DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

K953530 · Biosound, Inc. · IYO · Apr 8, 1996 · Radiology

Device Facts

• Record ID: K953530
• Device Name: DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A
• Applicant: Biosound, Inc.
• Product Code: IYO · Radiology
• Decision Date: Apr 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Indications for Use

The intended use is specific for each transducer: P12A - Vascular PT10A - Transcranial P10A - Cardiac PA11A - Cardiac/ Transcranial

Device Story

Diagnostic ultrasound transducers (P10A, P12A, PT10A, PA11-A) used for medical imaging. Devices convert electrical signals into ultrasonic waves and receive reflected echoes to produce diagnostic images or measurements. Operated by clinicians in clinical settings. PA11-A supports B-mode, M-mode, PW, CW, CFM, and Power Color modes; P10A, P12A, and PT10A are CW transducers. Output displayed on compatible ultrasound systems to assist in clinical diagnosis of cardiac, vascular, and transcranial structures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Diagnostic ultrasound transducers with operating frequencies ranging from 2.0 to 5.0 MHz. PA11-A features electronic connectors; P10A, P12A, and PT10A feature mechanical connectors. Safety requirements meet IEC 601-1 (CEI 62-5). Operating temperature range +10 to +40°C.

Indications for Use

Indicated for diagnostic ultrasound imaging and measurement in cardiac, vascular, and transcranial applications.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Esaote P10 Diagnostic Ultrasound Transducer (K896356)
• Esaote P12 Diagnostic Ultrasound Transducer (K896356)
• Esaote SMA26 Diagnostic Ultrasound Transducer (K944485/S3)
• Acuson S228 Diagnostic Ultrasound Transducer (K902515)

Submission Summary (Full Text)

{0}

Safety and Effectiveness Summary
Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A
Biosound, Inc.

APR - 8 1995

K953530

BIOSOUNI
AN ISADIE 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: 07-18-95

807.92(a)(2)

Trade Name: P10A, P12A, PT10A, PA11-A
Common Name: Diagnostic Ultrasound Transducers
Classification Name(s): Transducer, Ultrasonic, Diagnostic 892.1570

Biosound, Inc. - An Isadie Company
7990 Castleway Drive - Indianapolis, IN 46250
317 849 1793 800 429 4374 FAX [phone]

{1}

Safety and Effectiveness Summary
Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A
Biosound, Inc.

7.92(a)(3)

# Predicate Device(s)

- Esaote P10 Diagnostic Ultrasound Transducer K896356
- Esaote P12 Diagnostic Ultrasound Transducer K896356
- Esaote SMA26 Diagnostic Ultrasound Transducer K944485/S3
- Acuson S228 Diagnostic Ultrasound Transducer K902515

Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table.

807.92(a)(6)

## SUBSTANTIAL EQUIVALENCE COMPARISON TABLE

| ESAOTE AU4 | Frequency MHz | Predicate Device | Frequency MHz | Application |
| --- | --- | --- | --- | --- |
| | | Esaote AU530
510 (k): 896356 | | |
| P12A | 4.7 | P12 | 5.0 | Vascular |
| 1OA | 2.3 | P1O | 2.5 | Cardiac |
| ESAOTE AU4 | Frequency MHz | Predicate Device | Frequency MHz | Application |
| --- | --- | --- | --- | --- |
| PT1OA | 2.0 | Acuson Probe S228
Cleared via K902515 | 2.0 | Transcranial |
| ESAOTE AU4 Code | Frequency MHz | Predicate Device | Frequency MHz | Application |
| --- | --- | --- | --- | --- |
| PA11-A | 2.5 - 3.5 B-Mode
2.3 - 2.8 PW/CFM/CW | Esaote Probe: SMA26
Cleared via K944485/S3 | 2.5 - 3.5 | Cardiac |
| | 2.5 - 3.5 B-Mode
2.3 - 2.8 PW/CFM/CW | Acuson Probe S228
Cleared via K902515 | 2.0 - 2.5 | Transcranial |

{2}

Safety and Effectiveness Summary
Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A
Biosound, Inc.

807.92(a)(4)

# Device Description

The subject devices are diagnostic ultrasound transducers described in the following tables.

## PA11-A

| MODES | CHARACTERISTICS |
| --- | --- |
| B mode | 2.5/3.5 MHz |
| M mode | 2.5/3.5 MHz |
| PW mode | 2.3/2.8 MHz |
| CW mode | 2.3/2.8 MHz |
| CFM mode | 2.3/2.8 MHz |
| Power Color | 2.3/2.8 MHz |
| Elevation & Focal Point | 80 mm |
| Angle | 30-90 deg. |
| Depth | 55.3 ÷ 260 mm |
| Connector | Both Electronic connectors |
| Cable length (meters) | 2.00 mt. |
| Operating Temperature (deg.C) | from +10 to +40 |
| Storing temperature (deg.C) | from -5 to +45 |
| Weight (Kg) | 500 G. |
| Safety Requirements | IEC 601-1(CEI62-5) |
| Application | Cardiac Transcranial |

{3}

Safety and Effectiveness Summary
Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A
Biosound, Inc.

# P10A, P12A, PT10A

| MODES | P10A | P12A |
| --- | --- | --- |
| MODE | CW | CW |
| Frequency | 2.5 MHz | 5.0 MHz |
| Connector | Both Mechanical connectors | Both Mechanical connectors |
| Cable length (meters) | 1850 mm | 1850 mm |
| Operating Temperature (deg.C) | from +10 to +40 | from +10 to +40 |
| Storing temperature (deg.C) | from -5 to +45 | from -5 to +45 |
| Weight (Kg) | 200 G. | 200 G. |
| Safety Requirements | IEC 601-1(CEI62-5) | IEC 601-1(CEI62-5) |
| Application | Cardiac | Vascular |

807.92(a)(5)

## Intended Use(s)

The intended use is specific for each transducer: P12A - Vascular
PT10A - Transcranial
P10A - Cardiac
PA11A - Cardiac/ Transcranial