DIAGNOSTIC ULTRASOUND TRANDUCER

K953819 · Biosound, Inc. · ITX · Mar 1, 1996 · Radiology

Device Facts

• Record ID: K953819
• Device Name: DIAGNOSTIC ULTRASOUND TRANDUCER
• Applicant: Biosound, Inc.
• Product Code: ITX · Radiology
• Decision Date: Mar 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

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 Story

INT13 is a linear array diagnostic ultrasound transducer for open abdominal surgery. It captures ultrasound signals to image abdominal anatomy and assess blood flow via B-mode, M-mode, PW-mode, and CFM. Operated by surgeons or clinicians during open procedures, the device connects to an ultrasound system to display real-time images. These images assist clinicians in visualizing internal structures and vascular flow, facilitating intraoperative decision-making. The device is constructed from PVC, Ultem, and epoxy, and is sterilized using Cidex solutions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Linear array transducer; operating frequencies 3.5-10.0 MHz depending on mode (B, M, PW, CFM). Materials: PVC (Putnam Plastics), Ultem (GE Plastics), TRA-Bond Epoxy. Safety standard: IEC 601-1 (CEI62-5). Sterilization: Cidex solution. Dimensions: 2.5m cable, 0.3kg weight.

Indications for Use

Indicated for patients undergoing open abdominal surgical procedures requiring ultrasound imaging of abdominal anatomy and blood flow assessment.

Regulatory Classification

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.

Predicate Devices

• Hitachi Intraoperative Ultrasound Transducer EUP - 033J (K884644)

Reference Devices

• Esaote LP12 Laparoscopic probe (K941935)

Submission Summary (Full Text)

{0}

Safety and Effectiveness Summary
INT13 Intraoperative Diagnostic Ultrasound Transducer
Biosound, Inc.
K953819
PAGE 1 of 3
MAR - 1 1996
BIOSOUNI
K953819

# Safety and Effectiveness Summary

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: [phone]
Facsimile: [phone]

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

1
Biosound, Inc. • An Examiner Biomedical Company
7990 Castleway Drive • Indianapolis, Indiana 46250
412-428-4374 • FAX [phone]

{1}

K 953819
P-223

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

807.92(a)(4)

# 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. The table below provides further descriptive information about the INT13 transducer.

## 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.

{2}

K953819
P. 3 of 3

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

807.92(a)(5)

## Intended Use(s)

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.

807.92(a)(6)

## Substantial Equivalence

## SUBSTANTIAL EQUIVALENCE COMPARISON TABLE

| Characteristic | Esaote INT13 | Hitachi EUP 088 J
K884644 |
| --- | --- | --- |
| 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.