SONOLINE ELEGRA WITH SIESCAPE FEATURE

K961833 · Siemens Medical Solutions USA, Inc. · IYO · Oct 29, 1996 · Radiology

Device Facts

• Record ID: K961833
• Device Name: SONOLINE ELEGRA WITH SIESCAPE FEATURE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYO · Radiology
• Decision Date: Oct 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, and Peripheral Vascular applications. The addition of SieScape with Measurements will not change or add to the intended uses above, which are identical to those included in the original submission for the Elegra. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The addition of SieScape with Measurements will allow for measurements across a wider field of view than with standard B-mode imaging ultrasound systems.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via transducers; displays B-Mode, M-Mode, Color, PW Doppler, and CW Doppler on CRT. SieScape modification enables panoramic imaging, allowing measurements across wider fields of view than standard B-mode. Operated by clinicians in clinical settings. System processes echo pulses into visual displays for anatomical measurement and clinical diagnosis. Provides real-time thermal and mechanical indices for bioeffect monitoring. Benefits include expanded visualization of large anatomical structures for improved diagnostic assessment.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Mobile diagnostic ultrasound system; software-controlled electronics; CRT display. Complies with UL 2601, CSA 22.2 No. 601-1, and AIUM/NEMA 1992 standards for thermal/mechanical indices. Operates via ultrasonic pulse-echo principle.

Indications for Use

Indicated for diagnostic ultrasound imaging in general radiology, abdominal, intraoperative, small parts, transcranial, OB/GYN, pelvic, neonatal/adult cephalic, urology, and vascular 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

• Siemens SONOLINE Elegra Platform 256 Diagnostic Ultrasound System (K945072)

Submission Summary (Full Text)

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OCT-16-1996 12:20
13214804224 P.14
Siemens Medical Systems, Inc.
Ultrasound Group
SieScape™ Modification to SONOLINE Elegra Ultrasound System
510(k) Submission

# 510(K) SUMMARY

OCT 29 1996

SONOLINE Elegra Diagnostic Ultrasound system with SieScape K961833

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

1. Submitted By:
Siemens Medical Systems, Inc., Ultrasound Group
22010 S.E. 51st Street
Issaquah, WA 98027-7002

Contact Person:
Steve Hesler
Manager of Regulatory Affairs
[phone]

Date Prepared:
May 10, 1996

2. Proprietary Name:
SONOLINE Elegra Platform 256 Diagnostic Ultrasound System

Common/Usual Name:
Diagnostic Ultrasound System with Accessories

Classification Name:
Ultrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 892.1550)

3. Predicate Device:
Siemens SONOLINE Elegra Platform 256 Diagnostic Ultrasound System (K945072), 11/21/95

4. Device Description:
The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.

{1}

13014804224 P.15

Siemens Medical Systems, Inc. Ultrasound Group

SieScape™ Modification to SONOLINE Elegra Ultrasound System 510(k) Submission

The SONOLINE ELEGRA, has been designed to meet the following product safety standards:

- UL 2601, Safety Requirements for Medical Equipment
- CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment
- Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.
- 93/42/EEC Medical Devices Directive EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC Requirements for Medical Equipment

## 5. Intended Uses:

The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, and Peripheral Vascular applications. The addition of SieScape with Measurements will not change or add to the intended uses above, which are identical to those included in the original submission for the Elegra.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The addition of SieScape with Measurements will allow for measurements across a wider field of view than with standard B-mode imaging ultrasound systems.

## 6. Technological Comparison to Predicate Device:

The SONOLINE Elegra incorporating SieScape with Measurements is similar to the SONOLINE Elegra in that both incorporate software controlled electronics to transmit ultrasonic pulses, via a transducer, into a patient, then receive return (echo) pulses and to convert those pulses into a visual display, to be used for diagnosis of various disease states. The operating principles of both systems are the identical. However, the SONOLINE Elegra with SieScape Measurements allows for measurements on larger anatomical features than would be possible with the previously cleared Elegra.

Both systems incorporate an on-screen display of Mechanical (MI) and Thermal (TI) Indices, in compliance with the Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.

End of 510(k) Summary