(214 days)
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.
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. 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.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it details performance testing categories and states that the iCertainty system was evaluated to be "substantially equivalent to currently marketed perfusion flow imaging systems, and substantially equivalent to the PeriCam PSI (K120884)."
However, it does mention some performance aspects in comparison with predicate devices, which can be inferred as performance characteristics the device meets.
| Feature | Requirement (Implicit Acceptance Criteria) | Reported Device Performance (iCertainty) |
|---|---|---|
| Intended Use/Indications | 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. | Meets the stated intended use. Substantially equivalent to predicate in intended use. |
| Target Users | Surgeons, physicians, nurses, and other trained medical professionals. | Meets the target user profile. Substantially equivalent to predicate. |
| Targeted Anatomical Sites | Targeted surgical tissues exposed to the device field of view, including central organ and peripheral tissues. | Meets the targeted anatomical sites. Substantially equivalent to predicate. |
| Mechanism of Action | Use laser light to illuminate target tissues and analyze reflected light to generate blood perfusion images. | Employs a dual laser-based system (450nm and 785nm) with optical reflectance and laser speckle contrast analysis to process and image reflected patterns from blood, generating blood perfusion images up to a depth of 4-5mm. Substantially equivalent to predicate (PeriCam PSI) and similar to reference (Novadaq SPY) in underlying principles. |
| Imaging Distance | Comparable to predicate devices. | $32 \pm 3$ cm. Substantially equivalent to SPY (10cm) and comparable to PeriCam PSI (30cm). |
| Field of View | Comparable to predicate devices. | 9 cm x 9 cm. Comparable to PeriCam PSI (up to 24x24cm) and larger than SPY (5x7cm). |
| Depth of Penetration and Detection | Documented penetration and detection. | 4-5 mm documented penetration and 4-5 mm documented detection. Similar to SPY (5-6mm reported penetration), not comparable to PeriCam PSI (not reported). |
| Resolution and Contrast | Similar resolution and contrast to predicate devices. | Image Resolution: 112µm/pixel; Max: 1600 x 800 Data Points, 1600 x 800 pixels; Speckle Contrast: 0-1. Substantially equivalent to predicate. |
| Image Presentation | Display imaging that the user can interpret. | Visible color and MSPV (mean speckle perfusion value). Displays both visible light and perfusion image side-by-side. Substantially equivalent to predicate. |
| Imaging Depiction | Depict blood flow and perfusion. | Depicts blood flow and perfusion. Substantially equivalent to predicate. |
| User Interface | Functional and comparable to predicate devices. | Keyboard, Graphical User Interface, Buttons on Camera head. Substantially equivalent to predicate. |
| Mode of Use | Configurable for appropriate orientation for imaging. | Mobile cart with an extension arm for positioning over the patient. Substantially equivalent to predicate. |
| Setup | Adjustable arm stabilized for use, utilizing a computer. | Adjustable arm with laser and camera componentry mounted to a mobile cart with video screens, keyboard, and computer. Substantially equivalent to predicate. |
| Imaging Cycles | Multiple imaging episodes per evaluation. | 10 imaging cycles, limited by software. Substantially equivalent to predicate. |
| Size | Functional design that accommodates necessary components. | 81.3 x 81.3 x 198.1 cm, 221 kg (all-in-one device). Substantially equivalent to predicate. |
| Maintenance/Cleaning | Instructions for cleaning/disinfection. | Used with a sterile drape; user manual provides cleaning instructions. Substantially equivalent to predicate. |
| Biocompatibility | No patient contact; user contact materials are safe. | Does not come into contact with the patient. User-contact materials (arm, camera head, cart) are plastic and metal. Substantially equivalent to predicate. |
| Operating Conditions | Similar to predicate devices. | Temperature: 10°C to 30°C; Relative Humidity: 30-80% non-condensing; Atmospheric Pressure: 700hPA to 1060hPA. Substantially equivalent to predicate. |
| Power Supply | Operates on standard Mains power supply in the United States. | Operates on standard Mains power supply in the United States. Substantially equivalent to predicate. |
| Safety and EMC | Compliant with IEC 60601-1 and 60601-1-2. | Compliant with IEC 60601-1 and 60601-1-2. Substantially equivalent to predicate. |
| Sterile Barrier | Compatibility with sterile barrier/drape. | Tested for sterile barrier/drape compatibility. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 40 patients.
