(73 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and focuses on hardware changes (new transducer with equivalent functionality and new materials).
No
The provided information does not describe any therapeutic function; it only mentions an "EV transducer" whose functionality is equivalent to an existing device (SD 800) and has new patient contact materials. The original 510(k) for the SD 800 (K935923) would need to be consulted to determine if it is a therapeutic device, but based solely on this input, there is no indication of therapeutic use.
Yes
The device is an "EV transducer" which is a component of the "SD 800 platform". The predicate device, K935923, is explicitly named as "SD 800 and EV transducer". The SD 800 platform, being an ultrasound system, is used for medical imaging, which is a diagnostic procedure.
No
The device description explicitly mentions a "new EV transducer," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: It explicitly states "No change from existing SD 800 platform reviewed during 510(k) 935923." The predicate device (K935923) is an ultrasound system (SD 800) with an EV transducer. Ultrasound systems are medical devices used for imaging the body, not for testing samples in vitro (outside the body).
- Device Description: It describes an "EV transducer" for an ultrasound platform. Transducers are components of ultrasound machines that emit and receive sound waves to create images.
- Input Imaging Modality: It clearly states "Ultrasound." Ultrasound is an imaging modality, not an in vitro diagnostic method.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis based on laboratory tests
Therefore, the information strongly indicates that this device is an ultrasound transducer, which is a component of an ultrasound imaging system, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
90 IYN, 90 IYQ
Device Description
Functionality: The new EV transducer has equivalent functionality to the existing transducer now being used.
Scientific Concepts: same as existing EV transducer
Significant Characteristics of the Modification: The new EV transducer has new patient contact materials. It is this change that creates the need to file a 510(k) with the FDA.
The transducer is an existing transducer being sold and marketed by Echo ultrasound. Acoustic performance of the system / transducer combination will be handled as a 510(k) to file based on Appendix I of the February 1993 Ultrasound Guidance.
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
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Attachment C
SD 800 SW Modification
K9 70034
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: December 16,1996
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- Trade Name: SD 800 SonoDiagnost Ultrasound Imaging System Common Name : Ultrasound Imaging System Classification Pro Codes: 90 IYN & 90 IYQ
3) Identification of Predicate Device:
The predicate device for this submittal is the existing SD 800 and EV transducer which were reviewed by FDA on the SD 800 system that was submitted as part of K935923.
4) Description of the device or modification being submitted for premarket approval.
Functionality: The new EV transducer has equivalent functionality to the existing transducer now being used.
Scientific Concepts: same as existing EV transducer
Significant Characteristics of the Modification: The new EV transducer has new patient contact materials. It is this change that creates the need to file a 510(k) with the FDA.
The transducer is an existing transducer being sold and marketed by Echo ultrasound. Acoustic performance of the system / transducer combination will be handled as a 510(k) to file based on Appendix I of the February 1993 Ultrasound Guidance.
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Statement of Intended Use: No change from existing SD 800 platform reviewed during 510(k) 935923.
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Predicate Device Comparison: There are no significant differences in safety and efficacy between the 21370A and 21370B transducers. A detailed comparision of the transducers can be found in the 510(k) report.