PHASED ARRAY TRANSDUCER - - PVF -375DT by TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: This transducer is indicated for adjunctive non-quantitative visualization of the target study area.

Device Description

The PVF-375DT volume imaging transducer is a modification of the PVF-375MT convex transducer that was cleared for the SSA-340A, SSA-270A and SSH-140A diagnostic ultrasound imaging systems. It will add volume imaging to conventional diagnostic ultrasound images. Volume imaging is due to the physical characteristics of the device and is intended to assist with patient education during an examination.

AI/ML Overview

The provided text is a 510(k) summary for a diagnostic ultrasound transducer (PVF-375DT). It describes a modification to an existing device, the PVF-375MT, to add "volume imaging" capability.

However, the summary does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone AI performance).

Instead, the submission emphasizes that:

The PVF-375DT is a modification of a previously cleared device (PVF-375MT).
It adds "volume imaging" due to its physical characteristics.
This volume imaging is intended to assist with patient education during an examination.
It follows previously cleared software verification and validation procedures.
It employs the same general technology as the predicate device.
It does not affect cleared patient contact materials or acoustic output intensities.
The manufacturer believes it is substantially equivalent because it does not change the cleared safety and effectiveness attributes or indications for use of the predicate device.

The FDA's response confirms substantial equivalence but requests a post-clearance special report containing acoustic output measurements based on production line devices, as per Appendix G of their guidance for diagnostic ultrasound systems and transducers. This indicates that while the device was deemed substantially equivalent based on the provided information, further safety (acoustic output) verification was required post-market.

Therefore, many of the requested details for a comprehensive device study report are not present in this 510(k) summary because the approval relies on substantial equivalence to a predicate device rather than a new de novo approval requiring extensive new clinical performance studies.

Given the limitations of the provided text, I cannot complete all sections of your request. I will fill in what is available and explicitly state where information is not provided.

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit from Substantial Equivalence Basis)	Reported Device Performance
Safety: Acoustic output and patient contact materials are equivalent to the predicate device.	"It does not affect cleared patient contact materials or acoustic output intensities."
Effectiveness: General technology and indications for use are equivalent to the predicate device.	"employs the same general technology as that most lately cleared for the PVF-375MT.""does not change the cleared safety and effectiveness attributes or the indications for use of the PVF-375MT."
Functionality: Provides volume imaging capability.	"It will add volume imaging to conventional diagnostic ultrasound images.""intended to assist with patient education during an examination."
Software Validation: Follows established procedures.	"follows previously cleared software verification and validation procedures."
Risk Assessment: No new or increased risk of injury.	"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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The submission relies on engineering principles and comparison to a predicate device, not a new clinical test set for performance.
Data Provenance: Not applicable for a clinical test set as described. The data provenance mentioned refers to TAMS Complaint and MDR files, which would be retrospective internal company data, likely from the US and other countries where the predicate device was marketed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new clinical test set requiring expert-established ground truth is mentioned in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new clinical test set requiring adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasound transducer, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an ultrasound transducer, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of a new clinical performance study. The ground truth for safety implicitly relies on the proven safety and performance history of the predicate device (PVF-375MT) and general ultrasound safety standards. Functionality (volume imaging) is based on the physical design.

8. The sample size for the training set

Not applicable. This 510(k) submission does not describe an AI/algorithm-based device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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FEB 11 1998 510(k) Summary

Toshiba America Medical Systems, Inc. Submitter's Name: P.O. Box 2068, 2441 Michelle Drive, Tustin CA 92781-2068 Submitter's Address: Steven M. Kay, Regulatory Affairs Specialist, (714) 730-5000 Submitter's Contact: Establishment Registration Number: 2020563

Phased Array Transducer - - PVF-375DT Device Proprietary Name: Diagnostic Ultrasound Transducer Common Name: [Fed. Reg. No .: 892.1570, Pro. Code: 90-ITX]

Regulatory Class: II 514 Performance Standards: None Special Controls: None Prescription Status: Prescription Device

Modification of the PVF-375MT Reason for Submission:

Substantial Equivalence Summary:

The PVF-375DT follows previously cleared software verification and validation procedures and employs the same general technology as that most lately cleared for the PVF-375MT. 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.

TAMS believes that the PVF-375DT is substantially equivalent to the PVF-375MT because it does not change the cleared safety and effectiveness attributes or the indications for use of the PVF-375MT.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with outstretched arms, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the figure, emphasizing the department's name and national scope.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1898

Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92781-2068

Re: K972771 Phased Array Tranducer - PVF-375DT Dated: November 7, 1997 Received: November 13, 1997 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Biggins:

We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the SSA-340A, SSA-270 and SSA-140A Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

PVF-375DT

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

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Page 2 - Paul Biggins

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D. at (301) 594-1212.

Sincerely vours.

David A. Segerman
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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	Ultrasound Device Indications Statement Page	1 of 1
510(k) Number (if known):	K972771
Device Name:	PVF-375DT convex phased array transducer

Fill out one form for each ultrasound system and each transducer.

Clinical Application	B	M	PWD
Ophthalmic		✓
Fetal	✓	✓	✓
Abdominal	✓	✓	✓
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-Esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparascopic
Musculo-Skeletal
Other (Specify)

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use-

Additional Comments: This transducer is indicated for adjunctive non-quantitative visualization of the target study area.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Seymour

chictive. Abdominal. El . 10(k) Number

Regulation Number and Section

§ 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.