- Data Provenance: The study involved evaluation of human anatomy (hand, forearm, and ankle). The document does not explicitly state the country of origin, but given the FDA 510(k) submission, it is likely that the study was conducted in the US or in a region acceptable to US regulatory standards. The study appears to be prospective as it involved "Evaluation of human anatomy... demonstrated that the iCertainty images blood flow distribution."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the human evaluation on the 40 patients. It only states that the evaluation "demonstrated that the iCertainty images blood flow distribution (flow and perfusion)."
4. Adjudication method for the test set
The document does not specify an adjudication method like 2+1, 3+1, or none.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document mentions "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)." This suggests a clinical evaluation. However, the document does not report a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance, nor does it provide an effect size for such improvement. The iCertainty system is described as an "adjunctive method," implying it assists evaluation, but the study described is focused on the device's ability to image blood flow, not on reader performance with or without the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies that the device provides images for a human operator to interpret ("Realtime images are displayed to the surgeon on an imaging display"). The described clinical assessment is about the device's ability to "image blood flow distribution," rather than the performance of an algorithm to make a diagnosis or assessment on its own. Therefore, it does not explicitly state that a standalone (algorithm only) performance study was conducted. The device is intended as an "adjunctive method," strongly suggesting human-in-the-loop operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the human clinical evaluation on 40 patients, the document states it "demonstrated that the iCertainty images blood flow distribution (flow and perfusion)." It does not explicitly define the "ground truth" method used for this human evaluation. Given the nature of blood flow imaging, it's possible that comparison was made against physiological expectations or qualitative assessment by clinicians, but the specific method (e.g., expert consensus on other gold standard imaging, direct physiological measurement) is not detailed.
For the animal studies, it states: "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." This indicates a comparative approach to normal vs. diseased states to assess the device's ability to detect different perfusion levels, but the exact "ground truth" (e.g., histological confirmation of disease, other perfusion measurement techniques) specific to the animal study is not explicitly mentioned.
8. The sample size for the training set
The document does not specify the sample size for the training set for any algorithms used in the iCertainty system.
9. How the ground truth for the training set was established
Since the document does not specify a training set, it also does not provide information on how the ground truth for any training set was established.
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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.
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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
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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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| 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 bloodflow distribution (flow in vessels and perfusion intissues) in real time. The device employs a mobile cart sothat it can be configured in the appropriate orientation toproperly image the tissue in an operating roomenvironment without restrictions. When a practitionerelects to use imaging as an adjunct to evaluate blood flowdistribution the device is moved into the appropriate |
510(k) Summary
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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)
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| Device Comparisons | |||
|---|---|---|---|
| Feature | iCertainty ProposedDevice | Primary PredicatePeriCam PSI (K120884) | Reference DeviceNovadaq Spy (K063345) |
| Intended Use /Indications | ...for non-invasive two-dimensional imaging asan adjunctive method forevaluation of blood flowdistribution (flow andperfusion) in tissues, up toa depth of 4-5mm. | ...for non-invasive two-dimensional imaging ofperipheral tissue bloodperfusion. | ... for capturing andviewing fluorescentimages for the visualassessment of blood flowas an adjunctive methodfor the evaluation oftissue perfusion, andrelated tissue transfercirculation in tissue andfree flaps used in plastic,micro- and reconstructivesurgical procedures. |
| Conclusion – Both the subject and predicate devices have the same intended use asan adjunctive method for evaluation of blood flow and perfusion. | |||
