(106 days)
Use of the Venturi™ Negative Pressure Wound Therapy system is indicated for use for patients with acute or chronic wounds that may be benefited by the application of neqative pressure therapy and the potential wound healing effects of removal of fluids including wound exudates, irrigation fluids, and infectious materials. Venturi is intended for use in acute care settings only.
The Talley Venturi™ system consists of a powered suction pump for the application of vacuum to wounds for fluid removal. Consumables for use with the pump include collection canister, connection tubing, drain, and wound dressing products.
The provided document, K080897, is a 510(k) summary for the Talley Venturi™ Negative Pressure Wound Therapy system. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through technological characteristics and basic performance testing, rather than an elaborate clinical study with detailed acceptance criteria and performance metrics in the way a new, high-risk device might be evaluated.
Therefore, many of the requested elements for a study proving acceptance criteria are not explicitly present or are not applicable in this 510(k) submission. I will extract the information that is available and explain where the requested information is not provided by the document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Canister Vacuum Test | Criteria: Loss of vacuum measured over a prescribed period. Units pass or fail. (Specific threshold values are not provided in the summary) |
| Performance: Performed on 100% of production units to check for air-tightness and recognition of sensor pins. | |
| Vacuum Pump Test | Criteria: Tested flow and pressure levels compared with defined minimum values to determine pass or fail. (Specific minimum values are not provided in the summary) |
| Performance: Performed on 100% of production sub-assemblies. | |
| Soak Test | Criteria: Device runs for 48 hours prior to final test. (Pass/fail criteria based on successful operation for 48 hours). |
| Performance: Performed on 100% of assembled production pump units. | |
| Final System Test | Criteria: All functions and buttons, correct pressure calibration, air tightness, canister recognition, warning systems and alarms, and charging system operational. (Specific quantitative thresholds for calibration, air tightness, etc., are not provided in the summary). |
| Performance: Performed on 100% of production units. | |
| Technological Equivalence | Criteria: Operates at the same pressure ranges as predicate devices; consumable accessories correspond to those of predicate devices. |
| Performance: "The Talley Venturi™ system includes the same type suction pump as the predicate devices, operating at the same pressure ranges. Consumable accessories include collection canister, tubing, drains, and wound dressing components, These accessories correspond with accessories available with the predicate devices." |
Study Details and Missing Information:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document indicates that all performance tests (Canister Vacuum, Vacuum Pump, Soak, and Final System Tests) were performed on 100% of production units or sub-assemblies. This implies a continuous quality control process for manufacturing rather than a discrete "test set" in the context of a clinical study or performance verification using a limited sample.
- Data Provenance: Not explicitly stated. The tests described are manufacturing quality control checks, so the data would originate from the manufacturing facility. There is no mention of country of origin for clinical data, as this is not a clinical study. The testing described is prospective as it's part of the manufacturing process for each unit.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. The "ground truth" for the engineering performance tests (e.g., proper pressure, air-tightness) is established by predefined engineering specifications and calibration standards for the device components and system, not by clinical experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None specified. The tests described are pass/fail engineering tests based on objective measurements against internal specifications. There is no expert adjudication process mentioned.
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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:
- No. This document is for a Negative Pressure Wound Therapy system (a physical medical device, essentially a pump), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI effectiveness are not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. As above, this is a physical medical device, not an algorithm. Performance is assessed based on the device's physical functions.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the engineering performance tests mentioned is based on predefined engineering specifications and calibration standards for vacuum, pressure, and operational functions.
- For the overall substantial equivalence claim, the "ground truth" is the performance and established safety of the predicate devices (Blue Sky Versatile 1 System K042134, K052456 and Boehringer Labs Suction Pump system K061788). The new device is deemed acceptable if its technological characteristics and performance are comparable.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of an engineering performance study for a physical device like this. This would typically apply to machine learning algorithms.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant to the information provided.
§ 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.