FLUOBEAM® LX Red is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The FLUOBEAM® LX Red is indicated for use in capturing 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 FLUOBEAM® LX Red 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 Red 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 confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

Device Description

FLUOBEAM® LX Red is an imaging system intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The FLUOBEAM® LX Red 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.

FLUOBEAM® LX Red 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 autofluorescence of this tissue. Use of the FLUOBEAM® LX Red 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 locating visually identified gland/tissues.

FLUOBEAM® LX Red enables surgeons to observe fluorescent images of parathyroid glands, blood vessels and related tissue perfusion. Fluorescence can be observed thanks to natural fluorescence of parathyroid glands or thanks to a fluorescent product, indocyanine green (ICG), injected intravenously into patients before the surgery allowing the perfusion assessment.

Class 1 infrared laser light is used to excite the fluorescent tissues of parathyroid glands or the ICG 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 Red consists 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 Red 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 Red imaging software on the computer.

The modified device FLUOBEAM® LX Red has therefore exactly the same principle of operation of the predicate device. The modified device FLUOBEAM® LX Red is a device modification of the FLUOBEAM® LX device. Compared to the predicate device FLUOBEAM® LX, change of wavelength and detection range is being implemented for modified device FLUOBEAM® LX Red to improve performance in terms of sensitivity for the location of parathyroid glands due to the auto-fluorescence of this tissue while maintaining sensitivity to indocyanine green (ICG).

AI/ML Overview

The FLUOBEAM® LX Red is an imaging system designed to provide real-time near-infrared (NIR) fluorescence imaging of tissue during surgical procedures. It is indicated for visual assessment of blood flow using indocyanine green (ICG) as an adjunctive method, and for assisting in the location of parathyroid glands due to their autofluorescence.

Here’s a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	Laser Safety	Meets IEC 60825-1 (Class 1 laser product)
Performance - Imaging	Homogeneity of excitation illumination pattern	Demonstrated equivalence through bench testing
Performance - Imaging	Live image quality (spatial resolution)	Demonstrated equivalence through bench testing
Performance - Imaging	Live image quality (acquisition frame rate)	Demonstrated equivalence through bench testing
Performance - Imaging	Fluorescence sensitivity	Demonstrated equivalence through bench testing
Clinical Performance (ICG Fluorescence)	ICG fluorescence imaging of blood flow in comparison to predicate device	Performance supported by clinical tests on 5 patients
Clinical Performance (Autofluorescence)	Sensitivity for location of parathyroid glands due to autofluorescence	Improved performance compared to predicate device (implied by change in wavelength/detection range)
Clinical Performance (ICG Sensitivity)	Maintaining sensitivity to indocyanine green (ICG)	Maintained sensitivity compared to predicate device (implied by change in wavelength/detection range)
Overall Performance	Function as intended and perform comparably to predicate device	Tests demonstrated that FLUOBEAM® LX Red met acceptance criteria, functioned as intended, and performed comparably to the predicate device FLUOBEAM® LX.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: 5 patients for the clinical tests on ICG fluorescence imaging.
Data Provenance: Not explicitly stated, but given it's for a European company (FLUOPTICS SAS, France), the data is likely from a European country. The text does not specify if it was retrospective or prospective, but clinical tests are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The general indication statement mentions that the device is intended to "assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care," suggesting that expert assessment and histology are the ground truth, but doesn't specify the number or qualifications of experts involved in the study itself.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance was not mentioned. This device is an imaging system, not an AI-driven algorithm with a human-in-the-loop component.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This device is an imaging system, not solely an algorithm. Its performance is intrinsically linked to the physical hardware (camera, light source) and software for image acquisition and display. Therefore, a "standalone algorithm only" performance study, as typically understood for AI, is not applicable in this context. The document describes bench tests for image quality and sensitivity, and clinical tests for its imaging capabilities.

7. The type of ground truth used:

For ICG fluorescence imaging for blood flow assessment: The ground truth is implied by comparison to the predicate device in clinical settings, and by the "visual assessment of blood flow." Ultimately, the standard of care for confirming tissue perfusion and viability would involve clinical observation, surgical assessment, and potentially other diagnostic tools.
For parathyroid gland location: The ground truth is implied to be "visually identified gland/tissues" by experienced visual assessment and "biopsy with conventional histopathological confirmation per standard of care."

8. The sample size for the training set:

This information is not provided as the document does not mention any machine learning or AI models with distinct training sets. The device's performance is established through engineering design, bench testing, and limited clinical validation.

