(214 days)
No
The description focuses on laser illumination, camera imaging, and real-time processing of reflected patterns using optical reflectance and laser speckle contrast analysis. There is no mention of AI or ML algorithms being used for image analysis or interpretation.
No.
The device is described as an imaging system intended for non-invasive two-dimensional imaging of blood flow distribution, used as an adjunctive method for evaluation. Its function is to visualize and display information, not to actively treat or modify physiological processes.
Yes
The device is intended for "non-invasive two-dimensional imaging as an adjunctive method for evaluation of blood flow distribution (flow and perfusion) in tissues," which is a diagnostic purpose. It helps surgeons visualize and evaluate blood flow distribution in real-time during procedures, aiding in their assessment of the patient's condition.
No
The device description explicitly details hardware components including a mobile cart, extension arm, optical head unit (OHU) containing lasers and camera equipment, a central computer, imaging display, and a separate data entry display and keyboard. While it performs image processing, it is not solely software.
Based on the provided information, the iCertainty System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The iCertainty System is used for non-invasive imaging of tissues directly on the patient. It does not involve the collection or analysis of samples like blood, urine, or tissue biopsies.
- The intended use is for imaging blood flow distribution in tissues. This is a direct measurement on the living patient, not an analysis of a biological specimen in a laboratory setting.
- The device description clearly outlines its use in an operating room environment, positioned over the patient. This is consistent with an in vivo imaging device, not an in vitro diagnostic device.
Therefore, the iCertainty System falls under the category of an in vivo imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DPW
Device Description
The iCertainty System is a device used to image blood flow distribution (flow in vessels and perfusion in tissues) in real time. The device employs a mobile cart so that it can be configured in the appropriate orientation to properly image the tissue in an operating room environment without restrictions. When a practitioner elects to use imaging as an adjunct to evaluate blood flow distribution the device is moved into the appropriate 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. Real-time 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Laser light illumination with digital camera recording
Anatomical Site
Targeted surgical tissues exposed to the device field of view, including both central organ and peripheral tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, physicians, nurses and other trained medical professionals, operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was performed to verify that the performance of the iCertainty system is substantially equivalent to currently marketed perfusion flow imaging systems, and substantially equivalent to the PeriCam PSI (K120884). Testing included:
- use testing
- data entry and integrity
- electrical safety
- electromagnetic compatibility
- sterile barrier/drape compatibility
- cleaning
In vivo blood flow and perfusion was evaluated through animal studies investigating skin/epidermis, static solid organ, vascular and moving solid organs in normal and diseased state.
Assessment of Clinical Data: Evaluation of human anatomy (hand, forearm and ankle from 40 patients) demonstrated that the iCertainty images blood flow distribution (flow and perfusion).
Overall Conclusions: Based on the indications for use, technological characteristics, and comparison to predicate devices, the iCertainty System has been shown to be substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K120884 PeriCam PSI
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K063345 Novadaq SPY
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized depiction of a human figure. To the right of it is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in bold blue letters, and "ADMINISTRATION" in smaller blue letters below.
