(111 days)
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness bums, flaps and grafts.
The subject Avance Tubing serves as the connecting link between the Avance NPWT pump and the Avance dressings, thereby delivering negative pressure wound therapy from the pump to the wound bed and facilitating the transport of fluid and exudate from the wound site to the canister. It consists of a 1.5 m length of tubing with connectors on each end to facilitate connection to other components of the Avance NPWT System.
The subject Avance Y-Connector allows connection of multiple Avance dressings to one Avance pump in order to accommodate large or multiple wounds. It consists of y-tubing with connectors on all ends to facilitate connection to other components of the Avance NPWT System. A maximum of one Avance Y-Connector may be used to connect up to two large dressing kits to a single pump.
The subject Avance ViewPad used in conjunction with the Avance dressings; it is placed on top of the wound cover (film), connected to the wound filler via a hole cut in the wound cover, and then connected to the Avance NPWT pump tubing for delivery of NPWT and transport of fluids and exudate away from the wound. The subject Avance ViewPad is similar to the existing ViewPad component of the Avance Foam Dressing Kits (K141847), with the exception of a green colorant that has been added to the connector and a modification to the design of the slide clamp.
This document describes the premarket notification for Avance Tubing, Avance Y-Connector, and Avance ViewPad, which are components of a Negative Pressure Wound Therapy (NPWT) system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the devices were evaluated through non-clinical bench testing. The general acceptance criteria were that the devices "performed as intended in the test setups, and all predefined acceptance criteria were met." Specific quantitative acceptance criteria are not explicitly detailed in this summary, but the reported performance is that they met all such criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device does not negatively affect fluid transport by the NPWT system | Performed as intended; fluid transport maintained |
| Pressure is delivered in accordance with pump settings | Performed as intended; pressure delivery maintained |
| Alarm functionality of the NPWT pump is maintained | Performed as intended; alarm functionality maintained |
| Biocompatibility (cytotoxicity, sensitization, irritation) | Non-cytotoxic, non-sensitizing, non-irritating (meets ISO 10993 criteria) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the exact sample size (number of devices or test runs) for the non-clinical bench testing. It only states that "Bench testing has been performed."
- Data Provenance: The testing was conducted as part of the premarket notification for the devices by the manufacturer, Mölnlycke Health Care. It is considered prospective data generated specifically for regulatory submission. The country of origin for the data is not explicitly stated, but the manufacturer is Mölnlycke Health Care, US LLC, located in Norcross, Georgia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable as the studies conducted were non-clinical bench tests, not clinical studies involving expert interpretation of medical data or ground truth established by medical professionals. The "ground truth" here refers to the functional performance of the device against engineering specifications and industry standards.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies conducted were non-clinical bench tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts assess the same cases to arrive at a consensus for ground truth. In bench testing, performance is measured objectively against predefined engineering specifications.
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:
This information is not applicable. The submission is for components of a Negative Pressure Wound Therapy system, which are physical medical devices, not an AI or computer-aided diagnostic (CAD) system. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable as the submitted devices are physical medical device components, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical testing was based on predefined engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and functional performance requirements. These requirements dictated that the device should:
- Not negatively affect fluid transport.
- Deliver pressure according to pump settings.
- Maintain alarm functionality.
- Meet biocompatibility criteria (non-cytotoxic, non-sensitizing, non-irritating).
8. The Sample Size for the Training Set:
This information is not applicable. The tested devices are physical components, not machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for these physical devices.
§ 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.