The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.

A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, 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, 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 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT/heurosurgeons and urologists.

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as 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 pediatric patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the L12 LED Light Source with Advanced Imaging Modality 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 L12 LED Light Source with Advanced Imaging Modality 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 L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Device Description

Stryker's Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light, near-infrared illumination and transillumination, and cyan spectral imaging system. Near-infrared illumination is used for fluorescence imaging using SPY AGENT™ GREEN (indocyanine green for injection, USP) or CYTALUX™ (pafalocianine) injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. Cyan Spectral Imaging is intended as an alternative mode of visualization that uses narrow bands for illumination during endoscopic surgery to provide greater visualization of surface structures and fine capillary patterns of the mucosal membrane.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Stryker 1788 4K Camera System with Advanced Imaging Modality and L12 LED Light Source with AIM:

A table of acceptance criteria and the reported device performance cannot be fully constructed from the provided document. The document primarily lists regulatory standards and general performance categories, indicating that the device "passed" these tests. It does not provide specific quantitative acceptance criteria or detailed reported performance values for each criterion.

However, based on the Performance Data section (page 9), we can infer the types of tests conducted and their general outcome:

Inferred Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Specific Standard/Test (if mentioned)
Safety Testing
Electromagnetic Compatibility	Pass	IEC 60601-1-2:2014, IEC 60601-4-2:2016
Electrical Safety	Pass	ANSI AAMI ES 60601-1:2005 + A1:2012 + A2:2021, IEC 60601-1-6:2010 + A1:2013 + A2:2020, IEC 60601-2-18:2009
Laser Safety	Pass	IEC 60825-1:2014, IEC 62471 / Comparative testing to legally marketed predicate device
System Functionality
Sterilization	Pass	ISO 17664-1:2021, ISO 17664-2:2021, ISO 14937:2009, AAMI TIR12:2020, AAMI TIR30:2011, AAMI ST58:2013/(R)2018
Software Verification & Validation	Pass	IEC 62304:2015
Usability	Pass	IEC 62366:2015 + A1:2020
Imaging Performance
Bench Performance Testing	Pass (against device input specifications and predicate devices)	Spatial Uniformity, Minimum Detectable Fluorescence, Fluorescence Detection Depth, Clinically Meaningful Limits of Detection, Signal to Noise, Photobiological Safety (IEC 62417), Contrast
General Performance Testing	Pass (against user needs and intended uses)	(Not specified beyond general `user needs and intended uses`)

Here's the requested information based on the provided document:

A table of acceptance criteria and the reported device performance
- (See table above)
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document states: "NOTE: The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence." This implies that no clinical test set (patient data) was used in the assessment for substantial equivalence. The testing described appears to be primarily bench and laboratory-based. Therefore, sample size and data provenance in the context of clinical data are not applicable based on this document.
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)
- Since no clinical studies were performed, there's no mention of experts establishing ground truth for a clinical test set. The "Pass" results are based on compliance with engineering standards and comparisons to predicate devices in bench testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set demanding adjudication was used.
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
- No MRMC comparative effectiveness study was done. The document explicitly states: "The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence." There is also no mention of AI assistance in the context of human readers for this device. The "Advanced Imaging Modality" refers to specialized illumination and visualization techniques, not AI-powered image analysis for diagnosis.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an imaging system (camera and light source) that provides visual information to a surgeon. It is not an AI algorithm that operates standalone without human interpretation or intervention for diagnostic or therapeutic decisions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance testing, the implied "ground truth" or reference was primarily device input specifications and the performance of currently legally marketed predicate devices. For regulatory compliance, the ground truth was adherence to FDA-recognized voluntary consensus standards (e.g., IEC standards for electrical safety, usability, software, etc.).
The sample size for the training set
- Not applicable. This document describes a medical imaging hardware system, not a machine learning model that requires a training set.
How the ground truth for the training set was established
- Not applicable. As there is no machine learning component requiring a training set, the establishment of ground truth for such a set is not mentioned.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, the FDA logo is displayed in blue, with the acronym "FDA" stacked above the words "U.S. FOOD & DRUG ADMINISTRATION."

September 20, 2023

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

Re: K231854

Trade/Device Name: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, GWG, NWB, OWN, FCS, FCW Dated: June 23, 2023 Received: June 23, 2023

Dear April Malmborg:

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/cfpm/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.

