Modus IR

K231986 · Synaptive Medical, Inc. · IZI · Mar 25, 2024 · Radiology

Device Facts

• Record ID: K231986
• Device Name: Modus IR
• Applicant: Synaptive Medical, Inc.
• Product Code: IZI · Radiology
• Decision Date: Mar 25, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.

Device Story

Modus IR is an accessory to the Synaptive surgical exoscope; provides intraoperative fluorescence imaging to visualize vessels and blood flow not visible under white light. Input: optical signals from surgical field illuminated by 5 LEDs (5500 mW total power) at specific excitation wavelengths (748-802 nm) to excite ICG. CMOS cameras detect emitted fluorescent signals (820-1000 nm). Output: real-time video feed displayed on primary/secondary monitors. Used in OR by neurosurgeons/surgical staff. Enables visualization of vessel patency and blood flow; aids clinical decision-making during neuro/plastic/reconstructive procedures. Benefits: improved visualization of vasculature compared to white light, assisting in surgical assessment of aneurysms, vessel occlusion, and bypass patency.

Clinical Evidence

Bench testing and in vivo animal study (GLP compliant). Bench testing compared sensitivity, spatial resolution, photometric resolution, and latency against predicate; Modus IR showed lower limit of detection, higher spatial resolution, and lower latency. In vivo study used two porcine models; 10 blinded neurosurgeons evaluated 40 comparative video sets. Results showed 100% confirmation of functional equivalence in visualizing blood flow and vessel architecture.

Technological Characteristics

Accessory to surgical exoscope; CMOS camera sensors; 5 LEDs (5500 mW total power); excitation 748-802 nm, emission 820-1000 nm; motorized optical zoom (7:1) and digital zoom (up to 12:1); PC-based control system; SSD storage; non-sterile; no patient-contacting materials.

Indications for Use

Indicated for fluorescence imaging with indocyanine green (ICG) to visualize micro- and macro-vasculature and blood flow in cerebrovasculature for patients undergoing neurosurgery, plastic, or reconstructive surgery.

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

• INFRARED 800 with FLOW 800 option (K100468)

Submission Summary (Full Text)

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March 25, 2024

Image /page/0/Picture/1 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Synaptive Medical Inc. Tahmina Afzali Senior Regulatory Affairs Specialist 555 Richmond St West, Suite 800 Toronto, ON, M5V 3B1 Canada

Re: K231986

Trade/Device Name: Modus IR Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: IZI Dated: February 22, 2024 Received: February 23, 2024

Dear Tahmina Afzali:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Adam D. Adam D. Pierce -S Date: 2024.03.25 Pierce -S 17:09:27 -04'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological

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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K231986

Device Name Modus IR

### Indications for Use (Describe)

Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.

| 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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# 510(k) Summary

The 510(k) Summary for Modus IR is provided below in accordance with 21 CFR 807.92.

#### I. Submitter

| Applicant Name: | Synaptive Medical Inc. |
|--------------------|---------------------------------------------------------------------------------------------------------|
| Address: | 555 Richmond St West, Suite 800<br>Toronto ON<br>Canada M5V 3B1 |
| Applicant Contact: | Tahmina Afzali |
| Contact Telephone: | 647-925-3435 |
| Contact Email: | [e-mail] |
| Secondary Contact: | Matthis Hamy<br>Senior Manager, Regulatory Affairs<br>647-243-3333<br>[e-mail] |
| Date Prepared | March 18, 2024 |

#### II. Device Name

| Device Trade Name: | Modus IR |
|----------------------|-----------------------------|
| Common Name: | Angiographic x-ray system |
| Classification Name: | System, X-Ray, Angiographic |
| Regulation Number: | 21 CFR 892.1600 |
| Regulatory Class: | II |
| Product Code: | IZI |

#### Legally Marketed Predicate Device III.

Predicate Device: INFRARED 800 with FLOW 800 option

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| 510(k) Number | K100468 |
|----------------------|-----------------------------|
| Classification Name: | System, X-Ray, Angiographic |
| Regulation Number: | 21 CFR 892.1600 |
| Regulatory Class: | II |
| Product Code: | IZI |

#### IV. Device Description Summary

Modus IR is an accessory of the Synaptive surgical exoscope. Modus IR provides surgical staff with a means to visualize vessels and blood flow during surgical procedures that may not be visible under white light conditions. When used with the appropriate imaging agent, light output at a specific wavelength excites the imaging agent, which emits light at a specific wavelength that is detected by the optical system, thereby allowing the user to differentiate the structure that the imaging agent has concentrated in. The imaging agent is not packaged or sold as part of Modus IR. It is the responsibility of the user to source and administer the applicable imaging agent according to the excitation and observation wavelengths of Modus IR. Modus IR is selectively enabled by authorized personnel using software configuration management.

#### V. Indication for Use

Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macrovasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.

