(57 days)
No
The summary does not mention AI, ML, or related concepts, and the device description is limited to a transducer.
No
Explanation: The device is described as a "diagnostic ultrasound system" and a "phased array transducer," both indicating its use for diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" states that the device "will add adult transcranial indications for use to the SSA-380A diagnostic ultrasound system." This explicitly labels the system, which the transducer is part of, as diagnostic.
No
The device description explicitly states it is a "Phased Array Transducer," which is a hardware component of an ultrasound system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "phased array transducer" for "adult transcranial indications" used with a "diagnostic ultrasound system." This describes a device used for imaging the body, not for testing samples of bodily fluids or tissues outside the body.
- Device Description: The description confirms it's a "Phased Array Transducer," which is a component of an ultrasound system used for generating and receiving sound waves for imaging.
- Input Imaging Modality: It explicitly states "Diagnostic Ultrasound," which is an imaging technique.
- Anatomical Site: "Transcranial" refers to imaging through the skull, which is an anatomical site within the body.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health. This device is used in vivo (within the body) for diagnostic imaging.
N/A
Intended Use / Indications for Use
The PSK-20CT phased array transducer will add adult transcranial indications for use to the SSA-380A diagnostic ultrasound system.
Product codes
90-ITX
Device Description
The PSK-20CT phased array transducer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
adult
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)
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
MAR - 4 1997
510(k) Summary
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|---|---|
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, Tustin CA 92781-2068 |
| Submitter's Contact: | Steven M. Kay, Regulatory Affairs Specialist, (714) 730-5000 |
| Establishment Registration Number: 2020563 |
| Device Proprietary Name: | Phased Array Transducer - - PSK-20CT |
|---|---|
| Common Name: | Diagnostic Ultrasound Transducer |
| [Fed. Reg. No.: 892.1570, Pro. Code: 90-ITX] |
| Regulatory Class: | II |
|---|---|
| 514 Performance Standards: | None |
| Special Controls: | None |
| Prescription Status: | Prescription Device |
Reason for Submission:
Modification of the SSA-380A
Substantial Equivalence Summary:
The PSK-20CT phased array transducer will add adult transcranial indications for use to the SSA-380A diagnostic ultrasound system. The addition of the PSK-20CT transducer follows the same software verification and validation procedures and employs the same general technology as that previously cleared for the SSA-380A system and transducers in K933743. The SSA-380A system software and hardware is only upgraded to recognize the addition of the PSK-20CT. Cleared patient contact materials and acoustic output intensities are unchanged. No other system changes were required. The PSK-20CT transducer is similar to the PSH-25GT transducer that was cleared for transcranial use with the SSA-270A and SSH-140A diagnostic ultrasound systems in K941593.
Based on a review of TAMS Complaint and MDR files for similar transducers, any potential failure of this transducer is not expected to result in an injury to the patient.