(274 days)
The SONOLINE Versa Pro ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Laparoscopic applications.
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 SONOLINE Versa Pro is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Modes, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.
This 510(k) summary describes a diagnostic ultrasound system and the addition of a new probe. However, it does not contain any information about acceptance criteria or a study proving that the device meets such criteria for performance.
Therefore, I cannot provide the requested information, including the table and details about sample sizes, experts, adjudication, or standalone performance. The document focuses on safety standards, intended uses, and technological comparison to predicate devices, not on specific performance metrics or studies demonstrating compliance with such metrics using clinical data.
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510(K) SUMMARY
SONOLINE ® Versa Pro Diagnostic Ultrasound System, Addition of 6.5 MHz Laparoscopic Probe
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.
- Submitted By: 1. Siemens Medical Systems, Inc., Ultrasound Group 22010 SE 51st Street Issaquah, WA 98027-7002
Contact Person:
Steve Hesler Manager of Requlatory Affairs (206) 557-1629
Date Prepared: July 22, 1996
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- Proprietary Name: SONOLINE Versa Pro Diagnostic Ultrasound System
Common/ Usual Name: Diagnostic Ultrasound System with Accessories
- Proprietary Name: SONOLINE Versa Pro Diagnostic Ultrasound System
Classification Name:
Ultrasonic Pulsed Doppler Imaging System (Product Code 90 YIN, 21 CFR 892.1550)
3. Predicate Device:
Siemens SONOLINE Versa Diagnostic Ultrasound System (K945773), 8/7/95. Tetrad Corp., Laparoscope Ultrasound Transducer (K924204), 6/7/93.
4. Device Description:
The SONOLINE Versa Pro is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Modes, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display .
The SONOLINE Versa Pro has been designed to meet the following product safety standards:
APR 2 4 1997
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- 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, AlUM/NEMA, 1992.
- 93/94/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 Versa Pro ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Laparoscopic applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Technological Comparison to Predicate Device: 6.
The SONOLINE Versa Pro is identical to the SONOLINE Versa 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 provide information for use in the diagnosis of various disease states as well as normal conditions such as pregnancy and physical development. The operating principles of both systems are identical.
The Siemens 6.5 MHz Laparoscopic Probe is technologically equivalent to the Tetrad Laparoscope in that both incorporate a linear array transducer of 6.0 MHz center frequency on the end of an articulating arm. Both are intended for intra-abdominal uttrasound examinations via small abdominal incisions.
End of 510(k) Summary
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.