1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes

K211202 · Stryker · GWG · Aug 6, 2021 · Neurology

Device Facts

• Record ID: K211202
• Device Name: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
• Applicant: Stryker
• Product Code: GWG · Neurology
• Decision Date: Aug 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Endoscopic white light and near-infrared illumination and imaging during endoscopic procedures.

Device Story

The AIM System is an endoscopic 4K visible and near-infrared (NIR) imaging system. It consists of a camera system, L11 LED light source, SafeLight cable, endoscopes, IRIS Ureteral Kit, and SPY AGENT GREEN imaging agent. The system uses an optical endoscope and coupler to project light onto CMOS image sensors, which acquire continuous image data. This data is processed into a video stream for display. Surgeons use the system in OR settings to perform minimally invasive procedures, including neurosurgery and laparoscopy. The device provides real-time visual assessment of tissue perfusion, blood flow, and anatomical structures (biliary ducts, ureters, lymphatics) via fluorescence and transillumination. This visual feedback assists surgeons in intraoperative decision-making, potentially improving surgical outcomes by enhancing visualization of critical structures and tissue health.

Clinical Evidence

No new clinical trials were conducted. Safety and effectiveness for neurosurgery indications were supported by published literature. Bench testing included electrical safety, EMC, laser safety, biocompatibility (ISO 10993), cleaning, sterilization, software validation (IEC 62304), and usability (IEC 62366-1). Comparative animal testing was performed in compliance with GLP (21 CFR Part 58) to validate performance against legally marketed devices.

Technological Characteristics

System includes 4K camera, L11 LED light source (RGB LEDs/Infrared Laser), SafeLight cable, and rigid rod lens endoscopes (3.1mm/4.0mm OD). Imaging modes: White light, NIR fluorescence (806nm), NIR transillumination (830nm). Biocompatibility per ISO 10993. Sterilization via moist heat or hydrogen peroxide. Connectivity: Digital video output. Laser safety: Class 1M.

Indications for Use

Indicated for adults and pediatric patients (aged one month and older for general surgery; >6 years for endonasal skull base surgery; 12-17 years for biliary duct visualization). Used for general laparoscopy, ear endoscopy, sinuscopy, neurosurgery, and plastic surgery. Enables real-time endoscopic visible and near-infrared fluorescence imaging (with SPY AGENT GREEN) for visual assessment of vessels, blood flow, tissue perfusion, lymphatic system visualization, and biliary duct visualization. Also indicated for ureter transillumination.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• Karl Storz ICG Imaging System (K180146)
• AIM System (K210088)

Reference Devices

• Precision S 4K Sinuscope (K191102)

Submission Summary (Full Text)

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August 6, 2021

Stryker April Malmborg Senior Director, Regulatory Affairs 5900 Optical Court San Jose. California 95138

Re: K211202

Trade/Device Name: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, GWG, OWN, FCS, FCW, EOB Dated: July 8, 2021 Received: July 9, 2021

Dear April Malmborg:

We have reviewed vour 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

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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 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 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,

for

Adam Pierce Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological 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) K211202

#### Device Name

AIM (Advanced Imaging Modality) System

#### Indications for Use (Describe)

1688 4K Camera System with Advanced Imaging Modality (AIM):

The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.

A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, neurosurgeons and urologists.

L11 LED Light Source with Advanced Imaging Modality (AIM) and SafeLight Cable:

Upon intravenous administration of SPY AGENTTM GREEN (indocyanine green for injection, USP), the L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediativ patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Additionally, the L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near-infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The L11 LED Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

#### Precision S 4K Sinuscope:

The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including thinology, endoscopic plastic and reconstructive surgery. The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years ofage.

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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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c).

