Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.

Device Description

EXPLORER AIR® II is a fluorescence imaging system, which enables users to visually assess blood flow to evaluate tissue perfusion and tissue-transfer circulation. It can be used on any part of the body during plastic, reconstructive, gastrointestinal, and organ transplant surgeries. EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band centered around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.

AI/ML Overview

The provided text describes the regulatory clearance of the EXPLORER AIR® II device by the FDA. It outlines the device's intended use, technological characteristics, and comparisons to a predicate device (SPY Elite Intraoperative Perfusion Assessment System). However, it does not contain the detailed information required to describe specific acceptance criteria for AI/ML performance, nor a study design with a test set, ground truth experts, or MRMC study results.

The document discusses performance data related to:

Electrical safety and electromagnetic compatibility (EMC)
Photobiological safety
Verification of optical, mechanical and functional requirements (including fluorescent performance, physical properties, environmental conditions, optical requirements, design/ergonomics, usage requirements, power supply, data export, mechanical restrictions)
ICG (Indocyanine green) testing for detection capability and limit of detection
Human factors validation
Software verification and validation testing

While these are performance tests, they are focused on the hardware, general functionality, and safety of the imaging system itself, rather than an AI/ML algorithm's diagnostic or prognostic performance in assessing blood flow and tissue perfusion from the images. The device's function is described as "capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion," indicating that the visual assessment is primarily done by the human user. The software section mentions that a malfunction could lead to a delay in care if the physician were to rely on EXPLORER AIR® II instead of performing a visual assessment, implying the device is an assistive tool for visual assessment, not an automated diagnostic AI.

Therefore, I cannot extract the requested information about AI model acceptance criteria, test sets, expert ground truth, or MRMC studies from this document. The device described appears to be a medical imaging system that facilitates visual assessment by a human, not an AI/ML software as a medical device (SaMD) that performs automated analysis or provides diagnostic output based on AI.

To answer your request based on the provided text, I must state that the document does not contain the information about an AI/ML component's performance study as described in your prompt.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SurgVision GmbH Daniela Mahan Regulatory Affairs Manager Kistlerhof Strasse 70, Building 79 Munich, Bavaria 81379 Germany

February 25, 2022

Re: K214097

Trade/Device Name: Explorer Air II Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI Dated: December 15, 2021 Received: December 28, 2021

Dear Daniela Mahan:

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.

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Neil R.P. Ogden, M.S. Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K214097

Device Name EXPLORER AIR® II

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the SurgVision logo. The word "SurgVision" is written in a combination of light blue and dark blue colors. Below the word "SurgVision" is the text "A Bracco Company" in a smaller font size. To the right of the word "SurgVision" is a stylized image of an eye.

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Device Identification

Trade or Proprietary Name:Common or Usual Name:Classification Name:	EXPLORER AIR® IIAngiographic X-Ray SystemAngiographic X-Ray System
Device Class:Classification:Product Code:	Class II21 CFR 892.1600IZI
Manufacturer:	SurgVision GmbHKistlerhof Strasse 70, Building 79Munich 81379Germany
Contact Name:	Ms. Daniela Mahan, Esq., RACRegulatory Affairs Manager+49 15785116008daniela.mahan@surgvision.com
Date Prepared:	February 10, 2022

Predicate Devices

The subject EXPLORER AIR® II is the same or similar to the following device:

Product Name	Manufacturer	510(k) Number	Date of FDA Clearance
SPY Elite Intraoperative Perfusion Assessment System	Novadaq Technologies ULC., now a part of Stryker	K182907	January 23, 2019

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for SurgVision, a Bracco Company. The word "Surg" is in a light blue color, while "Vision" is in a darker blue. To the right of the word "Vision" is a graphic of a circle with a smaller circle inside of it, connected by a line to another small circle. Below the word "SurgVision" is the text "A Bracco Company" in a smaller font size.

EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley.

EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band centered around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.

The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions. The EXPLORER AIR® Sterile Drape is manufactured by Exact Medical Manufacturing, Inc., and has been cleared in K101689.

Indications for Use

Technological Characteristics

As was established in this submission, the subject EXPLORER AIR® II is the same or similar to the predicate device cleared by the FDA for commercial distribution in the United States. The subject device was shown to be the same or similar and has the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. Both the subject and predicate devices utilize the same mode of imaging - near infrared fluorescence imaging, with ICG as the imaging agent, used in the hospital operating room. The proposed and predicate devices have basic components - an imaging console/trolley, camera able to detect fluorescence, monitors and software. Further comparison is provided in Table 1 below.

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Image /page/5/Picture/0 description: The image shows the SurgVision logo. The word "Surg" is in light blue, and the word "Vision" is in dark blue. To the right of the word "Vision" is a light blue icon that looks like a magnifying glass. Underneath the word "SurgVision" is the text "A Bracco Company".

