DIAGNOSTIC ULTRASOUND TRANSDUCER

K953759 · Biosound, Inc. · ITX · Mar 1, 1996 · Radiology

Device Facts

• Record ID: K953759
• Device Name: DIAGNOSTIC ULTRASOUND TRANSDUCER
• 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 LP13 is a diagnostic ultrasound transducer for use in laparoscopic surgery. The transducer can be used to image abdominal anatomy during laparoscopic surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels

Device Story

LP13 is a laparoscopic diagnostic ultrasound transducer; introduced into the abdomen via trocar. Features a movable distal tip controlled by handle levers to optimize imaging position. Operates in B, M, PW, and CFM modes. Used by surgeons during laparoscopic procedures to visualize abdominal anatomy and blood flow. Output displayed on compatible ultrasound system for clinical decision-making; aids in surgical navigation and assessment of abdominal structures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Linear array transducer. Materials: PVC (Putnum Plastics), Ultem (GE Plastics), FDA TRA-Bond Epoxy. Operating frequencies: 7.5-10.0 MHz (B/M-mode), 3.5-7.0 MHz (PW/CFM-mode). Movable tip (+/- 90 degrees). Safety standard: IEC 601-1. Sterilization: Cidex solution.

Indications for Use

Indicated for use in laparoscopic surgery to image abdominal anatomy and provide information about blood flow in abdominal vessels.

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

• Aloka UST 5522 - 7.5 Transducer (K925486)

Reference Devices

• LP12 transducer (K941935)
• Cidex solution (K924434)

Submission Summary (Full Text)

{0}

Safety and Effectiveness Summary
LP13 Laparoscopic Diagnostic Ultrasound Transducer
Biosound, Inc.
K 953759
P. 1 of 3
MAR - 1 1996
BIOSOUNI
AN ESAUTE COMPANY

# 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: LP13 Laparoscopic Transducer
Common Name: Diagnostic Ultrasound Transducers
Classification Name(s): Transducer, Ultrasonic, Diagnostic 892.1570

807.92(a)(3)

## Predicate Device(s)

- Aloka UST 5522 - 7.5 Transducer K925486

Biosound, Inc. - An Esaute Company
7990 Castleway Drive - Indianapolis, IN 46250
317-849-1793 - 800-428-4374 - FAX [phone]

{1}

Safety and Effectiveness Summary
LP13 Laparoscopic Diagnostic Ultrasound Transducer
Biosound, Inc.
K 953759
p. 2 of 3

807.92(a)(4)

# Device Description

The LP13 is a diagnostic ultrasound transducer intended to be used in laparoscopic surgical procedures. The transducer is introduced into the abdomen through a trocar following the procedure described in the operator's manual. The distal tip of the device contains the transducer element and is movable. Movement of the transducer is controlled by the levers located on the handle of the device.

## Specifications

| Intended use | Abdominal, Laparoscopic |
| --- | --- |
| Operating Modes | B, M, PW, CFM |
| Operating 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 |
| Movement Range of Transducer | +1- 90° |
| Cable Length | 3 Meters |
| Operating Temperature | +5 to +35 C° |
| Storing Temperature | -5 to +45 C° |
| Weight | 0.3 Kg |
| Safety Standard | IEC 601-1 (CEI 62-5) |

The materials comprising the transducer are the same as those described and accepted in K941935. The materials are listed here again for reference:

1) PVC from Putnum Plastics
2) Ultem from General Electric Plastics
3) FDA TRA-Bond Epoxy

## Sterilization

Sterilization can be accomplished in the same way as described in K941935 for the LP12 transducer, with Cidex™ solution. Cidex™ solution was cleared by the FDA under K924434. The procedure is described in the operator's manual.

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K953759
P-3 & 3

Safety and Effectiveness Summary
LP13 Laparoscopic Diagnostic Ultrasound Transducer
Biosound, Inc.
807.92(a)(5)

# Intended Use(s)

The LP13 is a diagnostic ultrasound transducer for use in laparoscopic surgery. The transducer can be used to image abdominal anatomy during laparoscopic 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 LP13 | Aloka
UST5522
K925486 |
| --- | --- | --- |
| Intended Use | Abdominal
Laparoscopic | Abdominal
Laparoscopic |
| Technology | Linear Array | Linear Array |
| Operating Modes | B, PW, M, CFM | B, PW, M |
| Diameter | 9.5 mm | 10.0 mm |
| Moveable Transducer | Yes | No |
| Frequencies | 7.5 - 10.0 Mhz | 7.5 Mhz |
| Safety Standard | IEC 601-1 | IEC 601-1 |

The table above illustrates the equivalence of the compared devices. The LP13 offers and additional mode which enhances its clinical utility. A moveable transducer allows the operator to achieve the best image by achieving an optimum imaging position; a feature not offered by the Aloka device. Based on the about comparison and in light of the minor differences noted, we believe the devices compared above are substantially equivalent

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