(225 days)
The Cardinal Health NPWT PRO HC system is 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 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 PRO HC system is an AC-powered, portable suction device with battery backup that provides localized negative pressure 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 HC system provides care in the acute, extended and home care settings.
The Cardinal Health NPWT PRO HC system functions the Cardinal Health NPWT PRO devices. The Cardinal Health NPWT PRO HC system includes a built-in placement holder for the 300cc or 500cc collection canisters. It has a pushbutton ON/OFF operation with five userselectable pressure settings. The system produces optional negative pressure settings of 50mmHg. 75mmHg. 100mmHg. 125mmHg. and 150mmHg. It has alarms for Low Pressure/Leak. Full Canister, and Low Battery and an alert when the device is due for service. These alarms include both audible and visual indications.
The purpose of this 510(k) submission is to introduce the Cardinal Health NPWT PRO HC system. The Cardinal Health NPWT PRO HC system is identical to the NPWT PRO with the exception of: 1) addition of two motorized pumps for increased air flow volume; (2) one additional battery; and (3) a slightly larger case to accommodate the additional pumps and battery. The user interface for the PRO HC is identical to the PRO.
The provided text describes a 510(k) premarket notification for the Cardinal Health NPWT PRO HC System, a negative pressure wound therapy device. The submission focuses on demonstrating substantial equivalence to a predicate device (Cardinal Health NPWT PRO Family) rather than proving the device meets new acceptance criteria for clinical efficacy. The device is a powered suction pump, and the "acceptance criteria" discussed are primarily related to its functional performance and safety, ensuring it performs comparably to the predicate device.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Functional Performance | Deliver negative pressure at individual pressure settings (50, 75, 100, 125, 150 mmHg) | Verified that the PRO HC provides negative pressure at individual pressure settings, identical to the predicate device. |
| Deliver negative pressure wound therapy in continuous and intermittent operating modes | Verified that the device delivers negative pressure wound therapy in a continuous and intermittent operating mode identical to the predicate device. | |
| Canister Full alarm functionality | Verified using wound fluid designed to simulate real exudate. | |
| System performance and Leak alarm functionality with high air leaks at the dressing site | Verified. | |
| System performance in all pressure settings with simulated exudate | Verified. | |
| System performance with all sizes of disposable foam dressing kits and accessories | Verified. | |
| Electrical Safety and EMC | Compliance with IEC 60601-1 (safety) and IEC 60601-1-11 (home care safety) | Complies with IEC 60601-1 and IEC 60601-1-11 standards. |
| Compliance with IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 standard. | |
| Software Verification/Validation | Software performs as intended, no significant flaws leading to injury | Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance. The device's software was considered "Moderate" level of concern, indicating that a failure or latent flaw could directly result in minor injury. |
| Clinical Usability | Proper use of the device in a home environment by healthcare providers and patients | 33 subjects (17 healthcare providers, 16 patients) participated. All met predetermined acceptance criteria, and no new risks were identified. (Note: This testing was conducted on the predicate device, NPWT PRO, but deemed applicable to PRO HC due to identical user interface). |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical (Bench) Tests: The document does not specify a numerical sample size for the individual bench tests (e.g., how many times each pressure setting was tested, or how many simulated leaks were induced). These are typically engineering verification tests.
- Electrical Safety & EMC Tests: No specific sample size is given. These tests are usually conducted on a representative sample of the finished device.
- Software Verification & Validation: No specific sample size is given for tests of the software itself beyond the general statement of "testing was conducted."
- Clinical Usability Testing:
- Sample Size: 17 healthcare providers and 16 patients (total 33 subjects).
- Data Provenance: The study was conducted in a "home care setting," implying it was conducted domestically (likely USA, given the FDA submission context) and would be considered prospective for the usability aspect. The data relates to the predicate device (NPWT PRO) but is stated to be applicable to the PRO HC due to identical user interfaces.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Functional, Electrical Safety, EMC, Software Tests: The "ground truth" for these tests is based on engineering specifications, recognized national/international standards (e.g., IEC 60601 series), and FDA guidance for software. These are not typically established by human experts in a "ground truth" sense, but rather by objective measurements against predefined criteria.
- Clinical Usability Testing: The "ground truth" was whether participants could properly use the device and meet "predetermined acceptance criteria." These criteria would have been established by the device manufacturer, likely with input from clinical experts or human factors engineers. The qualifications of these specific experts are not detailed in the provided text. The participants themselves (17 healthcare providers and 16 patients) were the subjects whose performance was evaluated against these criteria.
4. Adjudication Method for the Test Set
- For the functional, electrical safety, EMC, and software tests, adjudication is not explicitly described. These are objective tests where results either meet the specification/standard or they do not.
- For the Clinical Usability Testing, the document states, "All 33 subjects met the predetermined acceptance criteria." This implies a clear set of criteria were established beforehand, and subjects' performance was evaluated against these. There is no mention of an "adjudication method" like 2+1 or 3+1, which are typically used for subjective diagnostic interpretations. It was a direct assessment against predefined performance tasks.
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
- No MRMC or AI Comparative Effectiveness Study was done. This device is a medical pump for negative pressure wound therapy, not a diagnostic imaging device utilizing AI. The focus of the submission is on physical and software performance and user interaction, not on improving human reader performance with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone "algorithm only" performance was done in the context of AI. As mentioned above, this is not an AI-driven diagnostic device. The "standalone" performance closest to this concept would be the device's functional performance (e.g., maintaining negative pressure) as measured in bench testing, independent of direct human interaction other than setting it up.
7. The type of ground truth used
- Functional Performance: Engineering specifications and objective measurements (e.g., pressure readings, alarm activation).
- Electrical Safety & EMC: Compliance with international standards (IEC 60601 family).
- Software Verification & Validation: Adherence to software development lifecycle processes and satisfactory performance during testing against requirements, guided by FDA software guidance.
- Clinical Usability Testing: Predetermined acceptance criteria for task performance and absence of new risks, likely established by human factors experts/designers, with patients' and healthcare providers' successful completion of tasks serving as the empirical data.
8. The Sample Size for the Training Set
- Not applicable in the context of typical AI/ML model training. The software on this device is stated as "firmware control of the device" in the full 510(k) and is not described as involving a learning algorithm that requires a "training set" in the machine learning sense. The software undergoes traditional verification and validation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the AI/ML sense described for this 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.