Medstone 1050 Extracorporeal Shock Wave Lithotriptor

• • Terminated Z-0884-04 FDA Unclassified (pre-2012) ·initiated 11 Jun 2004 ·on shared PMA P870015

  Units are defective in that the identification and certification labels were inadequate or missing. The beam limiting device was not appropriate for general purpose radiographic procedures and the beam limiting device could ot collimate down to 125 square centimeters or less as required.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Medstone 1050 Extracorporeal Shock Wave Lithotript

Trade Name

Medstone 1050 Ectracorporeal Shock Wave Lithotript

Generic Name

Lithotriptor, extracorporeal shock-wave, urological

PMA Number

P870015 ↗

FDA Product Code

LNS

Device Class

Class II

Regulation

21 CFR Part 876.5990

Advisory Committee

Gastroenterology, Urology

FDA Decision

APRL

• Sts-T Lithotripter, Model Sts-T

  Class II

  FDA 510(k) K010900 Active Cleared 5 Apr 2001

• UroPro 2000 Tomographic Option

  Class II

  FDA 510(k) K013620 Active Cleared 22 Jan 2002

• Sts(Tm) Fluoroscopic Imaging Module

  Class II

  FDA 510(k) K905278 Active Cleared 4 Feb 1991

• Medstone STS Lithotripter

  Class III

  FDA PMA P970042 Withdrawn Approved 5 Sep 2000

• What clinical specialties is the Medstone 1050 primarily used in, and why is this relevant for my practice?

  The Medstone 1050 Extracorporeal Shock Wave Lithotriptor is designed for use in urology and gastroenterology departments, as indicated by its advisory committee classification (GU) and medical specialty designation. This device is specifically intended for non-invasive fragmentation of urinary stones (renal or ureteral calculi) using extracorporeal shock waves, making it particularly relevant for clinicians treating patients with kidney or ureteral stones. Its application aligns with procedures in these specialties where stone removal or reduction is a key objective.

• Is the Medstone 1050 a single-use or reusable device, and what does this mean for maintenance and cost considerations?

  The Medstone 1050 is a reusable medical instrument, meaning it is designed for repeated use in clinical settings after proper cleaning, maintenance, and calibration. This requires an investment in upkeep—including regular servicing—to ensure accurate shock wave delivery and device performance. Reusability also impacts cost structures, as facilities must account for maintenance, sterilization (if applicable), and potential replacement parts over time.

• What regulatory pathway does the Medstone 1050 follow, and how does this affect its availability or use in my facility?

  The Medstone 1050 holds FDA Premarket Approval (PMA) under PMA number P870015, which means it has undergone rigorous review to demonstrate safety and effectiveness for its intended use. This approval ensures the device meets regulatory standards outlined in 21 CFR 876.5990 for extracorporeal shock-wave lithotriptors. While this does not directly limit its availability, it confirms the device’s compliance with U.S. medical device regulations, which may influence procurement decisions or insurance coverage requirements.

• What types of urinary stones can the Medstone 1050 treat, and how does its design address this purpose?

  The Medstone 1050 is designed to fragment renal or ureteral calculi (kidney and ureter stones) using focused acoustic energy delivered via extracorporeal shock waves. This non-invasive approach breaks stones into smaller particles, facilitating their natural passage through the urinary tract. The device’s lithotripsy technology is specifically tailored for urological applications, making it suitable for treating common types of urinary stones, such as calcium oxalate or struvite calculi, though clinical effectiveness may vary based on stone composition and size.