(217 days)
No
The description focuses on image acquisition, display, and basic manipulation (tagging, comparison, playback, export). There is no mention of AI/ML algorithms for image analysis, interpretation, or decision support. The performance studies focus on detection capabilities and image quality metrics (CNR), not on the performance of any AI/ML model.
No
The device is described as an imaging system used to capture and view fluorescent images for visual assessment of blood flow and tissue perfusion, and to perform intraoperative fluorescence imaging of tissues. It enhances the surgeon's vision by visualizing fluorescence, but it does not directly treat or provide therapy to the patient.
Yes
The device is used for "visual assessment of blood flow and tissue perfusion" and "intraoperative fluorescence imaging of tissues that have taken up the drug," which are diagnostic purposes to understand physiological states or identify specific tissues.
No
The device description explicitly states that the EXPLORER AIR® II consists of an imaging system with cameras, an articulated arm, a trolley, and monitors, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, the EXPLORER AIR® II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- EXPLORER AIR® II Function: The EXPLORER AIR® II is an imaging system used during surgery to visualize blood flow and tissue perfusion within the patient's body. It uses fluorescence imaging after a dye is administered to the patient. This is an in vivo (within the living body) imaging technique, not an in vitro diagnostic test.
The device description and intended use clearly indicate that the EXPLORER AIR® II is used for real-time visualization of tissues and blood flow during surgical procedures on the patient. This is fundamentally different from the purpose of an IVD 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.
Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
Product codes
IZI
Device Description
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) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760mm) and emitted in the band 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.
This Traditional 510(k) premarket notification is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine, for use with infrared imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
near infrared fluorescence (NIR) imaging
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients one month of age and older.
Intended User / Care Setting
Not Found
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)
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. The expansion of the indication of the subject device does not change the biocompatibility, electrical safety, electromagnetic compatibility, or cleaning or sterilization from the previous clearance in K214097. Performance of the EXPLORER AIR® II with pafolacianine was verified and software validation was conducted to include the additional protocol for imaging pafolacianine.
Pafolacianine Testing
The EXPLORER AIR® II was tested to demonstrate its capability to detect pafolacianine at different concentrations. A calculation of the lowest concentration at a specified contrast-to-noise ratio (CNR) was tested in two devices, showing consistent results and demonstrating the EXPLORER AIR® II detects pafolacianine.
Additional comparison testing with the secondary predicate device (K210265) was conducted to support substantial equivalence in regards to differences in light source and excitation waveleneth. The EXPLORER AIR® II was able to visualize lower concentration samples of pafolacianine compared to the additional predicate device, both by analysis of the image contrast (CNR) and by observation of the images.
Human Factors
Human Factors Report was updated to document the inclusion of the new expanded indication for use of the device with pafolacianine. An assessment of user profiles, environment of use, training. user interactions with the device and procedure workflow for the new indication were assessed. It was concluded that all these factors remain the same, and identified risks, mitigations and verification was conducted and found acceptable. Therefore, the EXPLORER AIR® II has been found to be safe and effective for the intended users in the intended use environment for the new indication of use of the subject device with pafolacianine.
Software Verification and Validation
Software verification and validation testing were updated and conducted. 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 and draft "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on November 4, 2021. The software for this device was considered a "Moderate" level of concern and "Basic Documentation Level", 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
SurgVision GmbH Daniela Mahan Regulatory Affairs Manager Kistlerhof Strasse 70. Building 79 Munich, Bavaria 81379 Germany
February 28, 2023
Re: K222240
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: January 23, 2023 Received: January 23, 2023
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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,
Colin K. Chen -S
for
Jessica Carr Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222240
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.
Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 logo for SurgVision, a Bracco Company. The word "Surg" is in a light blue color, while the word "Vision" is in a darker blue color. Below the word "Vision" is the text "A Bracco Company" in a smaller font. To the right of the word "Vision" 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: | EXPLORER AIR® II |
|---|---|
| Common or Usual Name: | Angiographic X-Ray System |
| Classification Name: | Angiographic X-Ray System |
| Device Class: | Class II |
| Classification: | 21 CFR 892.1600 |
| Product Code: | 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: | Februrary 16th, 2023 |
Predicate Devices
Primary Predicate Device
| Product Name | Manufacturer | 510(k) Number | Date of Concurrence |
|---|---|---|---|
| EXPLORER AIR II | SurgVision GmbH | K214097 | February 25, 2022 |
Additional Predicate Device
| Product Name | Manufacturer | 510(k) Number | Date of Concurrence |
|---|---|---|---|
| VS3 Iridium System | Visionsense Ltd. | ||
| (Medtronic) | K210265 | November 22, 2021 |
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Image /page/4/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 graphic of a circle with a smaller circle inside of it, connected to another circle by a line.
Device Description
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) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760mm) and emitted in the band 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.
This Traditional 510(k) premarket notification is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine, for use with infrared imaging.
Indications for Use
Upon intravenous administration and use of an ICG (Indocvanine 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.
Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
Technological Characteristics
The EXPLORER AIR® II has the same performance as the primary predicate device EXPLORER AIR® II cleared in K214097 and is similar to additional predicate device VS3 Iridium System cleared in K210265 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 and pafolacianine as the imaging agents, used in the hospital operating room. The proposed and predicate devices have the same basic
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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. Underneath the word "Vision" is the phrase "A Bracco Company" in a smaller font.
components - an imaging console/trolley, camera able to detect fluorescence, monitors and software.
| Device &
Predicate
Device(s): | K222240
EXPLORER
AIR® II | K214097
EXPLORER
AIR® II | K210265
VS3 Iridium System | Comparison |
|-------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device Characteristics | | | | |
| Device class | II | II | II | Same. |
| Product code | IZI | IZI | OWN | Same as primary predicate device.
Different from additional predicate device, however, the code also relates to imaging (Confocal Optical Imaging). |
| Regulation
number | 892.1600 | 892.1600 | 876.1500 | Same as primary predicate device.
Different from additional predicate device, however, this sub chapter focuses on the endoscopy technique, but the technology is regulated by the generic Angiographic X-Ray System chapter. |
| Light source | Visible light:
White light LED
IR: NIR LED | Visible light:
White light LED
IR: NIR LED | Visible light:
White light LED
IR: Infrared laser | Same as primary predicate device.
Same as additional predicate device for visible light illumination (LED), but different for near infrared illumination. LED-based NIR excitation is inherently safer than the laser-based excitation of the additional predicate device. Both devices are able to produce NIR fluorescence images, supported by comparison test results summarized in the Performance Data section below. |
| Wavelength | White light LED: 400 - 700 nm
IR: 740 – 760 nm | White light LED: 400 - 700 nm
IR: 740 - 760 nm | White light LED: 400 - 700 nm
IR: 785 nm | Same as primary predicate device.
Similar to additional predicate device regarding IR. Both devices excite pafolacianine within the peak absorption region of its spectrum, supported by comparison test results summarized in the Performance Data section below. |
| Working
distance | 23 cm | 23 cm | 20 – 45 cm | Same as primary predicate device.
Similar to additional predicate device, indicating a range. The differences come from the specific device design. |
| Irradiance at
target | 19.8 mW/cm2 | 19.8 mW/cm2 | At 40 cm: 6 mW/cm²
Max: 47 mW/cm2 | Same as primary predicate device.
Similar to additional predicate device, the EXPLORER AIR® II is within the range established for the VS3 Iridium System. |
| Mode of
imaging | NIR fluorescence | NIR fluorescence | NIR fluorescence | Same. |
| Camera | CMOS and
sCMOS | CMOS and
sCMOS | Silicon Image
Sensor | Same or Similar. |
| Contrast agent | ICG,
Pafolacianine | ICG | ICG,
Pafolacianine | Different from primary predicate device. This submission seeks to add pafolacianine as a second agent, addressing identified risks, mitigations, and their verification.
Same as additional predicate device. |
| Input voltage | 100-120 V | 100-120 V | 120 VAC or 230 VAC | Same. |
| Input
frequency | 50/60 Hz | 50/60 Hz | 50 Hz @ 230 VAC or 60 Hz @ 120 VAC | Same. |
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Image /page/6/Picture/0 description: The image shows the SurgVision logo. The logo consists of the word "SurgVision" 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.
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. The expansion of the indication of the subject device does not change the biocompatibility, electrical safety, electromagnetic compatibility, or cleaning or sterilization from the previous clearance in K214097. Performance of the EXPLORER AIR® II with pafolacianine was verified and software validation was conducted to include the additional protocol for imaging pafolacianine.
Pafolacianine Testing
The EXPLORER AIR® II was tested to demonstrate its capability to detect pafolacianine at different concentrations. A calculation of the lowest concentration at a specified contrast-to-noise ratio (CNR) was tested in two devices, showing consistent results and demonstrating the EXPLORER AIR® II detects pafolacianine.
Additional comparison testing with the secondary predicate device (K210265) was conducted to support substantial equivalence in regards to differences in light source and excitation waveleneth. The EXPLORER AIR® II was able to visualize lower concentration samples of pafolacianine compared to the additional predicate device, both by analysis of the image contrast (CNR) and by observation of the images.
Human Factors
Human Factors Report was updated to document the inclusion of the new expanded indication for use of the device with pafolacianine. An assessment of user profiles, environment of use, training. user interactions with the device and procedure workflow for the new indication were assessed. It was concluded that all these factors remain the same, and identified risks, mitigations and verification was conducted and found acceptable. Therefore, the EXPLORER AIR® II has been found to be safe and effective for the intended users in the intended use environment for the new indication of use of the subject device with pafolacianine.
Software Verification and Validation
Software verification and validation testing were updated and conducted. 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 and draft "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on November 4, 2021. The software for this device was considered a "Moderate" level of concern and "Basic Documentation Level", 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.
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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 a smaller font. To the right of the word "Vision" is a stylized image of an eye.
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 devices.