This device is intended to be used for applications in fetal, abdominal, intra-operative, pediatric, small organ, transrectal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either transrectally or intraoperatively. It is intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-3500 is intended to be used in a doctors office and all hospital environments: ER ICU, CCU, OR, etc. This device is intended to be use on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.

The UF-3500 applies ultrasound energy though the abdominal wall to obtain an image of the fetus and abdominal organs that can be used to determine the qestational age of the fetus or to detect abnormalities of the fetus or abdominal.organs.

The UF-3500, when used with the transrectal probe, applies ultrasound energy though the rectal wall to obtain an image of the abdominal organs that can be used to detect abnormalities of these organs.

Device Description

The model UF-3500 is a portable, General Purpose Ultrasound Scanner. This ultrasonic device is designed to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interface and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. The resulting information is displayed on the system's 7 inch diagonal video monitor as a 16 level greyscale B-Mode image.

The system provides user flexibility for different measurement and calculations that are incorporated into the unit. General measurements include distance, area, circumferential length, volume, and angle. Fetal calculations include gestational week, expected date of confinement, and fetal weight. All fetal measurements are derived from either Tokyo University's system, Osaka University's system or the American/European system; the same systems used on the UF-4500

The UF-3500 can be used with any of eight (8) different linear transducers, only one of which may be active at any one time. An option is provided that will allow two probes to be simultaneously connected to the UF-3500; again, only one of which may be active at any time.

AI/ML Overview

This 510(k) summary describes a general-purpose ultrasound scanner, the FUKUDA DENSHI FF sonic model UF-3500. It focuses on demonstrating substantial equivalence to a predicate device (FUKUDA DENSHI FF sonic model UF-4500) rather than presenting a study with specific acceptance criteria and performance metrics in the way a new, AI-driven diagnostic device would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set data) are not applicable or not provided in this type of submission. The "acceptance criteria" here are generally compliance with safety and performance standards for ultrasound devices, and "device performance" is demonstrated through meeting these standards and showing equivalence to the predicate device.

Here's an analysis based on the provided text, addressing the points where information is available:

Acceptance Criteria and Device Performance Analysis (FUKUDA DENSHI FF sonic model UF-3500)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Substantial Equivalence	Device must be substantially equivalent to the predicate device (FUKUDA DENSHI FF sonic model UF-4500) in terms of safety and effectiveness.	Laboratory testing "demonstrate[s] that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device."
Design Specifications	Device must meet all design specifications.	"Laboratery testing was conducted to validate and verify the FUKUDA DENSHI FF sonic model UF-3500 General Purpose Ultrasound Scanner met all design specifications..."
Environmental Testing	Compliance with environmental testing identified in FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document.	"This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 'Reviewer Guidance Document for Premarket notification Submissions' Draft Guidance Document."
Acoustic Output	Compliance with AIUM "Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment", 1992 and power levels below pre-amendment acoustic power intensity levels listed in "Revised 510(k) Diagnostic Ultrasound Guidance for 1993" document.	"Additional testing was performed to demonstrate compliance with the voluntary AlUM 'Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment', 1992" and "The UF-3500's acoustic out power levels were tested and found to be below the preamendment acoustic power intensity levels listed in the 'Revised 510(k) Diagnostic Ultrasound Guidance for 1993' document."
Electrical Safety	Compliance with ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus", and UL 601, CSA 22.2 and AAMI standards for electrical safety for medical equipment (to prevent excessive electrical chassis leakage current).	"Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation." (General statement about hazard analysis). "The device is designed to meet UL 601, CSA 22.2 and AAMI standards for electrical safety for medical equipment..." Also, "Additional testing was performed to demonstrate compliance with the voluntary... ANSI/AAMI ES1-1993, 'Safe current limits for electromedical apparatus'."
Hazard Analysis & Software Validation	Hazard analysis of the system and its software, and validation of the system's overall operation. Addressed safety issues of software-controlled medical devices. Prevent misdiagnosis due to inadequate design of signal processing, measurement circuitry, or program.	"Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation." "Any safety issues that may be raised by a software controlled medical device are the same issues already addressed by the predicate device and are addressed in the systems hazard analysis and in the system validation." "The design of the UF-3500 has taken into account all the above [risks including misdiagnosis]."

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/Not provided. This submission describes engineering and compliance testing of the ultrasound machine itself, not a clinical study on patient data.
Data Provenance: Not applicable/Not provided. The testing relates to the device's adherence to technical standards and its inherent safety characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. Ground truth in the context of diagnostic AI is not relevant for this type of submission which focuses on the base performance and safety of a physical ultrasound scanner.