## Submitter:

| Applicant: | Stryker Endoscopy<br>5900 Optical Court<br>San Jose, CA 95138 |
|-----------------|--------------------------------------------------------------------------------|
| Contact Person: | Jessie Duong<br>Manager, Regulatory Affairs<br>Email: [e-mail] |
| Date Prepared: | July 7, 2021 |

#### Subject Device:

The subject device is the AIM (Advanced Imaging Modality) System, specifically the following system components:

| Name of Device: | 1688 4K Camera System with Advanced Imaging Modality |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|
| Common or<br>Usual Name | 3-chip Video Camera |
| Classification<br>Name: | Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500)<br>Endoscope, Neurological (21 C.F.R. §882.1480) |
| Regulatory Class: | II |
| Product Code: | GCJ<br>GWG |
| 510(k) Review<br>Panel: | General & Plastic Surgery<br>Neurology |

| Name of Device: | L11 LED Light Source with Advanced Imaging Modality |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or<br>Usual Name | Light Source, Illuminator |
| Classification<br>Name: | Confocal Optical Imaging1 (21 C.F.R. §876.1500)<br>Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020)<br>Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.4020)<br>Endoscope, Neurological (21 C.F.R. §882.1480) |
| Regulatory Class: | II |
| Product Code: | OWN1<br>FSC2<br>FCW3<br>GWG4 |
| 510(k) Review<br>Panel: | General & Plastic Surgery1<br>Gastroenterology/ Urology2,3<br>Neurology4 |

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1When used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging

2When used to transilluminate the ureter during open or laparoscopic surgical procedures

3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging.

4 When used to provide standard endoscopic visible light and near-infrared imaging during minimally invasive cranial

neurosurgery and endonasal skull base surgery.

| Name of Device | Precision S 4K Sinuscope |
|----------------------|------------------------------------------------------------------------------------------|
| Common or Usual Name | Sinuscope |
| Classification Name | Nasopharyngoscope (21 C.F.R. §874.4760)<br>Endoscope, Neurological (21 C.F.R. §882.1480) |
| Regulatory Class | Class II |
| Product Code | EOB<br>GWG |
| 510(k) Review Panel: | Ear Nose & Throat<br>Neurology |

#### Predicate Device(s):

| Karl Storz ICG Imaging System | K180146 (primary) |
|-----------------------------------------------------------------------------------|---------------------|
| AIM System: 1688 4K Camera<br>System, L11 LED Light Source and<br>SafeLight Cable | K210088 (secondary) |

NOTE: The predicate device has not been subject to a design-related recall.

#### Reference Device(s):

| Precision S 4K Sinuscope | K191102 |
|--------------------------|---------|
|--------------------------|---------|

#### Device Description:

The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing nearinfrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) An Endoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT 104 GREEN (indocyanine green for injection, USP) an optical imaging agent used for fluorescence imaging.

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# Indications for Use:

