Who is the manufacturer of Explorer Air II?

Surgvision GmbH filed the 510(k) submission for Explorer Air II (K214097).

What is the FDA product code for Explorer Air II?

IZI. It is classified under 21 CFR 892.1600 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Explorer Air II?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Explorer Air II?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Explorer Air II

K214097 · Surgvision GmbH · IZI · Feb 25, 2022 · Radiology

Device Facts

Record ID	K214097
Device Name	Explorer Air II
Applicant	Surgvision GmbH
Product Code	IZI · Radiology
Decision Date	Feb 25, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1600
Device Class	Class 2
Attributes	Pediatric

Intended Use

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 Story

Fluorescence imaging system for intraoperative assessment of blood flow and tissue perfusion. Inputs: NIR fluorescence signals from ICG-labeled tissue and color images. Operation: Camera head (CMOS/sCMOS sensors) mounted on articulated arm/trolley captures NIR fluorescence (excited by 740-760nm LEDs) and color images; system processes signals to generate composite overlay; displays live feed, recorded video, and comparison views on primary touchscreen and secondary monitor. Used in hospital operating rooms by surgeons and nurses. Output: Visual display of perfusion; enables surgeons to evaluate tissue viability/circulation in real-time. Benefits: Enhanced visualization of blood flow to support surgical decision-making during complex procedures.

Clinical Evidence

Bench testing only. Performance verified via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), photobiological safety (IEC 62471), and non-laser light source safety (IEC 60601-2-57). Optical/mechanical requirements verified via inspection/analysis. ICG detection capability demonstrated via signal-to-noise ratio (SNR) testing across multiple units. Human factors validation performed per IEC 62366-1/2 and FDA guidance.

Technological Characteristics

Mobile trolley-based system with articulated arm. Imaging: CMOS (color) and sCMOS (fluorescence) sensors. Illumination: White light LEDs (400-700nm) and NIR LEDs (740-760nm). Two 650nm laser pointers for distance adjustment (Class 2). Connectivity: DICOM export. Software: Moderate level of concern. Sterile drape required for use. Complies with IEC 60601-1, IEC 60601-1-2, IEC 62471, IEC 60601-2-57.

Indications for Use

Indicated for adult and pediatric patients (≥1 month) undergoing vascular, gastrointestinal, organ transplant, or plastic/micro/reconstructive surgery to visually assess blood flow and tissue perfusion via ICG fluorescence imaging.

Regulatory Classification

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.

Predicate Devices

SPY Elite Intraoperative Perfusion Assessment System (K182907)

