(292 days)
The portable Medela® Invia Motion negative pressure wound therapy (NPWT) system is indicated 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 intended for the use in hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients with chronic, acute, subacute, traumatic, dehisced wounds, partial-thickness burns, ulcers (such as diabetic, neuropathic, pressure or venous insufficiency), flaps and grafts.
The Medela Invia Motion Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Motion NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The INVIA Motion is also compatible with Avance NPWT kits manufactured by Mölnlyke Healthcare.
Invia Motion NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Invia Motion NPWT pump is a single patient use pump for continuous or intermittent operation and has a lifetime of 60 days.
Invia Motion NPWT pump is portable and can be operated independent of the electrical Invia Motion power supply due to a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults.
Invia Motion NPWT system is intended for use in a home or other health care facility by medical personnel or trained lay users adhering to the instructions for use. The user may not be hard of hearing or deaf and must have normal visual acuity.
The provided text describes the Medela AG Invia Motion Negative Pressure Wound Therapy System and its 510(k) summary. However, it does not contain specific acceptance criteria, performance metrics, or details of a study designed to prove the device meets such criteria in a quantifiable manner as commonly expected for medical device evaluations that utilize AI or advanced diagnostics.
Instead, the non-clinical tests described focus on regulatory compliance, usability, and bench testing to demonstrate performance equivalence to predicate devices, rather than establishing direct clinical efficacy or performance against predefined, quantitative acceptance criteria via a clinical study with a specified sample size and ground truth.
Therefore, many sections of your requested output cannot be populated from the provided text. I will fill in what information is available and note when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Description | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Non-Clinical Tests | ||
| Electrical Safety | Compliance with IEC 60601-1 | Complies with IEC 60601-1 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Home Healthcare Environment Use | Compliance with IEC 60601-1-11 | Complies with IEC 60601-1-11 |
| Biocompatibility | Compliance with ISO 10993-1 | Complies with ISO 10993-1 |
| Sterilization Validation | (Not specified beyond "Sterilization validation") | (Validation completed) |
| Usability - Healthcare Professionals (HCPs) | Successful completion of tasks and resolution of close-calls/use-errors | All close-calls and use-errors observed during HCP use-scenarios and sub-tasks were resolved during the evaluation and did not affect patient safety. |
| Usability - Patient Lay Users (LUs) | 100% successful completion of target population use tasks | All 15 LU end-users (100%) successfully completed their target population use tasks by performing routine maintenance of the device and identifying and troubleshooting device acoustic and optical display signals to maintain safe and effective performance of the device. |
| Bench Testing (Performance and Reliability) | Design specifications met, equivalent performance to predicate device in maintaining set pressures and removing fluids in simulated wounds. | Bench testing demonstrated that the design specifications were met, including device performance and reliability. Comparison of performance with predicate device concluded equivalence in maintaining set pressures across the specification range and in removing fluids in simulated wounds. |
| Clinical Tests | (No clinical acceptance criteria or studies described) | (No clinical studies were conducted). |
2. Sample size used for the test set and the data provenance
-
Usability Study (a form of test set):
- Sample Size: 15 Healthcare Professionals (HCPs) and 15 patient Lay Users (LUs).
- Data Provenance: Conducted in the United States. Prospective (evaluation of users interacting with the device).
-
Bench Testing:
- Sample Size: Not specified.
- Data Provenance: Not specified (likely in-house lab testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Usability Study: The "ground truth" for the usability study was the successful completion of tasks and the identification/resolution of use errors. This was observed and assessed by the study administrators/evaluators, whose qualifications are not specified.
- Bench Testing: The "ground truth" for bench testing would be the engineering specifications and performance characteristics of the predicate device for comparison. No experts in the sense of clinical decision-makers were involved in establishing this ground truth from the provided text.
4. Adjudication method for the test set
- Usability Study: The text implies direct observation and assessment of user performance against predefined tasks and safety criteria. There is no mention of independent adjudication or a consensus method (like 2+1 or 3+1) among multiple observers.
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 study was done. The device is a Negative Pressure Wound Therapy System, not an AI-assisted diagnostic or imaging interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a therapeutic system, not an algorithm, and is operated by a human user (HCP or lay user).
7. The type of ground truth used
- Usability Study: Expert observation/assessment of user task completion and safety during device operation.
- Bench Testing: Engineering specifications and performance data of the device itself, and comparative performance data from predicate devices in simulated wound environments.
- Clinical: No clinical ground truth was established as no clinical studies were performed.
8. The sample size for the training set
- Not applicable. The device is a therapeutic system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
§ 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.