(96 days)
No
The summary describes a transducer, which is a hardware component of an ultrasound system. There is no mention of AI, ML, or any software-based image processing that would typically indicate the presence of such technology. The focus is on the intended use and compatibility with existing cleared ultrasound systems.
No
The device is described as an "Endocavitary Transducer" used with a "diagnostic ultrasound system" for "diagnostic" applications, indicating its purpose is for imaging and diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" states that the device "will be used with the SSA-380A diagnostic ultrasound system". This explicitly labels the system it connects to as diagnostic, and by extension, the transducer is part of a diagnostic system.
No
The device description explicitly states it is an "Endocavitary Transducer," which is a hardware component used in ultrasound systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as a transducer for a diagnostic ultrasound system used for imaging various anatomical sites (cardiac, fetal, small organ, peripheral vascular, abdominal, transvaginal). This is a diagnostic imaging device, not a device used to examine specimens in vitro (outside the body).
- Device Description: It's described as an "Endocavitary Transducer," which is a component of an ultrasound system.
- Input Imaging Modality: It uses "Diagnostic Ultrasound," which is an imaging technique performed in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other typical components of an IVD.
IVDs are devices used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used to generate images of internal structures within the body.
N/A
Intended Use / Indications for Use
Not Found
Product codes
90-ITX
Device Description
PVK-720ST Endocavitary Transducer will be used with the SSA-380A diagnostic ultrasound system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic Ultrasound
Anatomical Site
transvaginal
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)
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 1 0 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: | PVK-720ST Endocavitary Transducer |
|---|---|
| Common Name: | Diagnostic Ultrasound Transducer |
| [Fed. Reg. No.: 892.1570, Pro. Code: 90-ITX] |
Regulatory Class: П 514 Performance Standards: None Special Controls: None Prescription Status: Prescription Device
Reason for Submission:
Modification of the SSA-380A
Substantial Equivalence Summary:
The PVK-720ST Endocavitary Transducer will be used with the SSA-380A diagnostic ultrasound system, which was cleared for cardiac; fetal, small organ and peripheral vascular applications in K933743 and abdominal organ imaging in K943303. The SSA-380A system software is only upgraded to recognize the addition of the PVK-720ST Endocavitary Transducer. No other system changes were required. The PVK-720ST Endocavitary Transducer is similar to the PVE-582V endocavitary transducer that was cleared for transvaginal use with the SSA-270A diagnostic ultrasound system in K891453.
The PVK-720ST follows the same software verification and validation procedures and employs the same general technology as that previously cleared for the SSA-380A system in K933743. It does not affect cleared patient contact materials or acoustic output intensities. 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.