Related Devices

K222240 — EXPLORER AIR® II · Surgvision GmbH · Feb 28, 2023
K230407 — FloNavi Open Field Fluorescence Imaging System · Guangdong Optomedic Technologies, Inc. · Jul 17, 2023
K133719 — PDE-NEO · Hamamatsu Photonics K.K. · Mar 27, 2014
K192761 — Asimov-MKS Imaging System · Onlume, Inc. · Jan 17, 2020
K180146 — KARL STORZ ICG Imaging System · Karl Storz Endoscopy America, Inc. · Apr 17, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 803) 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K214097 Device Name EXPLORER AIR® II Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="true" type="checkbox"/> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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® II Angiographic X-Ray System Angiographic X-Ray System | |-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Device Class: Classification: Product Code: | Class II 21 CFR 892.1600 IZI | | Manufacturer: | SurgVision GmbH Kistlerhof Strasse 70, Building 79 Munich 81379 Germany | | Contact Name: | Ms. Daniela Mahan, Esq., RAC Regulatory Affairs Manager +49 15785116008 daniela.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 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. {4}------------------------------------------------ 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 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. #### 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. {5}------------------------------------------------ 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 Perfusion Assessment System (K182907) | EXPLORER AIR® II | Conclusion | | Image of the device | Image: SPY Elite Intraoperative Perfusion Assessment System | Image: EXPLORER AIR® II | Similar | | Device Class | Class II | Class II | Same | | Product Code | IZI | IZI | Same | | Regulation Number | 21 CFR 892.1600 | 21 CFR 892.1600 | Same | | Device Classification Name | Angiographic X-Ray System | Angiographic X-Ray System | Same | | Device Description summary | The SPY Elite System is an angiographic fluorescence imaging system which is used for nearinfrared fluorescence imaging during open surgery, with indocyanine green (ICG) as the imaging agent. The SPY Elite System allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels, micro-vessels, tissue and organ perfusion in real time during various surgical procedures. | The EXPLORER AIR® II is an angiographic fluorescence imaging system which is used for nearinfrared fluorescence imaging during open surgery, with indocyanine green (ICG) as the imaging agent. The EXPLORER AIR® II allows surgeons to capture, review, compare, playback and export high-quality fluorescence images of blood flow in vessels, micro-vessels, tissue and organ perfusion in real time during various surgical procedures. | Same | | Intended Use / Indications for Use | Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY Elite System used with SPY AGENT™ GREEN is indicated for use in adult and pediatric patients one month of age and older. | 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, | Similar. Slight differences in the wording of the indications for use for describing the same intra-operative situation. These slight differences do not create a new intended use nor a different indication for use. The subject and predicate devices are intended to capture and view fluorescent | | | | | | | | The SPY Elite System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. | micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older. | images for the visual assessment of blood flow. | | Principle of Operation | NIR light from the illumination module in the imaging console is transmitted to the imaging head via fiber-optic cable. The imaging head is positioned over the patient such that the NIR excitation light is emitted and illuminates the area of interest. When the patient is injected with ICG, the ICG binds to the plasma in the blood and travels to the area of interest through the bloodstream. The NIR excitation light emitted by the SPY Elite imaging device causes the ICG to fluoresce. The fluorescence image signal is processed and simultaneously recorded in computer memory and displayed on the video monitors in real time. | The camera head is positioned over the patient such that the NIR excitation light is emitted and illuminates the area of interest. When the patient is injected with ICG, the ICG binds to the plasma in the blood and travels to the area of interest through the bloodstream. The NIR excitation light emitted by the EXPLORER AIR® II causes the ICG to fluoresce. The fluorescence image signal is processed and simultaneously recorded in computer memory and displayed on the video monitors in real time. | Same | | Design | - The device is a mobile camera system consisting of a trolley and a camera head suspended on an articulated arm. - The device has two monitors. | - The EXPLORER AIR® II is a mobile camera system consisting of a trolley and a camera head which is suspended on an articulated camera head arm. - The device has 2 monitors, a primary touchscreen display for operator use and a secondary display which is the surgeon monitor. | Same | | Environment of Use | Hospital | Hospital | Same | | Patient Contact | No direct or indirect patient contact. | No direct or indirect patient contact. | Same | | Users | Operators trained in the use of fluorescence imaging during surgical procedures. | Trained nurses and surgeons. | Same | | System Components | SPY Elite contains a radiation source, a detector (CCD camera), and signal processing software. The major components of SPY Elite are: - Imaging Console - CINEVAQ Software (1x) - Analysis and Comparison Dashboar - CINEVAQ Software (2x) - Analysis Dashboard and Case Management for vascular imaging modality - DICOM Send Software | The EXPLORER AIR® II is comprised of: - Trolley - Camara head containing color and fluorescent cameras - Camera arm - Monitors (2) - Software | Similar | | Wavelength | White light LED: 830 nm NIR: 805 nm | White light LED: 400 - 700 nm NIR: 740 – 760 nm | Similar. Differences in the light source between the subject and predicate devices do not raise new questions of safety and effectiveness since despite differences in the exact illumination configuration (wavelength, coherence, power), both devices are able to produce near infrared fluorescence images (for example of the dye ICG). EXPLORER AIR® II complies with the relevant safety standards with respect to illumination (IEC 62471). EXPLORER AIR® II utilized LED-based NIR excitation, which is inherently safer than the laser-based excitation of the SPY Elite System. | | Alignment lasers | 650 nm (1 mW) | 650 nm (0.8 mW) | Similar. The two laser pointers of EXPLORER AIR® II are only used to adjust the working distance of the camera head and are switched on only for this purpose. No continuous laser light emission during the procedure. | | Working Distance | 30 cm | 23 cm | Similar. The minor differences in the optic working distance do not raise new questions of safety and effectiveness | | | | | | | | | | since the working distance is specific for | | | | | the used optical system / design. | | Irradiance at target | 29 mW/cm2 | 19.8 mW/cm2 | Similar. Differences in the irradiance between the subject and predicate devices do not raise new questions of safety and effectiveness since despite differences in the exact value the EXPLORER AIR® II value is lower than the predicate, but still capable of producing near infrared fluorescence images. EXPLORER AIR® II complies with the relevant safety standards with respect to illumination (IEC 62471). | | Field of view | 13 cm x 18 cm | 14 cm x 14 cm | Similar. The minor differences in the field of view do not raise new questions of safety and effectiveness since the working distance plus area is specific for the used optical system / design, and the image output is sufficient for the assessment of perfusion during surgery. | | Camera | CCD | CMOS and sCMOS | Similar. EXPLORER AIR® II comprises two cameras to acquire the fluorescence image and the color image separately. The sCMOS sensor is part of the fluorescence camera while the CMOS sensor is part of the color camera. This difference has no impact on safety and effectiveness given that both systems are capable of producing near infrared fluorescence images. | | Image output | 752 x 480 pixels | Fluorescence: 1200 x 1200 pixels Color: 2048 x 2048 pixels | Similar. Image output of the subject device is sufficient for the assessment of perfusion during surgery and therefore does not raise any new questions of safety and performance compared to K182907. | | Device Functionalities (image acquisition, enhancement, and display) | (1) Live feed of images displayed on the device's monitors. (2) Playback of recorded videos (3) Color overlays (4) Print/export images | (1) Live feed of images displayed on the device's monitors. (2) Playback and Comparison function of recorded images and videos (3) Composite image (4) Export images | Same | | Light source | Visible light illumination: White light LED IR illumination: Laser | - Visible light illumination: White light LEDs - IR illumination: NIR LEDs - Two (2) laser pointers for adjusting the working distance to the desired value. | Different. Differences in the light source between the subject and predicate devices do not raise new questions of safety and effectiveness since despite differences in the exact illumination configuration (wavelength, coherence, power), both devices are able to produce near infrared fluorescence images (for example of the dye ICG). EXPLORER AIR® II complies with the relevant safety standards with respect to illumination (IEC 62471). EXPLORER AIR® II utilized LED-based NIR excitation, which is inherently safer than the laser-based excitation of the SPY Elite System. | | Sterile Draping | Yes, draping is required when using the device in a sterile environment. The NOVADRAPE 8000 sterile drape is a custom sterile surgical drape that attaches to the imaging head of the SPY Elite device via a specially designed optical window and sterile tapes and is designed to maintain sterility of the operating field throughout the procedure. The NOVADRAPE 8000 sterile drape is supplied sterile and must be handled aseptically to maintain the sterile filed during surgery. | Yes, draping the EXPLORER AIR® II is a mandatory process before using the device in a sterile environment. The EXPLORER AIR® Sterile Drape is a custom surgical drape that attaches to the camera head and is designed to maintain sterility of the operating field throughout the procedure. The drape is supplied sterile and is intended for single use only. After use, dispose of the drape. | Similar. Both predicate and subject device require a sterile drape in order to be used in the sterile field. Each device references the compatible drape according 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 | {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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 {9}------------------------------------------------ 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 {10}------------------------------------------------ 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 {11}------------------------------------------------ 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®…

Explorer Air II

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