1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)

K212511 · Stryker · GCJ · Nov 4, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K212511
• Device Name: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
• Applicant: Stryker
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Endoscopic white light and near-infrared illumination and imaging during endoscopic procedures.

Device Story

1688 4K Camera System is an endoscopic imaging device for surgical visualization. System components include a Camera Control Unit (CCU), camera head with integral cable, and coupler for endoscope attachment. Input consists of optical images from the surgical site captured via rigid or flexible endoscopes; system is sensitive to visible and near-infrared (NIR) light. The CCU processes CMOS sensor data to generate 4K video output for display. Used in OR settings by surgeons (general, pediatric, gynecological, cardiac, thoracic, plastic, orthopedic, ENT, neuro, urological). Provides real-time visualization in white light, NIR-fluorescence, and NIR-transillumination modes. Output assists surgeons in identifying anatomical structures and tissues, potentially improving surgical precision and patient outcomes.

Clinical Evidence

Bench testing only. Performance validated via electrical safety (ANSI/AAMI ES60601-1), EMC (IEC 60601-1-2), cleaning/disinfection/sterilization (AAMI TIR30, TIR12, ISO 17664), software (IEC 62304), and usability (IEC 62366-1). Animal testing performed to confirm user needs. No clinical studies were required.

Technological Characteristics

System utilizes CMOS image sensors for 4K (3840x2160) video at 60 fps. Imaging modes: White Light, NIR-fluorescence, NIR-transillumination. Components: CCU, camera head, coupler. Connectivity: Digital video output. Standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18, IEC 60601-1-2. Processing: Alternate or simultaneous frame processing. Cleaning/disinfection: Manual/automated cleaning, thermal disinfection.

Indications for Use

Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery, and plastic surgery in adults and pediatric patients whenever a laparoscope/endoscope/arthroscope/sinuscope is indicated. Common procedures include cholecystectomy, hernia repair, appendectomy, pelvic lymph node detection, hysterectomy, spinal fusion, ACL reconstruction, knee/small joint arthroscopy, decompression fixation, wedge resection, lung/pleural biopsy, sympathectomy, pleurodesis, coronary artery bypass grafting, and cardiac valve replacement.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 1688 4K Camera System with Advanced Imaging Modality (K211202)

Submission Summary (Full Text)

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November 4, 2021

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

Re: K212511

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: August 6, 2021 Received: August 10, 2021

Dear Marlene Fraga:

We have reviewed vour 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/cdrb/ofdocs/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.

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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 801 and Part 809: 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 (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 [phone] or 301-796-7100).

Sincerely,

Long Chen, PhD Assistant Director Non-Light Based Energy Devices DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality

Enclosure

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#### Indications for Use

510(k) Number (if known)

#### K212511

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

#### Indications for Use (Describe)

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 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)

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 510(k) Summary

#### Submitter:

| Applicant: | Stryker Endoscopy<br>5900 Optical Court<br>San Jose, CA 95138 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marlene Fraga<br>Staff Regulatory Affairs Specialist, Software Interoperability<br>Email: [e-mail] |
| Date Prepared: | August 6, 2021 |

#### Subject Device:

| Name of Device: | 1688 4K Camera System with Advanced Imaging Modality | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|--|
| Common or<br>Usual Name | 3-chip Video Camera | |
| Classification<br>Name: | Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500)<br>Endoscope, Neurological (21 C.F.R. §882.1480) | |
| Regulatory Class: | II | |
| Product Code: | GCJ<br>GWG | |
| 510(k) Review<br>Panel: | General & Plastic Surgery<br>Neurology | |

#### Predicate Device(s):

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

NOTE: The predicate device has not been subject to a design-related recall.

