The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, 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, 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 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

L11 LED Light Source with Advanced Imaging Modality:

Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used 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.

Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

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

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. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible as well as near-infrared spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT™ GREEN (indocyanine green for injection, USP) used for fluorescence imaging.

The modified AIM System (subject device) and predicate device are the same, with the exception of the 1688 4K Pendulum Camera Head and the optional Defog feature. The 1688 4K Pendulum Camera Head was cleared under K200310 and works as intended with the L11 LED Light Source that was cleared under K182160, K191046 and K192292. The optional Defog feature reduces the likelihood of fogged images common to irrigated surgical procedures.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically found in a clinical study report for an AI/ML medical device. This document is an FDA 510(k) clearance letter and its associated summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance data for a novel algorithm's clinical efficacy.

The document discusses general "Performance Data" and "Image Quality Assessments" but states these were provided to demonstrate that the optional Defog feature works as intended and does not require clinical studies to support the determination of substantial equivalence. This implies that the performance evaluation was primarily technical and verification-based, not a multi-reader, multi-case clinical study to assess diagnostic accuracy or improvement in human performance.

Therefore, I cannot extract the level of detail requested for the acceptance criteria and the study that proves the device meets them (e.g., number of experts, adjudication method, effect size of human improvement with AI, ground truth specifics, training set size) because this information is not present in the provided 510(k) summary.

The only "acceptance criteria" explicitly mentioned are found under "Performance Data," suggesting successful completion of standard technical and quality assessments.

Here's what can be inferred from the text regarding acceptance criteria and performance, although it's very high-level:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Laser Output (Technical Performance)	Pass
System Temperature Verification	Pass
Image Quality Assessments	Pass (for the optional Defog feature)
Software Verification (IEC 62304:2015 compliant)	Pass

2. Sample size used for the test set and the data provenance: Not specified. The document indicates these were "performance data" and "image quality assessments" for the "optional Defog feature," suggesting a technical evaluation rather than a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. The nature of the evaluations (technical testing of a "Defog feature" and image quality) does not typically involve expert clinical ground truth establishment in the way an AI diagnostic algorithm would.
4. Adjudication method for the test set: Not specified.
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: No, the document explicitly states, "The AIM (Advanced Imaging Modality) System does not require clinical studies to support the determination of substantial equivalence." This type of MRMC study is not mentioned or implied. The device's primary function is as an imaging system, not an AI-driven diagnostic aid that would directly impact human reader performance in interpreting images. The AI element, if any, is more integrated into image enhancement (like the Defog feature) rather than a separate diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned as a distinct performance metric for a standalone AI algorithm. The "Performance Data" section lists technical tests. While the "Defog feature" is an algorithm, its performance seems to have been assessed technically (image quality) rather than as a standalone diagnostic tool.
7. The type of ground truth used: For the "Performance Testing" and "Software Verification," the ground truth would be based on engineering specifications, regulatory standards (like IEC 62304), and visual assessment for "Image Quality Assessments." For a "Defog feature," "ground truth" might refer to known conditions of fogging in test environments and the system's ability to mitigate them visually. It is not clinical ground truth established by expert consensus, pathology, or outcomes data.
8. The sample size for the training set: Not applicable and not specified. The document does not describe the development or training of a machine learning model in the context of a dataset for diagnostic performance.
9. How the ground truth for the training set was established: Not applicable and not specified.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Stryker Divya Sekar Staff Regulatory Affairs Specialist 5900 Optical Ct. San Jose. California 95138

October 8, 2020

Re: K202592

Trade/Device Name: Advanced Imaging Modality System (1688 4K Camera System with Advanced Imaging Modality, L11 LED Light Source with Advanced Imaging Modality) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, OWN, FCS, FCW Dated: September 4, 2020 Received: September 8, 2020

Dear Divya Sekar:

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/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,

Neil R.P. Ogden, MS Assistant Director, THT4A4 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) K202592

Device Name

Advanced Imaging Modality System (1688 4K Camera System with Advance Imaging Modality; L11 LED Light Source with Advanced Imaging Modality)

Indications for Use (Describe)

1688 4K Camera System with Advance Imaging Modality:

L11 LED Light Source with Advanced Imaging Modality:

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)

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 is submitted in accordance with the requirements of 21 C.F.R Part 807.92

Submitter:

Applicant:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	Divya SekarStaff Regulatory Affairs SpecialistPhone: (669) 204-4851Email: divya.sekar@stryker.com
Date Prepared:	September 8, 2020

