(273 days)
As an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.
The Fluobeam 800 Clinic® Imaging Device is an imaging system used in 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 in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries. The Fluobeam 800 Clinic® Imaging Device is intended for intraoperative visual assessment of blood vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood vessels and related tissue perfusion. Indocyanine green (ICG) is injected intravenously into patients. Class 1 infrared laser light is used to excite the fluorescence of ICG and illuminate the regions of a patient's body to be observed. A charge coupled device (CCD) camera captures the fluorescent image that is used to assess the blood vessels and related tissue perfusion. The Fluobeam 800 Clinic® Imaging Device consists of the following components: Fluobeam® camera unit and Fluocase 800 Control System. The Fluobeam® Camera Unit contains a CCD camera and laser sources and is used either by hand or attaching it to a mechanical arm. The Controller System receives the video signal of the fluorescent image from the Camera Unit, it digitizes it and sends it to a computer that outputs it on a display screen and/or records it. Adjustments of the fluorescent image are possible either by the Camera Unit or via a graphic interface on the computer.
Here's an analysis of the provided text regarding the Fluoptics Fluobeam 800 Clinic® Imaging Device, focusing on acceptance criteria and supporting studies:
It's important to note that the provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving specific quantitative acceptance criteria for its performance. The document states that the device functions as intended based on a review of published literature and the absence of adverse events in clinical use in Europe. It does not provide detailed performance metrics or a formal study with quantitative acceptance criteria as might be seen for novel high-risk devices or AI/ML-based algorithms requiring rigorous clinical validation.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no explicitly stated quantitative acceptance criteria or specific reported device performance metrics in terms of clinical accuracy, sensitivity, or specificity. The acceptance relies on:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device operates safely according to standards. | - Electrical per IEC 60601-1. |
- Electromagnetic Compatibility per IEC 60601-1-2.
- Laser safety per IEC 60825-1 (Class I laser product).
- "The Fluobeam 800 Clinic® Imaging Device has been sold and used clinically in Europe with no adverse events reported to date." |
| Effectiveness (Functional Equivalence): Device functions as intended for visual assessment of blood flow and tissue perfusion. | - "All tests demonstrate that the device functions as intended." - "A review of the published literature concludes that the device worked as intended by safely assessing the blood flow and related tissue perfusion during surgeries."
- "The intended use, indications for use, and the principles of operation of the Fluobeam 800 Clinic® Imaging Device and its predicate device are the same."
- "The minor technological and design differences do not raise new or different questions of safety or effectiveness, as confirmed by verification and validation testing described in the 510(k) submission."
- "All devices function as cameras allowing surgeons to view fluorescent images of blood flow and evaluation of tissue perfusion with the use of indocyanine green (ICG)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "clinical use in Europe" and a "review of the published literature," implying a test set from real-world usage and previous studies, but a specific number of patients or cases for a dedicated validation study is not provided.
- Data Provenance: Primarily retrospective, based on "clinical use in Europe" and "published literature." The country of origin for the "clinical use" is Europe, and the literature review would likely encompass various international studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified. The "review of the published literature" would implicitly involve the expert opinions and findings presented in those publications, but there's no mention of a specific panel of experts convened to establish ground truth for this 510(k) submission's validation.
- Qualifications of Experts: Not specified. It can be inferred that the experts involved in the published literature would be surgeons and medical professionals specializing in plastic, micro-, reconstructive, and organ transplant surgeries who use ICG fluorescence imaging.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Since there's no explicitly described dedicated test set with an independent ground truth establishment process led by a specific number of experts for this submission, no adjudication method is detailed. The "review of published literature" implies that prior studies' methodologies, including their ground truth establishment and potential adjudication, were considered.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text.
- Effect Size: Not applicable, as no MRMC study was described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The Fluobeam 800 Clinic® is an imaging system (hardware and software) designed for human visual assessment of blood flow. It is not an AI/ML algorithm that operates in a standalone capacity without human interpretation. It provides images that surgeons use to make decisions.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the effectiveness of visual assessment of blood flow and tissue perfusion, as supported by the "review of the published literature" and "clinical use in Europe," would be clinical outcomes and surgeons' intraoperative assessments of perfusion. This would likely be based on:
- Surgical observations of tissue viability and blood flow during procedures.
- Post-operative outcomes related to flap survival and graft integration.
- Correlation between ICG fluorescence patterns and actual perfusion as determined by clinical judgment.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Fluobeam 800 Clinic® is a traditional imaging device, not an AI/ML algorithm that requires a "training set" in the computational sense. Its design and functionality are based on established optical principles, laser physics, and ICG fluorescence properties, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as it's not an AI/ML device requiring a training set. The "ground truth" for its development would be based on fundamental scientific understanding of fluorescence imaging, ICG pharmacokinetics, and surgical needs for perfusion assessment.
§ 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.