(224 days)
The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as 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.
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
The Invia Motion Negative Pressure Wound Therapy (NPWT) system is available in six versions with different run times:
- 7 Days
- 15 Days
- 30 Days
- 60 Days
- 120 Days
- Endure: lasts for one patients entire therapy, max. 3 years
The Invia Motion Negative Pressure Wound Therapy system is comprised of the Invia Motion pump, Invia Motion Canister/Tubing Set 0.15l, Invia Motion Power Supply and Invia Motion Carrying Case. Additionally, several separately cleared accessories and kits are compatible with the Invia Motion NPWT System.
The Invia Motion 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. The Invia Motion NPWT pump provides treatment status through a display and acoustic signals. It 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.
This document is a 510(k) Premarket Notification from Medela AG for their Invia Motion Negative Pressure Wound Therapy System. It seeks to demonstrate substantial equivalence to previously cleared predicate devices, not to prove the device's efficacy through new clinical studies. Therefore, the information typically found in a study proving a device meets acceptance criteria for an AI/ML medical device (such as performance metrics, ground truth establishment, sample sizes for training/test sets, MRMC studies, etc.) is not present in this document.
This submission focuses on engineering, non-clinical, and usability testing to show that the new version of the device, despite some changes (like a new canister/tubing set and improved blockage detection), performs equivalently and safely to its predecessors.
Here's a breakdown of what can be extracted based on the provided document, and what cannot be answered as it's not relevant to a 510(k) for this type of device:
1. A table of acceptance criteria and the reported device performance
Since this is a mechanical/electromechanical device and not an AI/ML one, the acceptance criteria are based on functional performance, electrical safety, usability, and biocompatibility, rather than diagnostic accuracy metrics. The document summarizes the tests performed and states they were successful in demonstrating intended performance. Specific numerical "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (like sensitivity, specificity, AUC) are not applicable or provided here.
| Acceptance Criterion (Type of Testing) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Complies with IEC 60601-1:2005 (3rd Ed.) and US deviations. |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2: 2014 (4th Ed.). |
| Home Healthcare Use Safety | Complies with IEC 60601-1-11: 2015 (2nd Ed.). |
| Usability | Evaluated per IEC 60601-1-6: 2013 and IEC 62366: 2015; Usability validation study demonstrated correct and safe use. |
| Performance (Pressure at Wound) | Demonstrated steady rise to set vacuum, uniform/constant level, correspondence to selected level, and proper fluid removal using a wound model and simulated exudates. |
| Leakage Notifications | Tests confirmed correct behavior of leakage notification signals using wound model and simulated exudates. |
| Blockage Detection | Tests confirmed correct behavior of blockage notification signals using wound model and simulated exudates. |
| Motor Runtime/Lifetime | Bench testing verified 3000h runtime (3-year lifetime); confirmation of limited runtime for specific models performed during software testing. |
| Sterilization Process | Validated according to ISO 11135-1:2007 (including Annex A and B). |
| Shelf Life (Canister/Tubing) | Accelerated aging tests support 5-year shelf life per ASTM F1980-07. |
| Biocompatibility | Performed according to ISO 10993-1: 2009 (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity) at an accredited lab (NAMSA) under GLP requirements. Demonstrates safety. |
| Risk Analysis | Developed in accordance with ISO 14971: 2007. |
| Software V&V | Software verification and validation testing completed. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI/ML test set for diagnostic accuracy. The "test set" here refers to physical tests on the device and its components (e.g., specific wound models for performance, various environmental conditions for electrical safety). The provenance is from Medela AG's internal R&D and external testing laboratories. These are non-clinical bench tests, not data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of this device refers to physical properties and functional accuracy (e.g., actual vacuum pressure, correct fluid flow, sterility). These are established by engineering standards and measurement, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth for image interpretation or diagnosis. This document pertains to device functionality and safety.
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. This is not an AI/ML device, and no clinical studies (including MRMC studies) were required or performed. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Invia Motion Negative Pressure Wound Therapy System to its predicate device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm with diagnostic performance or human-in-the-loop interaction for diagnosis. Its "performance" is its ability to generate negative pressure, collect exudate, and alert to issues.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering and medical device standards, physical measurements, and simulated physiological conditions. Examples include:
- Physical measurements: Verification of vacuum levels, fluid volume dispensed/removed, motor runtime.
- Standards compliance: e.g., IEC 60601 series for electrical safety, ISO 14971 for risk management, ISO 11135-1 for sterilization, ISO 10993-1 for biocompatibility.
- Simulated environments: Use of "wound models and simulated wound exudates" to test pressure delivery, leakage, and blockage detection.
8. The sample size for the training set
Not applicable. There is no AI/ML component requiring a training set for diagnostic or predictive purposes.
9. How the ground truth for the training set was established
Not applicable. See #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.