(13 days)
The Fujinon ultrasonic processor SU-8000 is intended to be used in combination with Fujinon/Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General Application
Specific: Tran-esoph. (non-Card.), Other (Specify)
Mode of Operation: B, M, PWD, Color Doppler, Combined1
Other includes gastro-intestinal tract and surrounding organs
Fujinon Ultrasonic Processor SU-8000 is a new ultrasonic processor, which can be used with the previously-cleared ultrasonic gastrointestinal endoscopes, EG-530UR and EG-590UT via K063847.
Fujinon Ultrasonic Processor SU-8000 consists of a scan engine and a function box and SU-8000 is controlled by keyboard (model: CP-8000) SU-8000 connects to ultrasonic endoscopes, which emits ultrasound in a body cavity by driving ultrasonic transducers of the endoscope. SU-8000 also processes the reflection of ultrasonic signals the transducer and converts it to an ultrasound image.
SU-8000 is used in combination with ultrasonic endoscopes, video processor, light source, cart, recorder, foot switch and other peripheral devices (e.g. external monitor and printer), which is the same as the legally marketed device, SU-7000.
I am unable to provide a structured response about acceptance criteria and study details based on the provided text. The document is a 510(k) summary for the Fujinon Ultrasonic Processor SU-8000, which states:
- "No clinical test was conducted."
- The device was evaluated in accordance with various IEC safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, etc.).
- Substantial equivalence to a legally marketed device (SU-7000) was established based on having the same Indications for Use and very similar Functional and Technical requirements.
This type of submission focuses on demonstrating safety and effectiveness through adherence to recognized standards and substantial equivalence to existing devices, rather than through a new clinical study with specific acceptance criteria and performance metrics typically associated with AI/algorithm validation. Therefore, the requested information (such as sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth details for test/training sets) is not present in this document.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.