FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM

K132475 · Fluoptics · OWN · May 7, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K132475
• Device Name: FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
• Applicant: Fluoptics
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: May 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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.

Device Story

Fluobeam 800 Clinic Imaging Device captures fluorescent images to assess blood flow and tissue perfusion intraoperatively. System uses intravenous Indocyanine green (ICG) as contrast agent; Class 1 infrared laser excites ICG fluorescence. CCD camera in Fluobeam unit captures fluorescent signals; Fluocase 800 Control System digitizes video signal for computer display and recording. Operated by surgeons in clinical/surgical settings; handheld or mechanical arm-mounted. Provides real-time visual feedback on tissue perfusion; assists surgeons in evaluating blood vessels and tissue-transfer circulation. Benefits include improved intraoperative assessment of tissue viability in reconstructive and transplant procedures.

Clinical Evidence

No clinical trials conducted. Evidence based on bench testing (electrical safety per IEC 60601-1, EMC per IEC 60601-1-2, laser safety per IEC 60825-1) and literature review of clinical use in Europe.

Technological Characteristics

Fluorescence imaging system; CCD camera; Class 1 infrared laser excitation source. Components: Fluobeam camera unit, Fluocase 800 control system. Connectivity: digital video output to computer display. Standards: IEC 60601-1 (electrical), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety).

Indications for Use

Indicated for adult patients undergoing plastic, micro-, reconstructive, or organ transplant surgeries requiring visual assessment of blood flow and tissue perfusion.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PDE Fluorescent Angiographic System (Hamamatsu Photonics K.K.)

Submission Summary (Full Text)

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Fluoptics

# Section 8. Premarket Notification 510(k) Summary

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

# 510(k) Number: K132475

## Applicant Information:

| Date Prepared: | May 7, 2014 |
|-------------------|-----------------------------------------------------------------|
| Name: | Fluoptics |
| Address: | 7 Parvis Louis Neel, CS 20050<br>38040 Grenoble Cedex 9, France |
| Phone: | [phone] |
| Contact Person: | Michael A Daniel, Consultant |
| Phone Number: | [phone] |
| Office: | [phone] |
| Facsimile Number: | [phone] |

## Device Information:

| Device Trade Name: | Fluobeam 800 Clinic® Imaging Device with Fluocase 800™ Control System |
|---------------------------|-----------------------------------------------------------------------------------|
| Common Name: | Fluorescence imaging system |
| Classification Name(s): | Angiographic X-Ray System |
| Product Code/ Regulation: | OWN / 21 CFR 876.1500 |
| Classification: | Class II |

## Predicate Device:

| Submitter Name: | Hamamatsu Photonics K.K. |
|---------------------------|-----------------------------------------------------------|
| Submitter Address: | 812 Joko-cho, Higashi-ku, Hamamatsu City, 431-3196, JAPAN |
| Device Trade Name: | PDETTM |
| Device Common Name: | Fluorescent Angiographic System |
| Product Code/ Regulation: | IZI / 21 CFR 892.1600 |
| Classification: | Class II |

## Device Description:

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

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#### Fluoptics

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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.

## Indications for Use:

As 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 in plastic, micro- and reconstructive and organ transplant surgeries.

#### Performance Data:

The following electrical, performance, and clinical tests have been conducted with the Fluobeam 800 Clinic® Imaging Device and are described in the 510(k) submission. All tests demonstrate that the device functions as intended.

- 1. Electrical per IEC 60601-1.
- 2. Electromagnetic Compatibility per IEC 6060 1-1-2.
- 3. 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. 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.

#### Substantial Equivalence:

The predicate device is the Hamamatsu Photonics K.K., PDE Fluorescent Angiographic System. 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 Fluobeam 800 Clinic® Imaging Device and the predicate devices 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 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).

#### Summary:

Based upon descriptive information provided, verification testing completed and basic functionality and technological similarities, the Fluobeam 800 Clinic® Imaging Device is substantially equivalent to the cited predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 7, 2014

Fluoptics % Mr. Michael A. Daniel Daniel & Daniel Consulting, LLC 8 Snowberry Court Orinda, California 94563

Re: K132475

Trade/Device Name: Fluobeam 800 Clinic® Imaging Device with Fluocase 800" control system Regulation Number: 21 CFR 876.1500 Regulation Name: Confocal optical imaging Regulatory Class: Class II Product Code: OWN Dated: April 1, 2014 Received: April 4, 2014

Dear Mr. Daniel:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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### Page 2 - Mr. Michael A. Daniel

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar 2014.05.07 15:53:01 -04'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration .

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known) K132475

#### Device Name

Fluobeam 800 Clinic® Imaging Device with Fluocase 800™ control system

#### Indications for Use (Describe)

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.

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

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/4/Picture/12 description: The image contains the name "Neil R Ogden -S" on the first line. The second line contains the date "2014.05.07" followed by the time "15:23:42-04:00". There is also a logo to the right of the name.

FORM FDA 3881 (1/14)

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