(59 days)
Not Found
No
The description focuses on fluorescence imaging and image processing for visualization, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is used for imaging and visual assessment, not for directly treating or curing a medical condition.
Yes
The device aids in the "visual assessment of blood flow and tissue perfusion" to evaluate conditions during surgeries, which is a diagnostic function.
No
The device description explicitly states that the EXPLORER AIR® II consists of physical hardware components including cameras, an articulated arm, a trolley, a touch screen, and a secondary monitor. While it includes software for image processing and display, it is not solely software.
Based on the provided information, the EXPLORER AIR® II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- EXPLORER AIR® II Function: The EXPLORER AIR® II is an imaging system that visualizes fluorescence in vivo (within the living body) after a dye (ICG) is administered intravenously to the patient. It captures and displays images of blood flow and tissue perfusion directly within the surgical field.
- No Specimen Examination: The device does not involve the collection or examination of specimens taken from the body. It works by imaging the patient's tissues directly.
Therefore, the EXPLORER AIR® II falls under the category of an in vivo imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IZI
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.
The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence imaging, Near Infrared fluorescence (NIR) imaging
Anatomical Site
Any part of the body
Indicated Patient Age Range
Adult and pediatric patients one month of age and older.
Intended User / Care Setting
Trained nurses and surgeons. Hospital.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device safety and performance were verified by tests conducted by Surg Vision and accredited third party laboratories, including electrical safety and electromagnetic compatibility (EMC) testing (AAMI/ANSI ES60601-1:2005(R) 2012, A1:2012, IEC 60601-1-2:2014, IEC 62471 first edition 2006-07, IEC 60601-2-57 Edition 1.0 2011-01, and IEC 60825-1:2014). Results showed conformance to applicable requirements.
Verification of optical, mechanical, and functional requirements was performed by inspection, demonstration, and analysis, covering fluorescent performance, physical properties, environmental conditions, optical requirements, design and ergonomics, usage requirements, power supply, data export, and mechanical restrictions.
ICG Testing was conducted to demonstrate the device's capability to detect ICG and determine the limit of detection of fluorescence at different concentrations. Consistent results were shown across three devices.
Human Factors Validation was conducted according to IEC 62366-1 Edition 1.1 2020-06 and IEC 62366-2 edition 1.0 from 2016-04-27, and consistent with "Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff" issued on February 3, 2016. The device was validated as safe and effective for intended users and uses.
Software verification and validation testing was conducted following "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 was considered a "Moderate" level of concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
- 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) | |
|---|---|
| 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® 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.
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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 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 |
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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.