(269 days)
The Medela® Invia Liberty Negative Pressure Wound Therapy System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
The Medela Invia Liberty Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Liberty NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The Invia Liberty is also compatible with Avance NPWT kits manufactured by Mölnlyke Healthcare.
The Invia Liberty NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Acoustic and optical signals are triggered for variances from the set values as well as for faults. The Invia Liberty NPWT pump provides continuous or intermittent operation.
The Invia Liberty NPWT system may be used 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 Invia Liberty NPWT pump is portable and can be operated independent of the electrical power supply via its rechargeable battery.
The provided FDA 510(k) summary for the Medela Invia Liberty Negative Pressure Wound Therapy System does not contain acceptance criteria or study results in the format requested for an AI/ML device.
This document describes a medical device (a wound therapy pump) that is a hardware device with some software/firmware components, not an AI/ML diagnostic or prognostic tool. Therefore, the questions regarding AI/ML-specific performance metrics, ground truth, expert adjudication, sample sizes for training/test sets, and MRMC studies are not applicable to this submission.
Here's a breakdown of what the document does provide, and why it doesn't fit the requested AI/ML structure:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable in the Requested AI/ML format.
- The document presents a comparison table (within "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE") between the Invia Liberty NPWT System and its predicate device (Invia Wound Therapy K080357). This table compares specifications like suction capacity, max/min vacuum, therapy modes, and accessories.
- Performance is implied by equivalence to the predicate device and compliance with relevant safety and performance standards, rather than specific numerical acceptance criteria for diagnostic performance. For instance, suction capacity is reported as "5 l/min" for both the new device and the predicate, indicating equivalence.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is not a study assessing an AI/ML model's performance on a dataset. The non-clinical tests described are for hardware functionality, electrical safety, usability, and biocompatibility.
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 AI/ML diagnostic algorithms is not relevant here. The device's functionality is verified through engineering tests and adherence to standards.
4. Adjudication method for the test set:
- Not Applicable. No expert adjudication process is described as this is not a diagnostic device where different interpretations need to be reconciled.
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. This device is a treatment delivery system, not a diagnostic tool that assists human readers. No MRMC study was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device is the "algorithm" and hardware combination for delivering negative pressure wound therapy. "Standalone performance" would refer to its core function of delivering therapy safely and effectively, which is covered by the non-clinical tests.
7. The type of ground truth used:
- Not Applicable. The "ground truth" for this device's performance is established by engineering specifications, physical measurements (e.g., suction capacity, vacuum levels), and compliance with recognized safety and performance standards (e.g., IEC 60601 series).
8. The sample size for the training set:
- Not Applicable. There is no "training set" in the AI/ML sense. The device's firmware and algorithms are developed through traditional software engineering and control system design, not machine learning from a large dataset.
9. How the ground truth for the training set was established:
- Not Applicable. As there's no training set, there's no ground truth for it in this context.
Summary of what the document does describe regarding device validation:
The validation of the Invia Liberty Negative Pressure Wound Therapy System is based on non-clinical tests demonstrating its safety, effectiveness, and substantial equivalence to a legally marketed predicate device. This includes:
- Risk Analysis: To identify and mitigate potential hazards.
- Software Validation: For the device's firmware and control algorithms.
- Hardware Integration Testing: Ensuring all components work together correctly.
- Electrical Safety and Electromagnetic Compatibility Testing: Adherence to IEC 60601-1 and IEC 60601-1-2 standards.
- Safety Testing for Home Use: Adherence to IEC 60601-1-11 standard.
- Usability Evaluation: Adherence to IEC 60601-1-6 and IEC 62366 Standards.
- Performance Testing: Demonstrating functionality with Medela Invia Gauze Kits and Avance Foam Kits, including the double lumen tubing and quick connector. This would involve verifying that the pump achieves the specified negative pressures and suction in various configurations.
- Biocompatibility Testing: For materials in contact with the patient (cytotoxicity, sensitization, irritation).
- Cleaning Methods Validation: For reusable components.
- Sterilization Validation and Shelf Life Confirmation: For sterile components.
No clinical testing was performed for this 510(k) submission. The device is deemed substantially equivalent based on technological characteristics and non-clinical performance data compared to the predicate 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.