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 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 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 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 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 L12 LED Light Source with AIM 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 AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

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

Device Description

The L12 LED Light Source with AIM is part of the Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine 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. The L12 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.

AI/ML Overview

This document describes the Stryker L12 LED Light Source with AIM, which is an endoscopic imaging system used to provide real-time visible and near-infrared fluorescence imaging during various surgical procedures. The device received 510(k) clearance (K230754) based on substantial equivalence to predicate devices, primarily the 780 nm L11 LED Light Source with AIM (K221611).

The provided text does not contain details about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-enabled devices involving diagnostic accuracy or similar performance metrics. This is because the L12 LED Light Source with AIM is a hardware component (a light source) that enables certain imaging modalities, rather than a diagnostic algorithm itself. As such, its performance evaluation focuses on functional aspects and safety rather than diagnostic accuracy or human reader improvement.

Here's an analysis based on the information provided, specifically highlighting why certain requested sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are fundamental engineering and safety standards, and the reported performance is a simple "PASS" for these tests. There are no specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) provided as would be expected for an AI/ML-driven diagnostic device.

Acceptance Criteria Category	Specific Test/Criterion	Reported Device Performance
Software Performance	Light Source Software Functional Test	PASS
	Light Source Communication	PASS
Bench Performance	Light Source Light Output	PASS
	Light Source Power Draw	PASS
	Light Source Cable Compatibility	PASS
	Light Source Timing	PASS
Safety Standards Adherence	IEC 60601-1	Adheres
	IEC 60601-2-18	Adheres
	IEC 60601-1-2	Adheres
	IEC 60601-1-6	Adheres
	IEC 60825-1	Adheres

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

Not applicable. The device is a hardware component (light source). Performance testing was conducted in a bench setting on the device itself, not on a dataset of patient images or patient data.

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

Not applicable. This information is relevant for studies evaluating human perceptual or cognitive performance, typically in conjunction with AI/ML algorithms. The provided document describes safety and functional testing for a light source.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used to establish ground truth in image datasets, often by resolving discrepancies among expert readers. This device underwent bench and software functional testing.

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 device is not an AI/ML algorithm designed to assist human readers in image interpretation. It is a light source that enables certain imaging modalities. The document explicitly states: "The L12 LED Light Source does not require clinical studies to support the determination of substantial equivalence."

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

Not applicable. This is a hardware component, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense for AI/ML evaluation. The "ground truth" for the tests performed was defined by engineering specifications and expected functional outputs of the light source (e.g., specific light output, proper communication, correct timing).

8. The sample size for the training set

Not applicable. This device does not use a training set as it's not an AI/ML algorithm.

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

Not applicable. As above, there is no training set for this device.

Summary

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April 11, 2023

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

Re: K230754

Trade/Device Name: L12 LED Light Source with AIM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN, FCS, GWG, FCW Dated: March 17, 2023 Received: March 17, 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/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

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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 (OS) 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 mediation-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,

Jessica Carr -S

Jessica Carr, Ph.D. Acting 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) K230754

Device Name L12 LED Light Source with AIM

Indications for Use (Describe)

The L12 LED Light Source with AIM 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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stryker

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 : K230754

Submitter:

Applicant:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	April MalmborgSenior Director Regulatory AffairsEmail: april.malmborg@stryker.com
Date Prepared:	April 3, 2023

Subject Device:

Name of Device:	L12 LED Light Source with AIM
Common orUsual Name	Light Source, Illuminator
ClassificationName:	Endoscope and Accessories1,3 (21 C.F.R. §876.1500)Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020)Endoscope, Neurological4 (21 C.F.R. §882.1480)
Regulatory Class:	II
Product Code:	OWN1FCS2FCW3GWG4
510(k) ReviewPanel:	General & Plastic Surgery1Gastroenterology/ Urology2,3Neurology4

'When 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.

4When used to provide standard endoscopic visible light and near-infrared imaging during minimally invasive cranial neurosurgery and endonasal skull base surgery.

Predicate Device(s):

780 nm L11 LED Light Source with AIM (Stryker Endoscopy)	K221611*
	K214046

*primary predicate

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strvk

Device Description:

Indications for Use:

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 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 nearinfrared imaging.

Fluorescence imaging of biliary ducts with the L12 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.

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

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stryker

Comparison of Technological Characteristics with the Predicate Device:

Item	Subject DeviceL12 LED Light Source with AIM	Predicate Device780 nm L11 LED Light Sourcewith AIM
Manufacturer	Stryker	Same as subject device.
Submission Reference	Current submission	K221611, K214046
Intended Use	Endoscopic white light and near-infrared illumination and imaging during endoscopic procedures.	Same as subject device
Indications for Use	NOTE 1	Same as subject device
ImagingModes	White LightManualAutolight	Same as subject device
	Near-infrared FluorescenceENVContrastOverlay- Without IRIS- With IRIS	ENVContrastOverlay- Without IRIS
	Near-infrared transilluminationIRIS	Same as subject device
	Imaging AgentsSPY AGENTTM GREEN(indocyanine green for injection, USP)pafolacianine	Same as subject device
	Principles of OperationVia an optical light guide, endoscope and coupler, light is projected from a light source and either reflected or absorbed and fluoresced onto one or more complementary metal oxide semiconductor image sensors which acquire a continuous stream of image data. The image data is processed to provide a video stream that is then sent to a display for viewing.	Same as subject device.
System Components	Light Source (subject of this submission)SafeLight CableCamera SystemLaparoscopesIRIS Ureteral KitNOTE: This represents the components of the AIM System.	Same as subject device.
Safety Standards	IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60601-1-6IEC 60825-1	Same as subject device.
Laser Safety Classification	Class 1M	Same as subject device.
Light Source/Laser	RGB LEDs/Infrared Laser	Same as subject device.
Excitation Wavelength(s)	Near-infrared fluorescence: 780 nmNear-infrared transillumination: 830	Same as subject device.

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NOTE 1: 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 at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatic patients 12 to 17 years of age, using near-infrared 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 bilization. Additionally, the L12 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 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.

Test	Method	Result
Software	Light Source Software Functional Test	PASS
	Light Source Communication	PASS
Performance Testing - Bench	Light Source Light Output	PASS
	Light Source Power Draw	PASS
	Light Source Cable Compatibility	PASS
	Light Source Timing	PASS

Performance Data:

NOTE: The L12 LED Light Source with AIM is not patient contacting; therefore, biocompatibility testing was not required to support the determination of substantial equivalence.

NOTE: The L12 LED Light Source does not require clinical studies to support the determination of substantial equivalence.

Conclusions:

The L12 LED Light Source with AIM is the same or similar in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the L12 LED Light Source with AIM 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.