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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for Stryker's AIM (Advanced Imaging Modality) System. It details the device's indications for use and a comparison to predicate and reference devices, along with performance data. However, the document does not report specific acceptance criteria for device performance or a study demonstrating the device meets those criteria from an AI/algorithm performance perspective.

The "Performance Data" section (page 9) lists several tests completed and their "Pass" results, but these relate to general medical device standards (electrical safety, EMC, laser safety, biocompatibility, cleaning, sterilization, software validation, usability, and bench performance) and animal testing for general device functionality, not specific performance metrics against acceptance criteria for an AI or advanced imaging modality's analytical accuracy or diagnostic capability.

The "Clinical Data" section states: "Published literature was provided to support a reasonable assurance of safety and effectiveness for the AIM System for use in the neurosurgery indications." This implies that existing clinical evidence, likely from non-AI-specific studies, was used to support the device's safety and effectiveness for its intended neurosurgery applications. There is no mention of a study involving AI-driven performance metrics, ground truth, or expert review for the AIM system's "Advanced Imaging Modality" in the context of diagnostic or interpretive accuracy.

Therefore, the requested information cannot be fully provided from the given text as it focuses on general device regulatory clearance rather than specific algorithm performance evaluation.

Here's a breakdown of what can be inferred or explicitly stated based on the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Category	Acceptance Criteria (Not explicitly stated for AI/algorithm performance)	Reported Device Performance (General Device Performance)
Electrical Safety	Not specified	Pass (ANSI/AAMI ES60601-1:2005 + A1:2012; IEC 60601-2-18:2009; IEC 60601-1-6:2013)
EMC Testing	Not specified	Pass (IEC 60601-1-2:2014)
Laser Safety	Not specified	Pass (IEC 60825-1:2014)
Biocompatibility	Not specified	Pass (ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010; ISO 10093-11:2017)
Cleaning	Not specified	Pass (AAMI TIR30:2011; ISO 15883-5:2005)
Sterilization	Not specified	Pass (ISO 14937:2009; AAMI TIR12:2010; AAMI TIR30:2011)
Software Validation & Verification	Not specified	Pass (IEC 62304:2006)
Usability	Not specified	Pass (IEC 62366-1:2015)
Performance – Bench	In accordance with device input specifications	Pass
Performance – Animal	In accordance with device user needs, intended uses (Comparative testing to currently legally marketed device in compliance with 21 CFR Part 58. Good Laboratory Practice)	Pass

Note: The document explicitly states "There are no new issues of safety and/or effectiveness introduced by the AIM System". This implies that the device, including its advanced imaging modality, is considered equivalent to predicate devices in its safety and effectiveness profiles, which were previously established without explicit AI performance metrics in this submission.

Missing Information (as per the request, not present in the document):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document mentions "Published literature was provided to support a reasonable assurance of safety and effectiveness," but gives no specifics on the study design or data characteristics that would be relevant for an AI/algorithm performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided. This type of information would be crucial for an AI/algorithm performance study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. The document does not describe an MRMC study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not provided. The "Advanced Imaging Modality" is part of a system used by surgeons, suggesting a human-in-the-loop context, but no standalone algorithm performance is detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
The sample size for the training set: Not provided.
How the ground truth for the training set was established: Not provided.

Conclusion based on the document:

The FDA 510(k) clearance for the Stryker AIM System is based on established general medical device safety and performance standards, and a demonstration of substantial equivalence to predicate devices for its intended uses. The document does not contain specific information regarding the performance evaluation of an AI or advanced imaging algorithm against defined acceptance criteria, ground truth, or expert review, as would typically be required for a novel AI/ML-driven diagnostic or interpretive device. The "Advanced Imaging Modality" likely refers to enhanced visualization techniques (visible and near-infrared fluorescence imaging, transillumination) rather than an AI-driven analytical tool requiring specific AI performance metrics for clearance in this submission.

