iCertainty

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Rfpi % Jerzy Wojcik Sr Director RA/QA EdgeOne Medical 455 N Campbell Ave Chicago, Illinois 60612 December 14, 2018 Re: K181269 Trade/Device Name: iCertainty Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: November 20, 2018 Received: November 26, 2018 Dear Jerzy Wojcik: 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. {1}------------------------------------------------ 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Digitally signed by Neil R Neil R Ogden -S Date: 2018.12.14 Ogden -S Date: 2018.12.1-For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K181269 Device Name iCertainty Indications for Use (Describe) The iCertainty System is intended for non-invasive two-dimensional imaging as an adjunctive method for evaluation of blood flow distribution (flow and perfusion) in tissues, up to a depth of 4-5mm. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |---------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Date Summary Prepared: | December 12, 2018 | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Owner: | RFPi | | Contact Person: | Jeffery Basham | | | CEO, RFPi | | | 1800 N Greene Street, Suite K | | | Greenville, NC 27834 | | | 919-280-2953 | | | Jeff.basham@rfpi-co.com | | 510(k) Consultant Contact: | | | | Jerzy Wojcik | | | Sr. Director RA/QA, EdgeOne Medical | | | 455 N Campbell Ave, Suite 2N | | | Chicago, IL 60612 | | | 312-300-6643 | | | Jerzy.wojcik@edgeonemedical.com | | Device Name: | iCertainty | | Trade Name: | iCertainty | | Common Name: | Flowmeter, Blood,<br>Cardiovascular | | Regulation: | 870.2100 | | Class: | II | | Product Code: | DPW | | Predicate Device(s): | | | | Primary Predicate K120884 PeriCam PSI | | | Reference Device K063345 Novadaq SPY | | Device Description: | The iCertainty System is a device used to image blood<br>flow distribution (flow in vessels and perfusion in<br>tissues) in real time. The device employs a mobile cart so<br>that it can be configured in the appropriate orientation to<br>properly image the tissue in an operating room<br>environment without restrictions. When a practitioner<br>elects to use imaging as an adjunct to evaluate blood flow<br>distribution the device is moved into the appropriate | ## 510(k) Summary {4}------------------------------------------------ position and an extension arm with an optical head unit (OHU, containing the lasers/camera equipment) is positioned over the patient as described in the instructions for use. The OHU is moved to a specified height (focused) over the target image area and the imaging is performed. The imaging can be performed as often as deemed necessary by the surgeon during the procedure to visualize blood flow distribution (blood flow in vessels and perfusion in tissues) in the target tissues being operated upon. The device employs a dual laser-based system with a camera imaging system. The two lasers (450nm and 785nm) illuminate the surface and blood flow distribution up to a depth of 4-5mm of the target tissue. A digital camera records the image in real time. All real-time blood flow distribution analyses are performed on a central computer within the device. Realtime images are displayed to the surgeon on an imaging display. Data entry is performed on a separate display and data entry keyboard. A sterile drape is used as an accessory to protect the sterile operating field from contamination during use. - Statement of Intended Use: The iCertainty System is intended for non-invasive twodimensional imaging as an adjunctive method for evaluation of blood flow distribution (flow and perfusion) in tissues, up to a depth of 4-5mm. - Accessory Device: Premier Guard sterile drape (K041501) {5}------------------------------------------------ | Device Comparisons | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | iCertainty Proposed<br>Device | Primary Predicate<br>PeriCam PSI (K120884) | Reference Device<br>Novadaq Spy (K063345) | | Intended Use /<br>Indications | ...for non-invasive two-<br>dimensional imaging as<br>an adjunctive method for<br>evaluation of blood flow<br>distribution (flow and<br>perfusion) in tissues, up to<br>a depth of 4-5mm. | ...for non-invasive two-<br>dimensional imaging of<br>peripheral tissue blood<br>perfusion. | ... for capturing and<br>viewing fluorescent<br>images for the visual<br>assessment of blood flow<br>as an adjunctive method<br>for the evaluation of<br>tissue perfusion, and<br>related tissue transfer<br>circulation in tissue and<br>free flaps used in plastic,<br>micro- and reconstructive<br>surgical procedures. | | Conclusion – Both the subject and predicate devices have the same intended use as<br>an adjunctive method for evaluation of blood flow and perfusion. | | | | | Target Users | Surgeons, physicians,<br>nurses and other trained<br>medical professionals | Surgeons, physicians,<br>nurses and other trained<br>medical professionals | Surgeons, physicians,<br>nurses and other trained<br>medical professionals | | Conclusion – Substantially equivalent. All three devices have the same target users. | | | | | Targeted<br>anatomical sites | Targeted surgical tissues<br>exposed to the device field<br>of view, including both<br>central organ and<br>peripheral tissues | Targeted peripheral<br>tissues exposed to the<br>device field of view | Targeted surgical tissues<br>exposed to the device field<br>of view, including both<br>central organ and<br>peripheral tissues | | Conclusion - Substantially equivalent. All three devices image tissue that are in the<br>field of view of the device, including central organ and peripheral tissues in the subject<br>and primary predicate devices. | | | | | Mechanism of<br>Action /<br>Technology | Laser light illuminates the<br>target surface tissue.