(98 days)
High resolution ultrasound imaging of wounds such as:
- Clean, closed surgical incisions
- Skin graft donor sites
- Superficial wounds such as abrasion, skin tears, and blisters
- Chafed skin or irritated skin
- Ulcers-cavernous and non-cavernous
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Wounds, Mode of Operation: B
Not Found
This document is a 510(k) premarket notification clearance letter from the FDA for the Hudson 2020/2040/2060 Ultrasound Scanners and their corresponding transducers. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. This is a regulatory pathway for medical devices and does not typically involve the presentation of specific performance studies against acceptance criteria in the same way a de novo or PMA submission might.
Therefore, I cannot extract the requested information about acceptance criteria or a study proving the device meets them from the provided text.
§ 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.