(182 days)
The Cardinal Health NPWT PRO/PRO to GO/PRO at Home systems are an integrated wound management system. indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The systems are intended for patients with chronic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), The systems are intended for use in acute, extended and home care settings.
The Cardinal Health NPWT PRO family of systems are AC-powered, portable suction devices with battery backup that provide localized negative pressure wound therapy when used with the Cardinal NPWT Dressings to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressings, canister tubing with clamps and connectors, and polyurethane drapes with adhesive. The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
The provided document is a 510(k) summary for the Cardinal Health NPWT PRO/PRO to GO/PRO at Home Systems. It outlines the device description, indications for use, comparison with a predicate device, and performance data submitted to support substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" for the device's main therapeutic function (wound healing or fluid removal) in a quantitative manner. Instead, the performance data focuses on demonstrating safety, basic functionality, and usability comparable to a predicate device.
| Acceptance Criterion (Implicit/Derived) | Reported Device Performance |
|---|---|
| Electrical Safety (Compliance with relevant standards) | The system complies with the IEC 60601-1 and IEC 60601-1-11 standards for safety. |
| Electromagnetic Compatibility (EMC) (Compliance with relevant standards) | The system complies with the IEC 60601-1-2 standard for EMC. |
| Software Functionality and Safety (Verification & Validation) | Software verification and validation testing were conducted. The software was considered a "Moderate" level of concern. Documentation was provided as recommended by FDA guidance. |
| Clinical Usability (Safe and effective use by intended users) | A single-center, unblinded, observational, simulated use usability evaluation was conducted. Results were used to update the risk analysis plan and user manual, suggesting that identified usability issues were addressed to ensure safe and effective use. The study concluded that the device should perform as well as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Usability Testing:
- Sample Size: 34 adult Healthcare Professionals (HCPs) and lay-user Subjects as patient/caregiver surrogates.
- Data Provenance: The study was a "single-center" evaluation, implying a single location (country not specified, but likely US given FDA submission). It was a "simulated use" study, making it prospective observational data for usability, not clinical efficacy in actual patient settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Electrical Safety, EMC, Software V&V: These tests are typically performed by engineers and technicians following established protocols. The document does not specify the number or qualifications of experts involved in these specific tests.
- Clinical Usability Testing: The "Healthcare Professionals (HCPs)" served as subjects testing the device's usability. Their qualifications are not explicitly detailed beyond being "Healthcare Professionals." The "ground truth" for this test would be the objective observation of their interactions with the device and their subjective feedback on its usability and any errors/challenges encountered. No external experts were explicitly mentioned for establishing a ground truth of the usability itself, as the users were the evaluators.
4. Adjudication Method for the Test Set:
- Clinical Usability Testing: The document states that a "final interview to capture root cause for any use errors or close calls, and any remaining Subject feedback or questions was conducted." This suggests a form of 1:1 interview and data collection from each participant, rather than a multi-expert adjudication panel for the test results. There's no mention of a formal 2+1 or 3+1 adjudication method. For the other performance tests (Electrical Safety, EMC, Software V&V), these are typically pass/fail criteria based on objective measurements against standards, so adjudication is not usually applicable in the same way.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically used for diagnostic devices (e.g., imaging AI) and involves comparing human reader performance with and without AI assistance across multiple cases. The Cardinal Health NPWT system is a therapeutic device, not a diagnostic one, so an MRMC study is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a physical, powered suction pump system, not an AI algorithm. Its function inherently involves a human user (HCP or patient/caregiver). Performance is not assessed as an "algorithm only" in the way an AI diagnostic tool would be. The "software verification and validation testing" evaluates the internal logic and safety of the device's software, which is a component of the overall system, but not in a "standalone algorithm" context for clinical efficacy.
7. Type of Ground Truth Used:
- Electrical Safety & EMC: Compliance with international safety standards (IEC 60601 series). The "ground truth" is adherence to these objective, measurable standards.
- Software Verification & Validation: Adherence to defined software requirements and FDA guidance. The "ground truth" is the confirmation that the software performs as specified and safely.
- Clinical Usability Testing: Observations of user interaction, identification of use errors or close calls, and subjective feedback from the users (HCPs and lay-user surrogates). The "ground truth" here is the objective and subjective data collected on the device's practical usability.
8. Sample Size for the Training Set:
- Not applicable / Not explicitly stated. This device is a hardware system with embedded software. It is not an AI/machine learning device that typically involves a distinct "training set" of data in the way a diagnostic algorithm (e.g., for image analysis) requires. The software developed for the device would have undergone development and testing, but not typically referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As implied above, this is not an AI/ML device requiring a data training set with established ground truth labels in the typical sense. The software development process would involve establishing "ground truth" for its own functionality through design specifications, coding standards, and rigorous testing against those specifications.
§ 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.