(296 days)
The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates 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 by removing exudate and infectious material.
When used on closed surgical incisions, the Invia Motion NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Motion NPWT system is appropriate for use for the following indications:
- Acute or subacute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/Neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions
The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates 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 by removing exudate and infectious material.
When used on closed surgical incisions, the Invia Liberty NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Liberty NPWT system is appropriate for use for the following indications:
- Acute or subacute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/Neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions
The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates 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 exudate and infectious material.
When used on closed surgical incisions, the Invia Foam Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Foam Dressing Kit with FitPad is appropriate for use for the following indications:
- Acute or subacute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/Neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions
The Invia Gauze Dressing Kit with FitPad in comunction with the Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates 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 exudate and infectious material.
When used on closed surgical incisions, the Invia Gauze Dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Gauze Dressing Kit with FitPad is appropriate for use for the following indications:
- Acute or subacute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/Neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions
The labeling of the Invia Motion Negative Pressure Wound Therapy (NPWT) System, Invia Liberty NPWT System, Invia Foam Dressing Kit with FitPad and Invia Gauze Dressing Kit with FitPad has been modified to expand the indications for use to include closed surgical incisions. When used on closed surgical incisions, the devices are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
INVIA MOTION NPWT SYSTEM
The Invia Motion Negative Pressure Wound Therapy system is available in six versions with different run times. The Invia Motion NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Motion NPWT pump is a single patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Motion NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The Invia Motion suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.
INVIA LIBERTY NPWT SYSTEM
The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy that provides therapy status through a display and acoustic signals. The Invia Liberty NPWT pump is a multi-patient use pump which provides continuous or intermittent operation and multiple negative pressure selection options. The Invia Liberty NPWT pump is portable and can be operated using a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
The Invia Liberty suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) facilitates use and information handling.
A variety Negative Pressure Wound Therapy Kits are available for use with the Invia Motion and Invia Liberty NPWT Systems, including the Invia Foam Dressing Kits with FitPad.
INVIA FOAM AND GAUZE DRESSING KITS WITH FITPAD
The Invia FitPad Kit Assortment includes Foam Kits in sizes Small, Medium, Large and X-Large as well as Gauze Kits with FitPad in sizes Medium and Large. The Invia Foam and Gauze Dressing Kits with FitPad provide a double lumen suction interface (FitPad) with Quickconnector. The double lumen suction interface allows flushing down to the dressing and detection of blockage along the entire length of tubing, controlling pressure at the wound site and enabling for easy and secure connection between canister tubing and dressing tubing.
This document describes the premarket notification for the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems, and their associated Foam and Gauze Dressing Kits with FitPad. The submission seeks to expand the indications for use to include closed surgical incisions.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" with numerical targets and corresponding device performance values in a typical format for a medical device study (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are implied by demonstrating substantial equivalence to predicate devices for the new expanded indication (closed surgical incisions) and by successful completion of various non-clinical performance and safety tests.
The "reported device performance" is described qualitatively through these tests.
Implied Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device operation does not introduce new or increased risks for closed surgical incisions. | Potential risks associated with the new closed surgical incision were evaluated in accordance with ISO 14971:2007 (Risk Management for Medical Devices). The usability engineering process, including human factors validation testing, demonstrated that the design promotes safe use and mitigates critical, safety-related errors. Software verification and validation testing for non-significant changes were completed. Electromagnetic compatibility testing per IEC 60601-1-2:2014 (4th edition) was completed. Verification that EO and ECH residuals remain below maximum specified levels in compliance with ISO 10993-7 (Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals) was completed. |
| Effectiveness/Performance (Closed Surgical Incision Application): The device effectively manages the environment of closed surgical incisions by creating and maintaining negative pressure and removing exudate. | Performance testing demonstrated: |
- A steady rise of negative pressure at test onset to the set vacuum level.
- A uniform and constant vacuum level throughout the test period.
- The vacuum level corresponds to the selected set vacuum level of the pump.
- The volume of fluid dispensed to the wound model corresponded to the volume of fluid removed from the wound model and collected into the pump canister.
- Constant fluid removal was observed with no evidence of fluid accumulation on top of the closed surgical incisional wound model.
- Compared equivalently to the predicate ActiV.A.C. Therapy Unit (K120033) for use on closed surgical incisions. |
| Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices for the expanded indication. | The non-clinical tests described demonstrate that the device is substantially equivalent to the predicate devices for the new indication of closed surgical incisions. The differences do not introduce new intended uses or raise different questions of safety and effectiveness. |
| Functional Equivalence: Non-significant changes to components (software, hardware, labeling, sterile packaging) maintain performance. | Software verification and validation testing were completed for non-significant changes. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance testing using simulated wound models.
- Sample size: Not explicitly stated as a numerical count of "cases" or "patients." Performance testing was conducted on "a closed surgical incision model and simulated wound exudates." The typical approach for such tests involves a sufficient number of runs or samples to demonstrate consistent performance within the system. Specific sample sizes for individual tests (e.g., bioburden, materials testing) are not detailed.
- Data Provenance: The studies are non-clinical, meaning they were conducted in a laboratory or simulated environment, not on human patients. Therefore, terms like "country of origin of the data" or "retrospective/prospective" in the context of patient data do not apply. The submitter is Medela AG, based in Baar Zug, Switzerland, implying the tests were likely conducted under their quality system, possibly internally or at contract labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is a non-clinical submission, and no ground truth established by medical experts (like radiologists) is relevant or mentioned. The "ground truth" for the performance testing cited would be engineering specifications and validated test methods to measure parameters like pressure, flow, and fluid removal accuracy against established standards and predicate device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As a non-clinical performance study using simulated models, there is no need for adjudication by human experts as would be required for clinical image interpretation or diagnostic performance studies. The "results" are objective measurements.
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. The submission is for Negative Pressure Wound Therapy (NPWT) systems and dressings, which are physical medical devices, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its mechanical and functional design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" is based on:
- Engineering Specifications: The device's predetermined operational parameters (e.g., set vacuum levels, flow rates).
- Validated Test Methods: Standardized procedures for measuring device performance (e.g., pressure output, fluid removal volume).
- Predicate Device Performance: Direct comparison to the established performance characteristics of the legally marketed predicate devices (ActiV.A.C. Therapy Unit K120033).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that uses training sets.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.