| Subject Device | Predicate Devices | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AIM System<br>This Submission | Karl Storz ICG Imaging System<br>(K180146, primary) | AIM System<br>(K210088, secondary) |
| Intended Use:<br>Endoscopic white light and near-infrared<br>illumination and imaging during endoscopic<br>procedures. | Intended Use:<br>Same as subject device | Intended Use:<br>Same as subject device. |
| Indications for Use:<br>L11 LED Light Source with AIM and<br>SafeLight Cable | Indications for Use:<br>Karl Storz ICG Imaging System | Indications for Use:<br>L11 LED Light Source with AIM<br>and SafeLight Cable |
| Upon intravenous administration of SPY<br>AGENTTM GREEN (indocyanine green for<br>injection, USP), the L11 LED Light Source<br>with AIM and SafeLightTM Cable are used<br>with SPY AGENT GREEN to provide real-<br>time endoscopic visible and near infrared<br>fluorescence imaging. The L11 LED Light<br>Source with AIM and SafeLight Cable<br>enable surgeons to perform minimally<br>invasive surgery using standard endoscopic<br>visual light as well as visual assessment of<br>vessels, blood flow and related tissue<br>perfusion in adults and pediatric patients<br>aged one month and older, and visualization<br>of at least one of the major extra-hepatic<br>bile ducts (cystic duct, common bile duct<br>and common hepatic duct) in adults and<br>pediatric patients 12 to 17 years of age,<br>using near-infrared imaging. | The KARL STORZ ICG Imaging<br>System is intended to provide real-<br>time visible (VIS) and near-infrared<br>(NIR) fluorescence imaging.<br><br>The KARL STORZ Endoscopic ICG<br>System enables surgeons to perform<br>minimally invasive surgery using<br>standard endoscopic visible light as<br>well as visual assessment of vessels,<br>blood flow and related tissue<br>perfusion, or at least one of the major<br>extra-hepatic bile ducts (cystic duct,<br>common bile duct and common<br>hepatic duct), using near infrared<br>imaging. Fluorescence imaging of<br>biliary ducts with the KARL STORZ<br>Endoscopic ICG System is intended<br>for use with standard of care white<br>light and, when indicated,<br>intraoperative cholangiography. The<br>device is not intended for standalone<br>use for biliary duct visualization. | Upon intravenous administration of<br>SPY AGENTTM GREEN<br>(indocyanine green for injection,<br>USP), the L11 LED Light Source<br>with AIM and SafeLightTM Cable is<br>used with SPY AGENT GREEN to<br>provide real-time endoscopic visible<br>and near infrared fluorescence<br>imaging. The L11 LED Light Source<br>with AIM and SafeLight Cable<br>enable surgeons to perform<br>minimally invasive surgery using<br>endoscope visual light as well as<br>visual assessment of vessels, blood<br>flow and related tissue perfusion in<br>adults and pediatric patients aged one<br>month or older, and visualization of<br>at least one of the major extra-hepatic<br>bile ducts (cystic duct, common bile<br>duct and common hepatic duct) in<br>adults and pediatric patients 12 to 17<br>years of age, using near-infrared<br>imaging. |
| Fluorescence imaging of biliary ducts with<br>the L11 LED Light Source with AIM and<br>SafeLight Cable is intended for use with<br>standard-of-care white light and, when<br>indicated, intraoperative cholangiography.<br>The devices are not intended for standalone<br>use for biliary duct visualization. | Additionally, the KARL STORZ<br>Endoscopic ICG System enables<br>surgeon to perform minimally<br>invasive cranial neurosurgery in<br>adults and pediatrics and endonasal<br>skull base surgery in adults and<br>pediatrics > 6 years of age using<br>standard endoscopic visible light as<br>well as visual assessment of vessels,<br>blood flow and related tissue<br>perfusion using near infrared<br>imaging. | Fluorescence imaging of biliary ducts<br>with the L11 LED Light Source with<br>AIM and SafeLight Cable is intended<br>for use with standard-of-care white<br>light and, when indicated,<br>intraoperative cholangiography. The<br>devices are not intended for<br>standalone use for biliary duct<br>visualization. |
