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510(k) Data Aggregation
(306 days)
ACCURO MEDICAL PRODUCTS LLC
The WoundPro Apex Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro Apex is intended for use in a healthcare facility only.
Types of Wounds Indicated are:
- Diabetic/Neuropathic ulcers
- Pressure ulcers
- Chronic wounds
- Acute wounds
- Dehisced wounds
The Apex is part of the Wound Pro family of products offered by Accuro Medical Products LLC.
The Apex is a powered suction pump that uses controlled negative pressure. The control unit incorporates a maintenance free brushless DC motor and is powered by a rechargeable battery power source. Optionally the unit can be connected to mains power using the included Medical Grade Switching power converter.
Apex has a negative pressure setting range of 20mm to 150mmHg which is electronically monitored and controlled. The pump includes push button user interface controls and an electronic display with audible and visual alarm indicators.
The device can accommodate 300cc and 800cc canister sizes.
The unit can be operated on a countertop and has provisions for connection to IV poles, bed side rails, or footboard mounting.
The unit may be sold individually or as part of a system includes the following items:
- 1 Apex NPWT Pump
- 1 Mounting Clamp for IV Pole, Bedrail, or Footboard mounting
- 1 Hospital grade Charging Connection to 110V power source
- 1 Medium (flat drain) dressing kit. Kit includes:
- Non-adherent contact layer
- Anti-bacterial Gauze
- Drain Tube
- Drain Clamp
- Cover Dressing
- Instructions for use
- 1 Disposable 300cc Canister
- 1 Canister Tubing Set. Set includes:
- Dual lumen Tubing (runs between the canister and the connector)
- Clamp
- Connector for attachment to dual lumen tube to the drain
- Carrying Case
Accuro Medical WoundPro Apex Acceptance Criteria and Performance Study
The Accuro Medical WoundPro Apex is a powered suction pump designed for negative pressure wound therapy. The 510(k) submission (K100823) claims substantial equivalence to predicate devices (Medela Invia - K080357 and Blue Sky Vista - K061367) based on technological characteristics and performance data.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a formal table with pass/fail metrics. Instead, the "Performance Data" section outlines various non-clinical tests conducted, and the "Summary of Technological Characteristics" asserts substantial equivalence to predicate devices across several features. For this analysis, the predicate device specifications are used as an implicit benchmark for acceptance.
| Feature / Acceptance Criteria (Implicit from Predicate Devices) | Reported WoundPro Apex Performance |
|---|---|
| Electrical Safety | Compliant with all electrical safety requirements including IEC 60601-1-2. Passed non-clinical testing for electrical safety. |
| Electromagnetic Compatibility (EMC) | Passed non-clinical testing for electromagnetic compatibility (EMC). |
| Software Validation | Passed non-clinical testing for software validation. |
| Accuracy of Canister Volume Marks | Passed non-clinical testing for accuracy of canister volume marks. |
| Filter Ability to Shut off Fluid Flow (when wet) | Passed non-clinical testing; compared to predicate devices. |
| Tubing Clamp & Cap Ability to Prevent Leaking | Passed non-clinical testing; compared to predicate devices. |
| Battery Life (on sealed wound) | Passed non-clinical testing; compared to predicate devices. |
| System Ability to Maintain Consistent Vacuum (on batteries) | Passed non-clinical testing; compared to predicate devices. |
| Vacuum Setting Accuracy | Passed non-clinical testing at different vacuum settings; compared to predicate devices. |
| Fluid Extraction Test | Passed non-clinical testing, comparing fluid volumes removed from simulated wound at different flow rates and vacuum settings; compared to predicate devices. |
| Indications for Use | Substantially equivalent to predicate devices (Medela Invia and Blue Sky Vista). |
| Technological Characteristics (e.g., weight, dimensions, | Substantially equivalent to predicate devices. (While slight differences exist, these features, along with power source, vacuum range, suction capacity, canister volume, and modes of operation, were deemed substantially equivalent.) Construction materials are also substantially equivalent. Patient contact materials are biocompatible and off-the-shelf sterile wound dressing materials. |
2. Sample Size for Test Set and Data Provenance
The document describes non-clinical bench testing for the performance evaluation of the WoundPro Apex. It does not specify a "test set" in terms of patient data or a clinical study. The data provenance is laboratory-based testing performed by the applicant, Accuro Medical Products LLC. There is no information provided about country of origin of data or whether it was retrospective or prospective, as it pertains to non-clinical tests.
3. Number of Experts for Ground Truth and Qualifications
Since the study described is a non-clinical bench testing and a substantial equivalence claim, there's no mention of experts establishing ground truth in the context of clinical outcomes or images. The "ground truth" for the performance tests would be defined by engineering specifications, regulatory standards (e.g., IEC 60601-1-2), and comparative measurements against predicate devices.
4. Adjudication Method for Test Set
Not applicable. As no human-interpretive test set (e.g., images for diagnosis) is described, there is no need for an adjudication method. The performance assessment is based on objective measurements and comparisons against established specifications and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. This device is a negative pressure wound therapy pump, not an AI-powered diagnostic or assistive tool for human interpretation.
6. Standalone (Algorithm Only) Performance
Not applicable. The Accuro Medical WoundPro Apex is a medical device (powered suction pump) and not an algorithm or AI-driven system that would have "standalone performance" in the context of a diagnostic or interpretive task. Its performance is its functional operation.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance tests would be:
- Engineering specifications and regulatory standards: For electrical safety, EMC, software validation, and accuracy of measurements (e.g., canister volume, vacuum settings).
- Predicate device performance data: For comparative tests like filter ability, tubing clamp effectiveness, battery life, consistent vacuum maintenance, and fluid extraction. The assumption for substantial equivalence is that the predicate devices are safe and effective, and thus their performance serves as the benchmark.
8. Sample Size for Training Set
Not applicable. This device is a hardware medical device and does not involve AI or machine learning models that require a "training set."
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for an AI/ML model for this device.
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