(96 days)
PVK-720ST Endocavitary Transducer
This 510(k) summary for the PVK-720ST Endocavitary Transducer does not contain information about acceptance criteria or a study proving device performance against such criteria.
The document primarily focuses on establishing substantial equivalence to previously cleared devices (SSA-380A and PVE-582V) based on:
- Intended Use: Used with the SSA-380A diagnostic ultrasound system for existing cleared applications.
- Technological Characteristics: Similar general technology, software verification/validation procedures, patient contact materials, and acoustic output intensities to previously cleared transducers and systems.
- Safety: A review of complaint files for similar transducers indicates potential failure is not expected to result in patient injury.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies is not present in this document. This 510(k) relies on the substantial equivalence pathway, which often leverages existing data and regulatory clearances rather than requiring new, comprehensive performance studies as might be seen for novel devices or those undergoing PMA (Pre-Market Approval).
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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.
§ 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.