(126 days)
The Negative Pressure Wound Therapy Device is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed.
The Negative Pressure Wound Therapy Device is indicated for the following wound types: chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps, and grafts.
The Negative Pressure Wound Therapy Device is a portable, rechargeable, battery powered pump capable of delivering bespoke continuous and/or intermittent negative pressure intended to allow wound management by draining and removing wound exudates, infectious material, and tissue debris from the wound bed. The Negative Pressure Wound Device is packaged and provided with the following components: Negative Pressure Wound Therapy Pump and Collection Canister.
Patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, diabetic ulcers, neuropathic ulcers, pressure ulcers, flaps, and grafts may benefit from this system.
The Negative Pressure Wound Therapy Device used with wound dressings can produce a negative pressure environment in either intermittent or continuous mode. This allows the user to program the specific pressure ranging from 50mmHg to 200mmHg (V-Move) and 0 to 200 mmHg (V-Grand).
In intermittent mode, the pump will alternate between applying pressure for 5 continuous minutes and reducing pressure to 0 for 2 minutes for V-Move. In intermittent mode, therapy pressure, operating time, and interval time can be adjusted for V-Grand.
The Negative Pressure Wound Therapy Device is compatible with the Longterm NPWT Foam Dressing Kit (K211571).
The device is used in professional medical facilities.
The Negative Pressure Wound Therapy pump accessories that are included in this 510(k) submission and will be commercialized separately are the following: 300cc Collection Canister 500cc Collection Canister 1000cc Collection Canister
The provided document is an FDA 510(k) clearance letter for a Negative Pressure Wound Therapy Device (V-Move, V-Grand). It does not contain any information about acceptance criteria or a study proving the device meets those criteria (e.g., accuracy, sensitivity, specificity, or human improvement with AI assistance).
The document primarily focuses on:
- Substantial Equivalence: Comparing the new device to existing predicate devices (K132225 and K162159) based on indications for use, contraindications, principle of operation, vacuum modes, negative pressure ranges, canister sizes, prescription use, sterility, weight, user life, energy source, tubing material, and battery type.
- Non-Clinical Testing: Mentioning that non-clinical tests were conducted for safety (ANSI AAMI ES60601-1, IEC60601-1-2), biocompatibility (not required as components are not tissue contacting), performance (bench tests including safety, environmental, device performance, and function tests), and software validation.
- Absence of Clinical Study: Explicitly stating that "No clinical testing was required to support substantial equivalence."
Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because such information is not present. The device is cleared based on substantial equivalence to predicate devices rather than direct performance metrics derived from clinical or AI-driven studies.
To address your request, if this were a device involving AI or complex performance metrics, the missing information would typically include:
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Table of Acceptance Criteria and Reported Device Performance: This would specify quantitative metrics (e.g., accuracy, sensitivity, specificity, precision, F1-score) and the threshold they needed to meet for acceptance, along with the actual performance achieved in a test set.
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Sample Size and Data Provenance: Details on the number of cases/patients in the test set, their country of origin, and whether the data was collected retrospectively or prospectively.
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Number and Qualifications of Experts for Ground Truth: The number of human experts (e.g., radiologists, pathologists) who reviewed the test data to establish the correct diagnoses or labels, along with their professional qualifications and experience.
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Adjudication Method: How disagreements among experts were resolved to arrive at a definitive ground truth (e.g., majority vote, senior expert arbitration).
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: If human readers were involved, whether a study was conducted to assess the improvement in human performance (e.g., diagnostic accuracy) when assisted by the AI device compared to unassisted human performance, and the calculated effect size.
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Standalone Performance: Data on the device's performance (e.g., diagnostic accuracy) when operating without human intervention.
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Type of Ground Truth: Whether the ground truth was established by expert consensus, surgical pathology, long-term patient outcomes, or other definitive methods.
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Training Set Sample Size: The number of cases/patients used to train the device's algorithm.
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Training Set Ground Truth Establishment: How the ground truth for the training data was determined.
In summary, the provided document does not contain the specific information requested about acceptance criteria and performance study results because it details a 510(k) clearance based on substantial equivalence, not a performance study with detailed AI or clinical metrics.
§ 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.