way an AI/ML model for diagnosis would be.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned or implied for an AI/ML model, this question is not relevant.
Summary of what the document does tell us about proving the device meets criteria:
- The study done was bench testing.
- The purpose of the testing was to verify that the modifications (dual lumen tubing, modified canister with three ports) perform as intended by allowing the detection of blockages/occlusions and triggering an alarm on the pump.
- The specific tests included:
- Proper functioning of device features and alarms (specifically the new occlusion detection alarm).
- Pressure stability testing.
- Exudate removal testing.
- Usability testing.
- The conclusion was that the performance data demonstrated the modifications function as intended with no change in safety or effectiveness compared to the predicate device, leading to a determination of substantial equivalence.
- No clinical or animal performance studies were required for this specific substantial equivalence determination for the modification.
§ 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.