(152 days)
Upon intravenous administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence angiography.
The FloNavi Open Field Fluorescence Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The FloNavi Open Field Fluorescence Imaging System is an imaging system used in hospitals for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation for use in imaging during various surgical procedures.
The FloNavi Open Field Fluorescence Imaging System has two system models: HD system and 4K system. Each system consists of the following main components: Imaging Head, Image Processing Unit, power supply cord and video cables.
The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the regions of a patient's body to be observed for color imaging. The cameras in the Imaging Head capture the fluorescent image under near infrared illumination or a color image under white light illumination. The Image Processing Unit receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the FloNavi Open Field Fluorescence Imaging System are possible through switches at either the Imaging Head or the Image Processing Unit.
The FloNavi Open Field Fluorescence Imaging System is a reusable device and provided nonsterile. Its components should be cleaned and low-level disinfected prior to the first use and after every subsequent use.
The FloNavi Open Field Fluorescence Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion and for visualization of the lymphatic system. It is a Class II device.
Here's an analysis of the acceptance criteria and supporting study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the device as being "Substantially Equivalent (SE) to the predicate device" (SPY Portable Handheld Imaging (SPY-PHI) System, K200737). The acceptance criteria are implicitly linked to the predicate device's performance and the subject device's ability to meet its own design specifications and relevant safety standards.
| Acceptance Criteria Category | Specific Criteria (Implicit for SE, based on predicate) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with relevant electrical, EMC, and photobiological safety standards. | The device complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62471. |
| Performance | Ability to capture and display fluorescence and white light images; functional operation as intended. | Performance testing demonstrated that the proposed system performs according to specifications and functions as intended. |
| Software Validation | Software meets "Moderate level of concern" requirements per FDA guidance. | Software was validated as "Moderate level of concern" in accordance with FDA guidance documents. |
| Biocompatibility | (Not explicitly mentioned, but typically required for devices with patient contact) | (Not explicitly mentioned in the provided text.) |
| Sterility | (Not explicitly mentioned, but the device is stated as reusable and non-sterile, implying reprocessing procedures are defined.) | The device is provided nonsterile. Components should be cleaned and low-level disinfected prior to first use and after every subsequent use. |
2. Sample Size and Data Provenance for Test Set
The document mentions "Performance testing and animal testing" were conducted.
- Sample Size:
- Performance Testing: Not specified.
- Animal Testing: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth - Test Set
Not applicable/Not specified. The document does not describe a clinical study involving human readers or expert-established ground truth for the "test set" in the context of diagnostic accuracy. The testing primarily focuses on the device's functional and safety performance, as well as animal studies.
4. Adjudication Method for Test Set
Not applicable/Not specified. No such adjudication method is mentioned as the studies described appear to be non-clinical performance and animal studies, not reader studies for diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device appears to be an imaging system, not an AI-powered diagnostic algorithm enhancing human reading.
6. Standalone (Algorithm Only) Performance Study
No. The document presents the FloNavi Open Field Fluorescence Imaging System as a standalone imaging device, not an AI algorithm. The performance testing and animal testing evaluate the device itself.
7. Type of Ground Truth Used
For the performance and animal testing mentioned, the "ground truth" would likely be based on:
- Engineering Specifications: For the technical performance aspects (e.g., image resolution, light output).
- Physiological Response: In animal testing, the "ground truth" for fluorescence imaging would be the actual blood flow, tissue perfusion, or lymphatic system visualization as observed and validated within the animal model, potentially through direct observation or comparison with established methods.
8. Sample Size for Training Set
Not applicable. This device is presented as an imaging system, not an AI/machine learning algorithm requiring a separate training set.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no mention of an AI/machine learning component requiring a training set.
§ 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.