PVK-720ST ENDOCAVITARY TRANSDUCER

K964865 · Toshiba America Medical Systems, In.C · ITX · Mar 10, 1997 · Radiology

Device Facts

• Record ID: K964865
• Device Name: PVK-720ST ENDOCAVITARY TRANSDUCER
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: ITX · Radiology
• Decision Date: Mar 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

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.

Device Story

PVK-720ST Endocavitary Transducer; accessory for SSA-380A diagnostic ultrasound system. Transducer captures acoustic signals for imaging; system processes signals for display. Used in clinical settings by trained sonographers/physicians. Output provides real-time visualization of internal structures to assist in diagnostic decision-making. System software/hardware updated to recognize new transducer; no other system changes. Benefits include expanded diagnostic capability for endocavitary applications.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Endocavitary ultrasound transducer. Compatible with SSA-380A system. Maintains existing patient contact materials and acoustic output intensities. Software updated to recognize transducer hardware.

Indications for Use

Indicated for diagnostic ultrasound imaging of cardiac, fetal, small organ, peripheral vascular, and abdominal structures in patients requiring such examinations.

Regulatory Classification

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.

Predicate Devices

• PVE-582V endocavitary transducer (K891453)

Reference Devices

• SSA-380A diagnostic ultrasound system (K933743, K943303)
• SSA-270A diagnostic ultrasound system (K891453)

Submission Summary (Full Text)

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K964865

MAR 10 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, [phone]
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: II
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 and hardware 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.

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