<br>Using both optical<br>reflectance and laser<br>speckle contrast analysis,<br>the pattern reflected from<br>the blood in the tissue is<br>processed and imaged to<br>generate images of blood<br>perfusion in target tissues<br>up to a depth of 4-5 mm. | Laser light illuminates the<br>target surface tissue.<br>Using laser speckle<br>contrast analysis, the<br>pattern reflected from the<br>blood in the tissue is<br>processed and imaged to<br>generate images of blood<br>perfusion (depth not<br>determined, should be<br>similar to iCertainty by<br>optical physics<br>parameters). | Laser light illuminates the<br>target surface tissue<br>which has a fluorescent<br>dye coursing through<br>blood vessels introduced<br>through an intravenous<br>injection. The laser<br>excites the dye, which<br>emits an infrared light.<br>The infrared pattern<br>reflected is processed and<br>imaged to generate<br>images of blood perfusion | | Device Comparisons | | | | | Feature | iCertainty Proposed<br>Device | Primary Predicate<br>PeriCam PSI (K120884) | Reference Device<br>Novadaq Spy (K063345) | | | Conclusion - Substantially equivalent to the predicate, PeriCam PSI and similar to<br>the reference, Novadaq SPY. All three devices: | | | | | • | use laser light illumination of target tissues, then analyze the reflected light<br>to generate images of blood perfusion; | | | | • | have a laser illumination system, camera, computer software for analysis and<br>display capabilities when in use; | | | | • | have the capability to view, record and replay images of blood flow and<br>perfusion in target tissues. | | | | Differences between the subject and predicate and reference devices are: | | | | | • | the reference device requires an invasive injection of a fluorophobe ICG dye; | | | | • | the subject and predicate device do not require an invasive injection; | | | | • | the subject and predicate device use laser speckle contrast imaging analysis; | | | | • | the reference device relatively quantifies the intensity of fluorescence as an<br>indicator of flow and perfusion; | | | | • | the subject device displays both the visible light and perfusion image side by<br>side for user reference and orientation; | | | | • | the predicates and reference present only the perfusion image. | | | | The iCertainty technology used to achieve the intended use as compared to the<br>predicate does not raise new questions of safety or effectiveness. Refer to Section 12.2<br>for further substantial equivalence discussion. | | | | Method of Use | After preparing the device<br>for use, the iCertainty is<br>positioned above the<br>targeted imaging site. The<br>device is activated, and<br>images are collected and<br>viewed by the operator. If<br>desired, the images can be<br>viewed again at a later<br>time. | After preparing the device<br>for use, the PeriCam PSI is<br>positioned above the<br>targeted imaging site. The<br>device is activated, and<br>images are collected and<br>viewed by the operator. If<br>desired, the images can be<br>viewed again at a later<br>time. | After preparing the device<br>for use, the patient is<br>injected with a fluorescent<br>dye. Novadaq SPY is<br>positioned above the<br>targeted imaging site. The<br>dye must be delivered to<br>the target tissue by the<br>circulatory system. The<br>device is activated, and<br>images are collected and<br>viewed by the operator. If<br>desired, the images can be<br>viewed again at a later<br>time. | | | Conclusion - Substantially equivalent. All three devices utilize the same method of<br>use, in that the device is positioned over the target area and activated for collection of<br>images for immediate viewing and/or again at a later time. Refer to Section 12.3 for<br>further substantial equivalence discussion. | | | | Electrical Safety<br>and<br>Electromagnetic<br>Compatibility | IEC 60601-1 and<br>60601-1-2 compliant | IEC 60601-1 and<br>60601-1-2 compliant | IEC 60601-1 and<br>60601-1-2 compliant | | | Conclusion - Substantially equivalent. All three devices are compliant with<br>standards for electrical safety and compatibility. | | | | Imaging<br>Distance (Optical<br>Head to Target<br>Tissue) | $32 +/- 3$ cm | 30 cm | 10 cm | | | Conclusion – substantially equivalent. The subject device and SPY predicate device<br>have comparable imaging distances. |…