(67 days)
The DevMed is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate cancer.
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The provided text is a 510(k) summary for the DevMed™ Stepping and Stabilizing System, which is a device used for precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments, specifically for prostate cancer.
The document does not describe any acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market, which is the basis for 510(k) clearance.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment. The provided text explicitly states that the "510(k) 'Substantial Equivalence' Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed" and lists comparisons based on intended use, technological characteristics, and materials.
Key takeaway from the provided text: The DevMed™ Stepping and Stabilizing System was cleared based on its substantial equivalence to previously cleared devices, not on a study proving it meets specific performance acceptance criteria in the way a new medical device would typically be evaluated for efficacy or diagnostic performance.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.