Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 and common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the AIM Light Source 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.

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

Device Description

The Stryker AIM LED Light Source (L10 & L11) is part of the Stryker Infrared Fluorescence (IRF) Imaging System, which is an endoscopic illumination and imaging system for real-time high definition (HD) visible light and near-infrared fluorescence imaging of indocyanine green (ICG) during minimally invasive surgery.

The Stryker Infrared Fluorescence Imaging System consists of the following main components:

. A light source console and a light cable for outputting light within a visible light spectrum as well as near-infrared light spectrum;
. A camera control unit for processing near-infrared and visible light images, and a coupler that is attached to the laparoscope and camera head (cleared separately);
A laparoscope for visible light and near-infrared light illumination and imaging ● (cleared separately)
An imaging agent kit containing ICG ●

The Stryker AIM LED Light Source uses an illuminator with a laser light source to illuminate the area of surgery. The device is used in conjunction with ICG to achieve its intended use in fluorescence angiography. The ICG is administered intravenously prior to image obtainment. A laser light is illuminated to the site of the surgery using a laparoscope. Absorption of laser light causes excitation of the ICG in the vessels resulting in emission of infrared light at a different wavelength. The camera system captures the infrared emission, processes the image and displays it on a surgical monitor.

AI/ML Overview

This document describes a 510(k) premarket notification for the Stryker L10 and L11 LED Light Source with AIM (Advanced Imaging Modality). This notification primarily concerns a labeling modification allowing the use of the device with Stryker's SPY AGENT™ GREEN (Indocyanine green for injection, USP). As such, the study described focuses on demonstrating compatibility rather than proving a new performance characteristic of the device itself.

Therefore, the information typically requested regarding acceptance criteria for an AI/ML device, such as specific performance metrics, sample sizes for test/training sets, expert consensus, and MRMC studies, is not applicable to this submission. This is because the device being approved is a medical light source, not an AI/ML diagnostic or assistive device. The submission primarily relies on demonstrating substantial equivalence to previously cleared predicate devices and compatibility with a specific imaging agent.

However, I can extract the relevant information about the "study" that was conducted to support the labeling modification:

1. A table of acceptance criteria and the reported device performance:

Since this is not an AI/ML device, there are no acceptance criteria related to algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" here implicitly refer to the demonstration of visual equivalence/compatibility.

Acceptance Criterion (Implicit)	Reported Device Performance
Visual equivalence of fluorescence with Stryker's SPY AGENT™ GREEN compared to a commercially available ICG imaging agent.	"Results from the imaging studies demonstrated that there was no visible difference observed in fluorescence between Stryker's SPY AGENT™ GREEN and another commercially available ICG imaging agent." This indicates that the device produces visually equivalent fluorescence imaging results with both ICG agents, implying compatibility and therefore meeting the implicit acceptance criterion for the labeling change.

Acceptance Criterion (Implicit)

Reported Device Performance

Visual equivalence of fluorescence with Stryker's SPY AGENT™ GREEN compared to a commercially available ICG imaging agent.

"Results from the imaging studies demonstrated that there was no visible difference observed in fluorescence between Stryker's SPY AGENT™ GREEN and another commercially available ICG imaging agent." This indicates that the device produces visually equivalent fluorescence imaging results with both ICG agents, implying compatibility and therefore meeting the implicit acceptance criterion for the labeling change.

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

Sample size: Not specified. The document refers to "imaging studies" but does not quantify the number of images, cases, or subjects.
Data provenance: Not specified, but given the nature of the device and testing, it would likely be laboratory-based bench testing rather than real-world clinical data. It is not indicated if it was retrospective or prospective.

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

Not applicable as this was a visual comparison study to demonstrate compatibility, not a diagnostic accuracy study requiring expert-established ground truth. The assessment was based on "visible difference," likely by qualified personnel involved in the bench testing.

4. Adjudication method for the test set:

Not applicable.

5. 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 applicable. This is not an AI-assisted device.

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

Not applicable. This is a medical device (light source), not an algorithm.

7. The type of ground truth used:

Implicitly, the "ground truth" was the expected fluorescence visualization when using a known, commercially available ICG imaging agent, against which the performance with SPY AGENT™ GREEN was compared. This is a technical (bench) demonstration of compatibility, not a clinical ground truth like pathology or outcome data.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable.

In summary, the provided document details a 510(k) submission for a medical light source that aims to modify its labeling to include compatibility with a new imaging agent. The "study" referenced is a bench test demonstrating visual equivalence of fluorescence with the new agent compared to an existing one. It is crucial to understand that the detailed criteria typically applied to AI/ML device approvals are not relevant here.

Summary

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Stryker Agatha Szeliga Regulatory Affairs Manager 5900 Optical Court San Jose, California 95138

May 10, 2019

Re: K191046

Trade/Device Name: L10 LED Light Source with AIM, L11 LED Light Source with AIM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN, FCS, FCW Dated: April 19, 2019 Received: April 19, 2019

Dear Agatha Szeliga:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Stevenson, For Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191046

Device Name

Stryker L10 and L11 LED Light Source with AIM (Advanced Imaging Modality)

Indications for Use (Describe)

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

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

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)

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This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.

