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

Device Description

The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.

AI/ML Overview

This document, a 510(k) Summary for the Stryker 1688 4K Camera System with Advanced Imaging Modality (AIM), primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's diagnostic performance against specific clinical acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods is either not explicitly stated or not applicable in the context of this type of regulatory submission.

However, based on the provided text, I can infer and present some of the requested information related to the device's performance data that was provided in support of the substantial equivalence determination.

1. Table of Acceptance Criteria and Reported Device Performance

For regulatory purposes to demonstrate substantial equivalence, the "acceptance criteria" here relate to compliance with recognized standards and successful completion of specified tests.

Acceptance Criteria (Test)	Reported Device Performance (Result)
Electrical Safety (ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 60601-2-18:2009, IEC 60601-1-6:2010 + A1:2013)	Pass
Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2014)	Pass
Performance - Bench (CCU Timing, Video Compatibility)	Pass
Software Verification (IEC 62304:2015)	Pass

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

The document does not describe a clinical "test set" in the traditional sense of a study evaluating diagnostic accuracy on patient data. The performance data provided are related to engineering and regulatory compliance testing. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable here.

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

Not applicable. This submission focuses on engineering and safety compliance, not clinical diagnostic accuracy assessed by experts against ground truth.

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

Not applicable. As above, there is no clinical test set requiring expert adjudication for ground truth.

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 such study is mentioned or implied in this document. The device description explicitly states it is an "endoscopic camera system that produces live video in the surgical field," which implies it is a viewing tool for human users, not an AI-assisted diagnostic device. The "Advanced Imaging Modality" refers to visible and near-infrared imaging for fluorescence and transillumination, not AI.

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

Not applicable. This device is an imaging system intended for human-in-the-loop performance, providing visual information to a surgeon. There is no mention of a standalone algorithm for automated analysis.

7. The type of ground truth used

For the engineering and regulatory compliance tests:

Electrical Safety, EMC, Software Verification: The "ground truth" is compliance with the specifications and requirements of the cited international standards (IEC, ANSI/AAMI).
Performance - Bench: The "ground truth" is successful operation according to internal design specifications for CCU Timing and Video Compatibility.

There is no mention of clinical ground truth (e.g., pathology, clinical outcomes) as this submission does not present a clinical performance study.

8. The sample size for the training set

Not applicable. Since there is no mention of an algorithm based on machine learning or AI that would require a "training set," this information is not provided.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned.

Summary

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February 23, 2023

Stryker Michelle Stephens Senior Staff Regulatory Affairs Specialist 5900 Optical Ct San Jose, California 95138

Re: K230216

Trade/Device Name: 1688 4K Camera Control Unit with Advanced Imaging Modality Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, GWG Dated: January 25, 2023 Received: January 26, 2023

Dear Michelle Stephens:

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,

Jianting Wang -S

Jianting Wang 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)

K230216

Device Name

1688 4K Camera System with Advanced Imaging Modality (AIM)

Indications for Use (Describe)

A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, neurosurgeons and urologists.

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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510(k) Summary

Submitter:

Applicant:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	Michelle StephensSenior Staff Regulatory Affairs SpecialistEmail: michelle.stephens@stryker.comPhone: (408) 754-2473
Date Prepared:	February 16, 2023

Subject Device:

Name of Device:	1688 4K Camera System with Advanced Imaging Modality
Common orUsual Name	3-chip Video Camera
ClassificationName:	Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500)Endoscope, Neurological (21 C.F.R. §882.1480)
Regulatory Class:	II
Product Code:	GCJGWG
510(k) ReviewPanel:	General & Plastic SurgeryNeurology

Predicate Device(s):

780 nm 1688 4K Camera System with Advanced Imaging Modality(primary predicate)	K214046
1688 4K Camera System with Advanced Imaging Modality(reference device)	K222130

Device Description:

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Indications for Use:

Subject Device	Predicate Devices
1688 4K Camera SystemThis Submission	780 nm 1688 4KCamera System(K214046 –primary predicate)	1688 4K CameraSystem withAdvanced ImagingModality(K222130 –reference device)
Intended Use:	Intended Use:	Intended Use:
Endoscopic white light and near-infrared illumination and imaging during endoscopic procedures.	Same as subject device	Same as subject device
Indications for Use:	Indications for Use:	Indications for Use:
The 1688 Video Camera 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 1688 Video Camera is indicated for adults and pediatric patients.A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, 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 and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists	Same as subject device	Same as subject device
Item	Subject Device1688 4K Camera System(This Submission)	Predicate Devices
		780 nm 1688 4K Camera System(K214046-primarypredicate)	1688 4K Camera Systemwith Advanced ImagingModality(K222130 - reference device)
Manufacturer	Stryker	Same as subject device	Same as subject device
ImagingModes	White LightNear-infrared - fluorescenceNear-infrared –transillumination	Same as subject device	Same as subject device
CameraSystemComponents	Camera Control UnitCamera Head(s) – Standard,Integrated, Inline, Pendulum,AutoclavableCoupler(s) - AIM 4K, AIM4K Autoclavable	Camera Control UnitCamera Head(s) – Standard,Integrated, Inline, PendulumCoupler(s) - AIM 4K	Camera Control UnitCamera Head(s) – Standard,Integrated, Inline, Pendulum,AutoclaveCoupler(s) - AIM 4K, AIM4K Autoclave
Principles ofOperations	Via an optical endoscope andcoupler, light is projectedfrom a light source onto oneor more complementarymetal oxide semiconductorimage sensors which acquirea continuous stream of imagedata. The image data isprocessed to provide a videostream that is then sent to adisplay for viewing.	Same as subject device	Same as subject device
SafetyStandards	IEC 60601-1IEC 60601-1-6IEC 60601-2-18IEC 60601-1-2	Same as subject device	Same as subject device
Modes ofOperation	Alternate Frame processingSimultaneous Frameprocessing	Same as subject device	Same as subject device
Image Sensor	CMOS image sensor	Same as subject device	Same as subject device
ImageProcessing/Video OutputResolution	Digital4K (up to 3840 x 2160)	Same as subject device	Same as subject device
Frame Rate	60 frames per second	Same as subject device	Same as subject device
CameraControl UnitPCB DigitalBoard	Revision FNOTE: Modified to accountfor End of Life (EOL) andsupply chain shortages.	Revision E	Revision E

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Comparison of Technological Characteristics with the Predicate Device:

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Performance Data:

The following performance data were provided in support of the substantial equivalence determination:

Test	Method	Result
Electrical Safety	In accordance with:ANSI/AAMI ES60601-1:2005 + A1:2012IEC 60601-2-18:2009IEC 60601-1-6:2010 + A1:2013	Pass
ElectromagneticCompatibility (EMC)	In accordance with IEC 60601-1-2:2014	Pass
Performance - Bench	CCU TimingVideo Compatibility	Pass
Software Verification	In accordance with IEC 62304:2015	Pass

NOTE: The 1688 4K Camera System is not patient contacting; therefore, biocompatibility testing was not required to support the determination of substantial equivalence. Additionally, the device modifications to the 1688 4K Camera System do not require clinical studies to support the determination of substantial equivalence.

Conclusions:

The 1688 4K Camera System is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. There are no different issues of safety and/or effectiveness introduced by the 1688 4K Camera System.

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.