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.

A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repari, 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.

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

The provided text is a 510(k) Summary for the Stryker 1688 4K Camera System with Advanced Imaging Modality. This document primarily focuses on establishing substantial equivalence to a predicate device, as required for FDA clearance. It does not contain the kind of detailed performance study information typically associated with AI/ML device evaluations, such as specific acceptance criteria for algorithm performance, sample sizes for test sets, expert ground truth establishment, or MRMC studies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

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

The document doesn't provide acceptance criteria and reported performance in the typical sense of algorithm-specific metrics (e.g., sensitivity, specificity, AUC). Instead, it lists performance testing for general device functionality, electrical safety, and electromagnetic compatibility.

Acceptance Criteria (Internal/General Device Function)	Reported Device Performance
Environmental RF Interference	Pass
Electrical Safety (ANSI AAMI ES 60601-1, IEC 60601-1-6, IEC 60601-2-18)	Pass
Electromagnetic Compatibility (IEC 60601-1-2)	Pass

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

Sample Size for Test Set: Not specified for any AI/ML performance evaluation. The "Performance Data" section refers to engineering tests, not a clinical or image-based test set.
Data Provenance: Not applicable, as no data set for AI/ML evaluation is described.

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

Not applicable, as no ground truth establishment for AI/ML performance evaluation is described.

4. Adjudication method (e.g. 2+1, 3+1, none) 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:

No MRMC study is mentioned. The device is an endoscopic camera system, and the document focuses on its technical specifications and safety. There is no indication of AI assistance that would involve human readers.

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

This filing is for an endoscopic camera system. While it has an "Advanced Imaging Modality" (AIM), the document does not describe it as an AI/ML algorithm requiring standalone performance evaluation in the context of clinical decision-making. The AIM likely refers to specific imaging capabilities (e.g., near-infrared fluorescence, transillumination) rather than an interpretative AI algorithm.

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

Not applicable.

8. The sample size for the training set:

Not applicable, as no AI/ML training is described.

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

Not applicable.

Summary of what is present:

The document describes the Stryker 1688 4K Camera System with Advanced Imaging Modality (AIM). It states that the device is "substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices." (K211202).

The performance data listed pertains to general device safety and functionality tests:

Environmental RF Interference: Pass
Electrical Safety (according to standards IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18): Pass
Electromagnetic Compatibility (according to standard IEC 60601-1-2): Pass

The "Advanced Imaging Modality" in this context refers to capabilities like "Near-infrared fluorescence" and "Near-infrared transillumination," which are imaging techniques, not necessarily an AI/ML algorithm that predicts or diagnoses. The 510(k) focuses on the camera system itself as an endoscope and accessories, not an AI diagnostic tool.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.

August 19, 2022

Stryker Marlene Fraga Sr. Staff, Regulatory Affairs Specialist, Software Interoperability 5900 Optical Court San Jose, California 95138

Re: K222130

Trade/Device Name: 1688 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: July 13, 2022 Received: July 18, 2022

Dear Marlene Fraga:

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

{1}------------------------------------------------

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 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,

for Long Chen, Ph.D. 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

{2}------------------------------------------------

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) K222130

Device Name

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

Indications for Use (Describe)

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)
--------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

stryker

510(k) Summary

Submitter:

Applicant:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person:	Marlene FragaSr. Staff Regulatory Affairs Specialist, Software InteroperabilityEmail: marlene.fraga@stryker.com
Date Prepared:	July 13, 2022

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:	GCJ	GWG
510(k) ReviewPanel:	General & Plastic Surgery	Neurology

Predicate Device(s):

1688 4K Camera System with Advanced Imaging Modality	K211202
------------------------------------------------------	---------

Reference Device(s):

1688 4K Camera System with Advanced Imaging Modality	K220895, K212511
------------------------------------------------------	------------------

Device Description:

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is written in all lowercase letters.

Indications for Use:

	Subject Device	Predicate Device	Reference Devices
Item	1688 4K Camera SystemThis Submission	1688 4K Camera System(K211202)	1688 4K Camera System(K220895)	1688 4K Camera System(K212511)
IntendedUse	Endoscopic white light and near-infrared illumination and imaging during endoscopic procedures.	Same as subject device	Same as subject device	Same as subject device
Indicationsfor 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	Same as subject device
Item	Subject Device1688 4K Camera System(This Submission)	Predicate Device1688 4K Camera System(K211202)	Reference Devices
			1688 4K Camera System(K220895)	1688 4K Camera System(K212511)
Manufacturer	Stryker	Same as subject device	Same as subject device	Same as subject device
Imaging Modes	White LightNear-infrared fluorescenceNear-infraredtransillumination	Same as subject device	Same as subject device	Same as subject device
Camera SystemComponents	Camera Control Unit	Camera Control Unit	Same as subject device	Same as subject device
	Camera Head(s) - Standard,Integrated, Inline,Pendulum, Autoclave	Camera Head(s) -Standard, Integrated,Inline, Pendulum	Same as subject device	Same as subject device
	Coupler(s) - AIM 4K, AIM4K Autoclave	Coupler(s) - AIM 4K	Same as subject device	Same as subject device
Principles ofOperations	Via an optical light guide,endoscope and coupler, lightis projected from a lightsource and either reflectedor absorbed and fluorescedonto one or morecomplementary metal oxidesemiconductor imagesensors which acquire acontinuous 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	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	Same as subject device
Modes ofOperation	Alternate Frame processingSimultaneous Frameprocessing	Same as subject device	Same as subject device	Same as subject device
Image Sensor	CMOS image sensor	Same as subject device	Same as subject device	Same as subject device
ImageProcessing/Video Output	Digital	Same as subject device	Same as subject device	Same as subject device
Resolution	4K (up to 3840 x 2160)	Same as subject device	Same as subject device	Same as subject device
Frame Rate	60 frames per second	Same as subject device	Same as subject device	Same as subject device
Camera HeadCable ProximalPCBA	Soft-termination capacitor	Conventionaltermination capacitor	Conventionaltermination capacitor	Conventionaltermination capacitor

{5}------------------------------------------------

stryker

Comparison of Technological Characteristics with the Predicate Device:

{6}------------------------------------------------

stryker

Performance Data:

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

Test	Method	Result
Performance Testing	Environmental RF Interference	Pass
Electrical Safety and EMC	Electrical Safety (ANSI AAMI ES 60601-1, IEC 60601-1-6, IEC 60601-2-18) Electromagnetic Compatibility (IEC 60601-1-2)	Pass

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. In summary, the 1688 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.