(237 days)
The RIWO NET SYSTEM 5590 is used for controlling an operating system by voice control, touch screen monitor or remote control unit in diagnostic and therapeutic endoscopy.
The RIWO NET System 5590 provides central user control of an endoscopic operating system using either voice or remote control from the sterile area or touch screen monitor. The RI
The provided document does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it is an FDA 510(k) summary for the RIWO NET Operating Control System Model #5590, demonstrating substantial equivalence to predicate devices.
Based on the information available in the document, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Conforms to international standards: UL-2601-1, IEC60601-1 with A1 and A2, IEC 60601-1-1 with A1, IEC 60601-1-2. |
| Not specified in document | Designed and tested to guarantee safety and effectiveness when used according to instructions manual. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "No clinical tests performed," suggesting that performance data relies on compliance with standards rather than a specific test set based on patient data.
- Data Provenance: Not applicable, as no clinical tests or human data sets were used for performance evaluation described in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. No clinical tests were performed, and thus no ground truth based on expert review of patient data was established or used as part of this submission.
4. Adjudication Method for the Test Set
- Not applicable. No clinical tests were performed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests performed."
6. If a Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study in the context of an "algorithm only" (i.e., AI performance) was not done. The device is a control system. Its performance evaluation focused on its ability to control other endoscopic devices and compliance with safety standards, not on diagnostic or AI-driven tasks. The phrase "Compliance with international standards" (UL-2601-1, IEC60601-1, IEC 60601-1-1, IEC 60601-1-2) serves as the basis for its performance claims.
7. The Type of Ground Truth Used
- Not applicable in the conventional sense of clinical performance or diagnostic accuracy. The "ground truth" for this device's acceptance is its adherence to specified engineering and safety standards, and its functional capability to control other medical devices as intended.
8. The Sample Size for the Training Set
- Not applicable. This device is an operating control system, not an AI or machine learning device that requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set or associated ground truth was relevant for this device's submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document indicates that the acceptance criteria for the RIWO NET System 5590 were met through compliance with international safety and performance standards. These standards include:
- UL-2601-1
- IEC60601-1 with A1 and A2
- IEC 60601-1-1 with A1
- IEC 60601-1-2
The study proving this involved testing the device against these established standards. The device was "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." No clinical tests were performed on human subjects or clinical data sets for this 510(k) submission, as the device's function is to control other endoscopic equipment, and its safety and effectiveness are primarily assessed through engineering principles and compliance with recognized industrial and medical device standards. The basis for substantial equivalence also relies on comparison to predicate devices with similar functionalities that have already demonstrated safety and effectiveness.
§ 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.