Subject Device:

The subject device is the Advanced Imaging Modality System (1688 4K Camera System with Advance Imaging Modality; L11 LED Light Source with Advanced Imaging Modality), and specifically the following system components:

Name of Device:	1688 4K Camera System with Advance Imaging Modality
Common or UsualName	3-chip Video Camera
Classification Name:	Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500)
Regulatory Class:	II
Product Code:	GCJ
510(k) Review Panel:	General & Plastic Surgery

Name of Device:	L11 LED Light Source with 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. §876.4020)
Regulatory Class:	II
Product Code:	OWN1
	FCS2
	FCW3
510(k) Review Panel:	General & Plastic Surgery1
	Gastroenterology/ Urology2,3

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.

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Predicate Device(s):

PrimaryPredicateDevice	Advanced Imaging Modality System (1688 4K CameraSystem with Advance Imaging Modality; L11 LEDLight Source with Advanced Imaging Modality)	K182160
ReferencePredicateDevices	1688 4K Camera System with Advance ImagingModality	K200310
	L11 LED Light Source with Advanced ImagingModality	K192292,K191046

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

Device Description:

Indications for Use:

1688 4K Camera System with Advanced Imaging Modality:

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

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Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

L11 LED Light Source with Advanced Imaging Modality:

Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight™ Cable is used 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.

Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLight™ Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

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

NOTE: The 1688 4K Camera System with Advance Imaging Modality indications for use is identical to the predicate device cleared under K182160.

The L11 LED Light Source with Advanced Imaging Modality indications for use is similar to the predicate device cleared under K182160. The differences in the L11 LED Light Source with Advanced Imaging Modality indications for use were cleared under K191046 and K192292 (when used with 1688 4K Camera System cleared via K182160).

Item	Subject DeviceAIM (Advanced Imaging Modality) System	Predicate DeviceAIM (Advanced Imaging Modality) System
Manufacturer	Stryker	Same as subject device
Submission Reference	Current Submission	K182160
Intended Use	Endoscopic visible and near-infrared lightillumination and imaging during surgicalendoscopic procedures	Same as subject device
Imaging Modes	White Light (Manual & Autolight1)Near-infrared - fluorescenceNear-infrared - transillumination	White Light (Manual & Autolight)Near-infrared - fluorescenceNear-infrared - transillumination

Comparison of Technological Characteristics with the Predicate Device:

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Item	Subject DeviceAIM (Advanced Imaging Modality) System	Predicate DeviceAIM (Advanced Imaging Modality) System
Safety Standards	IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60825-1	Same as subject device
CameraSystem	System Components	Camera Control UnitCamera Head(s): Standard &IntegratedCoupler
	Camera Control UnitCamera Head(s): Standard,Integrated, and Pendulum2Coupler
	Principles of Operation	Via an optical scope and coupler, light isprojected onto one or more complementarymetal oxide semiconductor image sensorswhich acquire a continuous stream of imagedata. The image data is processed to providea video stream that is then sent to a displayfor viewing.	Same as subject device
	Image Sensor	CMOS image sensor	Same as subject device
	Image Processing/Video Output	Digital	Same as subject device
	Resolution	4K (up to 3840 x 2160)	Same as subject device
	Frame Rate	60 frames per second	Same as subject device
LightSource	Principles of Operation	An electronic driver controls Red/Green/BlueLEDs & a near-infrared laser diode which arecombined through dichroic mirrors andprojected onto an output light collimator. Afiber output bundle can be inserted into thelight source to couple light to the distal endand into an endoscope.	Same as subject device
	Light Source/Laser	RGB LEDsInfrared Laser	Same as subject device

l The optional Defog feature is available in Autolight imaging mode for the subject device. It reduces the likelihood of fogged images common to irrigated surgical procedures.

2 The 1688 4K Pendulum Camera Head was cleared under K200310.

Performance Data:

The following performance data, including image quality assessments, were provided to demonstrate the optional Defog feature works as intended under clinically relevant ambient conditions (i.e. temperature and relative humidity) to support the substantial equivalence determination:

Test	Method	Results
Performance Testing	Laser OutputSystem Temperature VerificationImage Quality Assessments	Pass
Software Verification	IEC 62304:2015	Pass

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

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Conclusions:

The comparison of the indications for use, technological characteristics and performance data demonstrates the subject device is substantially equivalent to the predicate device.

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.