(90 days)
Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It has been designed for combined use with the ultrasound generator 2271 for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved.
The Suction pump 2207 is a roller pump that generates a continuous vacuum for aspirating the particles and liquids during ultrasound lithotripsy into a fluid trap (bottle).
The provided text describes a 510(k) summary for a medical device, the Richard Wolf Suction Pump 2207. It does not contain information about a study proving the device meets specific acceptance criteria in the way a diagnostic AI/ML device would. Instead, it describes general safety and performance aspects for regulatory submission.
However, I can extract information related to what would be considered "performance" in a medical device context for this submission:
Here's the breakdown of the available information structured to match your request, with an emphasis on what's not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with electrical safety standards (UL 2601 and IEC 601-1) | The Suction pump 2207 is conforming to standards UL 2601 and IEC 601-1. |
| Functionality in generating continuous vacuum for aspiration | The Suction pump 2207 is a roller pump that generates a continuous vacuum for aspirating the particles and liquids during ultrasound lithotripsy into a fluid trap. |
| Functionality for aspirating disintegrated kidney, bladder, and ureter stones and liquids | Designed for combined use with ultrasound generator 2271 for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved. |
| Feedback control of vacuum/suction rate | The vacuum applied to the fluid trap (and with it the suction rate) is continuously measured and feedback-controlled by software. |
| Suction monitoring | The suction is monitored by a flow detector. |
| Safety interruption if pump housing cover is opened | A safety circuit interrupts the suction if the cover of the pump housing is opened. |
| Interface for increasing suction rate during ultrasound activation | The suction pump has an interface to our Intracorporeal Ultrasound Lithotripter 2271 for increasing the suction rate during activation of ultrasound. |
| Safety and effectiveness when used according to instructions | These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document refers to the regulatory submission for a physical medical device (suction pump), not a diagnostic algorithm or a study with a test set of data. The "testing" mentioned is likely internal engineering and electrical safety testing.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on images) is not relevant for this type of device submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical suction pump, not a diagnostic imaging AI.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of AI/ML. For this physical device, "ground truth" would refer to its physical conformity to engineering specifications and safety standards. The document states it conforms to UL 2601 and IEC 601-1.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
In summary, the provided document describes a 510(k) submission for a medical device (a suction pump) focusing on its intended use, technological characteristics, and conformance to existing safety standards. It explicitly states, "No clinical tests performed." The "performance data" refers to compliance with electrical safety standards, not clinical efficacy trials or AI/ML diagnostic performance metrics.
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”