(58 days)
The diagnostic ultrasound system (U60) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
The U60 is a portable Diagnostic Ultrasound System, which applies advanced technologies. Various image parameter adjustments, 15.0 inch LCD and diverse probes are configured to provide clear and stable images.
The provided text is a 510(k) premarket notification for the Edan Instruments U60 Diagnostic Ultrasound System. This type of FDA submission aims to demonstrate "substantial equivalence" to a predicate device, rather than proving safety and effectiveness from scratch through extensive clinical trials for a new, revolutionary device.
Therefore, the document does not contain detailed information about acceptance criteria and studies demonstrating that the device meets those acceptance criteria in the way one might expect for a novel AI/ML device or a device with new clinical indications. Instead, it focuses on demonstrating that the U60 is substantially equivalent to a predicate device (the U50 Diagnostic Ultrasound System) by showing similar design, intended use, indications for use, fundamental scientific technology, and performance, while complying with relevant safety standards.
Here's a breakdown of what can and cannot be extracted from the document based on your request:
Information Present in the Document:
- 1. Table of Acceptance Criteria and Reported Device Performance:
- The document presents a comparison table (within "9. Predicate Device Comparison") between the U60 (subject device) and the U50 (predicate device) across various parameters. This table effectively serves as the "acceptance criteria" for demonstrating substantial equivalence, where the acceptance criteria is generally "same" or "similar" to the predicate.
- Table of Performance (Comparison to Predicate):
| Item | U60 R1.0 Ultrasound System (Edan Instruments) Performance | U50 R2.2 Ultrasound System (Edan Instruments) Performance | Comparison Result |
|---|---|---|---|
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Same |
| Indications for Use | Applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics for abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications. | Same as U60 | Same |
| Safety Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, AIUM, NEMA UD 2, UD3 | Same | Same |
| Patient Contact Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Software life cycle processes | Complies with IEC 62304 | Complies with IEC 62304 | Same |
| Mode of Operations | Continuous operation | Continuous operation | Same |
| General Imaging mode | B-Mode, M-Mode, Color, PDI/DPDI, PW, CW | B-Mode, M-Mode, Color, PDI/DPDI, PW, CW | Same |
| Measurements (B-Mode) | Distance, Area, Volume, Ratio, Histogram, Angle | Same | Same |
| Measurements (M-Mode) | Distance, Time, Slope, Heart Rate | Same | Same |
| Measurements (D-Mode) | Time, Heart Rate, Velocity, Acceleration, RI, PI, Auto (auto trace) | Same | Same |
| Scanning method | Electronic convex, Electronic linear with slant scanning | Same | Same |
| Cine loop | 1227 frames | 1227 frames | Same |
| Focus Number | Max=4 | Max=4 | Same |
| Software Packages | Abdomen, obstetric, small parts, gynecology, cardiology, urology, vascular, Pediatrics. | Same | Same |
| Principle of Operation | Applying high voltage burst to Piezoelectric material in transducer and detect reflected echo to construct diagnostic image | Same | Same |
| Acoustic Output | Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0), Derated ISPTA: 720 W/cm² max, Mechanic Index ≤1.9 max or Derated ISPPA 190 W/cm² max | Same | Same |
| Transducer Types | Convex Array, Linear Array, Micro Convex Array, Phased Array | Same | Same |
| Transducer Frequency | 2.0-15.0 MHz | 2.0-15.0 MHz | Same |
| Primary Display | 15inch (1024*768) | 12.1inch (1024*768) | Difference |
| Dimensions/Weight | 220 mm (W) × 370 mm (L) × 350 mm (H), 8.1kg net weight | 330 mm (W) × 320 mm (L) × 220 mm (H), 7.8kg net weight | Difference |
| Printer | B/W video thermal printer, Color video thermal printer, Graph/text laser jet printer | Same | Same |
| Storage Media | DVD, USB stick | DVD, USB stick | Same |
| Temperature (Operating) | 0°C ~40°C | 5°C ~40°C | Difference |
| Temperature (Transport/Storage) | -20~55°C | -20~55°C | Same |
| Relative humidity (Operating) | 15% ~ 95%RH (no condensation) | 25% ~ 80%RH (no condensation) | Difference |
| Relative humidity (Transport/Storage) | 15% ~ 95%RH (no condensation) | 25% ~ 93%RH (no condensation) | Difference |
| Atmospheric pressure (Operating) | 860hPa ~1060hPa | 860hPa ~1060hPa | Same |
| Atmospheric pressure (Transport/Storage) | 700hPa ~1060hPa | 700hPa ~1060hPa | Same |
| Power Requirements | AC: 100-240V 50/60Hz | AC: 100-240V 50/60Hz | Same |
| Operation System | Linux | Linux | Same |
| Safety Classifications | Class I (Type BF, main unit: IPX0, probes: IPX7, footswitch: IP68, not suitable for use in flammable gas) | Same | Same |
| Displayed depth | 20-320mm (Probe Dependent) | 20-320mm (Probe Dependent) | Same |
| Gray Scales | 256 | 256 | Same |
| Dynamic range | 150dB | 150dB | Same |
| TGC | 8 segments | 8 segments | Same |
| Zoom | Up to 400% | Up to 400% | Same |
| B-Mode Measurement Accuracy | Depth/Distance: Max 324mm, Accuracy ≤±5% | ||
| Area: Max 1126 cm², Accuracy ≤±10% | |||
| Angle: 0-180°, Accuracy ≤±3% | |||
| Ratio: Max 1.0, Accuracy |
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.