9. How the ground truth for the training set was established:

This information is not applicable as the document does not mention a training set in the context of machine learning or AI.

Summary

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July 28, 2023

Fluoptics Sas % Rama Hannineh Regulatory Affairs Specialist Getinge 45 Barbour Pond Dr. Wayne, New Jersey 07470

Re: K230898

Trade/Device Name: FLUOBEAM® LX Red Regulation Number: 21 CFR 878.4550 Regulation Name: Autofluorescence Detection Device For General Surgery And Dermatological Use Regulatory Class: Class II Product Code: QDG Dated: June 30, 2023 Received: July 3, 2023

Dear Rama Hannineh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jianting Wang -S

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230898

Device Name FLUOBEAM LX Red

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Premarket Notification Special 510(k) Summary

This summary of Special 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

K230898 510(k) Number: ______________________________________________________________________________________________________________________________________________________________

Applicant Information:

Date Prepared:	July 27, 2023
Name:Address:	FLUOPTICS SAS44 rue des berges38000 Grenoble, France
Phone:	+33 (0)4 85 87 06 60
Contact Person:Email:	Rama Hannineh, Regulatory Affairs Specialistrama.hannineh@getinge.com
Office:	(973) 709-7744

Device Information:

Device Trade Name:	FLUOBEAM® LX Red
Common Name:	Fluorescence imaging system
Classification Name(s):	Parathyroid Autofluorescence Imaging Device
Product Code/ Regulation:	QDG / 21 CFR 878.4550
Classification:	Class II

Predicate Device:

Submitter Name:	FLUOPTICS SAS
Submitter Address:	44 rue des berges – 38000 Grenoble - FRANCE
Device Trade Name:	FLUOBEAM® LX (K190891)
Device Common Name:	Fluorescence imaging system
Product Code/Regulation:	QDG / 21 CFR 878.4550
Classification:	Class II

Device Description:

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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.

Indications for Use:

FLUOBEAM® LX Red is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The FLUOBEAM® LX Red 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.

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Use of the FLUOBEAM® LX Red 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 locating visually identified gland/tissues.

Comparison of Technological Characteristics:

The FLUOBEAM® LX Red has the same principle technological characteristics as the predicate device: it emits a Class 1 laser light at a wavelength of 685nm in order to generate fluorescent light in the range 710-900nm. For the FLUOBEAM® LX Red device, change of wavelength and detection range is being implemented to improve performance in terms of sensitivity for the location of parathyroid glands due to the auto-fluorescence of this tissue while maintaining sensitivity to indocyanine green (ICG).

Bench testing was performed to support a determination of substantial equivalence (refer to performance testing below) between the FLUOBEAM® LX Red and the predicate device FLUOBEAM® LX. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and its performance, compared to the predicate device.

The introduction of this new FLUOBEAM® LX Red raises no new or different issues of safety and effectiveness such that the subject FLUOBEAM® LX Red is substantially equivalent to the predicate device.

Performance Data:

Performance and safety testing according to international standards has been performed: - Laser safety per IEC 60825-1 (Class I laser product).

Bench tests were also carried out to demonstrate equivalence: -the homogeneity of the excitation illumination pattern; -the live image quality (spatial resolution and acquisition frame rate); -the fluorescence sensitivity.

Clinical Tests were performed on 5 patients to support the performance of the subject device in terms of ICG fluorescence imaging of the blood flow in comparison to the predicate device.

All these tests conducted with FLUOBEAM® LX Red are described in this Special 510(k) submission. The results of these performance evaluations demonstrated that the FLUOBEAM® LX Red met the acceptance criteria defined in the product specification, functioned as intended, and performed comparably to the predicate device FLUOBEAM® LX.

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Substantial Equivalence:

The predicate device is the FLUOBEAM® LX, Fluorescent Imaging System from FLUOPTICSoSAS. FLUOBEAM® LX Red is a device modification of the FLUOBEAM® LX

The intended use, indications for use, and the principles of operation of the FLUOBEAM® LX Red and its predicate are the same. FLUOBEAM® LX Red and the predicate device have similar technological characteristics and 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 this Special 510(k) submission. Both devices function as cameras allowing surgeons to view fluorescence images of blood flow and evaluation of tissue perfusion with the use of indocyanine green (ICG); or visualization of parathyroid glands by autofluorescence.

Summary:

Based upon descriptive information provided, verification testing completed and basic functionality and technological similarities, the FLUOBEAM® LX Red is substantially equivalent to the cited predicate device.

Regulation Number and Section

§ 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.