(33 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Musculo-skeletal Conventional and Musculo-skeletal Superficial. Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vicinity of the shoulder, elbow, wrist, knee, and/or ankle.
The Fukuda Denshi model UF-4500 (K022208) and the model UF-3500 (K955543) are general-purpose ultrasound systems that have been previously found to be substantially equivalent under the Food and Drug Administration's 510(k) process. These devices have not been changed or modified in any way. All software and hardware, all portions of the device that control the acoustic power out are unchanged. The addition of both conventional and musculoskeletal imaging as intended uses require no changes to the operating instructions.
The provided text describes a 510(k) submission for adding new intended uses (conventional and superficial musculoskeletal imaging) to existing Fukuda Denshi ultrasound scanners (UF-3500 and UF-4500).
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria for diagnostic performance or reported performance metrics in a typical table format. The "Testing" section broadly concludes the device's capability.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Acoustic Output Limits | Remains below maximums established for Track 1 devices by "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 30, 1997). | |
| (Specific limits for Peripheral Vessel, Cardiac, Fetal Imaging & Other, Ophthalmic are provided in a table, e.g., ISPTA3 |
§ 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.