#### VI. Comparison of Technological Characteristics with the Predicate Device

Modus IR is substantially equivalent to INFRARED 800 with FLOW 800 option. Modus IR shares the same fundamental technology characteristics, including principles of operation and mechanism of action as the predicate device, as shown in the Table 1 below. In both devices, the patient is exposed to the light emitted from the light source to illuminate the surgical field as part of intended operation, and visualization of a real time image is provided. For Modus IR, the video feed from the CMOS cameras are exclusively displayed on a primary monitor and optionally a second monitor. For the predicate device, CCD cameras are utilized as sensors and video and images are presented on a monitor. Modus IR provides greater optical zoom and the addition of digital zoom capabilities compared to the predicate device.

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Modus IR and the predicate devices produce light to illuminate the same fluorescence agent Indocyanine Green (ICG) and visualize the emitted fluorescent signal from the distribution of the fluorescence agent in the patient's blood vessels during the operation. Modus IR and INFRARED 800 with FLOW 800 have slightly different excitation and detection wavelength ranges. However, both devices excite Indocyanine Green (ICG) before its peak absorption at 805 nm, with Modus IR's excitation range (748 - 802 nm) being closer to the peak compared to the predicate's excitation range (700 - 780 nm). They also detect emissions in nearly identical ranges (820 - 1000 nm for Modus IR and 820 - 900 nm for the predicate), with Modus IR having a slightly higher upper limit. Overall, Modus IR's excitation and emission wavelengths fall within the specifications of the fluorophore.

| Table 1. Subject and Predicate Devices Technological Characteristics | | |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device | Subject Device |
| | Carl Zeiss | Synaptive Medical Inc. |
| | INFRARED 800 with the FLOW 800 option | Modus IR |
| Basic Function | INFRARED 800 with the FLOW 800 option is an accessory to the OPMI Pentero surgical microscope for visualizing blood flow intraoperatively. FLOW 800 provides the surgeon with a processing mode that allows convenient handling and visualization of the INFRARED 800 video data. | Modus IR is an accessory to the Synaptive surgical exoscope for visualizing vessels and blood flow during surgical procedures. |
| Indication for Use | The Carl Zeiss Surgical INFRARED 800 with the FLOW 800 option is a surgical microscope accessory used in viewing and visual assessment of intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with the FLOW 800 option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastic and reconstructive procedures and coronary artery bypass graft surgery. | Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries. |
| | Predicate Device | Subject Device |
| | Carl Zeiss | Synaptive Medical Inc. |
| | INFRARED 800 with the FLOW 800<br>option | Modus IR |
| Energy used<br>and/or delivered | The patient is exposed to the light emitted<br>from the light source to illuminate the<br>surgical field, as part of intended operation. | The patient is exposed to the light<br>emitted from the light source to<br>illuminate the surgical field as part of<br>intended operation. |
| Sensor | CCD video camera. Infrared- sensitive video<br>camera, black & white camera.<br><br>Standard Definition resolution (720 x 480) | CMOS video camera with sensors for<br>white light and Infrared<br><br>High-Definition resolution (1920 x<br>1080) |
| Fluorescence<br>Agent | Indocyanine Green (ICG) | Indocyanine Green (ICG) |
| Activation of<br>Fluorescent<br>option | The press of a single configured fluorescence<br>button on the surgical microscope activates<br>the fluorescence function | Configuration management enables the<br>fluorescence visualization accessory.<br>Once enabled, the press of a single<br>button on the user interface activates<br>the fluorescence function. |
| Visualization of<br>Real-time<br>images | Yes | Yes |
| Display | Video and images are presented on monitor.<br>Picture-in-picture available. | Video feed from surgical camera is<br>displayed on a primary surgeon monitor<br>and optionally a second monitor.<br>Picture-in-picture available. |
| Termination of<br>the fluorescence<br>option | Determined by surgeon or will turn off<br>automatically after 5 minutes. | Determined by surgeon by turning<br>on/off of the fluorescence option. |
| Light Source | 2x 300W Xenon lamps | 5 LEDs with combined power of<br>5500 mW |
| White Light<br>Application | 400 - 700 nm | 400 – 700 nm |
| Fluorescence<br>Excitation/<br>Detection<br>wavelength range | 700 - 780 nm / 820 - 900 nm | 748 - 802 nm / 820 - 1000 nm |
| Distance of<br>Imaging Head to<br>Patient | 200 – 500 mm | 300 - 650 mm |
| Camera<br>Adaptation | Integrated into the microscope head | Integrated into the microscope head |
| Zoom | Motorized 6:1 | Motorized (optical) 7:1<br>Digital up to 12:1 |
| Autofocus | Yes | Yes |
| Control System | Personal Computer | Personal Computer |
| Storage | HDD, DVD | SSD |
| | Predicate Device<br>Carl Zeiss<br>INFRARED 800 with the FLOW 800<br>option | Subject Device<br>Synaptive Medical Inc.<br>Modus IR |
| Biocompatibility | No direct contact with the patient. | No direct contact with the patient. |

Table 1. Subiect and Predicate Devices Technological Characteristics

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#### VII. Tests Summary

## Sterilization and Shelf Life

The device is provided non-sterile. Shelf-Life is not applicable.

### Biocompatibility

The device does not have patient-contacting materials; therefore, a biocompatibility assessment is not needed.

