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.

Device Description

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.

AI/ML Overview

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.

Summary

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Safety and Effectiveness Summary INT13 Intraoperative Diagnostic Ultrasound Transducer Biosound, Inc.

MAR - 1 1996

Safety and Effectivene

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The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR ¶807.92(a).

807.92(a)(1)

Submitter Information

Wayne Nethercutt Director, Regulatory Affairs 7990 Castleway Drive Indianapolis, IN 46250

Phone: (317) 849-1793

Facsimile: (317) 841-8616

Contact Person: Wayne Nethercutt

Date: 08-09-95

807.92(a)(2)

Trade Name: INT 13 Intraoperative Transducer

Common Name: Diagnostic Ultrasound Transducers

Classification Name(s): Transducer, Ultrasonic, Diagnostic 892.1570

807.92(a)(3)

Predicate Device(s)

. Hitachi Intraoperative Ultrasound Transducer EUP - 033J K884644

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K 953819
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Safety and Effectiveness Summary INT13 Intraoperative Diagnostic Ultrasound Transchicer Biosound, Inc.

807.92(a)(4)

DEVICE DESCRIPTION

SPECIFICATIONS

Operating Temperature	+5 to +35 C°
Storing Temperature	-5 to +45 C°
Weight	0.3 Kg
Safety Requirement	IEC 601-1 (CEI62-5)
Operating Modes and Frequencies
B - Mode	7.5 - 10.0 Mhz
M - Mode	7.5 - 10.0 Mhz
PW - Mode	3.5 - 4.7 - 7.0 Mhz
CFM	3.5 - 4.7 - 7.0 Mhz
Intended Use	Intraoperative, Abdominal
Technology	Linear Array
Cable Length	2.5 Meters

MATERIALS

Esaote has chosen to construct the INT13 transducer with the same materials they used in constructing the LP12 Laparoscopic probe. The LP12 device is currently under review with FDA under K941935 Esaote has received FDA's letter stating that all requirements have been satisfied for part one of K941935 (two-part submission), and that FDA is awaiting only acoustic output data. The materials for the laparoscopic probe described in K941935, and those used for the subject device, INT13, are:

PVC, Putnam Plastics Ultem, General Electric Plastics FDA, TRA-Bond Epoxy

Both probes will be used in the same type of application; abdominal intraoperative imaging

STERILIZATION

The INT13 transducer can be sterilized with Cidex™ solutions. The procedure for sterilizing the INT13 transducer is provided in the operator's manual.

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Safety and Effectiveness Summary INT13 Intraoperative Diagnostic Ultrasound Transducer Biosound, Inc.

807.92(a)(5)

Intended Use(s)

807.92(a)(6)

Substantial Equivalence

SUBSTANTIAL EQUIVALENCE COMPARISON TABLE

Characteristic	Esaote INT13	Hitachi EUP 088 JK884644
Intended Use	Abdominal, Intraoperative	Abdominal, Intraoperative
Technology	Linear Array	Linear Array
Frequencies Mhz	7.5 - 10.0	7.5
Operating Modes	B, PW, M, CFM	B, PW, M, CFM
Cable length	2.5 meters	2.2 meters
Safety Standard	IEC 601-1	IEC 601-1

The table above illustrates the equivalence of the compared devices. The intended use, and imaging characteristics of the compared products are equivalent. The Esaote product offers more frequencies than the Hitachi product which enhances the clinical utility of the Esaote product. Based on the comparison table above, we believe the two products are substantially equivalent.

Regulation Number and Section

§ 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.