(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.
{0}------------------------------------------------
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 2005038040 Grenoble Cedex 9, France |
| Phone: | +33 (0)4 38 78 37 97 |
| Contact Person: | Michael A Daniel, Consultant |
| Phone Number: | (415) 407-0223 |
| Office: | (775) 392-2970 |
| Facsimile Number: | (775) 392-2972 |
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
{1}------------------------------------------------
Fluoptics
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.
-
- Electrical per IEC 60601-1.
-
- Electromagnetic Compatibility per IEC 6060 1-1-2.
-
- 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. 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.
{2}------------------------------------------------
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
{3}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{4}------------------------------------------------
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)
.
§ 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.