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)
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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, |
| 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 |
| flow distribution (flow in vessels and perfusion in | |
| tissues) in real time. The device employs a mobile cart so | |
| that it can be configured in the appropriate orientation to | |
| properly image the tissue in an operating room | |
| environment without restrictions. When a practitioner | |
| elects to use imaging as an adjunct to evaluate blood flow | |
| 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 | ||
| Device | Primary Predicate | ||
| PeriCam PSI (K120884) | Reference Device | ||
| Novadaq Spy (K063345) | |||
| Intended Use / | |||
| Indications | ...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. | ...for non-invasive two- | ||
| dimensional imaging of | |||
| peripheral tissue blood | |||
| perfusion. | ... for 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 | |||
| surgical procedures. | |||
| Conclusion – Both the subject and predicate devices have the same intended use as | |||
| an adjunctive method for evaluation of blood flow and perfusion. | |||
| Target Users | Surgeons, physicians, | ||
| nurses and other trained | |||
| medical professionals | Surgeons, physicians, | ||
| nurses and other trained | |||
| medical professionals | Surgeons, physicians, | ||
| nurses and other trained | |||
| medical professionals | |||
| Conclusion – Substantially equivalent. All three devices have the same target users. | |||
| Targeted | |||
| anatomical sites | Targeted surgical tissues | ||
| exposed to the device field | |||
| of view, including both | |||
| central organ and | |||
| peripheral tissues | Targeted peripheral | ||
| tissues exposed to the | |||
| device field of view | Targeted surgical tissues | ||
| exposed to the device field | |||
| of view, including both | |||
| central organ and | |||
| peripheral tissues | |||
| Conclusion - Substantially equivalent. All three devices image tissue that are in the | |||
| field of view of the device, including central organ and peripheral tissues in the subject | |||
| and primary predicate devices. | |||
| Mechanism of | |||
| Action / | |||
| Technology | Laser light illuminates the | ||
| target surface tissue. | |||
| Using both optical | |||
| reflectance and laser | |||
| speckle contrast analysis, | |||
| the pattern reflected from | |||
| the blood in the tissue is | |||
| processed and imaged to | |||
| generate images of blood | |||
| perfusion in target tissues | |||
| up to a depth of 4-5 mm. | Laser light illuminates the | ||
| target surface tissue. | |||
| Using laser speckle | |||
| contrast analysis, the | |||
| pattern reflected from the | |||
| blood in the tissue is | |||
| processed and imaged to | |||
| generate images of blood | |||
| perfusion (depth not | |||
| determined, should be | |||
| similar to iCertainty by | |||
| optical physics | |||
| parameters). | Laser light illuminates the | ||
| target surface tissue | |||
| which has a fluorescent | |||
| dye coursing through | |||
| blood vessels introduced | |||
| through an intravenous | |||
| injection. The laser | |||
| excites the dye, which | |||
| emits an infrared light. | |||
| The infrared pattern | |||
| reflected is processed and | |||
| imaged to generate | |||
| images of blood perfusion | |||
| Device Comparisons | |||
| Feature | iCertainty Proposed | ||
| Device | Primary Predicate | ||
| PeriCam PSI (K120884) | Reference Device | ||
| Novadaq Spy (K063345) | |||
| Conclusion - Substantially equivalent to the predicate, PeriCam PSI and similar to | |||
| the reference, Novadaq SPY. All three devices: | |||
| • | use laser light illumination of target tissues, then analyze the reflected light | ||
| to generate images of blood perfusion; | |||
| • | have a laser illumination system, camera, computer software for analysis and | ||
| display capabilities when in use; | |||
| • | have the capability to view, record and replay images of blood flow and | ||
| 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 | ||
| indicator of flow and perfusion; | |||
| • | the subject device displays both the visible light and perfusion image side by | ||
| 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 | |||
| predicate does not raise new questions of safety or effectiveness. Refer to Section 12.2 | |||
| for further substantial equivalence discussion. | |||
| Method of Use | After preparing the device | ||
| for use, the iCertainty is | |||