Summary

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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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Page

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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:

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

Precision S 4K Sinuscope:

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 Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	Jessie DuongManager, Regulatory AffairsEmail: jessie.duong@stryker.com
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 orUsual Name	3-chip Video Camera
ClassificationName:	Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500)Endoscope, Neurological (21 C.F.R. §882.1480)
Regulatory Class:	II
Product Code:	GCJGWG
510(k) ReviewPanel:	General & Plastic SurgeryNeurology

Name of Device:	L11 LED Light Source with Advanced Imaging Modality
Common orUsual Name	Light Source, Illuminator
ClassificationName:	Confocal Optical Imaging1 (21 C.F.R. §876.1500)Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020)Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.4020)Endoscope, Neurological (21 C.F.R. §882.1480)
Regulatory Class:	II
Product Code:	OWN1FSC2FCW3GWG4
510(k) ReviewPanel:	General & Plastic Surgery1Gastroenterology/ Urology2,3Neurology4

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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)Endoscope, Neurological (21 C.F.R. §882.1480)
Regulatory Class	Class II
Product Code	EOBGWG
510(k) Review Panel:	Ear Nose & ThroatNeurology

Predicate Device(s):

Karl Storz ICG Imaging System	K180146 (primary)
AIM System: 1688 4K CameraSystem, L11 LED Light Source andSafeLight 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:

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Indications for Use:

Subject Device	Predicate Devices
AIM SystemThis Submission	Karl Storz ICG Imaging System(K180146, primary)	AIM System(K210088, secondary)
Intended Use:Endoscopic white light and near-infraredillumination and imaging during endoscopicprocedures.	Intended Use:Same as subject device	Intended Use:Same as subject device.
Indications for Use:L11 LED Light Source with AIM andSafeLight Cable	Indications for Use:Karl Storz ICG Imaging System	Indications for Use:L11 LED Light Source with AIMand SafeLight Cable
Upon intravenous administration of SPYAGENTTM GREEN (indocyanine green forinjection, USP), the L11 LED Light Sourcewith AIM and SafeLightTM Cable are usedwith SPY AGENT GREEN to provide real-time endoscopic visible and near infraredfluorescence imaging. The L11 LED LightSource with AIM and SafeLight Cableenable surgeons to perform minimallyinvasive surgery using standard endoscopicvisual light as well as visual assessment ofvessels, blood flow and related tissueperfusion in adults and pediatric patientsaged one month and older, and visualizationof at least one of the major extra-hepaticbile ducts (cystic duct, common bile ductand common hepatic duct) in adults andpediatric patients 12 to 17 years of age,using near-infrared imaging.	The KARL STORZ ICG ImagingSystem is intended to provide real-time visible (VIS) and near-infrared(NIR) fluorescence imaging.The KARL STORZ Endoscopic ICGSystem enables surgeons to performminimally invasive surgery usingstandard endoscopic visible light aswell as visual assessment of vessels,blood flow and related tissueperfusion, or at least one of the majorextra-hepatic bile ducts (cystic duct,common bile duct and commonhepatic duct), using near infraredimaging. Fluorescence imaging ofbiliary ducts with the KARL STORZEndoscopic ICG System is intendedfor use with standard of care whitelight and, when indicated,intraoperative cholangiography. Thedevice is not intended for standaloneuse for biliary duct visualization.	Upon intravenous administration ofSPY AGENTTM GREEN(indocyanine green for injection,USP), the L11 LED Light Sourcewith AIM and SafeLightTM Cable isused with SPY AGENT GREEN toprovide real-time endoscopic visibleand near infrared fluorescenceimaging. The L11 LED Light Sourcewith AIM and SafeLight Cableenable surgeons to performminimally invasive surgery usingendoscope visual light as well asvisual assessment of vessels, bloodflow and related tissue perfusion inadults and pediatric patients aged onemonth or older, and visualization ofat least one of the major extra-hepaticbile ducts (cystic duct, common bileduct and common hepatic duct) inadults and pediatric patients 12 to 17years of age, using near-infraredimaging.
Fluorescence imaging of biliary ducts withthe L11 LED Light Source with AIM andSafeLight Cable is intended for use withstandard-of-care white light and, whenindicated, intraoperative cholangiography.The devices are not intended for standaloneuse for biliary duct visualization.	Additionally, the KARL STORZEndoscopic ICG System enablessurgeon to perform minimallyinvasive cranial neurosurgery inadults and pediatrics and endonasalskull base surgery in adults andpediatrics > 6 years of age usingstandard endoscopic visible light aswell as visual assessment of vessels,blood flow and related tissueperfusion using near infraredimaging.	Fluorescence imaging of biliary ductswith the L11 LED Light Source withAIM and SafeLight Cable is intendedfor use with standard-of-care whitelight and, when indicated,intraoperative cholangiography. Thedevices are not intended forstandalone use for biliary ductvisualization.
Additionally, the L11 LED Light Sourcewith AIM and SafeLight Cable enablesurgeons to perform minimally invasivecranial neurosurgery in adults and pediatricpatients and endonasal skull base surgery inadults and pediatric patients > 6 years ofage using standard endoscopic visible lightas well as visual assessment of vessels,blood flow and related tissue perfusionusing near infrared imaging.	The KARL STORZ VITOM II ICGSystem is intended for capturing andviewing fluorescent images for thevisual assessment of blood flow, asan adjunctive method for theevaluation of tissue perfusion, andrelated tissue-transfer circulation intissue and free flaps used in plastic,micro- and reconstructive surgicalprocedures. The VITOM II ICG	Upon interstitial administration ofSPY AGENT GREEN, the L11 LEDLight Source with AIM andSafeLight Cable is used to performintraoperative fluorescence imagingand visualization of the lymphaticsystem, including lymphatic vesselsand lymph nodes.The L11 LED Light Source is alsointended to transilluminate the ureterduring open or laparoscopic surgical
Upon interstitial administration of SPYAGENT GREEN, the L11 LED LightSource with AIM and SafeLight Cable isused to perform intraoperative fluorescenceimaging and visualization of the lymphaticsystem, including lymphatic vessels andlymph nodes.
Subject Device		Predicate Devices
AIM SystemThis Submission	Karl Storz ICG Imaging System(K180146, primary)	AIM System(K210088, secondary)
The L11 LED Light Source is also intendedto transilluminate the ureter during open orlaparoscopic surgical procedures.	magnified view of the surgical fieldin standard white light.
1688 4K Camera SystemThe 1688 Video Camera is indicated for usein general laparoscopy, nasopharyngoscopy,ear endoscopy, sinuscopy, neurosurgery andplastic surgery whenever a laparoscope/endoscope/ arthroscope/ sinuscope isindicated for use. The 1688 Video Camerais indicated for adults and pediatric patients.A few examples of the more commonendoscope surgeries are Laparoscopiccholecystectomy, Laparoscopic herniarepair, Laparoscopic appendectomy,Laparoscopic pelvic lymph node detection,Laparoscopically assisted hysterectomy,Laparoscopic and thorascopic anteriorspinal fusion, Anterior cruciate ligamentreconstruction, Knee arthroscopy, Smalljoint arthroscopy, Decompression fixation,Wedge resection, Lung biopsy, Pleuralbiopsy, Dorsal sympathectomy, Pleurodesis,Internal mammary artery dissection forcoronary artery bypass, Coronary arterybypass grafting where endoscopicvisualization is indicated and Examinationof the evacuated cardiac chamber duringperformance of valve replacement.The users of the 1688 Video Camera aregeneral and pediatric surgeons,gynecologists, cardiac surgeons, thoracicsurgeons, plastic surgeons, orthopedicsurgeons, ENT surgeons, neurosurgeonsand urologists.		1688 4K Camera SystemThe 1688 Video Camera is indicatedfor use in general laparoscopy,nasopharyngoscopy, ear endoscopy,sinuscopy, and plastic surgerywhenever a laparoscope/ endoscope/arthroscope is indicated for use. The1688 Video Camera is indicated foradults and pediatric patients aged onemonth or older.A few examples of the more commonendoscope surgeries are Laparoscopiccholecystectomy, Laparoscopichernia repair, Laparoscopicappendectomy, Laparoscopic pelviclymph node detection,Laparoscopically assistedhysterectomy, Laparoscopic andthorascopic anterior spinal fusion,Anterior cruciate ligamentreconstruction, Knee arthroscopy,Small joint arthroscopy,Decompression fixation, Wedgeresection, Lung biopsy, Pleuralbiopsy, Dorsal sympathectomy,Pleurodesis, Internal mammary arterydissection for coronary artery bypass,Coronary artery bypass graftingwhere endoscopic visualization isindicated and Examination of theevacuated cardiac chamber duringperformance of valve replacement.The users of the 1688 Video Cameraare general and pediatric surgeons,gynecologists, cardiac surgeons,thoracic surgeons, plastic surgeons,orthopedic surgeons, ENT/surgeonsand urologists.N/A
Precision S 4K SinuscopeThe Precision S 4K Sinuscope is intendedfor use in otolaryngology and head andneck procedures, including rhinology,endoscopic plastic and reconstructivesurgery.The Precision S 4K Sinuscope is alsointended for use in minimally invasivecranial neurosurgery in adults and pediatricpatients and endonasal skull base surgery inadults and pediatric patients > 6 years ofage.