| Target Users | Surgeons, physicians,nurses and other trainedmedical professionals | Surgeons, physicians,nurses and other trainedmedical professionals | Surgeons, physicians,nurses and other trainedmedical professionals |
| Conclusion – Substantially equivalent. All three devices have the same target users. | |||
| Targetedanatomical sites | Targeted surgical tissuesexposed to the device fieldof view, including bothcentral organ andperipheral tissues | Targeted peripheraltissues exposed to thedevice field of view | Targeted surgical tissuesexposed to the device fieldof view, including bothcentral organ andperipheral tissues |
| Conclusion - Substantially equivalent. All three devices image tissue that are in thefield of view of the device, including central organ and peripheral tissues in the subjectand primary predicate devices. | |||
| Mechanism ofAction /Technology | Laser light illuminates thetarget surface tissue.Using both opticalreflectance and laserspeckle contrast analysis,the pattern reflected fromthe blood in the tissue isprocessed and imaged togenerate images of bloodperfusion in target tissuesup to a depth of 4-5 mm. | Laser light illuminates thetarget surface tissue.Using laser specklecontrast analysis, thepattern reflected from theblood in the tissue isprocessed and imaged togenerate images of bloodperfusion (depth notdetermined, should besimilar to iCertainty byoptical physicsparameters). | Laser light illuminates thetarget surface tissuewhich has a fluorescentdye coursing throughblood vessels introducedthrough an intravenousinjection. The laserexcites the dye, whichemits an infrared light.The infrared patternreflected is processed andimaged to generateimages of blood perfusion |
| Device Comparisons | |||
| Feature | iCertainty ProposedDevice | Primary PredicatePeriCam PSI (K120884) | Reference DeviceNovadaq Spy (K063345) |
| Conclusion - Substantially equivalent to the predicate, PeriCam PSI and similar tothe reference, Novadaq SPY. All three devices: | |||
| • | use laser light illumination of target tissues, then analyze the reflected lightto generate images of blood perfusion; | ||
| • | have a laser illumination system, camera, computer software for analysis anddisplay capabilities when in use; | ||
| • | have the capability to view, record and replay images of blood flow andperfusion 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 anindicator of flow and perfusion; | ||
| • | the subject device displays both the visible light and perfusion image side byside 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 thepredicate does not raise new questions of safety or effectiveness. Refer to Section 12.2for further substantial equivalence discussion. | |||
| Method of Use | After preparing the devicefor use, the iCertainty ispositioned above thetargeted imaging site. Thedevice is activated, andimages are collected andviewed by the operator. Ifdesired, the images can beviewed again at a latertime. | After preparing the devicefor use, the PeriCam PSI ispositioned above thetargeted imaging site. Thedevice is activated, andimages are collected andviewed by the operator. Ifdesired, the images can beviewed again at a latertime. | After preparing the devicefor use, the patient isinjected with a fluorescentdye. Novadaq SPY ispositioned above thetargeted imaging site. Thedye must be delivered tothe target tissue by thecirculatory system. Thedevice is activated, andimages are collected andviewed by the operator. Ifdesired, the images can beviewed again at a latertime. |
| Conclusion - Substantially equivalent. All three devices utilize the same method ofuse, in that the device is positioned over the target area and activated for collection ofimages for immediate viewing and/or again at a later time. Refer to Section 12.3 forfurther substantial equivalence discussion. | |||
| Electrical SafetyandElectromagneticCompatibility | IEC 60601-1 and60601-1-2 compliant | IEC 60601-1 and60601-1-2 compliant | IEC 60601-1 and60601-1-2 compliant |
| Conclusion - Substantially equivalent. All three devices are compliant withstandards for electrical safety and compatibility. | |||
| ImagingDistance (OpticalHead to TargetTissue) | $32 +/- 3$ cm | 30 cm | 10 cm |
| Conclusion – substantially equivalent. The subject device and SPY predicate devicehave 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 PointsResolution:1600 x x800 pixelsSpeckle Contrast:0-1 | Max:1386 x 1038 Data PointsResolution:1386 x 1038 pixelsSpeckle Contrast:0-1 | Max:1024 x 768 Data PointsResolution: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 ProposedDevice | Primary PredicatePeriCam PSI (K120884) | Reference DeviceNovadaq Spy (K063345) |
| Setup | The iCertainty contains anadjustable arm whichcontains the laser andcamera componentry andis mounted to a mobilecart which containedvideo screens, keyboardand computer. | The device has anadjustable arm whichcontains the laser andcamera componentry andmust be mounted to atable or mobile cart (notpart of the device). ThePeriCam PSI is thenconnected via firewallcable to a firewall port ona computer. | The device has anadjustable extension armwhich contains thecamera. The laserillumination system ismounted in the cart andconnected to the Camerahead by fiberoptic cable.The mobile cart alsocontains video screens,keyboard and computer. |
