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510(k) Data Aggregation
(248 days)
This device is intended to be used for applications in fetal. abdominal, intraoperative (defined as the abdominal region and periphery), pediatric, small organ (defined as thyroid, breast and testes), cardiac, transrectal, transvaginal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either from the surface of the skin, transrectally, transvaginally or intraoperatively. The UF-5800A incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-5800A with optional Doppler (UF-5800DU) is a prescription device intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-5800 is intended to be used in a doctor's 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.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (Abdominal region and periphery), Pediatric, Small Organ (thyroid, breast, and testes), Cardiac, Transrectal, Transvaginal, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
The model UF-5800 is a portable, General Purpose Ultrasound Scanning System. The unit will be marketed as the UF-5800A General Purpose Ultrasound Scanner without Doppler. The addition of the optional UF-5800DU Doppler unit will add black and white Doppler capability to the UF-5800A. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on its gray scale monitor. The resulting information is displayed in M-mode, B-Mode, Doppler (both CW and pulsed) modes, or in combinations of modes on the system's 7 inch diagonal video monitor as a 16 level grayscale or black and white image.
The Fukuda Denshi FF sonic model UF-5800A is a general-purpose ultrasound scanner with an optional Doppler unit (UF-5800DU). Here's an analysis of its acceptance criteria and the study that proves it meets those criteria, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Fukuda Denshi FF sonic model UF-5800A are primarily based on demonstrating substantial equivalence to predicate devices and adherence to established safety and performance standards. The "reported device performance" section directly addresses how the device meets these criteria through various tests.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device must be as safe, as effective, and perform as well as or better than the legally marketed predicate devices (Fukuda Denshi models UF-4500 and UF-3500, and Medison SonoAce 4800). This includes technological characteristics not raising new safety/efficacy issues. | Laboratory testing was conducted to validate and verify that the UF-5800A and UF-5800DU "met all design specifications and is substantially equivalent to the currently marketed FUKUDA DENSHI models UF-4500 and UF-3500 as well as the Medison SonoAce 4800." The technological characteristics, including the microprocessor, linear and convex probes (same as predicate Fukuda Denshi devices), and acceptance of sector and CW Doppler probes (similar to Medison SonoAce 4800), were deemed not to raise new safety or efficacy issues. |
| Environmental Safety | Compliance with environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. | Environmental testing, as per the specified FDA guidance document, was performed. (Specific results are not detailed in this summary, but the conclusion states "demonstrate that the device is as safe..."). |
| Acoustic Output | Derated acoustic output limits must be below the maximums established for Track 1 devices as listed in the "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 30, 1997. Specific limits provided in the table: - Peripheral Vessel: ISPTA3 < 720 Mw/CM², MI < 1.9 - Cardiac: ISPTA3 < 430 Mw/CM², MI < 1.9 - Fetal Imaging & Other: ISPTA3 < 94 Mw/CM², MI < 1.9 - Ophthalmic: ISPTA3 < 17 Mw/CM², MI < 0.23 | "The device's derated acoustic output limits are below the maximums established for Track 1 devices as listed" in the specified guidance document. Additional testing was performed to demonstrate "compliance with the voluntary NEMA/AIUM 'Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment,' 1992." The FDA approval also requires a post-clearance special report containing "complete information, including acoustic output measurements based on production line devices," to verify these limits for production units. |
| Electrical Safety | Compliance with ANSI/AAMI ES1-1993, "safe current limits for electromedical apparatus." | Testing was performed to demonstrate "compliance with... ANSI/AAMI ES1-1993, 'safe current limits for electromedical apparatus.'" (Specific results are not detailed, but the conclusion states "demonstrate that the device is as safe..."). |
| Biocompatibility & Thermal | Patient contact materials must be biocompatible and meet thermal requirements. | "Patient contact materials were confirmed to be biocompatable and met thermal requirements." (Specific details or reports are not provided in this summary). |
| System Operation & Software | Hazard analysis of the system and its software, and testing conducted to verify the system's overall operation. Addressed safety issues of software-controlled medical devices similar to predicate devices. | "A hazard analysis of the system and its software was performed and testing was conducted to verify the systems overall operation." Safety issues related to software-controlled medical devices were stated to be "the same issues already addressed by the predicate devices and are addressed in the system's hazard analysis and in the system validation." (Specific details of the hazard analysis or validation are not provided). |
| Intended Use | Device must be suitable for the specified clinical applications (fetal, abdominal, intraoperative, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel scanning) and modes of operation (M-mode, B-Mode, Doppler, combinations). This includes appropriate probes and measurement packages. | The device is described as "intended to be used for applications in fetal, abdominal, intraoperative..., pediatric, small organ..., cardiac, transrectal, transvaginal, and peripheral vessel scanning." It displays in "M-mode, B-Mode, Doppler (both CW and pulsed) modes, or in combinations of modes." Various probes (linear, convex, sector, CW Doppler) are described as available and compatible for obtaining images from various surfaces/cavities. Built-in measurement and calculation packages are included. The Indications for Use forms for each probe (FUT-L104, FUT-L106, FUT-C111, FUT-TV36-5, FUT-TR31-5, FUT-IO07, FUT-IO03, FUT-IO10, FUT-IO17, FUT-SM181-35A, FUT-SM121-50A, FUT-SM201-25A, FUT-ID121-25A) explicitly list the accepted clinical applications and modes of operation for each specific probe. "N" indicates a new indication, implying these were evaluated and accepted. |
2. Sample Size Used for the Test Set and Data Provenance
The documentation does not provide details on the sample size used for the test set in terms of patient data or clinical images. The testing described focuses on engineering validation and verification of the device itself (environmental, acoustic, electrical, biocompatibility, software operation) rather than a performance study involving a specific clinical test set.
- Sample Size: Not specified for clinical data. The "test set" primarily refers to the device and its components undergoing laboratory tests.
- Data Provenance: Not applicable in the traditional sense of a clinical outcomes study. The testing is laboratory-based and device-centric.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study detailed is a technical validation and verification of the ultrasound system's safety and performance against engineering standards and substantial equivalence criteria, not a clinical trial requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a clinical test set requiring expert adjudication for ground truth establishment. The evaluation is based on engineering conformity and regulatory standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done, and therefore, no effect size of human readers improving with AI vs. without AI assistance is reported. This submission predates widespread AI integration in medical devices and focuses on foundational device safety and performance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a general-purpose ultrasound scanner, a hardware and software system for image acquisition and display, not an AI-driven algorithm with standalone diagnostic capabilities.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering Specifications and Design Documents: The UF-5800A/DU met "all design specifications."
- Regulatory Standards: Compliance with FDA guidance documents, NEMA/AIUM standards (for acoustic output), and ANSI/AAMI standards (for electrical safety).
- Predicate Device Performance: The device was deemed "as safe, as effective, and performs as well as or better than the legally marketed predicate devices."
- Biocompatibility and Thermal Requirements: Verified through specific testing.
- Hazard Analysis and System Validation: For overall operation and software safety.
There is no mention of ground truth established from expert consensus, pathology, or outcomes data in the context of a clinical performance study.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI models that require a "training set" of data in the contemporary sense. The "training" here would refer to the engineering design and development process based on established ultrasound physics and medical imaging principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of machine learning. The device's "training" and development were based on established scientific principles of ultrasound technology, engineering standards, and the successful designs of predicate devices.
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