4. Adjudication method for the test set

Not applicable/Not provided.

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/Not provided. This is not an AI-driven device and no MRMC study was mentioned.

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

Not applicable/Not provided. This is a general-purpose ultrasound scanner, not a standalone AI algorithm. Its performance is inherent in its hardware and basic software functions for image acquisition and basic measurements.

7. The type of ground truth used

Type of Ground Truth: For the technical and safety aspects, the "ground truth" is defined by the established industry standards (AIUM, ANSI/AAMI, UL, CSA) and FDA guidance documents. For functionality, the ground truth is its ability to replicate the functions and measurements of the predicate device.

8. The sample size for the training set

Not applicable/Not provided. This device does not use an AI model that requires a training set in the contemporary sense. Its "training" would be through engineering design and calibration.

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

Not applicable/Not provided.

Summary

{0}------------------------------------------------

K955543

510(k) Summary

FEB | | | |997

FUKUDA DENSHI FF sonic model UF-3500

General Purpose Ultrasound Scanner

Submitter:

FUKUDA DENSHI AMERICA CORP. 11725 NE 65th St., Building C Redmond WA 98052-4911 206/881-7737 Tel: 206/869-2018 Fax:

Contact Person:

David J. Geraghty Requiatory Affairs Manager FUKUDA DENSHI AMERICA CORP. 11725 NE 65th St., Building C Redmond WA 98052-4911 Tel: 206/881-7737 206/869-2018 Fax:

Date Prepared:

December 4, 1995 Revised October 23, 1996

Device Name:

Proprietary Name: FF sonic model UF-3500 General Purpose Ultrasound Scanner

Common Name:

General Purpose Ultrasound Scanner

Classification Name:

System, Imaging, Pulsed Echo, Ultrasonic

Legally Marketed Device:

FUKUDA DENSHI FF sonic model UF-4500 General Purpose Ultrasound Scanner (K922208)

K955543

{1}------------------------------------------------

Description:

..............................................................................................................................................................................

Intended Use:

K955543

ﺮ ﺗ

{2}------------------------------------------------

Technological Characteristics

The UF-3500 incorporates a microprocessor in the same manner as the predicate device. Transducers are limited to linear probes, again the same probes available for the predicate device. (Transrectal and intraoperative probes are added to the UF-4500 under a separate 510(k)filing.)

These technological differences do not effect the safety or efficacy of the device. Any safety issues that may be raised by a software controlled medical device are the same issues already addressed by the predicate device and are addressed in the systems hazard analysis and in the system validation.

Testing:

: "

Laboratery testing was conducted to validate and verify the FUKUDA DENSHI FF sonic model UF-3500 General Purpose Ultrasound Scanner met all design specifications and was substantially equivalent to the FUKUDA DENSHI model UF-4500. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the voluntary AlUM "Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment", 1992 and ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus". Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation.

Although the device is neither life supporting nor life sustaining, diagnostic information derived from the use of

K955543

January 16, 1997 Page 3 of 5

{3}------------------------------------------------

the device may be critical to the proper management of the patient.

The other area of concern is the safety of the patient in that the device intentionally inputs energy, projects a pulsed sound beam, into body tissue. The UF-3500's acoustic out power levels were tested and found to be below the preamendment acoustic power intensity levels listed in the "Revised 510(k) Diagnostic Ultrasound Guidance for 1993" document.

So, the areas of risk for this device are the same as other devices in this class, and are the following:

. Electrical shock Excessive electrical chassis leakage current can disturb the normal electrophysiology of the heart, and possibly leading to the onset of cardiac arrhythmias.
Excessive Ultrasound Energy . Excessive ultrasound energy can cause localized heating and possible tissue damage.
Misdiagnosis .
- Inadequate design of the signal processing and measurement circuitry or program can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
- Inadequate design of the device's software, used to make various measurements, can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.

The design of the UF-3500 has taken into account all the above. The device is designed to meet UL 601, CSA 22.2 and AAMI standards for electrical safety for medical equipment to prevent the possibility of excessive electrical leakage current to the patient.

{4}------------------------------------------------

Conclusion:

The conclusions drawn from the laboratory testing of the FUKUDA DENSHI FF sonic model UF-3500 General Purpose Ultrasound Scanner demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the FUKUDA DENSHI model UF-4500.

January 16, 1997 Page 5 of 5

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.