| positioned above the | |||
| targeted imaging site. The | |||
| device is activated, and | |||
| images are collected and | |||
| viewed by the operator. If | |||
| desired, the images can be | |||
| viewed again at a later | |||
| time. | After preparing the device | ||
| for use, the PeriCam PSI is | |||
| positioned above the | |||
| targeted imaging site. The | |||
| device is activated, and | |||
| images are collected and | |||
| viewed by the operator. If | |||
| desired, the images can be | |||
| viewed again at a later | |||
| time. | After preparing the device | ||
| for use, the patient is | |||
| injected with a fluorescent | |||
| dye. Novadaq SPY is | |||
| positioned above the | |||
| targeted imaging site. The | |||
| dye must be delivered to | |||
| the target tissue by the | |||
| circulatory system. The | |||
| device is activated, and | |||
| images are collected and | |||
| viewed by the operator. If | |||
| desired, the images can be | |||
| viewed again at a later | |||
| time. | |||
| Conclusion - Substantially equivalent. All three devices utilize the same method of | |||
| use, in that the device is positioned over the target area and activated for collection of | |||
| images for immediate viewing and/or again at a later time. Refer to Section 12.3 for | |||
| further substantial equivalence discussion. | |||
| Electrical Safety | |||
| and | |||
| Electromagnetic | |||
| Compatibility | IEC 60601-1 and | ||
| 60601-1-2 compliant | IEC 60601-1 and | ||
| 60601-1-2 compliant | IEC 60601-1 and | ||
| 60601-1-2 compliant | |||
| Conclusion - Substantially equivalent. All three devices are compliant with | |||
| standards for electrical safety and compatibility. | |||
| Imaging | |||
| Distance (Optical | |||
| Head to Target | |||
| Tissue) | $32 +/- 3$ cm | 30 cm | 10 cm |
| Conclusion – substantially equivalent. The subject device and SPY predicate device | |||
| have comparable imaging distances. | |||
| Field of View | 9 cm x 9 cm | Up to 24 cm x 24 cm | 5 cm x 7 cm |
| Feature | iCertainty Proposed Device | Primary Predicate PeriCam PSI (K120884) | Reference Device Novadaq Spy (K063345) |
| Conclusion - The subject device and the predicate have comparable fields of view. The SPY reference device has a smaller field of view compared to the subject device. The larger FOV provides for a larger area of the target tissue to be captured in the imaging acquisition, from the same imaging distance. | |||
| Depth of Penetration and detection | 4-5 mm Documented Penetration | Penetration and Detection not Reported | 5-6 mm Reported Penetration (Detection not reported) |
| 4-5 mm Documented Detection | |||
| Conclusion - similar to the reference device and not comparable to the Predicate. Only iCertainty has documented both depth of penetration and depth of detection. | |||
| Resolution and Contrast | Image Resolution: | ||
| 112µm/pixel | Image Resolution: | ||
| 100µm/pixel | Image Resolution: | ||
| not specified | |||
| Max: | |||
| 1600 x 800 Data Points | |||
| Resolution: | |||
| 1600 x x800 pixels | |||
| Speckle Contrast: | |||
| 0-1 | Max: | ||
| 1386 x 1038 Data Points | |||
| Resolution: | |||
| 1386 x 1038 pixels | |||
| Speckle Contrast: | |||
| 0-1 | Max: | ||
| 1024 x 768 Data Points | |||
| Resolution: | |||
| 1024 x 768 pixels | |||
| Conclusion - Substantially equivalent. All three devices have the similar resolution and contrast. | |||
| Image Presentation | Visible color and MSPV | Black and White NIR | Black and White NIR |
| Conclusion - Substantially equivalent. All three devices display imaging that the user can interpret. However, the subject device has the added benefit of a visible light image of anatomic detail for user reference and orientation | |||
| Imaging Depiction | Blood flow and perfusion | Blood flow and perfusion | Blood flow and perfusion |
| Conclusion - Substantially equivalent. Imaging from all three devices depict blood flow and perfusion. | |||
| User Interface | Keyboard, Graphical User Interface, Buttons on Camera head | Buttons on Camera head | Keyboard, Graphical User Interface, Buttons on Camera head |
| Conclusion - Substantially equivalent. The reference device and iCertainty use a keyboard, graphical user interface and buttons on the camera head. Even though the predicate does not include a keyboard and Graphical User Interface, both components are required to be provided by the user in order to operate the predicate. | |||