510(k) Pre-market Notification SurgVision EXPLORER AIR® 11 – K214097

	Predicate Device	Subject Device
Specification/Property	SPY Elite Intraoperative PerfusionAssessment System (K182907)	EXPLORER AIR® II	Conclusion
Image of thedevice	Image: SPY Elite Intraoperative Perfusion Assessment System	Image: EXPLORER AIR® II	Similar
Device Class	Class II	Class II	Same
Product Code	IZI	IZI	Same
RegulationNumber	21 CFR 892.1600	21 CFR 892.1600	Same
DeviceClassificationName	Angiographic X-Ray System	Angiographic X-Ray System	Same
DeviceDescriptionsummary	The SPY Elite System is an angiographicfluorescence imaging system which is usedfor nearinfrared fluorescence imaging duringopen surgery, with indocyanine green (ICG)as the imaging agent. The SPY Elite Systemallows surgeons to capture, review, print, andarchive high-quality fluorescence images ofblood flow in vessels, micro-vessels, tissueand organ perfusion in real time duringvarious surgical procedures.	The EXPLORER AIR® II is an angiographicfluorescence imaging system which is used fornearinfrared fluorescence imaging during opensurgery, with indocyanine green (ICG) as theimaging agent. The EXPLORER AIR® II allowssurgeons to capture, review, compare, playbackand export high-quality fluorescence images ofblood flow in vessels, micro-vessels, tissue andorgan perfusion in real time during varioussurgical procedures.	Same
Intended Use /Indications forUse	Upon intravenous administration of SPYAGENT™ GREEN (Indocyanine green forInjection, USP), the SPY Elite System is usedwith SPY AGENT™ GREEN to performintraoperative fluorescence angiography. TheSPY Elite System used with SPY AGENT™GREEN is indicated for use in adult andpediatric patients one month of age and older.	Upon intravenous administration and use of anICG (Indocyanine green for Injection)consistent with its approved label, theEXPLORER AIR® II is used in capturing andviewing fluorescent images for the visualassessment of blood flow and tissue perfusion,before, during, and after vascular,gastrointestinal, organ transplant, and plastic,	Similar. Slight differences in thewording of the indications for use fordescribing the same intra-operativesituation. These slight differences do notcreate a new intended use nor a differentindication for use.The subject and predicate devices areintended to capture and view fluorescent

	The SPY Elite System is indicated forfluorescence imaging of blood flow and tissueperfusion before, during, and after: vascular,gastrointestinal, organ transplant, and plastic,micro- and reconstructive surgeries.	micro- and reconstructive surgeries. TheEXPLORER AIR® II is indicated for use in adultand pediatric patients one month of age andolder.	images for the visual assessment ofblood flow.
Principle ofOperation	NIR light from the illumination module in theimaging console is transmitted to the imaginghead via fiber-optic cable. The imaging headis positioned over the patient such that theNIR excitation light is emitted and illuminatesthe area of interest. When the patient isinjected with ICG, the ICG binds to theplasma in the blood and travels to the area ofinterest through the bloodstream. The NIRexcitation light emitted by the SPY Eliteimaging device causes the ICG to fluoresce.The fluorescence image signal is processedand simultaneously recorded in computermemory and displayed on the video monitorsin real time.	The camera head is positioned over the patientsuch that the NIR excitation light is emitted andilluminates the area of interest. When thepatient is injected with ICG, the ICG binds tothe plasma in the blood and travels to the areaof interest through the bloodstream. The NIRexcitation light emitted by the EXPLORERAIR® II causes the ICG to fluoresce.The fluorescence image signal is processed andsimultaneously recorded in computer memoryand displayed on the video monitors in realtime.	Same
Design	- The device is a mobile camerasystem consisting of a trolley and acamera head suspended on anarticulated arm.- The device has two monitors.	- The EXPLORER AIR® II is a mobilecamera system consisting of a trolleyand a camera head which is suspendedon an articulated camera head arm.- The device has 2 monitors, a primarytouchscreen display for operator useand a secondary display which is thesurgeon monitor.	Same
Environmentof Use	Hospital	Hospital	Same
PatientContact	No direct or indirect patient contact.	No direct or indirect patient contact.	Same
Users	Operators trained in the use of fluorescenceimaging during surgical procedures.	Trained nurses and surgeons.	Same
SystemComponents	SPY Elite contains a radiation source, adetector (CCD camera), and signal processingsoftware.The major components of SPY Elite are:- Imaging Console- CINEVAQ Software (1x) - Analysisand Comparison Dashboar- CINEVAQ Software (2x) - AnalysisDashboard and Case Managementfor vascular imaging modality- DICOM Send Software	The EXPLORER AIR® II is comprised of:- Trolley- Camara head containing color andfluorescent cameras- Camera arm- Monitors (2)- Software	Similar
Wavelength	White light LED: 830 nmNIR: 805 nm	White light LED: 400 - 700 nmNIR: 740 – 760 nm	Similar. Differences in the light sourcebetween the subject and predicatedevices do not raise new questions ofsafety and effectiveness since despitedifferences in the exact illuminationconfiguration (wavelength, coherence,power), both devices are able to producenear infrared fluorescence images (forexample of the dye ICG).EXPLORER AIR® II complies with therelevant safety standards with respect toillumination (IEC 62471). EXPLORERAIR® II utilized LED-based NIRexcitation, which is inherently safer thanthe laser-based excitation of the SPYElite System.
Alignmentlasers	650 nm (1 mW)	650 nm (0.8 mW)	Similar. The two laser pointers ofEXPLORER AIR® II are only used toadjust the working distance of thecamera head and are switched on onlyfor this purpose. No continuous laserlight emission during the procedure.
WorkingDistance	30 cm	23 cm	Similar. The minor differences in theoptic working distance do not raise newquestions of safety and effectiveness