| Additionally, the L11 LED Light Source<br>with AIM and SafeLight Cable enable<br>surgeons to perform minimally invasive<br>cranial neurosurgery in adults and pediatric<br>patients and endonasal skull base surgery in<br>adults and pediatric patients > 6 years of<br>age using standard endoscopic visible light<br>as well as visual assessment of vessels,<br>blood flow and related tissue perfusion<br>using near infrared imaging. | The KARL STORZ VITOM II ICG<br>System is intended for capturing and<br>viewing fluorescent images for the<br>visual assessment of blood flow, as<br>an adjunctive method for the<br>evaluation of tissue perfusion, and<br>related tissue-transfer circulation in<br>tissue and free flaps used in plastic,<br>micro- and reconstructive surgical<br>procedures. The VITOM II ICG | Upon interstitial administration of<br>SPY AGENT GREEN, the L11 LED<br>Light Source with AIM and<br>SafeLight Cable is used to perform<br>intraoperative fluorescence imaging<br>and visualization of the lymphatic<br>system, including lymphatic vessels<br>and lymph nodes.<br><br>The L11 LED Light Source is also<br>intended to transilluminate the ureter<br>during open or laparoscopic surgical |
| Upon interstitial administration of SPY<br>AGENT GREEN, the L11 LED Light<br>Source with AIM and SafeLight Cable is<br>used to perform intraoperative fluorescence<br>imaging and visualization of the lymphatic<br>system, including lymphatic vessels and<br>lymph nodes. | | |
| Subject Device | | Predicate Devices |
| AIM System<br>This Submission | Karl Storz ICG Imaging System<br>(K180146, primary) | AIM System<br>(K210088, secondary) |
| The L11 LED Light Source is also intended<br>to transilluminate the ureter during open or<br>laparoscopic surgical procedures. | magnified view of the surgical field<br>in standard white light. | |
| 1688 4K Camera System<br>The 1688 Video Camera is indicated for use<br>in general laparoscopy, nasopharyngoscopy,<br>ear endoscopy, sinuscopy, neurosurgery and<br>plastic surgery whenever a laparoscope/<br>endoscope/ arthroscope/ sinuscope is<br>indicated for use. The 1688 Video Camera<br>is indicated for adults and pediatric patients.<br>A few examples of the more common<br>endoscope surgeries are Laparoscopic<br>cholecystectomy, Laparoscopic hernia<br>repair, Laparoscopic appendectomy,<br>Laparoscopic pelvic lymph node detection,<br>Laparoscopically assisted hysterectomy,<br>Laparoscopic and thorascopic anterior<br>spinal fusion, Anterior cruciate ligament<br>reconstruction, Knee arthroscopy, Small<br>joint arthroscopy, Decompression fixation,<br>Wedge resection, Lung biopsy, Pleural<br>biopsy, Dorsal sympathectomy, Pleurodesis,<br>Internal mammary artery dissection for<br>coronary artery bypass, Coronary artery<br>bypass grafting where endoscopic<br>visualization is indicated and Examination<br>of the evacuated cardiac chamber during<br>performance of valve replacement.<br>The users of the 1688 Video Camera are<br>general and pediatric surgeons,<br>gynecologists, cardiac surgeons, thoracic<br>surgeons, plastic surgeons, orthopedic<br>surgeons, ENT surgeons, neurosurgeons<br>and urologists. | | 1688 4K Camera System<br>The 1688 Video Camera is indicated<br>for use in general laparoscopy,<br>nasopharyngoscopy, ear endoscopy,<br>sinuscopy, and plastic surgery<br>whenever a laparoscope/ endoscope/<br>arthroscope is indicated for use. The<br>1688 Video Camera is indicated for<br>adults and pediatric patients aged one<br>month or older.<br>A few examples of the more common<br>endoscope surgeries are Laparoscopic<br>cholecystectomy, Laparoscopic<br>hernia repair, Laparoscopic<br>appendectomy, Laparoscopic pelvic<br>lymph node detection,<br>Laparoscopically assisted<br>hysterectomy, Laparoscopic and<br>thorascopic anterior spinal fusion,<br>Anterior cruciate ligament<br>reconstruction, Knee arthroscopy,<br>Small joint arthroscopy,<br>Decompression fixation, Wedge<br>resection, Lung biopsy, Pleural<br>biopsy, Dorsal sympathectomy,<br>Pleurodesis, Internal mammary artery<br>dissection for coronary artery bypass,<br>Coronary artery bypass grafting<br>where endoscopic visualization is<br>indicated and Examination of the<br>evacuated cardiac chamber during<br>performance of valve replacement.<br>The users of the 1688 Video Camera<br>are general and pediatric surgeons,<br>gynecologists, cardiac surgeons,<br>thoracic surgeons, plastic surgeons,<br>orthopedic surgeons, ENT/surgeons<br>and urologists.<br>N/A |
| Precision S 4K Sinuscope<br>The Precision S 4K Sinuscope is intended<br>for use in otolaryngology and head and<br>neck procedures, including rhinology,<br>endoscopic plastic and reconstructive<br>surgery.<br>The Precision S 4K Sinuscope is also<br>intended for use in minimally invasive<br>cranial neurosurgery in adults and pediatric<br>patients and endonasal skull base surgery in<br>adults and pediatric patients > 6 years of<br>age. | | |

