(81 days)
The CyberWand Sterile Probe Set is designed to be used only with the CyberWand Dual Action Ultrasonic Lithotripsy System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
The Cybersonics CyberWand Dual Probe Ultrasonic Lithotripsy System is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezoelectric elements. which are driven by a generator operating at 20400 - 22200 Hz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.
The provided document describes a Special 510(k) submission for the CyberWand Sterile Probe Set, focusing on its substantial equivalence to previously cleared devices and supporting a five-year shelf life. The study detailed is specifically for package integrity and shelf-life validation, not for the device's clinical performance in fragmenting urinary tract calculi.
Therefore, many of the typical acceptance criteria and study components related to clinical efficacy or AI performance (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable to this submission.
Here's the relevant information based on the provided text, primarily concerned with the device's shelf life and package integrity:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Validation Requirements for 5-Year Shelf Life) | Reported Device Performance | Study Results |
|---|---|---|
| Package Integrity Validation (2ACMI-07P1-O/2013-GMP-028) | Supported a five (5) year expiration date | Acceptable test results for all listed tests, determining that a five-year expiration date may be applied. |
| - Accelerated Aging of Packaging | Met | Acceptable |
| - Real Time Aging of Packaging | Met | Acceptable |
| - Simulated Ship Test & Inspection | Met | Acceptable |
| - Dye Penetration Testing for Single Barrier Packages | Met | Acceptable |
| - Burst Package Testing for Packages | Met | Acceptable |
| - Peel Strength Test for Package Seals | Met | Acceptable |
2. Sample size used for the test set and the data provenance:
- Sample Size: Testing was conducted on "representative samples" of the device. The exact number of samples is not specified in the document.
- Data Provenance: Not explicitly stated, but implies internal testing by Cybersonics, Inc. The document does not mention the country of origin for the data, nor whether it was retrospective or prospective in the sense of clinical data. For package integrity, it was prospective in the sense of aging tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This study is for package integrity and shelf life, not clinical performance requiring expert ground truth on medical outcomes.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 typically relate to expert review of clinical cases. This study involved physical and material property testing, not subjective expert judgment of clinical data.
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 a study comparing human performance with or without AI assistance, nor is it an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical instrument (lithotriptor probe), not an AI algorithm.
7. The type of ground truth used:
- For shelf life and package integrity, the "ground truth" was defined by objective physical and material property measurements and industry/internal standards for package integrity (e.g., passing specific thresholds for burst strength, peel strength, dye penetration).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning study that would involve a training set.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI/machine learning study, there is no training set or associated ground truth establishment method.
§ 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.”