			since the working distance is specific for
			the used optical system / design.
Irradiance attarget	29 mW/cm2	19.8 mW/cm2	Similar. Differences in the irradiancebetween the subject and predicatedevices do not raise new questions ofsafety and effectiveness since despitedifferences in the exact value theEXPLORER AIR® II value is lower thanthe predicate, but still capable ofproducing near infrared fluorescenceimages.EXPLORER AIR® II complies with therelevant safety standards with respect toillumination (IEC 62471).
Field of view	13 cm x 18 cm	14 cm x 14 cm	Similar. The minor differences in thefield of view do not raise new questionsof safety and effectiveness since theworking distance plus area is specific forthe used optical system / design, and theimage output is sufficient for theassessment of perfusion during surgery.
Camera	CCD	CMOS and sCMOS	Similar. EXPLORER AIR® II comprisestwo cameras to acquire the fluorescenceimage and the color image separately.The sCMOS sensor is part of thefluorescence camera while the CMOSsensor is part of the color camera. Thisdifference has no impact on safety andeffectiveness given that both systems arecapable of producing near infraredfluorescence images.
Image output	752 x 480 pixels	Fluorescence: 1200 x 1200 pixelsColor: 2048 x 2048 pixels	Similar. Image output of the subjectdevice is sufficient for the assessment ofperfusion during surgery and thereforedoes not raise any new questions ofsafety and performance compared toK182907.
DeviceFunctionalities(imageacquisition,enhancement,and display)	(1) Live feed of images displayed on thedevice's monitors.(2) Playback of recorded videos(3) Color overlays(4) Print/export images	(1) Live feed of images displayed on thedevice's monitors.(2) Playback and Comparison function ofrecorded images and videos(3) Composite image(4) Export images	Same
Light source	Visible light illumination: Whitelight LEDIR illumination: Laser	- Visible light illumination: White lightLEDs- IR illumination: NIR LEDs- Two (2) laser pointers for adjusting theworking distance to the desired value.	Different. Differences in the light sourcebetween the subject and predicatedevices do not raise new questions ofsafety and effectiveness since despitedifferences in the exact illuminationconfiguration (wavelength, coherence,power), both devices are able to producenear infrared fluorescence images (forexample of the dye ICG).EXPLORER AIR® II complies with therelevant safety standards with respect toillumination (IEC 62471). EXPLORERAIR® II utilized LED-based NIRexcitation, which is inherently safer thanthe laser-based excitation of the SPYElite System.
SterileDraping	Yes, draping is required when using thedevice in a sterile environment.The NOVADRAPE 8000 sterile drape is acustom sterile surgical drape that attaches tothe imaging head of the SPY Elite device viaa specially designed optical window andsterile tapes and is designed to maintainsterility of the operating field throughout theprocedure.The NOVADRAPE 8000 sterile drape issupplied sterile and must be handledaseptically to maintain the sterile filed duringsurgery.	Yes, draping the EXPLORER AIR® II is amandatory process before using the device in asterile environment.The EXPLORER AIR® Sterile Drape is acustom surgical drape that attaches to thecamera head and is designed to maintainsterility of the operating field throughout theprocedure.The drape is supplied sterile and is intended forsingle use only. After use, dispose of the drape.	Similar. Both predicate and subjectdevice require a sterile drape in order tobe used in the sterile field. Each devicereferences the compatible drapeaccording to its design.
Contrast	, namely SPY AGENT™ GREEN	TAN
Agent	(Indocvanine green for injection. USP)	ﻟﻠﺘﺎﺭﻳﺦ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ	Same

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Image /page/6/Picture/0 description: The image shows the logo for SurgVision, a Bracco Company. The word "SurgVision" is written in a sans-serif font, with "Surg" in a light gray color and "Vision" in a dark blue color. Below the name is the text "A Bracco Company" in a smaller, light gray font. To the right of the name is a stylized image of an eye, with a dark blue pupil and a light gray outline.

