(204 days)
Use of the Venturi™ NPWT v.II Advanced Vacuum System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patient's bedside.
The Talley Venturi™ system consists of a powered suction pump for the application of vacuum for fluid removal. Consumables for use with the pump include collection canister and connection tubing.
The provided document is a 510(k) summary for the Talley Venturi™ NPWT v.II Advanced Vacuum System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving clinical effectiveness or meeting specific performance criteria through a detailed study on human patients. Therefore, information typically found in clinical studies (like sample sizes for test sets, expert qualifications, MRMC studies, training set details, or ground truth establishment for clinical outcomes) is not present in this document because it is not required for a 510(k) summary of a powered suction pump.
The document primarily focuses on bench testing to ensure the device functions correctly and is safe, aligning with its substantial equivalence claim to predicate devices.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Internal/Bench Testing) | Reported Device Performance |
|---|---|
| Canister vacuum test: | Performed on 100% of production units. Checks for air-tightness and recognition of sensor pins. Loss of vacuum is measured over a prescribed period. Units pass or fail. |
| Vacuum pump test: | Performed on 100% of production sub-assemblies. Measures flow and pressure. Tested levels are compared with defined minimum values to determine pass or fail. |
| Soak test: | Performed on 100% of assembled production pump units. Units are run for 48 hours prior to final test to ensure durability and continuous operation. |
| Final system test: | Performed on 100% of production units. Tests include all functions and buttons, correct pressure calibration, air tightness, canister recognition, warning systems and alarms, and charging system operational. |
| Substantial Equivalence: | The Talley Venturi™ NPWT v.II Advanced Vacuum System is concluded to be substantially equivalent to the predicate devices (Blue Sky Versatile 1 System K021919 and Prodigy NPWT System K082415), operating at the same pressure ranges. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: The "Specific Performance Testing" section states that tests are performed on 100% of production units or 100% of production sub-assemblies. This implies a continuous quality control process rather than a one-time test set. For the purpose of regulatory submission, it refers to the units tested to demonstrate the device meets its own specifications.
- Data provenance: Not explicitly stated, but these are internal manufacturing and testing data from Talley Medical. There is no indication of country of origin for clinical data as no clinical data is presented. It's prospective testing in the sense that units are tested as they are produced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for these tests are objective, measurable physical parameters (e.g., pressure, flow, air-tightness) specified by engineering and design requirements, not subjective expert assessment.
4. Adjudication method for the test set:
- Not applicable. The tests are pass/fail based on objective measurements against defined minimum values or specified functionalities. There is no human adjudication process described for these engineering tests.
5. 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 is a mechanical device (powered suction pump), not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a powered suction pump, not an algorithm or AI system.
7. The type of ground truth used:
- For the described tests, the "ground truth" is defined by engineering specifications and functional requirements (e.g., specific pressure ranges, flow rates, air-tightness, correct operation of buttons, alarms, charging system).
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The development of the device would involve engineering design and iterative prototyping and testing, but not a dataset for algorithm training.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set in the context of AI/ML.
In summary: The document describes standard engineering and manufacturing quality control tests to ensure the device performs according to its design specifications and is substantially equivalent to existing predicate devices. It does not involve complex clinical studies or AI/ML evaluations.
§ 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.