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# Comparison of Technological Characteristics with the Predicate Device:

| Item | | Subject Device | Predicate Device | |
|--------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------|
| | | AIM System<br>(This Submission) | Karl Storz ICG Imaging<br>System (K180146, primary) | AIM System<br>(K210088 secondary) |
| Manufacturer | | Stryker | Karl Storz | Stryker |
| Imaging Modes | | White Light<br>Near-infrared - fluorescence<br>Near-infrared - transillumination | White Light<br>Near-infrared - fluorescence | Same as subject<br>device. |
| System Components | | Camera System<br>Light Source and Light Cable<br>Endoscopes<br>IRIS Ureteral Kit<br>SPY AGENT GREEN | Camera System<br>Light Source and Light<br>Cable<br>Endoscopes | |
| Principles of Operations | | Via an optical endoscope and coupler, light is projected from a light source<br>onto one or more complementary metal oxide semiconductor image sensors<br>which acquire a continuous stream of image data. The image data is<br>processed to provide a video stream that is then sent to a display for<br>viewing. | Same as subject device | |
| Safety Standards | | IEC 60601-1<br>IEC 60601-2-18<br>IEC 60601-1-2<br>IEC 60825-1 | IEC 60601-1<br>IEC 60601-2-18<br>IEC 60601-1-2 | |
| Camera<br>System | Image<br>Processing/<br>Video Output | Digital | Same as subject device | |
| | Light Source/<br>Laser | RGB LEDs<br>Infrared Laser | Xenon Lamp | |
| | | | | |
| Light<br>Source | Infrared<br>Wavelengths | 806nm (used for NIR fluorescence)<br>830nm (used for NIR transillumination) | 690-790nm | |
| | Laser Safety<br>Classification | Class 1M | Not applicable | |
| Endoscope | Endoscope Type | Rigid rod lens | Same as subject device | Reference device |
| | Endoscope<br>Performance<br>Standards | ISO 8600-1 | Same as subject device | (K191102) is the<br>same as subject<br>device |
| | Transmission<br>Spectrum | Visible and near-infrared | Same as subject device | |
| | Outer Diameter | 3.1mm, 4.0mm | 4mm<br>5mm, 10mm | |
| | Working Length<br>(Outer<br>Diameter) | 125mm - 180mm<br>(3.1mm, 4.0mm) | 180mm (4mm OD)<br>290mm (5mm OD)<br>310mm (10mm OD) | |
| | Field of View | 80° - 105° | 80° | |
| | Depth of Field | 7mm - 35mm | 8mm - 38mm | |
| | Biocompatibility | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-11 | Same as subject device | |
| | Cleaning | Manual and Automated | Same as subject device | |
| | Sterilization | Moist Heat<br>Hydrogen Peroxide | Moist Heat | |

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### Performance Data:

Testing was completed in accordance with the following:

| Test | Method | Result |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Electrical Safety | ANSI/AAMI ES60601-1:2005 + A1:2012; | Pass |
| | IEC 60601-2-18:2009 | |
| | IEC 60601-1-6:2013 | |
| EMC Testing | IEC 60601-1-2:2014 | Pass |
| Laser Safety | IEC 60825-1:2014 | Pass |
| Biocompatibility | ISO 10993-1:2009 | Pass |
| | ISO 10993-5:2009 | |
| | ISO 10993-10:2010 | |
| | ISO 10093-11:2017 | |
| Cleaning | AAMI TIR30:2011 | Pass |
| | ISO 15883-5:2005 | |
| Sterilization | ISO 14937:2009 | Pass |
| | AAMI TIR12:2010…