(86 days)
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 it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing granulation tissue formation and perfusion, and by removing exudate and infectious material.
The Invia Foam Dressing Kit with FitPad is appropriate for use on the following wounds:
- Acute or sub-acute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
Invia Gauze Dressing Kit with FitPad is intended for use in conjunction with the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems. The Invia Motion and Invia Liberty NPWT systems are intended for use in acute, extended and home care settings. Users are directed to the Invia Motion and Invia Liberty NPWT System labeling for additional safety information and instruction for use. To help ensure safe and effective use, the Invia Gauze Dressing Kits with FitPad are to be used only with the approved therapy units.
Invia Gauze Dressing Kit with FitPad is appropriate for use on the following wounds:
- Acute or sub-acute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and Grafts
INVIA FOAM DRESSING KITS WITH FITPAD: The Invia Foam Dressing Kit with FitPad consists of a foam, a suction interface (Invia FitPad) and transparent film (one or more pieces depending on the kit size). The foam is manufactured using a reticulate flexible polyether and polyurethane hydrophobic material, with a high tensile strength (20 PSI*) and charcoal color. The FitPad suction interface features a quick connecting interface to the canister tubing for easy and secure connection. The transparent film is designed with self-explanatory markings to facilitate the ease of use.
INVIA GAUZE DRESSING KITS WITH FITPAD: The Invia Foam Dressing Kit with FitPad consists of a gauze pad, one or two transparent films (depending on the kit size), a suction interface (Invia FitPad), and saline.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Invia Dressing Kits with FitPad:
This document primarily describes non-clinical and one specific clinical test related to the Invia Foam Dressing Kits with FitPad and Invia Gauze Dressing Kits with FitPad. It is a 510(k) summary for premarket notification, aiming to establish substantial equivalence to predicate devices, rather than a detailed report of a clinical trial proving specific performance acceptance criteria for an AI/ML device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in the context of this traditional medical device submission.
However, I can extract the acceptance criteria and study information that are present.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria with corresponding reported device performance values in the way one would expect for an AI/ML device (e.g., "sensitivity > 90%"). Instead, it lists compliance with established standards and general performance characteristics demonstrated.
| Acceptance Criteria / Standard Compliance | Reported Device Performance |
|---|---|
| Risk Management: Compliance with ISO 14971:2007 | A Risk Analysis was developed demonstrating compliance. |
| Biocompatibility: Compliance with EN ISO 10993-1, EN ISO 10993-5, EN ISO 10993-12, EN ISO 10993-18 (specifically for the Invia transparent film/adhesive drape) | Biocompatibility studies were conducted in accordance with these standards. (For the adhesive drape, a clinical study demonstrated it "is not a significant skin irritant" per ISO 10993-10 Annex C). |
| Sterilization Validation: Compliance with ISO 11135:2014 | Sterilization Validation was performed in accordance with this standard. |
| Accelerated Aging: Compliance with ASTM F1980 | Analysis on Accelerated Aging was conducted. |
| Packaging Validation: Compliance with DIN EN ISO 11607-1 | Packaging Validation was performed. |
| Transport Validation | Transport Validation was performed. |
| Usability: Compliance with EN 62366:2008 | Usability testing was conducted. |
| Performance Testing (Pressure Generation/Maintenance): Ability to accurately generate and maintain pressure under usage conditions in combination with the intended suction pumps. (Implied criterion: must perform comparably to predicate devices and function as intended for negative pressure wound therapy.) | Performance testing demonstrated that Invia Dressing Kits have the ability to accurately generate and maintain pressure under usage conditions in combination with the intended suction pumps. Verification and Validation testing demonstrated that no adverse effects have been introduced by differences from predicate devices and that the device performs as intended. |
| Clinical Performance (Skin Irritation): To demonstrate the Invia transparent film (adhesive drape) is not a significant skin irritant. | A clinical study conducted according to ISO 10993-10 (Annex C) demonstrated that the film is not a significant skin irritant. |
Missing Information and Not Applicable Categories for this Device Type:
- Sample size used for the test set and the data provenance: Not specified in this document for the non-clinical tests. For the clinical skin irritation study, the sample size is not stated, nor is the data provenance beyond "a clinical study was conducted". This is not a study on an AI/ML algorithm or diagnostic device with a "test set" in the common sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests (biocompatibility, sterilization, pressure maintenance) is established through standardized laboratory analyses and measurements, not expert consensus on images or medical records.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the types of tests described.
- 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 an NPWT dressing kit, not an AI/ML diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: In vitro and in vivo models according to ISO 10993 series.
- For sterilization: Microbiological tests (e.g., sterility assurance level verification).
- For pressure performance: Engineering measurements and functional testing.
- For skin irritation: Clinical observation and assessment as per ISO 10993-10 Annex C.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML 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.