(292 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a new transducer with equivalent functionality and new materials, not advanced processing.
No
The device is described as a "Diagnostic Ultrasound Imaging" device, and its intended use is for imaging, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic Ultrasound Imaging of the human body".
No
The device description explicitly states it is a "new intra-operative transducer," which is a hardware component used in ultrasound imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Diagnostic Ultrasound Imaging of the human body". This describes a device that uses physical energy (ultrasound waves) to create images of internal structures.
- Device Description: The description focuses on a transducer, which is a component of an ultrasound system used to send and receive ultrasound waves.
- Input Imaging Modality: The input modality is "Ultrasound".
- Anatomical Site: The anatomical sites are internal body parts.
IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose diseases or conditions. This device operates on the human body to create images.
N/A
Intended Use / Indications for Use
Diagnostic Ultrasound Imaging of the human body in the applications detailed below.
Clinical Applications:
- Intra-Operative: Cardiovascular
- Pediatric
- Cardiac Adult
- Cardiac Pediatric
- Peripheral Vessel
Modes of Operation: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B+M, B+M+CVI, B+PW)
Product codes
90 IYN, 90 IYQ, 90 ITX
Device Description
Functionality: The new transducer has equivalent functionality to the existing transducer now being used.
Scientific Concepts: same as existing intra-operative transducer
Significant Characteristics of the Modification: The new intra-operative transducer has new patient contact materials. It is this change that creates the need to file a 510(k) with the FDA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body, specifically for Intra-Operative: Cardiovascular, Pediatric, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel applications.
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
§ 892.1570 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
JAN 1 2 1998
Attachment C Intraoperative Imaging Transducer
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: March 3,1997
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- Trade Name of Platform: Sonos 5500 Imaging System (upgrade to Sonos 2500 system) Model Number of Transducer: 21380A Common Name : Ultrasound Imaging System Classification Pro Codes: 90 IYN & 90 IYQ