(175 days)
No change from existing SONOS 2500 platform reviewed during 510(k) 934041
This modification allows for transmission of an ultrasound signal at one frequency and receipt of the returning echo at a different frequency. A minor system modification is made to detect these harmonic echoes. New transducer, component modifications to two circuit boards and SW to recognize/drive the new transducer.
The provided text does not contain information on acceptance criteria or a study proving device performance against such criteria. The document describes a 510(k) summary for a modification to an ultrasound imaging system (Sonos 2500) to enable harmonic imaging. It focuses on the technical aspects of the modification and its predicate devices, not on clinical performance studies or specific performance metrics.
Therefore, I cannot fulfill the request to build the table and provide the details about a study, as this information is absent in the input.
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K9644309
APR 22 1997
Attachment C 510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
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- Submitter's Name / Contact Person: Paul Schrader Address: 3000 Minuteman Road, Andover Ma. 01810 Telephone Number: 508-659-2404 Date Summary was prepared: October 14,1996
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- Trade Name: Sonos 2500 Ultrasound Imaging System Common Name : Ultrasound Imaging System Classification Pro Codes: 90 IYN & 90 IYQ
3) Identification of Predicate Device:
There are two predicate devices used for this submittal. One predicate device for this submittal is the existing SONOS 2500 system which was reviewed by FDA with K934041 and found to be SE on September 22, 1994. The second predicate device is the ATL HDI 3000 system which was reviewed by FDA with K935009 and found to be SE on October 11,1994
4) Description of the device or modification being submitted for premarket approval.
Functionality: This modification allows for transmission of an ultrasound signal at one frequency and receipt of the returning echo at a different frequency.
Scientific Concepts: Rayleigh's theory predicts that a bubble resonating in an ultrasound field will radiate harmonic echoes at twice the frequency of the incident beam and that the harmonic echoes can be stronger than the fundamentals. Ultrasound contrast agents are made from many small bubbles. A minor system modification is made to detect these harmonic echoes
Significant Characteristics of the Modification: New transducer, component modifications to two circuit boards and SW to recognize/drive the new transducer. Significant Safety Concerns: None
FDA is reviewing the safety of contrast agents. Addition of harmonic imaging to the ultrasound systems does not increase ultrasound output relative to normal and fundamentals contrast imaging. The harmonic imaging modification only affects receive operation of the system.
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- Statement of Intended Use: No change from existing SONOS 2500 platform reviewed during 510(k) 934041
6) Predicate Device Comparison:
There are many ultrasound devices on the market that have the ability to image contrast agents and also have the ability to vary transmit and receive frequencies. This submittal uses two systems ( HP Sonos 2500 and ATL HDI 3000) for predicate device comparisons.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.