(114 days)
The V.A.C.Via™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The V.A.C. Via™ NPWT System consists of the following components:
• A sterile dressing system applied to the wound and connected via tubing to a therapy unit that generates negative pressure at the wound
• A sterile, disposable canister that collects wound exudates removed via the negative pressure
The KCI V.A.C. Via™ NPWT System is a negative pressure wound therapy device. The provided text outlines the acceptance criteria and supporting studies for its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Biocompatibility (Testing in accordance to ISO 10993-1 standards) | Conformance to ISO 10993-1 standards demonstrated. |
| Electrical Safety (Testing in accordance to IEC 60601-1 and UL 60601-1) | Conformance to IEC 60601-1 and UL 60601-1 standards demonstrated. |
| Electromagnetic Compatibility (EMC) (Testing in accordance to AAMI/ANSI/IEC 60601-1-2) | Conformance to AAMI/ANSI/IEC 60601-1-2 standards demonstrated. |
| Usability (Testing in accordance to IEC 60601-1-6) | Conformance to IEC 60601-1-6 standards demonstrated. |
| Alarm Systems (Testing in accordance to IEC 60601-1-8) | Conformance to IEC 60601-1-8 standards demonstrated. |
| Software Controls Verification and Validation (Ensure delivery of user selected negative pressure and continuous or intermittent therapy setting, pressure monitoring, and function of alarms) | Software controls verified and validated to ensure delivery of user selected negative pressure and continuous or intermittent therapy setting, pressure monitoring, and function of alarms. |
| Functional Ability (Deliver continuous or intermittent negative pressure at either 75mmHg or 125mmHg and transfer wound exudates to a collection canister for up to seven days) | Verification testing confirmed the functional ability of the V.A.C. Via™ NPWT System to deliver continuous or intermittent negative pressure at either 75mmHg or 125mmHg and transfer wound exudates to a collection canister for up to seven days. |
| Drape Adhesive Properties (Rheology and peel testing to demonstrate equivalent or improved intrinsic adhesive properties and peel strength respectively, as compared to the predicate drape adhesive) | Rheology and peel testing of the drape adhesive demonstrated equivalent or improved intrinsic adhesive properties and peel strength respectively, as compared to the predicate drape adhesive. The different monomer composition of the acrylic adhesive was chosen to improve sealing performance in the moist wound environment. |
| Human Factors Testing (Ensure inherent design features and labeling facilitate correct usage and effective response to alarms) | Human Factors testing ensured inherent design features and labeling facilitate correct usage and effective response to alarms. |
| Clinical Equivalence (Comparison of clinical outcomes or performance to predicate device) | "None required for determining substantial equivalence." The overall conclusion is that "Testing demonstrates that the V.A.C. Via™ NPWT System and ActiV.A.C.® Therapy System are substantially equivalent in terms of both indications for use and safe and effective delivery of negative pressure wound therapy." This implies that the device is expected to perform clinically similar to the predicate device based on its technological equivalence and successful non-clinical testing. |
2. Sample Sizes and Data Provenance for Test Set:
- The document describes non-clinical tests (biocompatibility, electrical safety, EMC, usability, alarm systems, software verification, functional ability, drape adhesive properties, human factors). These types of tests typically do not involve patient data or "test sets" in the same way clinical studies do. Instead, they involve validated laboratory methods and engineering tests using the device itself or its components.
- Data Provenance: The tests conducted are standard regulatory compliance tests. The 'origin' of the data is the internal testing conducted by KCI USA, Inc. as part of their device development and regulatory submission.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
- This information is not provided in the given text. For the types of non-clinical engineering and regulatory tests performed, the "ground truth" is typically established by adherence to recognized international standards (e.g., ISO, IEC, AAMI/ANSI) and internal design specifications, rather than expert consensus on a test set of medical cases. Human Factors testing would involve users, but the number and qualifications are not specified.
4. Adjudication Method for the Test Set:
- This information is not provided in the given text. Adjudication methods like "2+1" or "3+1" are characteristic of clinical studies involving expert review of patient data, which were explicitly stated as "none required" for this device's substantial equivalence determination.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not mentioned or conducted. The submission explicitly states "No clinical tests conducted for determination of substantial equivalence." This type of study would typically be part of clinical efficacy evaluation, which was not deemed necessary for this 510(k) submission.
6. Standalone (Algorithm Only) Performance Study:
- This device is a physical medical device (Negative Pressure Wound Therapy System), not an algorithm or AI software. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The software controls were verified and validated as part of the overall system's functionality.
7. Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is primarily based on:
- International and national medical device standards (e.g., ISO 10993-1, IEC 60601-1, UL 60601-1, AAMI/ANSI/IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8).
- Internal design specifications for functions like negative pressure delivery, exudate transfer, and alarm operation.
- Predicate device characteristics for comparison of technological features and adhesive properties.
8. Sample Size for the Training Set:
- This information is not applicable as the device is a physical medical device and not an AI/ML algorithm that undergoes a "training set" in the conventional sense. The "training" for a physical device involves its design and engineering iterations, followed by verification and validation, as opposed to data-driven training of a model.
9. How the Ground Truth for the Training Set was Established:
- As the concept of a "training set" for an AI/ML algorithm is not applicable, the establishing of ground truth for such a set is also not relevant to this device's submission. The documentation focuses on demonstrating the device meets established engineering, safety, and performance standards.
§ 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.