(58 days)
FLUOBEAM LX and FLUOBEAM LM are intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are indicated for use in capturing and viewing fluorescent images for the visualization of vessels, blood flow and tissue perfusion before, during and after organ transplant, plastic, micro- and reconstructive surgeries.
The FLUOBEAM LX and FLUOBEAM LM can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue.
Use of the FLUOBEAM LX and FLUOBEAM LM devices are intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.
Upon interstitial administration and use of ICG consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
FLUOBEAM LX and FLUOBEAM LM are imaging systems intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures.
Class 1 infrared laser light is used to excite the fluorescent tissues of parathyroid glands or the ICG or the pafolacianine and illuminate the regions of a patient's body to be observed. A camera inside the optical head captures the fluorescent image that is used to visualize the parathyroid glands or assess the blood vessels and related tissue perfusion. FLUOBEAM LX and FLUOBEAM LM consist of the following components: a hardware part with a camera unit (optical head) linked by a specific cable to a control box and a software part with FLUOSOFT LX or FLUOSOFT LM imaging software. The optical head contains a video camera and light sources (laser and LEDs) and is used by hand. The control box receives the video signal of the fluorescent image from the optical head, 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 optical head or via the FLUOSOFT LX imaging software and the FLUOSOFT LM imaging software on the computer.
The subject devices FLUOBEAM LX and FLUOBEAM LM have therefore exactly the same principle of operation of the predicate device. Only aesthetic aspects are different between FLUOBEAM LX and FLUOBEAM LM.
This Traditional 510(k) premarket notification of the FLUOBEAM LX and FLUOBEAM LM is to expand the indication for use statement to include the usage in the lymphatic system with the use of an ICG consistent with its approved label.
This Traditional 510(k) premarket notification of the FLUOBEAM LX and FLUOBEAM LM is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine, for use with infrared imaging.
The provided FDA 510(k) clearance letter and summary for the FLUOBEAM LX and LM Imaging Systems describe the device and its intended use, as well as the types of studies conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain a specific table of acceptance criteria nor detailed results of a study designed to explicitly "prove the device meets the acceptance criteria" in terms of clinical performance metrics. Instead, the focus is on demonstrating comparable performance to the predicate and reference devices through bench testing and, by extension, substantial equivalence for the expanded indications.
Based on the information provided, here's a breakdown of the requested elements:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly provide a table of acceptance criteria with corresponding reported device performance values in the style typically found in a clinical study report with quantitative metrics like sensitivity, specificity, accuracy, or a specific statistical threshold for performance.
Instead, the document states:
- "The results of these performance evaluations demonstrated that the FLUOBEAM LX and FLUOBEAM LM met the acceptance criteria defined in the product specification, functioned as intended, and performed comparably to the predicate device."
- "The FLUOBEAM LX and FLUOBEAM LM was able to visualize similar concentration samples of ICG compared to the reference device, both by analysis of the image contrast (SNR) and by observation of the images."
- "The FLUOBEAM LX and FLUOBEAM LM was able to visualize lower concentration samples of pafolacianine compared to the reference device, both by analysis of the image contrast (SNR) and by observation of the images."
This indicates that the "acceptance criteria" were qualitative (e.g., "capable of imaging ICG at different concentrations") and comparative (performing "similarly" or "better" than a reference device in terms of visualization capabilities and image contrast/SNR).
Without explicit quantitative acceptance criteria in the document, a direct table cannot be constructed. The reported performance is primarily descriptive and comparative to other devices.
2. Sample Size for the Test Set and Data Provenance
The document describes bench testing for the performance evaluation.
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." The testing involved "different concentrations" of ICG and pafolacianine in in vitro settings. This implies multiple samples at varying concentrations were used for the bench tests.
- Data Provenance: In vitro bench testing. No mention of human or animal data for the performance evaluation described. Therefore, there is no country of origin or retrospective/prospective designation relevant to clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
For the bench testing described, the "ground truth" would be the known concentrations of ICG and pafolacianine and the objective measurement of image contrast (SNR). This type of ground truth does not typically involve human expert interpretation in the same way clinical imaging studies do.
Therefore, no experts were used to establish ground truth in the context of the in vitro performance tests.
4. Adjudication Method for the Test Set
Given that the performance data presented is from in vitro bench testing involving objective measurements of image contrast (SNR) and visual observation of images by the testers/engineers, an adjudication method for a test set (e.g., 2+1, 3+1 by clinical experts) is not applicable or mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the provided document. The performance evaluation focuses on the standalone device's capability and its comparison to predicate/reference devices through bench testing, not on human reader performance with or without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
The performance evaluation described is implicitly a standalone (algorithm only) assessment. The bench tests evaluated the system's ability to image ICG and pafolacianine at different concentrations and analyze image contrast (SNR) without human interpretation as part of the core performance metric. While "observation of the images" by humans is mentioned, the primary performance measure (SNR) and the ability to visualize specific concentrations are inherent properties of the imaging system itself.
7. Type of Ground Truth Used
For the performance evaluation described:
- Type of Ground Truth: The ground truth used was known concentrations of ICG and pafolacianine for the in vitro imaging tests. The assessment involved comparing the device's ability to visualize these known concentrations and analyzing the Signal-to-Noise Ratio (SNR).
8. Sample Size for the Training Set
The document describes the FLUOBEAM LX and LM as imaging systems, which typically do not involve machine learning algorithms that require a "training set" in the traditional sense. The software updates mentioned likely relate to operational software, not an AI model trained on data.
Therefore, a "training set" is not applicable or mentioned in the context of this device and its clearance.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of machine learning is not applicable for this device as described.
§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.
(a)
Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.
(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.
(8) Labeling must include the following:
(i) Instructions for use;
(ii) The detection performance characteristics of the device when used as intended; and
(iii) A shelf life for any sterile components.