XIRALITE FLOURESCENCE IMAGING SYSTEM X4

{0}------------------------------------------------ # mive : . . ### K130003 #### 5 510(k) Summary # JAN 3 1 2014 ### [As Required by 21 CFR 807.92] 1 | Manufacturer's Name<br>and Address: | mivenion GmbH<br>Robert-Koch-Platz 4<br>10115 Berlin<br>Germany<br>Phone: +49 30 6883792 0<br>Fax: +49 30 6883792 99<br>Mail: info@mivenion.com | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer Contact<br>Information: | Dr. Malte Bahner<br>mivenion GmbH<br>Robert-Koch-Platz 4<br>10115 Berlin<br>Germany<br>Phone: +49 30 6883792 11<br>Fax: +49 30 6883792 99<br>Mail: bahner@mivenion.com | | Date 510(k) Summary<br>Prepared: | 2014 - 1 - 29 | | Proprietary Name: | Xiralite Fluorescence Imaging System X4 | | Common Name: | Fluorescence Angiographic System | | Regulation Description: | Angiographic x-ray system | | Regulation number: | 21 CFR 892.1600 | | Product Code: | IZI OWN | · mivenion GmbH. Robert-Koch-Platz 4, 10115 Berlin, Germany Page 1-6 . {1}------------------------------------------------ Spy Fluorescent Imaging System (K042961, K073088), Legally Marketed Novadaq Technologies Inc. Predicate Devices: Device Description: The Xiralite fluorescence imaging system X4 detects fluorescence signals in the defined field of view using a highly sensitive camera for signal detection and light emitting diodes (LEDs) for excitation. Fluorescence signals typically result from illumination of a specific fluorophore, the fluorescence dye indocyanine green (ICG), which is administered intravenously. Fluorescence signals are recorded at different periodical time points, thus the resulting images display an image sequence. The frame rate is between half a second and a few seconds, typically one second. The duration of the entire image acquisition is dependent on the pharmacokinetics of the administered fluorophore, with ICG typically six minutes. Acquiring fluorescence images for the visual assessment Intended Use: of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation. Acquiring fluorescence images for the visual assessment Indications for Use: of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation in hands. . {2}------------------------------------------------ ## miveníon ・・ া #### K13003 、 | Substantial Equivalence: | | | | | |--------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | No. | Applicant Device<br>Xiralite Fluorescence Imaging System X4 | Predicate Device<br>Spy Fluorescent Imaging System | Equivalence to Spy Fluorescent<br>Imaging System | | | 2. Application | | | | | | 2.1 | Intended Use | Acquiring fluorescent images for the visual<br>assessment of circulation as an method for<br>the evaluation of tissue perfusion and related<br>tissue microcirculation | Capturing and Viewing fluorescent images for the<br>visual assessment of blood flow as an adjunctive<br>method for the evaluation of tissue perfusion, andflaps used in plastic-, micro- and reconstructive<br>surgical procedures; | yes, the intended use is largely<br>identical | | 2.2 | Indications for<br>Use | Acquiring fluorescent images for the visual<br>assessment of circulation as an method for<br>the evaluation of tissue perfusion and related<br>tissue microcirculation in hands. | Capturing and Viewing fluorescent images for the<br>visual assessment of blood flow as an adjunctive<br>method for the evaluation of tissue perfusion, and<br>related tissue transfer circulation in tissue and free<br>flaps used in plastic-, micro- and reconstructive<br>surgical procedures; Intra-operative visual<br>assessment of the coronary vasculature and<br>bypass grafts during coronary artery bypass<br>(CABG) surgery | yes, the intended use is largely<br>identical | | 2.3 | Patient<br>Population | For use in all patients | Patients with vascular or reconstructive surgery | yes, a part of the patient<br>population is identical | | 2.4 | Anatomic<br>structures | Vascular bed, including microcirculation<br>(hands) | Vascular bed, including microcirculation (intra-<br>operative) | yes | | 2.5 | Environments<br>of use | Hospital, outpatient clinic, specialist office | Hospital | yes, a part of the environments of<br>use is identical | mivenion GmbH, Robert-Koch-Platz 4. 10115 Berlin. Germany . Page 3-6 · {3}------------------------------------------------ ### miveníon ' ،، #### K130003 | No. | | Applicant Device<br>Xiralite Fluorescence Imaging System X4 | Predicate Device<br>Spy Fluorescent Imaging System | Equivalence to Spy Fluorescent<br>Imaging System | |-----|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | 2.6 | User group | Health care professionals | Health care professionals | yes | | | 5. Technology | | | | | 5.1 | Principle | Interaction of radiation source with contrast dye | Interaction of radiation source with contrast dye | yes | | 5.2 | Method of... | displaying the distribution of an injected contrast dye in the vascular system, including microcirculation, over time | displaying the distribution of an injected contrast dye in the vascular system, including microcirculation, over time | yes | | 5.3 | Detector | CCD camera | CCD camera | yes | | 5.4 | Field of View<br>sufficient for<br>intended use | Yes, field of view of 1200cm2 (40cm x 30cm)<br>sufficient for intended use | Yes, field of view of 56cm2 (7.5cm x 7.5cm)<br>sufficient for intended use | yes | | 5.5 | Penetration<br>depth<br>sufficient for<br>intended use | Yes, penetration depth of light estimated to be 2 to 4cm in vivo, sufficient for intended use | Yes, penetration depth of light sufficient for intended use | yes | | 5.6 | Contrast dye<br>required | Yes (ICG) | Yes (ICG) | yes | | 5.7 | Components | Radiation source, detector, signal processing | Radiation