(169 days)
No
The document describes a standard ultrasound system and does not mention AI, ML, or related concepts in the device description, intended use, or other sections.
No
The device is described as a "diagnostic ultrasound system" and its function is to "acquire ultrasound data and display it" for "clinical diagnosis purposes." It is not intended for treatment or therapy.
Yes
The "Device Description" explicitly states that the SONOLINE Elegra is a "diagnostic ultrasound system," and the "Intended Use / Indications for Use" section mentions that the system provides "information that is used for clinical diagnosis purposes."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions hardware components like a "CRT display" and various imaging modes (B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppier Mode), indicating it is a hardware device with integrated software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The SONOLINE Elegra is an ultrasound imaging system. It uses sound waves to create images of internal body structures.
- Intended Use: The intended uses listed are all related to imaging and visualizing internal anatomy for diagnostic purposes. There is no mention of analyzing biological samples.
Therefore, the device's function and intended use clearly fall under the category of medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for 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 Bmode imaging ultrasound systems.
Product codes
IYN
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) Doppier Mode, or in a combination of modes, on a CRT display .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, and Peripheral Vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Siemens Medical Systems, Inc.
Ultrasound Group
no Modification to SONOLINE Elegra Ultrasound System 510(k) Submission
510(K) SUMMARY
OCT 2 9 1996
SONOLINE Elegra Diagnostic Ultrasound system with SieScape
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 Bv:
Siemens Medical Systems, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah. WA 98027-7002
Contact Person:
Steve Hesler Manager of Regulatory Affairs (206) 557-1629
Date Prepared:
May 10, 1996
-
- 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)
-
- Predicate Device:
Siemens SONOLINE Elegra Platform 256 Diagnostic Ultrasound System (K945072), 11/21/95
- Predicate Device:
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) Doppier Mode, or in a combination of modes, on a CRT display .
1
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, AlUM/NEMA, 1992.
- 93/42/EEC Medical Devices Directive ゃ EN60601 = (IEC 601-1-1 + IEC 601-1-2). Safety and EMC Requirements for Medical Equipment
Intended Uses: s.
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 Bmode 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.