K Number
DEN170092
Device Name
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
Manufacturer
Date Cleared
2018-11-02

(315 days)

Product Code
Regulation Number
878.4550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fluoptics Fluobeam® Imaging system is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluoptics Fluobeam® Imaging system is indicated for use 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, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries. The Fluoptics Fluobeam® Imaging system 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® device is 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 location of visually identified gland/tissues.
Device Description
The Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System is an autofluorescence imaging system that is capable of visualizing autofluorescent signals from the parathyroid glands. The device is a non-contacting imaging system that excites fluorescent molecules with non-ionizing near-infrared light at 750 nm and collects emissions from 800 nm to (6) (4) mm. The collected emissions are subsequently displayed as an image on a panel PC screen. The Fluobeam device is composed of the following components: - 1. The optical head (FluoBeam 800 Clinic® Device) - a. Contains 750 nm laser (for fluorescence excitation), NIR LEDs (b) (4) and white LEDs (normal illumination λ<800) - b. The excitation irradiance was measured as W/m² at a distance of 20 cm from the optical head. - Contains a CCD camera to collect fluorescence emissions from 800 nm to (1) (41mm C. - The head is a multiple patient, multiple use device used in the sterile field with a d. disposable sterile sheath (K850959). - 2. The electrical case (Fluocase™ 800) - The electrical case remains in the non-sterile area and contains all supporting ล. electronics to power, control, and monitor the optical head. - 3. The software (Fluosoft™) - a. Available as preinstalled software on the panel PC or as electronic media - b. Enables real-time visualization of fluorescence and autofluorescence signals acquired by the optical head. - c. Contains several modes (standard, advanced, perfusion, low signals, and time lapse) for visualizing fluorescence and autofluorescence images.
More Information

Not Found

Not Found

No
The device description and performance studies focus on real-time fluorescence imaging and image processing using standard software (Image J). There is no mention of AI, ML, or related concepts in the document.

No

Explanation: The device is an imaging system intended for visual assessment and to assist in the location of tissues. It does not provide any therapeutic intervention or treatment.

Yes

The device aids in the visual assessment of blood flow, evaluation of tissue perfusion, and location of parathyroid glands, all of which are diagnostic functions used to assess a medical condition or health status.

No

The device description explicitly lists hardware components: an optical head containing lasers, LEDs, and a CCD camera, and an electrical case containing supporting electronics. While software is a component, it is not the sole component of the medical device.

Based on the provided information, the Fluoptics Fluobeam® Imaging system is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • Fluobeam's Intended Use: The Fluobeam system is intended for real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. It is used to visualize tissue in situ (within the body) and provides visual assessment of blood flow and assists in locating parathyroid glands.
  • Device Description: The device is a non-contact imaging system that interacts directly with the patient's tissue during surgery. It does not process or analyze specimens taken from the body.
  • Performance Studies: The performance studies evaluate the device's ability to visualize and identify tissues in vivo or ex vivo on removed specimens, but the primary use is during surgery.

The Fluobeam system is an imaging device used to provide visual information to the surgeon during a procedure. It is not designed to perform tests on biological samples outside of the body, which is the core function of an IVD.

N/A

Intended Use / Indications for Use

The Fluoptics Fluobeam® Imaging system is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluoptics Fluobeam® Imaging system is indicated for use 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, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.

The Fluoptics Fluobeam® Imaging system 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® device is 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 location of visually identified gland/tissues.

Product codes (comma separated list FDA assigned to the subject device)

QDG

Device Description

The Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System is an autofluorescence imaging system that is capable of visualizing autofluorescent signals from the parathyroid glands. The device is a non-contacting imaging system that excites fluorescent molecules with non-ionizing near-infrared light at 750 nm and collects emissions from 800 nm to (6) (4) mm. The collected emissions are subsequently displayed as an image on a panel PC screen.

The Fluobeam device is composed of the following components:

    1. The optical head (FluoBeam 800 Clinic® Device)
    • a. Contains 750 nm laser (for fluorescence excitation), NIR LEDs (b) (4) and white LEDs (normal illumination λ6 months) hypocalcemia in the NIR- group.
  • Parathyroid identification rates were higher in the NIR+ group compared to NIR- group (76.3% vs. 65.7% of theoretically present parathyroids, p

§ 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.

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DE NOVO CLASSIFICATION REQUEST FOR FLUOPTICS FLUOBEAM 800 CLINIC® IMAGING DEVICE WITH FLUOCASE 800™ CONTROL SYSTEM

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Autofluorescence detection device for general surgery and dermatological use: 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.

