(172 days)
The Invia Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Invia Liberty NPWT System.
The Invia Abdominal Dressing Kit consists of an Organ Contact Layer (OCL), two foam pads, four transparent films and a suction interface (Invia FitPad).
- -The OCL is an oval polyurethane film with fenestrations intended to protect the abdominal content and enable fluid drainage from the abdomen.
- -The foam pad is an oval hydrophobic polyurethane foam with open cell structure intended to be placed over the OCL in order to distribute the negative pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.
- -The transparent film is a thin transparent polyurethane film with acrylic adhesive intended to fixate the wound filler and seal tight to the skin.
- The Invia FitPad is intended to distribute negative pressure to the wound and transport exudates from the abdominal cavity to the canister of the Invia Liberty Negative Pressure Wound Therapy (NPWT) pump.
The components of the Invia Abdominal Dressing Kit are packaged sterile and are for single use only.
The provided document is a 510(k) summary for the Medela AG Invia Abdominal Dressing Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel drug or high-risk device might.
Therefore, the information typically requested in your prompt regarding acceptance criteria, a standalone study, sample sizes, expert ground truth, adjudication methods, and MRMC studies, is largely not directly applicable or available in this document. This submission relies heavily on non-clinical tests to show that the new device performs similarly to its predicate.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical outcome. Instead, it demonstrates performance equivalence through non-clinical testing by comparing the Invia Abdominal Dressing Kit to its predicate. The "acceptance" can be inferred as successfully demonstrating equivalent functionality in laboratory settings.
| Acceptance Criterion (Inferred from non-clinical testing) | Reported Device Performance |
|---|---|
| Pressure Stability within Wound Model: Constant vacuum values maintained within 10% of setpoint. | Both the Invia Abdominal Dressing Kit and the predicate (Mölnlycke Avance Abdominal Dressing Kit) maintained constant vacuum values within the wound model. Testing demonstrated that the pressure at the wound is within 10% of the setpoint using a wound model for multiple vacuum settings over 30 minutes and 73 hours. |
| Effective Removal of Simulated Wound Exudate: Efficient liquid discharge through the interface and draining into the pump canister. | Both the Invia Abdominal Dressing Kit and the predicate demonstrated efficient liquid being discharged through the interface and draining into the pump canister at their intended settings. Testing further demonstrated effective removal of simulated wound exudate from the wound model for multiple vacuum settings over 30 minutes and 73 hours. Comparison to the predicate showed equivalent performance with NaCl exudate removal over 30 minutes. |
| Leakage and Blockage Notification Functionality: Verification of intended operation. | Tests were performed for a short period of time to verify the leakage and blockage notification functionality is in accordance with the description in the Invia Liberty Pump Instructions for use. The results were successful. |
| Sterility: Sterility Assurance Level (SAL) of at least 10^-6. | The ethylene oxide sterilization process was validated according to ISO 11135-1:2007, establishing that an SAL of at least 10^-6 is provided by the cycle and that EO residuals meet the limits in ANSI/AAMI/ISO 10993-7. |
| Packaging Integrity and Shelf Life: Packaging integrity maintained, 2-year shelf life supported. | The sealed Tyvek packaging underwent environmental conditioning, transit simulation and integrity testing (visual inspection per ASTM F1886, bubble leak integrity testing per ASTM F2096 and peel strength testing per ASTM F88), with successful results implied. Accelerated aging tests were performed to support this 2-year shelf life via methods published in FDA recognized standard ASTM F1980-07. |
| Biocompatibility: Meet requirements for prolonged contact and hemocompatibility. | Biocompatibility testing for foam, transparent film, and suction port evaluated endpoints for an external communicating device in prolonged contact with tissue/bone/dentin, including Hemocompatibility. Biocompatibility testing for the Organ Contact Layer (OCL) followed requirements for an implant device in prolonged contact with tissue/bone, including Hemocompatibility. Successful results (i.e., compliance with standards) are implied. |
| Usability: Low error rates in performance scenarios. | Human factors validation testing included 15 surgeons. Results show very low error rates observed for the performance scenarios, indicating successful usability. |
2. Sample Size for Test Set and Data Provenance:
- Non-clinical Performance Testing (Wound Model): The document mentions "a wound model, simulated wound exudates, and multiple pressure sensors." It also states "Multiple vacuum settings over 30 minutes and 73 hours were used." However, a specific numerical sample size (e.g., number of test runs, number of models) is not provided. The provenance is laboratory testing.
- Human Factors Validation Testing: "15 surgeons" were used. The provenance is internal usability testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Usability Experts: "Three usability experts" conducted heuristic evaluations. No specific qualifications beyond "usability experts" are provided in the document.
- Surgeons for Human Factors Validation: "15 surgeons with experience operating on open abdomens" were used. This indicates relevant expertise for the device's intended use. No further detailed qualifications (e.g., years of experience, subspecialty) are provided.
4. Adjudication Method for the Test Set:
- There is no mention of an adjudication method in the context of the non-clinical or human factors testing. These were primarily performance-based or observation-based assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Invia Abdominal Dressing Kit to its predicate device." This type of study focuses on device performance in a laboratory setting compared to a predicate, not how human readers improve with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This question is not applicable. The Invia Abdominal Dressing Kit is a physical medical device (dressing kit for negative pressure wound therapy), not an AI algorithm. Its performance is inherent to its physical properties and interaction with the NPWT system, not an algorithm.
7. Type of Ground Truth Used:
- Non-clinical Performance Testing: The "ground truth" was established by physical measurements and simulated conditions within a controlled laboratory wound model, using established scientific principles and comparison to a legally marketed predicate device under identical test conditions.
- Human Factors Validation: The "ground truth" was established by observing user performance (surgeons) against predefined usability scenarios and identifying errors or successful task completion.
8. Sample Size for the Training Set:
- This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established:
- This question is not applicable as there is no training set.
In summary:
This 510(k) submission primarily relies on non-clinical (laboratory) performance testing and human factors validation (usability) to demonstrate substantial equivalence to a predicate device. It explicitly states that clinical testing was not required. The "acceptance criteria" are therefore implicit in the successful demonstration that the device performs functionally and safely at least as well as the predicate in relevant non-clinical and simulated use environments.
§ 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.