(48 days)
The Visera Elite II Video System Center (OLYMPUS OTV-S300) is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
The subject device is a video system center (OTV-S300) to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment used with endoscopes. The subject device is an update to the Visera Elite II Video System Center cleared under K201200 to add an infrared (IR) function. The IR light source (CLV-S200-IR) uses the existing software in the subject device to enable the connection and ensure IR compatibility. The subject device has both a processor function and light source function. By switching on the illumination lamp in the subject device, the device provides light through the endoscopes directly for endoscopic observation. There are two modes: WLI (White light imaging) mode for normal observation and NBI (Narrow-band imaging) mode. By driving the CCD equipped in the endoscope, the subject device displays an endoscopic image on a monitor.
Acceptance Criteria & Device Performance: OLYMPUS OTV-S300 (Visera Elite II Video System Center)
Summary of Device Modification: The OLYMPUS OTV-S300 (Visera Elite II Video System Center) is an update to a previously cleared device (K201200) with the primary modification being the addition of infrared (IR) functionality.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (as demonstrated by the study) |
|---|---|---|
| Electrical Safety | Compliance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, and IEC 60601-2-18:2009 standards. | Electrical safety testing was conducted in accordance with the specified standards. Result: Implied compliance, as the submission states this testing was performed to support the device's safety and effectiveness. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 standards. | EMC testing was conducted in accordance with the specified standards. Result: Implied compliance, as the submission states this testing was performed to support the device's safety and effectiveness. |
| Software Verification & Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005) and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (2014). This implies the software functions correctly, securely, and as intended for integrating the IR functionality. | Software verification and validation testing for the subject device was conducted as recommended by the specified FDA guidance documents. Result: Implied compliance, as the submission states this testing was performed to ensure the software's proper function and cybersecurity. |
| Performance Testing (Bench - General) | The device incorporates the IR functionality and performs as intended, meeting design specifications. This includes, but is not limited to, the specific image quality parameters below. | Bench testing for the subject device incorporating the IR functionality was conducted to ensure that the subject device performs as intended and meets design specifications. Result: Implied compliance, as the submission concludes these tests demonstrate the device is safe and effective. |
| Performance Testing (Bench - Image Quality) | ||
| - Brightness | The image brightness with IR functionality meets design specifications. | Evaluated during bench testing. Result: Implied satisfactory performance meeting specifications. |
| - Image Intensity Uniformity | The uniformity of image intensity with IR functionality meets design specifications. | Evaluated during bench testing. Result: Implied satisfactory performance meeting specifications. |
| - Color Performance | The color performance of images (presumably in WLI and NBI modes, and potentially how IR integration affects it or allows for specific IR visualization) meets design specifications. | Evaluated during bench testing. Result: Implied satisfactory performance meeting specifications. |
| - Signal-to-Noise Ratio | The signal-to-noise ratio in images generated (with IR functionality) meets design specifications, ensuring image clarity. | Evaluated during bench testing. Result: Implied satisfactory performance meeting specifications. |
2. Sample Size for Test Set and Data Provenance:
The document describes bench testing and design verification and validation activities. It does not specify a sample size for a "test set" in terms of patient data or clinical images. The data provenance is related to in-house engineering and testing, not patient demographics or clinical data from specific countries. The studies conducted are design verification and validation tests, primarily technical in nature, rather than clinical studies using patient data.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
Not applicable. This submission relies on engineering and technical performance testing, not clinical evaluation requiring expert consensus on ground truth for a test set of images/data derived from patients.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The submission focuses on technical performance and safety/effectiveness equivalence to a predicate device, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The device is a "Video System Center" (hardware and integrated software) that provides imaging capabilities for endoscopes, not a standalone AI algorithm. Its performance is evaluated as an integrated system component.
7. Type of Ground Truth Used:
The "ground truth" for the performance criteria appears to be established through engineering design specifications and recognized international and national standards (e.g., ANSI/AAMI, IEC). Compliance with these standards and the device's own design specifications forms the basis of the "ground truth" for its technical performance.
8. Sample Size for the Training Set:
Not applicable. This device is a video system center for endoscopic imaging, not an AI model that undergoes "training" in the machine learning sense with a data set.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no "training set" in the context of this device.
§ 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.