NEW REGULATION NUMBER: 21 CFR 878.4550

CLASSIFICATION: Class II

PRODUCT CODE: QDG

BACKGROUND

DEVICE NAME: Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

SUBMISSION NUMBER: DEN170092

DATE DE NOVO RECEIVED: December 22, 2017

Fluoptics CONTACT: 7 Parvis Louis Neel, CS 20050 38040 Grenoble Cedex 9, France

INDICATIONS FOR USE

The Fluoptics Fluobeam® Imaging system is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluoptics Fluobeam® Imaging system is indicated for use 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, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.

The Fluoptics Fluobeam® Imaging system 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.

1

Use of the Fluobeam® device is 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 location of visually identified gland/tissues.

LIMITATIONS

The sale, distribution, and use of the Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System is restricted to prescription use in accordance with 21 & CFR 801.109.

The Fluobeam© 800 has not been evaluated in providing a diagnosis of parathyroid conditions including adenoma, carcinoma, and hyperplasia.

The clinical outcomes performance data was limited to total thyroidectomy patients and the impact of the device on clinical outcomes in patients with parathyroid disease (i.e., adenoma) is not as clear. Caution must also be exercised to evaluate autofluorescent tissue to confirm identity as parathyroid gland because thyroid colloid nodules or other tissues may have enhanced autofluorescence in some patients.

The performance of this device has not been definitively established in certain disease states such as secondary hyperparathyroidism, tertiary hyperparathyroidism, malignant parathyroid disease, or certain genetic conditions including Multiple Endocrine Neoplasia 1/2A. Additionally, the device has not been adequately tested for use to differentiate normal from abnormal or pathologic parathyroid glands.

PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

The Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System is an autofluorescence imaging system that is capable of visualizing autofluorescent signals from the parathyroid glands. The device is a non-contacting imaging system that excites fluorescent molecules with non-ionizing near-infrared light at 750 nm and collects emissions from 800 nm to (6) (4) mm. The collected emissions are subsequently displayed as an image on a panel PC screen.

The Fluobeam device is composed of the following components:

    1. The optical head (FluoBeam 800 Clinic® Device)
    • a. Contains 750 nm laser (for fluorescence excitation), NIR LEDs (b) (4) and white LEDs (normal illumination λ800 nm |
      | Working Distance | 20-30 cm |
      | Focal plane depth | 2 to 3 cm |
      | Field of View | Minimum: 2.2 cm x1.5 cm
      Maximum: 20 cm x 14 cm |
      | Resolution (focal plane) | 300 μm to 50 μm depending on
      magnification |
      | Magnification | X10 zoom |
      | Maximum frame rate | 25 images/sec |
      | Minimum exposure time | 1 ms |
      | Maximum exposure time | 1 s |
      | Camera bit depth | 8 bits |
      | Image size (pixels) | 696 x 576 pixels |
      | Image format | PNG |
      | Video format | MP4 |
      | Software operating system (OS)
      compatibility | Windows 7 or Windows 10 |
      | Laser power density | 5 ± 1 mW/cm² |
      | Infrared LED | (b) (4) nm |
      | White LED | Broadband LEDs with normal illumination
      λ6 months) hypocalcemia in the NIR- group, but do not state the rate in the NIR+ group.

In this study, parathyroid identification rates were higher in the NIR+ group compared to NIRgroup with significant Dunn's test p6 months) for comparison. These significant reductions are primarily observed in patients with more than three identified parathyroid glands. The authors posit that the use of the device earlier identification of parathyroid glands and enables surgeons to avoid injuring the parathyroid glands or their vascular supply. There was no observed increase in operative time with the use of the device, which the authors attribute to expedited dissection due to earlier identification of the parathyroid glands. This study offers support for the use of the device with observed improvement in clinically relevant outcomes, which are the most important consideration in effectiveness of the device.

STUDY 4: Kahramangil et al

The purpose of the fourth study was to compare the rate of detection of parathyroid glands with and without the sponsor device among patients undergoing thyroid and parathyroid surgery. This was a retrospective review of 210 prospectively-enrolled patients from three centers. One of the study sites the same hospital as Study 3 above. The authors of Study 4 do not provide the

13

years for data acquisition, and it cannot be determined if this study includes duplicate patients, although the included surgeries were broader in Study 4 (ie parathyroid and thyroid in study 4, just thyroid surgery in study 3). Patients were used as their own control, with the device used in every patient. The patient demographics is available in the table:

| Parameter | All patients
(n = 210) | Center 1
(n = 70) | Center 2
(n = 70) | Center 3
(n = 70) | p value |
|-----------------------------|---------------------------|----------------------|----------------------|----------------------|----------------|
| Age, years [mean (SD)] | 53.1 | 53.0 (12.0) | 51.6 (15.4) | 54.8 (14.2) | 0.31 |
| BMI, kg/m2 [mean (SD)] | 26.5 (6.5) | 21.4 (1.8) | 27.0 (5.4) | 31.3 (6.9) |