Submitter:

Applicant	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person	Agatha SzeligaRegulatory Affairs ManagerTel: 604-422-7516Fax: 604-232-9841E-mail: agatha.szeliga@stryker.com
Date Prepared	April 19, 2019

Subject Device:

Name of Device	Stryker L10 and L11 LED Light Source with AIM (Advanced Imaging Modality)
Common or Usual Name	Light Source, Illuminator
Classification Name	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. §876.1500)
Regulatory Class	II
Product Code	OWN1
	FCS2
	FCW3
510(k) Review Panel	General & Plastic Surgery1
	Gastroenterolgoy/ Urology2,3

1When used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging 2When used to trans-illuminate the ureter during open or laparoscopic surgical procedures 3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging

Predicate Device(s):

Stryker AIM Light Source and SafeLight Cable	K173866
L11 LED Light Source with AIM	K182160

Note: The predicate devices have not been subject to a design-related recall.

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Device Description:

The Stryker Infrared Fluorescence Imaging System consists of the following main components:

. A light source console and a light cable for outputting light within a visible light spectrum as well as near-infrared light spectrum;
. A camera control unit for processing near-infrared and visible light images, and a coupler that is attached to the laparoscope and camera head (cleared separately);
A laparoscope for visible light and near-infrared light illumination and imaging ● (cleared separately)
An imaging agent kit containing ICG ●

Indications for Use:

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

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Feature	Subject Device	Predicate Device	Predicate Device
	Stryker L10 and L11 LEDLight Source with AIM	Stryker AIM LightSource and SafeLightCable	L11 LED Light Sourcewith AdvancedImaging Modality(AIM)
Manufacturer	Stryker Endoscopy	Same as subject device	Same as subject device
SubmissionReference	Current Submission	K173866	K182160
Intended Use	Endoscopic visible and near-infrared imaging duringsurgical procedures	Same as subject device	Same as subject device
Indicationsfor Use	See NOTE 1	See NOTE 2	See NOTE 3
ImagingModes	White LightNear-infrared - FluorescenceNear-infrared -Transillumination	Same as subject device	Same as subject device
SafetyStandards	IEC 60601-1IEC 60601-1-2IEC 60825-1IEC 60601-2-18	Same as subject device	Same as subject device
Components	Light Source and SafeLightCable	Light Source andSafeLight Cable	Light Source andSafeLight Cable
	SPY AGENT™ GREEN Kit	ICG Imaging Agent Kits	ICG Imaging Agent Kits
Principle ofOperation	An electronic driver controlsRed/Green/Blue LEDs and anear-infrared laser diodewhich are combined throughdichroic mirrors andprojected onto an output lightcollimator. A fiber outputbundle can be inserted intothe light source to couplelight to the distal end and intoan endoscope.	Same as subject device	Same as subject device
Light Source/Laser	RGB LEDsInfrared laser	Same as subject device	Same as subject device
Single Use orReusable	Reusable	Same as subject device	Same as subject device
ContrastImagingAgent	SPY AGENT™ GREEN(Indocyanine green forinjection, USP)	Indocyanine green (ICG)	Indocyanine green(ICG)

Comparison of Technological Characteristics with the Predicate Device:

NOTE 1: Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment

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of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging.

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

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

NOTE 2: The Stryker® AIM Light Source and SafeLight Cable are indicated for use to provide realtime endoscopic visible and near-infrared fluorescence imaging. The Stryker® AIM Light Source and SafeLight Cable enable 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 duct, common bile duct and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the Stryker® AIM Light Source and SafeLight Cable are 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.

NOTE 3: The L11 AIM Light Source and SafeLight™ Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and Safe Light Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the L1 1 AIM Light Source 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. The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Performance Testing:

The labeling modification proposed within this 510(k) submission for the Stryker L10 and L11 LED Light Source with AIM does not have an impact on the performance characteristics of the devices that were cleared in the previous submissions.

Bench testing was performed to demonstrate compatibility of the Stryker L10 and L11 LED Light Source with AIM with Stryker's SPY AGENT™ GREEN (Indocyanine green for Injection, USP). Results from the imaging studies demonstrated that there was no visible difference observed in fluorescence between Stryker's SPY AGENT™ GREEN and another commercially available ICG imaging agent.

Conclusions:

The information presented within this Special 510(k) premarket notification demonstrates that the Stryker L10 and L11 LED Light Source with AIM is substantially equivalent in design, intended use, principle of operation, technological characteristics and safety features to the predicate devices. There are no new issues of safety and/or effectiveness introduced as a result of the labeling modification proposing the use of the Stryker L10 and L11 Light Source with AIM in conjunction with SPY AGENT™ GREEN imaging agent. It has been demonstrated that the Stryker L10 and L11 LED Light Source with AIM is compatible for use in fluorescence angiography with Stryker's SPY AGENT™ GREEN imaging agent.

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.

Indications for Use

Indications for Use (Describe)

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Submitter:

Subject Device:

Predicate Device(s):

Device Description:

Indications for Use:

Comparison of Technological Characteristics with the Predicate Device:

Performance Testing:

Conclusions:

§ 876.1500 Endoscope and accessories.

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