ULTRASOUND SYSTEM MODEL UF-3500

K955543 · Fukuda Denshi USA, Inc. · IYO · Feb 11, 1997 · Radiology

Device Facts

• Record ID: K955543
• Device Name: ULTRASOUND SYSTEM MODEL UF-3500
• Applicant: Fukuda Denshi USA, Inc.
• Product Code: IYO · Radiology
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This device is intended to be used for applications in fetal, abdominal, intra-operative, pediatric, small organ, transrectal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either transrectally or intraoperatively. It is intended to be used by or on the order of a physician or similarly qualified health care professional. The UF-3500 is intended to be used in a doctors office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.

Device Story

Portable general purpose ultrasound scanner; projects pulsed sound beams into body tissue; measures acoustic pulse duration/depth/location of tissue interfaces. Input: ultrasound transducer signals. Processing: microprocessor-based signal processing; calculates distance, area, circumference, volume, angle, and fetal metrics (gestational age, expected date of confinement, fetal weight). Output: 16-level greyscale B-Mode image on 7-inch monitor. Used in clinics/hospitals (ER, ICU, CCU, OR) by physicians/technicians. Healthcare providers use images/measurements for diagnostic assessment of fetal/abdominal abnormalities. Benefits: non-invasive visualization of internal structures for clinical management.

Clinical Evidence

Bench testing only. Validation included environmental testing per FDA 1993 guidance, acoustic output measurement per AIUM 1992 standards, and electrical safety testing per ANSI/AAMI ES1-1993. Hazard analysis and software validation conducted to verify design specifications.

Technological Characteristics

Portable ultrasound scanner; microprocessor-controlled; linear transducers; 7-inch greyscale monitor. Connectivity: supports up to two probes (one active). Electrical safety: UL 601, CSA 22.2, AAMI standards. Acoustic output: compliant with AIUM 1992 standards. Software: embedded microprocessor-based measurement and signal processing.

Indications for Use

Indicated for fetal, abdominal, intra-operative, pediatric, small organ, transrectal, and peripheral vessel scanning in neonate, pediatric, and adult patients. Used by or on order of physician/qualified healthcare professional in clinical/hospital settings.

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

• FUKUDA DENSHI FF sonic model UF-4500 General Purpose Ultrasound Scanner (K922208)

Submission Summary (Full Text)

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FEB 11 1997
K955543

# 510(k) Summary

## FUKUDA DENSHI FF sonic model UF-3500

General Purpose Ultrasound Scanner

## Submitter:

FUKUDA DENSHI AMERICA CORP.
11725 NE 65th St., Building C
Redmond WA 98052-4911
Tel: [phone]
Fax: [phone]

## Contact Person:

David J. Geraghty
Regulatory Affairs Manager
FUKUDA DENSHI AMERICA CORP.
11725 NE 65th St., Building C
Redmond WA 98052-4911
Tel: [phone]
Fax: [phone]

## Date Prepared:

December 4, 1995
Revised October 23, 1996

## Device Name:

### Proprietary Name:

FF sonic model UF-3500 General Purpose Ultrasound Scanner

### Common Name:

General Purpose Ultrasound Scanner

### Classification Name:

System, Imaging, Pulsed Echo, Ultrasonic

## Legally Marketed Device:

FUKUDA DENSHI FF sonic model UF-4500 General Purpose Ultrasound Scanner (K922208)

UF-3500 510(k) Additional Information
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# Description:

The model UF-3500 is a portable, General Purpose Ultrasound Scanner. This ultrasonic device is designed to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interface and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. The resulting information is displayed on the system's 7 inch diagonal video monitor as a 16 level greyscale B-Mode image.

The system provides user flexibility for different measurement and calculations that are incorporated into the unit. General measurements include distance, area, circumferential length, volume, and angle. Fetal calculations include gestational week, expected date of confinement, and fetal weight. All fetal measurements are derived from either Tokyo University's system, Osaka University's system or the American/European system; the same systems used on the UF-4500.

The UF-3500 can be used with any of eight (8) different linear transducers, only one of which may be active at any one time. An option is provided that will allow two probes to be simultaneously connected to the UF-3500; again, only one of which may be active at any time.

# Intended Use:

This device is intended to be used for applications in fetal, abdominal, intra-operative, pediatric, small organ, transrectal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either transrectally or intraoperatively. It is intended to be used by or on the order of a physician or similarly qualified health care professional. The UF-3500 is intended to be used in a doctors office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.

UF-3500 510(k) Additional Information
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January 16, 1997
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The UF-3500 applies ultrasound energy though the abdominal wall to obtain an image of the fetus and abdominal organs that can be used to determine the gestational age of the fetus or to detect abnormalities of the fetus or abdominal organs.

The UF-3500, when used with the transrectal probe, applies ultrasound energy though the rectal wall to obtain an image of the abdominal organs that can be used to detect abnormalities of these organs.

## Technological Characteristics

The UF-3500 incorporates a microprocessor in the same manner as the predicate device. Transducers are limited to linear probes, again the same probes available for the predicate device. (Transrectal and intraoperative probes are added to the UF-4500 under a separate 510(k)filing.)

These technological differences do not effect the safety or efficacy of the device. Any safety issues that may be raised by a software controlled medical device are the same issues already addressed by the predicate device and are addressed in the systems hazard analysis and in the system validation.

## Testing:

Laboratory testing was conducted to validate and verify the FUKUDA DENSHI FF sonic model UF-3500 General Purpose Ultrasound Scanner met all design specifications and was substantially equivalent to the FUKUDA DENSHI model UF-4500. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the voluntary AIUM "Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment", 1992 and ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus". Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation.

Although the device is neither life supporting nor life sustaining, diagnostic information derived from the use of

UF-3500 510(k) Additional Information
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the device may be critical to the proper management of the patient.

The other area of concern is the safety of the patient in that the device intentionally inputs energy, projects a pulsed sound beam, into body tissue. The UF-3500's acoustic out power levels were tested and found to be below the pre-amendment acoustic power intensity levels listed in the "Revised 510(k) Diagnostic Ultrasound Guidance for 1993" document.

So, the areas of risk for this device are the same as other devices in this class, and are the following:

- Electrical shock
Excessive electrical chassis leakage current can disturb the normal electrophysiology of the heart, and possibly leading to the onset of cardiac arrhythmias.

- Excessive Ultrasound Energy
Excessive ultrasound energy can cause localized heating and possible tissue damage.

- Misdiagnosis
- Inadequate design of the signal processing and measurement circuitry or program can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
- Inadequate design of the device's software, used to make various measurements, can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.

The design of the UF-3500 has taken into account all the above. The device is designed to meet UL 601, CSA 22.2 and AAMI standards for electrical safety for medical equipment to prevent the possibility of excessive electrical leakage current to the patient.

UF-3500 510(k) Additional Information
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# Conclusion:

The conclusions drawn from the laboratory testing of the FUKUDA DENSHI FF sonic model UF-3500 General Purpose Ultrasound Scanner demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the FUKUDA DENSHI model UF-4500.

UF-3500 510(k) Additional Information
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