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Comparison of Technological Characteristics with the Predicate Device:

Item		Subject Device	Predicate Device
		AIM System(This Submission)	Karl Storz ICG ImagingSystem (K180146, primary)	AIM System(K210088 secondary)
Manufacturer		Stryker	Karl Storz	Stryker
Imaging Modes		White LightNear-infrared - fluorescenceNear-infrared - transillumination	White LightNear-infrared - fluorescence	Same as subjectdevice.
System Components		Camera SystemLight Source and Light CableEndoscopesIRIS Ureteral KitSPY AGENT GREEN	Camera SystemLight Source and LightCableEndoscopes
Principles of Operations		Via an optical endoscope and coupler, light is projected from a light sourceonto one or more complementary metal oxide semiconductor image sensorswhich acquire a continuous stream of image data. The image data isprocessed to provide a video stream that is then sent to a display forviewing.	Same as subject device
Safety Standards		IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60825-1	IEC 60601-1IEC 60601-2-18IEC 60601-1-2
CameraSystem	ImageProcessing/Video Output	Digital	Same as subject device
	Light Source/Laser	RGB LEDsInfrared Laser	Xenon Lamp

LightSource	InfraredWavelengths	806nm (used for NIR fluorescence)830nm (used for NIR transillumination)	690-790nm
	Laser SafetyClassification	Class 1M	Not applicable
Endoscope	Endoscope Type	Rigid rod lens	Same as subject device	Reference device
	EndoscopePerformanceStandards	ISO 8600-1	Same as subject device	(K191102) is thesame as subjectdevice
	TransmissionSpectrum	Visible and near-infrared	Same as subject device
	Outer Diameter	3.1mm, 4.0mm	4mm5mm, 10mm
	Working Length(OuterDiameter)	125mm - 180mm(3.1mm, 4.0mm)	180mm (4mm OD)290mm (5mm OD)310mm (10mm OD)
	Field of View	80° - 105°	80°
	Depth of Field	7mm - 35mm	8mm - 38mm
	Biocompatibility	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-11	Same as subject device
	Cleaning	Manual and Automated	Same as subject device
	Sterilization	Moist HeatHydrogen 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
	AAMI TIR30:2011
Software Validation &Verification	IEC 62304:2006	Pass

Usability	IEC 62366-1:2015	Pass
Performance – Bench	In accordance with device input specifications	Pass
Performance - Animal	In accordance with device user needs, intended usesComparative testing to currently legally marketed device incompliance with 21 CFR Part 58. Good Laboratory Practice	Pass

Clinical Data:

Published literature was provided to support a reasonable assurance of safety and effectiveness for the AIM System for use in the neurosurgery indications.

Conclusions:

The AIM System is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. There are no new issues of safety and/or effectiveness introduced by the AIM System for 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.

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).