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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 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,

Tanisha L. Tanisha L. Hithe -S 2023.09.20 Hithe -S 09:19:05 -04'00'

Tanisha Hithe, MS, MHS 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

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Indications for Use

510(k) Number (if known)

K231854

Device Name

1788 4K Camera System with Advanced Imaging Modality

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Indications for Use

510(k) Number (if known)

K231854

Device Name

L12 LED Light Source with Advanced Imaging Modality

Indications for Use (Describe)

The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

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.

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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).

510(k) Number :

Submitter:

Applicant:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	April MalmborgSenior Director, Regulatory AffairsEmail: april.malmborg@stryker.comPh: (408) 754-2472
Date Prepared:	June 23, 2023

Subject Device:

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

Name of Device:	1788 4K Camera System with Advanced Imaging Modality
Common or Usual Name	3-chip Video Camera
Classification Name:	Endoscope and Accessories (21 C.F.R. §876.1500)Neurological Endoscope (21 C.F.R. §882.1480)
Regulatory Class:	II
Product Code:	GCJGWGNWB
510(k) Review Panel:	General & Plastic SurgeryNeurologyGastroenterology/ Urology

Name of Device:	L12 LED Light Source with AIM
Common or Usual Name	Light Source, Illuminator
Classification Name:	Endoscope and Accessories (21 C.F.R. §876.1500)
	Fiberoptic light ureteral catheter (21 C.F.R. §876.4020)
	Neurological Endoscope (21 C.F.R. §882.1480)
Regulatory Class:	II
Product Code:	OWN
	FCS
	FCW
	GWG
	NWB
510(k) Review Panel:	General & Plastic Surgery
	Gastroenterology/ Urology
	Neurology

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Predicate Device(s):

Advanced ImagingModality (AIM) System	1788 4K Camera SystemL12 LED Light Source	K230605 (primary)K230754 (primary)
Olympus VISERA ELITE Video System Center andXenon Light Source		K111425 (secondary)
PINPOINT Endoscopic Fluorescence Imaging System		K182606 (secondary)

Device Description:

Indications for Use:

1788 4K Camera System with Advanced Imaging Modality:

The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ sinuscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in 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, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, 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 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT/neurosurgeons and urologists.

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L12 LED Light Source with Advanced Imaging Modality:

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as 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 ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

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Comparison of Technological Characteristics with the Predicate Device:

Item		Subject Device	Predicate Devices
			Primary	Secondary	Secondary
		Advanced ImagingModality (AIM) System	PrimaryAdvanced ImagingModality (AIM) System	VISERA ELITE	PINPOINT System
Manufacturer		Stryker	Same as subject device	Olympus MedicalSystemCorporationK111425	Same as subjectdevice
Submission Reference(s)		Current Submission	K230605; K230754	K111425	K182606
Intended Use		Endoscopic illuminationand imaging duringendoscopic procedures	Same as subject device	Same as subjectdevice	Same as subjectdevice
Indications for Use		NOTE 1	Same as subject device	NOTE 2	NOTE 3
System Components		Camera System (subjectof submission)Light Source (subject ofsubmission) and SafeLightCableEndoscopesIRIS Ureteral KitImaging Agents	Same as subject device	Video CenterXenon LightSourceVideoscope	Video Processor/IlluminatorCamera HeadLight Guide CableLaparoscopesImaging Agent
Imaging Agents		SPY AGENT GREENPafolacianine	Same as subject device	Not applicable.	SPY AGENTGREEN
Principles of Operation		Via an endoscope, light isprojected by a light sourceonto one or more imagesensor(s) which acquire acontinuous stream ofimage data. The imagedata is processed toprovide a video streamthat is then sent to adisplay for viewing.	Same as subject device	Same as subjectdevice	Same as subjectdevice
Safety Standards		IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60601-4-2IEC 60825-1IEC 62471	IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60601-4-2IEC 60825-1	IEC 60601-1IEC 60601-2-18IEC 60601-2IEC 62471	IEC 60601-1IEC 60601-2-18IEC 60601-2IEC 60825-1
ImagingModes	White Light	White Light	Same as subject device	Same as subjectdevice	Same as subjectdevice
	NIRFluorescence	ENVContrastOverlay- without IRIS- with IRISColor SegmentedFluorescence- without IRIS- with IRIS	ENVContrastOverlay- without IRIS- with IRIS	Not applicable.	ContrastOverlayColor SegmentedFluorescence
	NIR Trans-illumination	IRIS	Same as subject device.	Not applicable.	Not applicable.
	Cyan SpectralImaging(CSI)	Cyan Spectral Imaging(CSI)	Not Applicable.	Narrow BandImaging	Not applicable.
CameraSystem	Image Sensor	CMOS image sensor	Same as subject device.	CCD imagesensor	Same as subjectdevice.
Item		Subject Device	Predicate Devices
		Advanced ImagingModality (AIM) System	PrimaryAdvanced ImagingModality (AIM) System	SecondaryVISERA ELITE	SecondaryPINPOINT System
	Image Processing/Video Output	Digital	Same as subject device.	Same as subject device.	Same as subject device.
	Resolution	4K (up to 3840 x 2160)Up to 1920 x 1080	Same as subject device.	Up to 1920 x 1080	Up to 1920 x 1080
	Frame Rate	60 frames per second	Same as subject device.	Same as subject device.	Same as subject device.
LightSource	Light Source/Laser	RGB LEDs/Infrared Laser	Same as subject device.	Xenon	Same as subject device.
	ExcitationWavelength	780 nm (used for NIRfluorescence)830 nm (used for NIRtransillumination)	Same as subject device.	Not applicable.	806 nm (used forNIR fluorescence)
	Laser SafetyClassification	Class 1M	Same as subject device.	Not applicable.	Class 3R

