(116 days)
Avance Y-connector S is intended for use in the Avance Negative Pressure Wound Therapy (NPWT) system, to connect and allow therapy of multiple wounds simultaneously by using one pump. 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 burns, flaps and grafts.
The subject of this submission is the Avance® Y-Connector S, which is an accessory to the Avance® Negative Pressure Wound Therapy (NPWT) System. It allows connection of multiple dressing kits to one pump in order to accommodate large or multiple wounds. We have classified this device as Class II as it is directly indicated for use with an NPWT Pump which falls under that classification, and the Avance® Y-Connector S forms an integral part of the overall system when multiple wound sites require therapy.
The Avance® Y-connector S is a polyurethane/polypropylene based single lumen Yconnector. It is designed to function with existing Avance® NPWT pumps and dressing kits by connecting the Avance® Canister Tubing to two single lumen transfer pads which are applied to the Avance® Foam dressings. Use of the Avance® Y-Connector S allows therapy and transportation of exudate from more than one wound simultaneously using one pump. A maximum of two Avance® Y-Connector S devices may be used to connect three wounds to one pump.
The Molnlycke Health Care Avance® Y-Connector S is an accessory to a Negative Pressure Wound Therapy (NPWT) system, allowing connection of multiple dressing kits to one pump for simultaneous treatment of large or multiple wounds. The provided documentation primarily focuses on demonstrating substantial equivalence to predicate devices and presents performance data from internal testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for a Y-Connector in an NPWT System) | Reported Device Performance (Avance® Y-Connector S) |
|---|---|
| Biocompatibility: Non-cytotoxic, non-irritant, non-sensitizing. | Cytotoxicity: Not cytotoxic (ISO 10993-5). |
| Primary Skin Irritation: Not irritants (ISO 10993-10). | |
| ISO Closed Patch Sensitization: Not sensitizers (ISO 10993-10). | |
| NPWT Functionality: Ability to maintain fluid transport adequately when connecting multiple wound models to a single pump. | NPWT Functionality: Fluid handling properties of the Avance® NPWT System (including Y-Connector S) are sufficient to accommodate the exudate flow rate from large exuding wounds. |
| Maintenance of system integrity (e.g., no leaks, proper suction). | Implied to be met as part of "NPWT Functionality" and equivalence to predicate devices. No specific quantitative criteria provided. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or test units. The "NPWT Functionality" test involved a "test setup included the use of the Avance® Y-Connector S to connect multiple wound models," suggesting a laboratory-based, non-clinical evaluation.
- Data Provenance: The testing was conducted internally by Molnlycke Health Care ("internal Mölnlycke test method"). This indicates the data is from the manufacturer's own product development and validation processes. No country of origin is specified for the data itself, but the applicant is Molnlycke Health Care US, LLC. The studies are by nature retrospective as they were conducted to support a 510(k) submission for an already developed device.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The studies described are primarily benchtop (biocompatibility and functional performance) and do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way, for example, a diagnostic AI device would.
4. Adjudication Method for Test Set
- Not applicable. There was no human interpretation or subjective assessment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging AI or diagnostic AI tools where human readers’ diagnostic accuracy or efficiency is being evaluated with and without AI assistance. The Avance® Y-Connector S is a physical accessory for a medical device and its performance is evaluated through material and functional testing, not through human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Yes, a standalone study was performed in the context of device functionality. The "NPWT Functionality" test and biocompatibility tests assess the device's inherent physical and functional properties without human intervention being part of its core performance mechanism. The device itself (the Y-connector) does not have an "algorithm" in the conventional sense of an AI/software device. Its performance is assessed as a standalone physical component within a system.
7. Type of Ground Truth Used
- Biocompatibility: Ground truth was established by adherence to recognized international standards (ISO 10993-5 and ISO 10993-10) for evaluating biological responses to medical devices.
- NPWT Functionality: Ground truth was based on an "internal Mölnlycke test method for fluid transport in NPWT," which likely defines objective criteria for what constitutes sufficient fluid transport. This would involve measurable parameters such as flow rate, pressure maintenance, and absence of leaks, against predefined thresholds.
8. Sample Size for the Training Set
- Not applicable. This device is a physical accessory, not a software or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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.