Search Results
Found 1 results
510(k) Data Aggregation
(28 days)
FUKUDA DENSHI MODEL FF SONIC UF-750XT
The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-750XT incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The FF sonic UF-750XT is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used 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:
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (Specify), Cardiac, Transvaginal, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Mode of Operation: B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Specify), Harmonic Imaging.
Other Indications or Modes: Small Organ is defined as thyroid, breast and testes. In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )
The Fukuda Denshi model FF sonic UF- 750XT is a compact and portable general-purpose diagnostic ultrasound scanner with a fold down keyboard, integrated 10.4 inch TFT color LCD display and interchangeable convex and linear transducers. The system has physical dimensions 380 mm W X 220 mm D X 370 mm H in transport configuration. The system provides data acquisition, processing and display capabilities. User interfaces include the drop down computer type keyboard which includes specialized controls, Doppler audio and a color LCD display.
The Fukuda Denshi Model FF sonic UF-750 XT Diagnostic Ultrasound System is a modification of a previously cleared device, the Fukuda Denshi model FF sonic UF-5800. The submission focuses on demonstrating substantial equivalence to the predicate device, rather than defining new performance metrics or conducting clinical trials to establish new acceptance criteria.
Therefore, the "acceptance criteria" for this device are aligned with ensuring it meets safety standards and performs comparably to the predicate device for its intended uses.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (derived from document) | Reported Device Performance |
|---|---|---|
| Predicate Equivalence | The device must be substantially equivalent to the currently marketed Fukuda Denshi FF sonic model UF-5800. This implies comparable technological characteristics, safety, and effectiveness. | The FF sonic UF-750XT incorporates the same fundamental technology as the predicate device. All probes are modified versions of the probes cleared with the predicate. The technology characteristics do not affect safety or efficacy. The device "was substantially equivalent to the currently marketed Fukuda Denshi FF sonic model UF-5800." |
| Safety Standards | Conformance to applicable medical device safety standards for thermal, mechanical, and electrical safety, as well as biocompatibility and effectiveness of cleaning and disinfection. Specific standards mentioned include: NEMA UD 2, NEMA UD 3, IEC 60601-1-1, IEC 60601-1-2. | The device "has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility and effectiveness of cleaning and disinfection." It "conforms to the following Standards: NEMA UD 2, NEMA UD 3, IEC 60601-1-1, IEC 60601-1-2." |
| Acoustic Output | Acoustic output must be measured and calculated per NEMA UD 2 (1998). All transducer/system combinations must not exceed a Thermal or Mechanical Index of 1.0. | Acoustic Output is measured and calculated per NEMA UD 2 (1998). All transducers are track 3 transducers, and testing validated that "no transducer/system combination exceeded a Thermal or Mechanical Index of 1.0." |
| Biocompatibility | All patient contact materials must be biocompatible. | "All patient contact materials are biocompatible and identical to the predicate Fukuda Denshi device." |
| Intended Use | The device should be safely usable for the specified clinical applications (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal) and modes of operation (B, M, PWD, Color Doppler, etc.). Any new indications (N) for specific transducers should be acceptable. | The intended use applications include fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, and musculo-skeletal. The forms for each transducer indicate "P" (previously cleared by FDA) for most applications and modes, with "N" (new indication for use) specifically for PWD (Pulsed Wave Doppler) mode for several applications across multiple transducers (e.g., Fetal, Abdominal, Pediatric, Small Organ - where applicable, Cardiac, Peripheral Vessel, Transvaginal - where applicable). This indicates that the device's performance for these "new" modalities on existing applications was assessed as acceptable. |
| Software Controlled Device | Any safety issues raised by a software controlled medical device should either be the same as those addressed by the predicate or addressed in the system hazard analysis or system validation. | "Any safety issues raised by a software controlled medical device are either the same as the issues already addressed by the predicate device or are addressed in the system hazard analysis or in the system validation." |
Study Proving Acceptance Criteria is Met:
The study that proves the device meets these acceptance criteria is primarily a laboratory testing and design review process comparing the modified device to its predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "sample size" in terms of patient data or clinical images for testing. The testing described is primarily bench testing of the device's hardware, software, and acoustic output.
- Data Provenance: Not applicable as clinical data or patient images were not used for the testing described in this document. The comparison is against the predicate device's established technological characteristics and safety profile.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, was not required or established for this submission. The "ground truth" was adherence to engineering and safety standards and demonstration of technological equivalence to the predicate.
- Qualifications of Experts: Not applicable. Testing was conducted by engineers and technicians, likely within Fukuda Denshi, to verify technical specifications.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There was no clinical data requiring expert adjudication to establish ground truth.
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:
- No MRMC study was done. This is a 510(k) for a hardware modification of an ultrasound system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No standalone algorithm performance study was done. This device is an ultrasound system and does not feature a standalone diagnostic algorithm in the context of AI.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission was based on:
- Engineering specifications and measurements: Verifying output parameters, electrical safety, mechanical safety, thermal performance, and acoustic output against established standards (NEMA, IEC).
- Predicate device characteristics: The UF-5800's proven safety and effectiveness served as the benchmark. The modified device's components and underlying technology were compared to the predicate.
- Biocompatibility statements: Validation that materials meet biocompatibility requirements.
8. The Sample Size for the Training Set:
- Not applicable. There was no "training set" in the context of machine learning or AI as this is a hardware device modification submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As no training set was used, no ground truth for a training set was established.
Ask a specific question about this device
Page 1 of 1