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NOTE 1: The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectorny, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectorny, 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 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT/neurosurgeons and urologists.

Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP), the L12 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatic patients 12 to 17 years of age, using nearinfrared imaging. Fluorescence imaging of biliary ducts with the L12 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 L12 Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediative 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. Upon interstitial administration of SPY AGENT GREEN, the L12 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. Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source and SafeLight™ Cable is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The L12 Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

NOTE 2: The video system center has been designed to be used with Olympus cameras heads, endoscopes, light source and monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. The light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

NOTE 3: Upon intravenous administration of SPY AGENT™ GREEN, the PINPOINT Endoscopic Fluorescence Imaging System is used with SPY AGENT GREEN to perform intraoperative fluorescence anglography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when intraoperative cholangiography. The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual 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 or common hepatic duct), using near infrared imaging of billary ducts with the

{9}------------------------------------------------

PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for bilization. Upon interstitial administration of SPY AGENT GREEN, the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Performance Data:

Test	Method	Result
ElectromagneticCompatibility	In accordance with FDA-recognized voluntary consensus standardIEC 60601-1-2:2014 (19-8)In accordance with FDA-recognized voluntary consensus standardIEC 60601-4-2:2016 (19-19)	PassPass
Electrical Safety	In accordance with FDA-recognized voluntary consensus standardANSI AAMI ES 60601-1:2005 + A1:2012 + A2: 2021 (19-46)In accordance with FDA-recognized voluntary consensus standardIEC 60601-1-6:2010 + A1:2013 + A2:2020 (5-132)In accordance with FDA-recognized voluntary consensus standardIEC 60601-2-18:2009 (9-114)	PassPassPass
Laser Safety	In accordance with FDA-recognized voluntary consensus standardIEC 60825-1:2014 (12-273)In accordance with FDA-recognized voluntary consensus standardIEC 62471 (12-249); and,Comparative testing to legally marketed predicate device	PassPass
Sterilization	In accordance with FDA-recognized voluntary consensus standardISO 17664-1:2021 (14-578)In accordance with FDA-recognized voluntary consensus standardISO 17664-2:2021 (14-579)In accordance with FDA-recognized voluntary consensus standardISO 14937:2009 (14-337)In accordance with AAMI TIR12:2020In accordance with AAMI TIR30:2011In accordance with FDA-recognized voluntary consensus standardAAMI ST58:2013/ (R)2018 (14-432)	PassPassPassPassPassPass
Software Verificationand Validation	In accordance with FDA-recognized voluntary consensus standardIEC 62304:2015 (13-79)	Pass
Usability	In accordance with FDA-recognized voluntary consensus standardIEC 62366:2015 + A1:2020 (5-129)	Pass
Performance Testing -Bench	In accordance with device input specificationsComparative testing to currently legally marketed predicate devices:Spatial UniformityMinimum Detectable FluorescenceFluorescence Detection DepthClinically Meaningful Limits of DetectionSignal to NoisePhotobiological Safety (IEC 62417)Contrast	PassPass
Performance Testing	In accordance with user needs and intended uses	Pass

NOTE: The Advanced Imaging Modality (AIM) System is not patient contacting; therefore, biocompatibility testing was not required to support the determination of substantial equivalence.

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NOTE: The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence.

Conclusions:

The Advanced Imaging Modality (AIM) System is the same or similar in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the Advanced Imaging Modality (AIM) System is the same or similar with respect to safety and effectiveness to the legally marketed predicate devices.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.