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Image /page/7/Picture/0 description: The image shows the SurgVision logo. The word "Surg" is in light blue, and the word "Vision" is in dark blue. Underneath the word "Vision" is the text "A Bracco Company" in light blue.

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Image /page/8/Picture/0 description: The image shows the logo for SurgVision, a Bracco Company. The word "Surg" is in a light blue color, while "Vision" is in a darker blue. To the right of the company name is a graphic that resembles a magnifying glass or a stylized eye.

SurgVision EXPLORER AIR® II – K210(k) Pre-market Notification

SurgVision EXPLORER AIR® II – K214097

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Image /page/9/Picture/0 description: The image shows the SurgVision logo. The word "Surg" is in light blue, and the word "Vision" is in dark blue. Underneath the words is the phrase "A Bracco Company" in light blue.

510(k) Pre-market Notification SurgVision EXPLORER AIR® 11 – K214097

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Image /page/10/Picture/0 description: The image shows the SurgVision logo. The word "Surg" is in light blue, and the word "Vision" is in dark blue. Underneath the word "Vision" is the text "A Bracco Company" in a smaller, light blue font. To the right of the word "Vision" is a stylized image of an eye.

510(k) Pre-market Notification SurgVision EXPLORER AIR® 11 – K214097

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Image /page/11/Picture/0 description: The image shows the SurgVision logo. The word "Surg" is in light blue, and the word "Vision" is in dark blue. Underneath the word "Vision" is the text "A Bracco Company" in a smaller font. To the right of the word "Vision" is a graphic of a circle with a smaller circle inside of it, connected to a smaller circle by a line.

Performance Data

The EXPLORER AIR® II was designed and developed by SurgVision in accordance with the applicable requirements and standards to establish performance and safety of the device. Device safety and performance were verified by tests conducted by Surg Vision and accredited third party laboratories. The following performance data were provided in support of substantial equivalence.

Electrical safety and electromagnetic compatibility (EMC)

The EXPLORER AIR® II was tested in accordance with AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2:2014 Medical Electrical Equipment – Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests conformance testing. Test results showed that EXPLORER AIR® II conforms to the applicable requirements.

Additionally, EXPLORER AIR® II complies with IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems and IEC 60601-2-57 Edition 1.0 2011-01 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use. An assessment and test according to IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements was conducted resulting in the EXPLORER AIR® II to classify as a Class 2 laser system (two lasers for distance adjustment only). Further analysis and application of IEC 60825 to the subject device is not required: the subject device does not utilize the lasers for achieving the intended use. For EXPLORER AIR® II the safety of lasers and illumination for the intended use have been checked according to the above referenced standards.

Test results showed that the EXPLORER AIR® II meets and conforms to the applicable requirements.

Verification of optical, mechanical and functional requirements

Requirements for optical and mechanical specifications were met via verification by inspection, demonstration and analysis. A summary of results, remarks and pass/fail for each individual requirement was provided for:

Fluorescent performance
Physical Properties
Environmental conditions ●
Optical Requirements
Design and ergonomics ●
Usage requirements ●

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Image /page/12/Picture/0 description: The image shows the SurgVision logo. The word "SurgVision" is written in a combination of light blue and dark blue. Below the word "SurgVision" is the text "A Bracco Company" in a smaller font size. To the right of the word "SurgVision" is a graphic that resembles a magnifying glass.

Power supply
. Data export
Mechanical restrictions ●

ICG Testing

The EXPLORER AIR® II was tested to demonstrate its capability to detect ICG and to determine the limit of detection of fluorescence when measuring ICG in different concentrations. A calculation of the lowest concentration at a specified signal-to-noise ratio (SNR) was tested in three devices, showing consistent results and demonstrating the EXPLORER AIR® II detects ICG.

Human Factors Validation

The EXPLORER AIR® II was validated to demonstrate it is safe and effective for the intended users and uses, in the intended use environments. The Human Factors Report was performed according to IEC 62366-1 Edition 1.1 2020-06, Medical devices - Part 1: Application of usability engineering to medical devices and IEC 62366-2 edition 1.0 from 2016-04-27, Medical devices - Part 2: Guidance on the application of usability engineering to medical devices. Further information on the planning and identification of all parameters to consider was documented according to the FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff", issued on February 3, 2016.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and FDA Staff" issued on May 11, 2005. The software for this device was considered a "Moderate" level of concern, since a malfunction of the device software could lead to a delay in care if the physician were to rely on EXPLORER AIR® II instead of performing a visual assessment of the perfusion in the interested tissue.

Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject EXPLORER AIR® II has been shown to be as safe, as effective, and to perform as well as the legally marketed predicate device.

END OF DOCUMENT

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.