source, detector, signal processing | yes | | 5.8 | Materials with<br>patient<br>contact | All materials with patient contact are biocompatible and can be disinfected | No patient contact | n/a | mivenion GmbH, Robert-Koch-Platz 4, 10115 Berlin, Germany . Page 4-6 {4}------------------------------------------------ Rationale for Substantial Equivalence: . . . Nonclinical tests Testing in vitro testing: Clinical tests In vivo testing: The comparison of the devices presented in the enclosed table demonstrates the substantial equivalence between the Xiralite fluorescence imaging system X4 and the predicate device. Like in most imaging procedures, the acquired images of the Xiralite fluorescence imaging system X4 as well as the images from the predicate device does not display a specific disease, but anatomical structures and their alteration by disease. The anatomical structure displayed by both devices is the vasculature, including the small vessels comprising the microcirculation. To enable this, both devices use the physical interaction of the output of a radiation source with a contrast dye injected into the vasculature. The generated radiation is focused on an anatomical region and displays the in vivo distribution of the contrast dye in the individual patient. All three devices are meant to be used solely by health care professionals. Non-clinical tests of the Xiralite fluorescence imaging system X4, covering mechanical, electrical and thermal safety, electromagnetic compatibility and biocompatibility, performed in accredited laboratories, have shown that the device is safe. These tests are performed according to consensus standards, therefore providing information with regard to the predicate devices, which were also tested according to the same applicable standards. Therefore, these tests provide further evidence of substantial equivalence in addition to the features presented in the enclosed table. Furthermore we performed a test to show a linear dependence of the measured signal intensities of fluorescence optical imaging with the Xiralite fluorescence imaging system X4 with the concentration of the fluorophore ICG. The shown linearity of the measured fluorescence signal intensity further supports substantial equivalence with the predicate device Philips Integris Systems, Release 2. The Xiralite fluorescence imaging system X4 has a CE mark as a medical device for the European Union. Since 2009, more than 35 systems have been in clinical use in hospitals as well as in physician offices, mainly in Germany. On these systems, more than 10.000 patient exams have been performed without reported adverse events attributable to the Xiralite fluorescence mivenion GmbH, Robert-Koch-Platz 4, 10115 Berlin, Germany {5}------------------------------------------------ #### imaging system X4. The feedback from users concludes that the device works as intended by safely providing fluorescence images for the visual assessment of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation. According to the available feedback from current clinical users in Europe and the lack of reported adverse events attributable to the Xiralite fluorescence imaging system X4 it can be concluded that the Xiralite fluorescence imaging system X4 is a safe medical device and performs as intended, namely by providing fluorescence images for the visual assessment of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation. Overall, it does not pose any new questions regarding safety or effectiveness conspared to the predicate device. #### Conclusion: As presented in the substantial equivalence comparison chart, the Xiralite fluorescence imaging system X4 and the predicate device have similar technological characteristics, and any minor differences do not raise different questions of safety or efficacy, as described in this submission. Furthermore, the Xiralite fluorescence imaging system X4 is at least as safe as the predicate device and performs as intended. This leads to the conclusion of substantial equivalence between the Xiralite fluorescence imaging system X4 and the predicate device. #### mivenion GmbH, Robert-Koch-Platz 4, 10115 Berlin, Germany {6}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image contains the text "Public Health Service" in a bold, sans-serif font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The text appears to be extracted from a document or sign. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 31, 2014 Mivenion GmbH Dr. Malte L. Bahner Managing Director Robert-Koch-Platz 4 Berlin, Germany, 10115 Re: K130003 Trade/Device Name: Xiralite Fluorescence Imaging System X4 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: IZI, OWN Dated: January 27, 2014 Received: January 30, 2014 Dear Dr. Bahner: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {7}------------------------------------------------ Page 2 - Dr. Malte L. Bahner 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/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 Small Manufacturers, International and Consumer Assistance 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, ## David Krause -S for 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 {8}------------------------------------------------ #### 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) K130003 #### Device Name Xiralite Flourescence Imaging System X4 #### Indications for Use (Describe) Acquiring fluorescent images for the visual assessment of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation in hands. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) . * 2 * (\$ A 10) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. 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