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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EXPLORER AIR® II device. The submission is to expand the device's indications for use to include the infrared dye, pafolacianine. The document focuses on demonstrating substantial equivalence to predicate devices, particularly concerning the new imaging agent.

Here's an analysis of the acceptance criteria and the study proving the device meets them based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific pass/fail values. Instead, it describes performance verification related to its capability with the new imaging agent, pafolacianine, and comparison to predicate devices. The implicit acceptance criterion is that the device can effectively detect pafolacianine and perform comparably or better than existing cleared devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Capability to detect pafolacianine at different concentrations and show consistent results.	The EXPLORER AIR® II was tested in two devices, showing consistent results and demonstrating detection of pafolacianine. A calculation of the lowest concentration at a specified contrast-to-noise ratio (CNR) was performed.
Comparative performance with secondary predicate device (K210265) regarding pafolacianine detection.	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.
Software validation for the new indication.	Software verification and validation testing were updated and conducted, confirming the inclusion of the additional protocol for imaging pafolacianine.
Human factors assessment for the new indication.	An updated Human Factors Report concluded that user profiles, environment of use, training, user interactions, and procedure workflow remain the same, with identified risks, mitigations, and verification found acceptable.

2. Sample size used for the test set and data provenance

The document refers to "testing... in two devices" for pafolacianine detection. This suggests the sample size for the core performance test was limited to these two devices (likely two units of the EXPLORER AIR® II). The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified, but it implies a controlled laboratory setting. The comparison testing with the secondary predicate device also falls under this testing.

3. Number of experts used to establish the ground truth for the test set and their qualifications

No information is provided regarding the use of experts to establish ground truth for the test set. The performance data presented seems to be based on objective measurements like image contrast (CNR) and visualization of known concentrations, rather than expert interpretation of a diagnostic task.

4. Adjudication method for the test set

No information on an adjudication method is provided. Given the nature of the tests (detection of known concentrations and image contrast analysis), an adjudication process by experts is not described or implied.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The performance data focuses on the device's technical capability to detect pafolacianine and a direct comparison of its imaging characteristics against a predicate device, not on human reader performance with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The performance tests described (pafolacianine detection at different concentrations, CNR analysis, visualization of samples) appear to be standalone assessments of the device's imaging capabilities without explicit human interpretation as part of the primary test endpoint. The software validation is also a standalone assessment of the algorithmic components.

7. The type of ground truth used

The ground truth for the pafolacianine testing appears to be based on:

Known concentrations of pafolacianine.
Objective measurements such as Contrast-to-Noise Ratio (CNR).
Direct observation of the images to confirm visualization of lower concentration samples.

This indicates a quantitative and controlled experimental ground truth, rather than clinical outcomes or expert consensus on patient cases.

8. The sample size for the training set

The document does not mention a training set sample size or the use of machine learning models that would require one. The verification approach described is primarily focused on demonstrating the physical and software performance of the imaging system with the new dye, rather than the development of a predictive algorithm using a training set.

9. How the ground truth for the training set was established

As no training set is mentioned for an algorithm, there is no information on how its ground truth was established.

Summary

{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)

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)

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 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 GmbHKistlerhof Strasse 70, Building 79Munich 81379Germany
Contact Name:	Ms. Daniela Mahan, Esq., RACRegulatory Affairs Manager+49 15785116008daniela.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

{4}------------------------------------------------

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

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.

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

{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. 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 &PredicateDevice(s):	K222240EXPLORERAIR® II	K214097EXPLORERAIR® II	K210265VS3 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).
Regulationnumber	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 LEDIR: NIR LED	Visible light:White light LEDIR: NIR LED	Visible light:White light LEDIR: 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 nmIR: 740 – 760 nm	White light LED: 400 - 700 nmIR: 740 - 760 nm	White light LED: 400 - 700 nmIR: 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.
Workingdistance	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 attarget	19.8 mW/cm2	19.8 mW/cm2	At 40 cm: 6 mW/cm²Max: 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 ofimaging	NIR fluorescence	NIR fluorescence	NIR fluorescence	Same.
Camera	CMOS andsCMOS	CMOS andsCMOS	Silicon ImageSensor	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.
Inputfrequency	50/60 Hz	50/60 Hz	50 Hz @ 230 VAC or 60 Hz @ 120 VAC	Same.

{6}------------------------------------------------

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.

{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 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.

END OF DOCUMENT

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

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