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The Econolith™ E3000 is indicated for use in non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.

Medispec Ltd.'s Econolith™ E3000 uses shock waves generated outside the patient's body to fragment urinary calculi within either the kidney or upper ureter. The device consists of an electrony draulic shock wave generator, control panel, and motorized patient table. Although the device does not provide imaging or monitoring functions, it does contain dedicated interfaces for the requisite fluoroscopic imaging and ECG monitoring.

The shock wave generator is a self-contained unit which includes an underwater electrode, a control system, and a high voltage power supply system.

The treatment table is specifically designed for use with the Econolith™ Lithotripter. The table can position the patient in multi-dimensions and also provides access to the patient's lumbar region through removable inserts.

The provided document is a 510(k) summary for the Medispec Ltd. Econolith™ E3000, an Extracorporeal Shock Wave Lithotripter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance results in the format requested.

Therefore, the document does not contain the detailed clinical study information required to fill out a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or adjudication methods for a standalone study designed to prove the device meets specific performance metrics.

The document primarily states that the device's "Technological Characteristics" are "in compliance with FDA Guidance for the Content of Premarket Notifications (510(k)) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, August 2000 and all applicable performance standards." This implies that the device was evaluated against existing standards and guidance, but the specifics of that evaluation (e.g., breakdown of performance metrics, sample sizes, and ground truth establishment) are not provided in this summary.

Based on the provided text, I cannot complete the requested information for a clinical study proving the device meets specific acceptance criteria.

The document's purpose is to show substantial equivalence, not to detail the results of a primary clinical study establishing performance against new acceptance criteria.

Information that can be extracted from the provided text, but does not directly answer the requested questions:

• Intended Use/Indications for Use: Non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.
• Predicate Device: HealthTronic's Lithotron Lithotripsy System (P970019).
• Basis for Substantial Equivalence: Similar intended use, principle of operations, ancillary equipment, and technological specifications.
• Regulatory Guidance: FDA Guidance for the Content of Premarket Notifications (510(k)) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, August 2000, and all applicable performance standards.

Conclusion: The provided 510(k) summary does not contain the detailed performance study information typically associated with establishing acceptance criteria and proving a device meets them through empirical data. It serves as a regulatory document demonstrating equivalence to an already approved device.

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