| Mode of Use | Mobile cart. When needed for imaging, the cart is positioned such that the arm can be extended into a position over the patient for imaging. | The device arm is mobile. When needed for imaging, the arm is mounted to a table or other surface such that the arm can be extended into a position over the patient for imaging. | Mobile cart. When needed for imaging, the cart is positioned such that the arm can be extended into a position over the patient for imaging. |
| Conclusion - Substantially equivalent. All three devices are configurable to achieve orientation. The reference device and iCertainty are mobile carts that can be configured in the appropriate orientation with an extension arm that is positioned to image tissue without restrictions. The predicate is fixed to a surface but has an extension arm as well. | |||
| Device Comparisons | |||
| Feature | iCertainty Proposed | ||
| Device | Primary Predicate | ||
| PeriCam PSI (K120884) | Reference Device | ||
| Novadaq Spy (K063345) | |||
| Setup | The iCertainty contains an | ||
| adjustable arm which | |||
| contains the laser and | |||
| camera componentry and | |||
| is mounted to a mobile | |||
| cart which contained | |||
| video screens, keyboard | |||
| and computer. | The device has an | ||
| adjustable arm which | |||
| contains the laser and | |||
| camera componentry and | |||
| must be mounted to a | |||
| table or mobile cart (not | |||
| part of the device). The | |||
| PeriCam PSI is then | |||
| connected via firewall | |||
| cable to a firewall port on | |||
| a computer. | The device has an | ||
| adjustable extension arm | |||
| which contains the | |||
| camera. The laser | |||
| illumination system is | |||
| mounted in the cart and | |||
| connected to the Camera | |||
| head by fiberoptic cable. | |||
| The mobile cart also | |||
| contains video screens, | |||
| keyboard and computer. | |||
| Conclusion - Substantially equivalent. All three devices have adjustable arms that | |||
| are stabilized for use, and utilize a computer to operate the device. While the | |||
| iCertainty and reference devices include a cart to which the arm is mounted and a | |||
| computer to process imaging, the predicate requires the computer to be supplied by | |||
| the user and the device to be mounted to a table or mobile cart. All three devices are | |||
| substantially equivalent in that all require the same componentry in order to achieve | |||
| their intended use. | |||
| Imaging Cycles | 10 imaging cycles, limited | ||
| by software | Multiple imaging episodes | ||
| per evaluation, limited by | |||
| software | 1 to 6 imaging cycles, | ||
| limited by ICG Dye | |||
| Conclusion - Substantially equivalent. Multiple imaging episodes can be obtained | |||
| per case/evaluation. | |||
| Size | 81.3 x 81.3 x 198.1 cm | ||
| 221 kg | PeriCam PSI Head: | ||
| 22 x 15 x 20 cm | |||
| PeriCam PSI Head | |||
| 2.3/2.4 kg | |||
| Arm and Stand | |||
| 7.1/10.1 kg | |||
| Total weight | |||
| 9.4/12.5 kg | |||
| (Standard/High resolution | |||
| models) | 81.2 x 81.2 x 180.4 cm | ||
| 165 kg | |||
| Conclusion - Substantially equivalent. The iCertainty and the reference devices are | |||
| all-in-one devices which include the computer and stand/table/cart, whereas the | |||
| predicate does not include the computer and stand/table/cart and this is smaller in size | |||
| specification. All three devices have an imaging arm. The iCertainty and reference | |||
| devices are of similar size, but the iCertainty device contains a larger counterweight, | |||
| and thus weighs more. All three camera head units are of relatively similar size (but | |||
| moderately different configurations). | |||
| Maintenance | |||
| Cleaning | iCertainty is used with a | ||
| sterile drape, which | |||
| protects the patient from | |||
| device contamination. | |||
| Additionally, if cleaning | |||
| or disinfection is required, | |||
| the user manual provides | |||
| instructions for cleaning. | The PeriCam PSI user | ||
| manual provides | |||
| instructions for cleaning. | The Novadaq SPY is used | ||
| with a sterile drape, which | |||
| protects the patient from | |||
| device contamination. | |||
| Additionally, if cleaning | |||
| or disinfection is required, | |||
| the user manual provides | |||
| instructions for cleaning. | |||
| Device Comparisons | |||
| Feature | iCertainty Proposed | ||
| Device | Primary Predicate | ||
| PeriCam PSI (K120884) | Reference Device | ||
| Novadaq Spy (K063345) | |||
| Conclusion - Substantially equivalent. Both the iCertainty and the reference device | |||
| use a sterile drape to isolate the device arm and camera head from the sterile operative | |||