### Verification and Validation Testing

### Software

Software verification and validation testing was conducted in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Device Software Functions" to demonstrate that the software performs as intended and meets user needs.

### Performance Bench Testing

Non-clinical verification and validation tests were performed with regards to the intended use, technical claims, requirement specifications and risk management results. Functional and system level testing demonstrated that the device meets the defined specifications.

The following performance bench tests and evaluations were conducted for Modus IR as comparison tests to the predicate device in support of the substantial equivalence determination and to ensure that the clinically relevant parameters for the Indications for Use of Modus IR are fulfilled:

| Test | Test Method Summary | Results |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Signal-to-noise<br>ratio (Sensitivity) | Imaging of an ICG-equivalent concentration sensitivity<br>target was conducted with both Subject and Predicate<br>devices. The sensitivity of Modus IR and the predicate was<br>measured across a range of working distances and at the<br>maximum zoom where the full target is visible. At each<br>working distance and zoom, the limit of detection and the<br>limit of quantification were calculated. The values were<br>then compared between the two devices. | Pass – Modus IR was<br>found to have lower<br>limit of detection and<br>limit of quantification<br>than the predicate at<br>comparable working<br>distances. |

Table 2. Performance Bench Testing Summary

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| Test | Test Method Summary | Results |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluorescence<br>excitation and<br>emissions | Review of excitation and emission wavelengths used by<br>Modus IR to excite and detect indocyanine green (ICG)<br>were compared to those used by the predicate device. | Pass – Although the<br>excitation and<br>emissions wavelengths<br>of Modus IR and the<br>predicate are not<br>identical, they are<br>considered equivalent. |
| Non-deformed,<br>non-rotated, non-<br>mirrored, and<br>centered video<br>image | Review of data gathered during the in-vivo animal study<br>where Modus IR and the predicate were directly compared.<br>A white light screenshot taken from each system was<br>compared to a freeze frame from an IR video clip recorded<br>on the system after the screenshot was taken. The infrared<br>image was qualitatively assessed. | Pass – IR images from<br>Modus IR were found<br>to be non-deformed,<br>non rotated, non-<br>mirrored and centered<br>relative to the white<br>light image. |
| Spatial resolution | Imaging of a resolution target made of ICG-equivalent<br>material that fluoresces in the NIR spectrum was conducted<br>with both Modus IR and predicate device. The horizontal<br>and vertical spatial resolution of each system was measured<br>across a range of working distances and zooms. The values<br>were then compared between equivalent working distances<br>and zooms of the two devices. | Pass – Modus IR was<br>found to have a higher<br>spatial resolution than<br>the predicate at each<br>working distance and<br>zoom configuration,<br>including at maximum<br>zoom. |
| Photometric<br>resolution | Quantization of the noise and number of levels available<br>per pixel (as determined by the bit-depth) were compared<br>between Modus IR and the predicate device. | Pass – Photometric<br>resolution was found to<br>be equivalent between<br>Modus IR and the<br>predicate. |
| Latency to external<br>monitor | For both Modus IR and the predicate device, image latency<br>to the same external monitor was measured and compared. | Pass – Average latency<br>of Modus IR was found<br>to be lower than the<br>predicate. |

In all performance bench tests and evaluations, Modus IR was found to perform as well or better than the predicate device. Based on these results, the images produced by Modus IR were equivalent to, or better than, those of the predicate device.

# In vivo Animal Testing

An in vivo animal study was conducted in compliance with 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) to confirm that Modus IR enables viewing of intraoperative blood flow and vessel architecture in a manner that is functionally equivalent to the predicate device INFRARED 800.

The study involved performing a cortical exposure in two healthy porcine models and capturing in vivo video clips of ICG flowing through vasculature using both the subject and predicate devices.

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Four comparative video sets were obtained and assessed by 10 neurosurgeons for equivalence, resulting in 40 comparative evaluations. The neurosurgeons were blinded to which system they were evaluating, and the video sets were presented to them in a randomized order and in a clinically equivalent setup on an external monitor as recommended by the user manuals for both the subject and predicate devices.

Results: In all evaluations, intraoperative blood flow and vessel architecture visualization was found to be functionally equivalent between Modus IR and INFRARED 800 (100% confirmation). Additionally, all IR Fusion video clips from Modus IR were found to be suitable for the visualization of intraoperative blood flow against background anatomical structures (100% confirmation).

The in vivo animal testing confirmed that Modus IR meets its intended use and provides functionally equivalent visualization of intraoperative blood flow and vessel architecture when compared to the predicate device.

#### VIII. Conclusion

The intended use for Modus IR is similar to the intended use of the predicate device, INFRARED 800 with FLOW 800 option. The technological characteristics of the subject device are similar to those of the predicate device, and the differences have been validated and do not raise any new questions of safety and effectiveness. Results of the verification testing, comparative performance bench testing and in vivo animal study demonstrated that Modus IR is as safe and effective and performs as well as the predicate device. Therefore, Modus IR is substantially equivalent to the predicate, INFRARED 800 with FLOW 800 option.