(73 days)
The V.A.C. ® Via™ Therapy System is an integrated wound management system for use in acute, extended and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy
Negative pressure wound therapy system
This is a 510(k) summary for the V.A.C.® Via™ Negative Pressure Wound Therapy System. This document does not describe a study that proves the device meets acceptance criteria in the manner typically associated with AI/ML device submissions. Instead, it demonstrates substantial equivalence to a predicate device. Therefore, many of the requested fields cannot be directly extracted or are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Not applicable in this format):
The document does not explicitly state "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/ML devices. Instead, it focuses on demonstrating that the modified device performs "as designed" and is "substantially equivalent" to its predicate device. The performance data presented refers to engineering and quality assurance tests, not clinical performance in terms of wound healing outcomes.
| Metric (if applicable for this device type) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Negative Pressure Delivery | Conformance to design specifications | Confirmed therapy unit delivers negative pressure therapy |
| Software Functionality | Performs as designed | Software verification and validation testing confirmed performance as designed |
| Electrical Safety & EMC Standards | Meets applicable standards | Testing confirmed device meets all applicable electrical safety and electromagnetic compatibility standards |
| Battery Life | Adequate power for appropriate negative pressure | Testing demonstrated battery supplies adequate power for appropriate negative pressure |
Specific Questions:
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A table of acceptance criteria and the reported device performance:
- Please refer to the table above. It's a reinterpretation of what "acceptance criteria" might mean for this type of medical device submission. The document emphasizes functional and safety performance rather than clinical efficacy metrics.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This is a 510(k) summary for a Negative Pressure Wound Therapy System, not an AI/ML device relying on a "test set" of patient data for performance evaluation. The "tests" mentioned are bench tests, software verification, and electrical safety tests, which do not involve patient data or typical clinical study designs.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. The ground truth for electrical safety, software functionality, and negative pressure delivery is established by engineering standards and design specifications, not by clinical experts reviewing data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no test set of clinical images or patient data requiring expert adjudication.
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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 is not an AI/ML device, and no MRMC study or AI assistance is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device is a physical system delivering negative pressure.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance tests (e.g., negative pressure delivery, software function, electrical safety) is established by engineering design specifications, regulatory standards (like electrical safety and EMC), and physical measurements. It is not based on expert consensus, pathology, or outcomes data in the clinical sense directly for these performance tests. The device's efficacy in wound healing is covered by its indications for use which is established through prior clinical evidence for similar predicate devices.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set of data.
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How the ground truth for the training set was established:
- Not applicable. No training set is used for this 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.