(175 days)
No
The summary describes a hardware and software modification to an existing ultrasound system to enable harmonic imaging, with no mention of AI or ML.
No
The device is described as allowing for transmission of an ultrasound signal and receipt of returning echoes, with modifications related to detecting harmonic echoes and driving a new transducer. This functionality is typical for diagnostic ultrasound imaging systems, not therapeutic devices. The predicate device, K934041 SONOS 2500 system, is also a diagnostic ultrasound system.
Yes
The device is described as an ultrasound system that transmits a signal and receives echoes to detect harmonic echoes, which is characteristic of diagnostic imaging used to visualize internal body structures.
No
The device description explicitly mentions a new transducer and component modifications to two circuit boards, indicating hardware components are part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description states "No change from existing SONOS 2500 platform reviewed during 510(k) 934041". The SONOS 2500 is an ultrasound system, which is used for medical imaging in vivo (within the living body), not for testing samples in vitro (outside the body).
- Device Description: The description details modifications to an ultrasound system and transducer for harmonic imaging. This is a technique used in ultrasound imaging, not for analyzing biological samples.
- Input Imaging Modality: The input modality is explicitly stated as "Ultrasound". Ultrasound is an imaging technique used on the body, not for analyzing samples in a lab.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or other conditions. This device is clearly described as an ultrasound system used for imaging the body.
N/A
Intended Use / Indications for Use
No change from existing SONOS 2500 platform reviewed during 510(k) 934041
Product codes
90 IYN, 90 IYQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.