(199 days)
The INT13 is a diagnostic ultrasound intraoperative transducer for use in abdominal surgery. The transducer can be used to image abdominal anatomy during abdominal surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels.
The Esaote INT13 intraoperative transducer is designed and intended to be used in open (open as opposed to laparoscopic used with a trocar) abdominal surgical procedures. More specifically, the transducer is intended to be used to image abdominal anatomy during open surgical procedures.
This document describes a 510(k) premarket notification for a new diagnostic ultrasound transducer, the INT13 Intraoperative Transducer by Biosound, Inc. This submission focuses on establishing substantial equivalence to a predicate device, the Hitachi Intraoperative Ultrasound Transducer EUP - 033J (K884644), rather than presenting a study with acceptance criteria for device performance.
Therefore, the requested information regarding acceptance criteria and a study to prove the device meets them cannot be extracted from the provided text because such a study is not described.
The document primarily focuses on:
- Device Description: Specifications, materials, sterilization process.
- Intended Use: Diagnostic ultrasound intraoperative transducer for abdominal surgery, including Doppler mode for blood flow.
- Substantial Equivalence Comparison: A table comparing the INT13 to the predicate device (Hitachi EUP 088 J) based on intended use, technology, frequencies, operating modes, cable length, and safety standard.
In summary, the provided text does not contain information about acceptance criteria or a study demonstrating the device meets performance metrics. The core of this 510(k) submission is to argue for substantial equivalence to an existing device, which is a different regulatory pathway than proving specific performance against predefined acceptance criteria from a new clinical study.
§ 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.