| field, and both include the same instructions for cleaning or disinfection of non-sterile | |||
| surfaces. The drapes do not alter the imaging characteristics. The predicate is not | |||
| used in a true sterile environment, and thus does not require a drape. All three devices | |||
| can be cleaned by the user/operator. | |||
| Biocompatibility | The iCertainty does not | ||
| come into contact with the | |||
| patient. Materials of | |||
| construction for the arm, | |||
| camera head and cart, | |||
| which are in contact with | |||
| the user/operator for the | |||
| purpose of movement and | |||
| manipulation, are | |||
| composed of plastic and | |||
| metal commonly found in | |||
| every-day materials. | |||
| The device does not | |||
| require the use on an | |||
| injected fluorescent dye to | The PeriCam PSI does not | ||
| come into contact with the | |||
| patient. Materials of | |||
| construction for the arm | |||
| and camera head, which | |||
| are in contact with the | |||
| user/operator for the | |||
| purpose of movement and | |||
| manipulation, are | |||
| composed of plastic and | |||
| metal commonly found in | |||
| every-day materials. | |||
| The device does not | |||
| require the use on an | |||
| injected fluorescent dye to | The Novadaq SPY does | ||
| not come into contact with | |||
| the patient. Materials of | |||
| construction for the arm, | |||
| camera head and cart, | |||
| which are in contact with | |||
| the user/operator for the | |||
| purpose of movement and | |||
| manipulation, are | |||
| composed of plastic and | |||
| metal commonly found in | |||
| every-day materials. | |||
| The device requires the | |||
| use of a biocompatible | |||
| fluorescent dye | |||
| (Indocyanine Green or | |||
| ICG) which has a low | |||
| toxicity profile. | |||
| achieve its intended use. | |||
| achieve its intended use. | |||
| Conclusion - Substantially equivalent. All three devices are not in contact with the | |||
| patient. User contact materials are considered safe common plastic and metal | |||
| materials. The reference device requires use of a low-toxicity profile fluorescent dye | |||
| to achieve intended use, while the iCertainty and predicate do not. The difference in | |||
| the biocompatibility comparison with the reference device does not raise new | |||
| questions of safety or effectiveness, and in fact reduces the safety risk for the iCertainty because the patient is not exposed to the fluorescent dye. | |||
| Operating | |||
| Conditions | Temperature: | ||
| 10°C to 30°C | |||
| Relative Humidity: | |||
| 30-80% non-condensing | |||
| Atmospheric Pressure | |||
| Range: | |||
| 700hPA to 1060hPA. | Temperature: | ||
| 15°C to 30°C | |||
| Relative Humidity: | |||
| 10-80% non-condensing | |||
| Atmospheric Pressure | |||
| Range: | |||
| 70 kPa to 160 kPa. | Temperature: | ||
| 10°C to 30°C | |||
| Relative Humidity: | |||
| 10% to 90%, non- | |||
| condensing | |||
| Atmospheric Pressure | |||
| Range: | |||
| 94 kPa to 102 kPa | |||
| Conclusion - Substantially equivalent. The operating conditions for all three devices | |||
| are similar. | |||
| Power Supply | Operates on standard | ||
| Mains power supply in the | |||
| United States. | Operates on standard | ||
| Mains power supply in the | |||
| United States. | Operates on standard | ||
| Mains power supply in the | |||
| United States. | |||
| Conclusion - Substantially equivalent. All three devices operate using a standard | |||
| Mains power supply in the United States. |
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Performance Data: Performance testing was performed to verify that the performance of the iCertainty system is substantially equivalent to currently marketed perfusion flow imaging
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systems, and substantially equivalent to the PeriCam PSI (K120884). Testing included:
- . use testing
- . data entry and integrity
- electrical safety ●
- . electromagnetic compatibility
- sterile barrier/drape compatibility
- . cleaning
In vivo blood flow and perfusion was evaluated through animal studies investigating skin/epidermis, static solid organ, vascular and moving solid organs in normal and diseased state.
- Assessment of Clinical Data: Evaluation of human anatomy (hand, forearm and ankle from 40 patients) demonstrated that the iCertainty images blood flow distribution (flow and perfusion).
- Overall Conclusions: Based on the indications for use, technological characteristics, and comparison to predicate devices, the iCertainty System has been shown to be substantially equivalent to the predicate.