The 1788 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope is indicated for use. The 1788 Video Camera is indicated for use in adults and pediatric patients.

Device Description

The 1788 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 spectrums. 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 1788 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

The Stryker 1788 4K Camera System with Advanced Imaging Modality (K230605) is an endoscopic camera system.

Here's an analysis of its acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Method)	Reported Device Performance
Electromagnetic Compatibility	IEC 60601-1-2:2014	Pass
Electrical Safety	ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-2-18:2009	Pass
Software	IEC 62304:2015	Pass
Performance Testing - Bench:
• Camera Head Soaker Cap Tether Pull Force	(Method not explicitly detailed but implied by "Pass")	Pass
• Camera Head to Camera Control Unit Connector Insertion/Removal Force	(Method not explicitly detailed but implied by "Pass")	Pass
• Camera Head Button to Camera Control Unit Activation Timing	(Method not explicitly detailed but implied by "Pass")	Pass

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide information about sample sizes for a 'test set' in the context of clinical or image-based evaluation. The performance data presented consists of engineering and software compliance testing. The data provenance is not specified beyond being generated by Stryker for its 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the provided documentation details engineering and software performance testing for a camera system, not the evaluation of a diagnostic or interpretive algorithm that would require expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons mentioned in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size:

No, an MRMC comparative effectiveness study was not explicitly conducted or referenced in the provided document. The device is a camera system providing visual input, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies to measure human reader improvement. The document explicitly states: "The 1788 4K Camera System does not require clinical studies to support the determination of substantial equivalence."

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

This information is not applicable as the device described is an endoscopic camera system, which provides visual information to a human user in a clinical setting; it is not a standalone algorithm performing a diagnostic task.

7. The Type of Ground Truth Used:

For the performance tests conducted, the "ground truth" refers to the established standards or specifications being tested against (e.g., IEC 60601-1-2:2014 for EMC, product design specifications for bench tests). It's not an expert consensus, pathology, or outcomes data in the sense of clinical decision-making.

8. The Sample Size for the Training Set:

This information is not applicable. The document describes a medical device (camera system), not an AI/ML algorithm that would typically require a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reasons mentioned in point 8.

Summary

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March 31, 2023

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

Re: K230605

Trade/Device Name: 1788 4K Camera System with Advanced Imaging Modality Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, GWG Dated: March 2, 2023 Received: March 3, 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,

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)

K230605

Device Name

1788 4K Camera System with Advanced Imaging Modality

Indications for Use (Describe)

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 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT/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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stryke

510(k) Summary

Submitter:

Applicant:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	April MalmborgSenior Director, Regulatory AffairsEmail: April.malmborg@stryker.comPhone: (408) 754-2473
Date Prepared:	March 3, 2023

Subject Device:

Name of Device:	1788 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):

K230216*, K214046 1688 4K Camera System with Advanced Imaging Modality *Primary predicate

Device Description:

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K230605

stryker

Indications for Use:

Item	Subject Device	Predicate Device
	1788 4K Camera System	1688 4K Camera System
Intended Use	Endoscopic white light and near-infrared illuminationand imaging during endoscopic procedures.	Same as subject device
Indicationsfor Use	The 1788 4K Camera System is indicated for use ingeneral laparoscopy, nasopharyngoscopy, ear endoscopy,sinuscopy, neurosurgery and plastic surgery whenever alaparoscope/ endoscope/ arthroscope/ sinuscope isindicated for use. The 1788 4K Camera System isindicated for adults and pediatric patients.A few examples of the more common endoscopesurgeries are Laparoscopic cholecystectomy,Laparoscopic hernia repair, Laparoscopic appendectomy,Laparoscopic pelvic lymph node detection,Laparoscopically assisted hysterectomy, Laparoscopicand thorascopic anterior spinal fusion, Anterior cruciateligament reconstruction, Knee arthroscopy, Small jointarthroscopy, Decompression fixation, Wedge resection,Lung biopsy, Pleural biopsy, Dorsal sympathectomy,Pleurodesis, Internal mammary artery dissection forcoronary artery bypass, Coronary artery bypass graftingwhere endoscopic visualization is indicated andExamination of the evacuated cardiac chamber duringperformance of valve replacement.The users of the 1788 Video Camera are general andpediatric surgeons, gynecologists, cardiac surgeons,thoracic surgeons, plastic surgeons, orthopedic surgeons,ENT surgeons, neurosurgeons and urologists.	Same as subject device.

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K230605

stryker

Comparison of Technological Characteristics with the Predicate Device:

Item	Subject Device	Predicate Device
	1788 4K Camera System	1688 4K Camera System
Manufacturer	Stryker	Same as subject device.
Submission Reference(s)	Current Submission	K230216, K214046
Imaging Modes	White LightNear-infrared fluorescenceNear-infrared transillumination	Same as subject device.
Principles of Operations	Via an optical endoscope andcoupler, light is projected from alight source onto one or morecomplementary metal oxidesemiconductor image sensorswhich acquire a continuous streamof image data. The image data isprocessed to provide a videostream that is then sent to a displayfor viewing.	Same as subject device.
Camera SystemComponents	Camera Control UnitCamera Head(s) – Standard,Inline, Integrated, PendulumCoupler(s) – AIM 4K	Camera Control UnitCamera Head(s) – Standard,Inline, Pendulum, AutoclavableCoupler(s) – AIM 4K, AIM 4KAutoclavable
Safety Standards	IEC 60601-1IEC 60601-1-6IEC 60601-2-18IEC 60601-1-2	Same as subject device.
Mode of Operation	Alternate Frame ProcessingSimultaneous Frame Processing	Same as subject device.
Image Sensor	CMOS image sensor	Same as subject device.
Image Processing/VideoOutput	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.

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stryke

Performance Data:

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

Test	Method	Results
ElectromagneticCompatibility	In accordance with IEC 60601-1-2:2014	Pass
Electrical Safety	In accordance with:• ANSI/AAMI ES60601-1:2005 + A1:2012• IEC 60601-1-6:2010 + A1:2013• IEC 60601-2-18:2009	Pass
Software	In accordance with IEC 62304:2015	Pass
PerformanceTesting - Bench	Camera Head Soaker Cap Tether Pull ForceCamera Head to Camera Control Unit Connector Insertion/ Removal ForceCamera Head Button to Camera Control Unit Activation Timing	Pass

NOTE: The 1788 4K Camera System is not patient contacting; therefore, biocompatibility testing was not required to support the determination of substantial equivalence.

NOTE: The 1788 4K Camera System does not require clinical studies to support the determination of substantial equivalence.

Conclusions:

The 1788 4K Camera System is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the 1788 4K Camera System is substantially equivalent with respect to safety and effectiveness to the legally marketed 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.