| Conclusion - Substantially equivalent. All three devices have adjustable arms thatare stabilized for use, and utilize a computer to operate the device. While theiCertainty and reference devices include a cart to which the arm is mounted and acomputer to process imaging, the predicate requires the computer to be supplied bythe user and the device to be mounted to a table or mobile cart. All three devices aresubstantially equivalent in that all require the same componentry in order to achievetheir intended use. | |||
| Imaging Cycles | 10 imaging cycles, limitedby software | Multiple imaging episodesper evaluation, limited bysoftware | 1 to 6 imaging cycles,limited by ICG Dye |
| Conclusion - Substantially equivalent. Multiple imaging episodes can be obtainedper case/evaluation. | |||
| Size | 81.3 x 81.3 x 198.1 cm221 kg | PeriCam PSI Head:22 x 15 x 20 cmPeriCam PSI Head2.3/2.4 kgArm and Stand7.1/10.1 kgTotal weight9.4/12.5 kg(Standard/High resolutionmodels) | 81.2 x 81.2 x 180.4 cm165 kg |
| Conclusion - Substantially equivalent. The iCertainty and the reference devices areall-in-one devices which include the computer and stand/table/cart, whereas thepredicate does not include the computer and stand/table/cart and this is smaller in sizespecification. All three devices have an imaging arm. The iCertainty and referencedevices 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 (butmoderately different configurations). | |||
| MaintenanceCleaning | iCertainty is used with asterile drape, whichprotects the patient fromdevice contamination.Additionally, if cleaningor disinfection is required,the user manual providesinstructions for cleaning. | The PeriCam PSI usermanual providesinstructions for cleaning. | The Novadaq SPY is usedwith a sterile drape, whichprotects the patient fromdevice contamination.Additionally, if cleaningor disinfection is required,the user manual providesinstructions for cleaning. |
| Device Comparisons | |||
| Feature | iCertainty ProposedDevice | Primary PredicatePeriCam PSI (K120884) | Reference DeviceNovadaq Spy (K063345) |
| Conclusion - Substantially equivalent. Both the iCertainty and the reference deviceuse a sterile drape to isolate the device arm and camera head from the sterile operativefield, and both include the same instructions for cleaning or disinfection of non-sterilesurfaces. The drapes do not alter the imaging characteristics. The predicate is notused in a true sterile environment, and thus does not require a drape. All three devicescan be cleaned by the user/operator. | |||
| Biocompatibility | The iCertainty does notcome into contact with thepatient. Materials ofconstruction for the arm,camera head and cart,which are in contact withthe user/operator for thepurpose of movement andmanipulation, arecomposed of plastic andmetal commonly found inevery-day materials.The device does notrequire the use on aninjected fluorescent dye to | The PeriCam PSI does notcome into contact with thepatient. Materials ofconstruction for the armand camera head, whichare in contact with theuser/operator for thepurpose of movement andmanipulation, arecomposed of plastic andmetal commonly found inevery-day materials.The device does notrequire the use on aninjected fluorescent dye to | The Novadaq SPY doesnot come into contact withthe patient. Materials ofconstruction for the arm,camera head and cart,which are in contact withthe user/operator for thepurpose of movement andmanipulation, arecomposed of plastic andmetal commonly found inevery-day materials.The device requires theuse of a biocompatiblefluorescent dye(Indocyanine Green orICG) which has a lowtoxicity profile. |
| achieve its intended use.achieve its intended use.Conclusion - Substantially equivalent. All three devices are not in contact with thepatient. User contact materials are considered safe common plastic and metalmaterials. The reference device requires use of a low-toxicity profile fluorescent dyeto achieve intended use, while the iCertainty and predicate do not. The difference inthe biocompatibility comparison with the reference device does not raise newquestions of safety or effectiveness, and in fact reduces the safety risk for the iCertainty because the patient is not exposed to the fluorescent dye. | |||
| OperatingConditions | Temperature:10°C to 30°CRelative Humidity:30-80% non-condensingAtmospheric PressureRange:700hPA to 1060hPA. | Temperature:15°C to 30°CRelative Humidity:10-80% non-condensingAtmospheric PressureRange:70 kPa to 160 kPa. | Temperature:10°C to 30°CRelative Humidity:10% to 90%, non-condensingAtmospheric PressureRange:94 kPa to 102 kPa |
| Conclusion - Substantially equivalent. The operating conditions for all three devicesare similar. | |||
| Power Supply | Operates on standardMains power supply in theUnited States. | Operates on standardMains power supply in theUnited States. | Operates on standardMains power supply in theUnited States. |
| Conclusion - Substantially equivalent. All three devices operate using a standardMains 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.
§ 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).