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The Bora UP 2080, BORA UP 2080 OP and BORA UP 2080 MOUNTING are intended as extraction suction units for aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient's bedside.

The MEDAP BORA is a high performance, low-noise suction pump designed for continuous operation and suitable for high flow/high vacuum. The vacuum for the MEDAP BORA is produced by an electrically driven pump unit. The pump must be operated with an overflow protection device. The overflow protection device with float prevents the unit from oversuction. In the event of a high filling level, the float rises, closes the suction line and prevents liquid from discharging. In addition, the hydrophobic bacterial and viral filter prevents the penetration of particles and liquid into the suction unit. A bacterial filter paper in the exhaust air area guarantees additional safety for patients and operators. The unit is equipped with a hydrophobic bacterial and viral filter to protect the inside of the pump from bacterial contamination. This hydrophobic bacterial and viral filter must be used when treating infectious patients. The vacuum can be set from 0 to -90kPa (0 to -675 mmHg) using a regulation switch and is controlled using a vacuum gauge.

This 510(k) premarket notification for the Maquet GmbH & Co. KG MEDAP BORA device does not contain information about specific acceptance criteria, device performance results, or a study design in the way one would typically find for an AI/ML-driven medical device. Instead, it describes a traditional medical device (a powered suction pump) and focuses on establishing substantial equivalence to a predicate device.

Therefore, many of the requested categories are not applicable to the provided document. I will fill in the available information and explicitly state when information is not present or not relevant for this type of submission.

1. A table of acceptance criteria and the reported device performance

"The BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting incorporate similar fundamental scientific technology as its predicate device."

"The performance data of BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting are equivalent to the predicate device." |
| - Intended Use | - Intended use is presented as equivalent (as extraction suction units for aspiration and removal of fluids and infectious material). |
| - Principles of Operation | - Operates as a high-performance, low-noise suction pump with an electrically driven unit, overflow protection, and bacterial/viral filters, similar to the predicate. |
| - Design | - Design is presented as equivalent to the predicate. |
| - Physical Characteristics | - Physical characteristics are presented as equivalent to the predicate. |
| - Performance (e.g., vacuum range, flow rate, safety features) | - Vacuum can be set from 0 to -90kPa (0 to -675 mmHg). Performance data stated as equivalent to the predicate device. Specific quantitative performance metrics beyond vacuum range are not detailed in this summary. Product features like overflow protection, hydrophobic bacterial/viral filters, and bacterial filter paper for exhaust air are mentioned as safety features. |
| - Safety | - Safety features (overflow protection, bacterial/viral filters) are described, and overall safety is presented as equivalent to the predicate. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This document describes a traditional medical device (powered suction pump) and does not involve AI/ML technology. Therefore, there is no "test set" in the context of evaluating an algorithm's performance on data. The evaluation is based on engineering principles, design specifications, and comparison to a predicate device.

3. 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. This is not an AI/ML device requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is not an AI/ML device requiring data adjudication.

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

• Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" for this device would be its ability to meet engineering specifications (e.g., vacuum pressure, flow rates, safety mechanisms) which are established through bench testing and compliance with relevant standards, rather than clinical ground truth as understood for AI/ML.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device.

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