#### 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.

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#### Indications for Use:

| Subject Device | Predicate Device |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| 1688 4k Camera System<br>This Submission | 1688 4K Camera System<br>(K211202) |
| Intended Use:<br>Endoscopic white light and near-infrared illumination and<br>imaging during endoscopic procedures. | Intended Use:<br>Same as subject device |
| Indications for Use:<br>The 1688 Video Camera is indicated for use in general<br>laparoscopy, nasopharyngoscopy, ear endoscopy,<br>sinuscopy, neurosurgery and plastic surgery whenever a<br>laparoscope/ endoscope/ arthroscope/ sinuscope is<br>indicated for use. The 1688 Video Camera is indicated for<br>adults and pediatric patients. | Indications for Use:<br>Same as subject device |
| A few examples of the more common endoscope surgeries<br>are Laparoscopic cholecystectomy, Laparoscopic hernia<br>repair, Laparoscopic appendectomy, Laparoscopic pelvic<br>lymph node detection, Laparoscopically assisted<br>hysterectomy, Laparoscopic and thorascopic anterior spinal<br>fusion, Anterior cruciate ligament reconstruction, Knee<br>arthroscopy, Small joint arthroscopy, Decompression<br>fixation, Wedge resection, Lung biopsy, Pleural biopsy,<br>Dorsal sympathectomy, Pleurodesis, Internal mammary<br>artery dissection for coronary artery bypass, Coronary<br>artery bypass grafting where endoscopic visualization is<br>indicated and Examination of the evacuated cardiac<br>chamber during performance of valve replacement. | |
| The users of the 1688 Video Camera are general and<br>pediatric surgeons, gynecologists, cardiac surgeons,<br>thoracic surgeons, plastic surgeons, orthopedic surgeons,<br>ENT surgeons, neurosurgeons and urologists. | |

#### Comparison of Technological Characteristics with the Predicate Device:

| Item | Subject Device | Predicate Device |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| | 1688 4K Camera System<br>(This Submission) | 1688 4K Camera System<br>(K211202) |
| Manufacturer | Stryker | Stryker |
| Imaging Modes | White Light<br>Near-infrared – fluorescence<br>Near-infrared – transillumination | Same as subject device |
| Item | Subject Device<br>1688 4K Camera System<br>(This Submission) | Predicate Device<br>1688 4K Camera System<br>(K211202) |
| Safety Standards | IEC 60601-1<br>IEC 60601-1-6<br>IEC 60601-2-18<br>IEC 60601-1-2 | Same as subject device |
| Principles of<br>Operations | Via an optical endoscope and<br>coupler, light is projected from a<br>light source onto one or more<br>complementary metal oxide<br>semiconductor image sensors<br>which acquire a continuous<br>stream of image data. The image<br>data is processed to provide a<br>video stream that is then sent to a<br>display for viewing. | Same as subject device |
| Modes of Operation | Alternate Frame processing<br>Simultaneous Frame processing | Same as subject device |
| Image Sensor | CMOS image sensor | Same as subject device |
| Image Processing/<br>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 |
| Camera System<br>Components | Camera Control Unit<br><br>Camera Head(s) – Standard,<br>Integrated, Inline, Pendulum,<br>Autoclave<br><br>Coupler(s) – AIM 4K, AIM 4K<br>Autoclave | Camera Control Unit<br><br>Camera Head(s) – Standard,<br>Integrated, Inline, Pendulum<br><br>Coupler(s) – AIM 4K |
| Compatible<br>Processing Methods | Cleaning Manual & Automated<br><br>Disinfection (optional) Thermal Disinfection | Same as subject device<br><br>Manual Disinfection |

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#### Performance Data:

Testing was completed in accordance with the following:

| Test | Method | Result |
|----------------------------------------|-------------------------------------------------------------------------------------------|--------|
| Electrical Safety | ANSI/AAMI ES60601-1:2005 + A1:2012<br>IEC 60601-2-18:2009<br>IEC 60601-1-6:2010 + A1:2013 | Pass |
| Electromagnetic<br>Compatibility (EMC) | IEC 60601-1-2:2014 | Pass |
| Cleaning | AAMI TIR30:2011 (R2016)<br>ISO/TS 15883-5:2005 | Pass |
| Disinfection | AAMI TIR12:2020<br>ISO 17664:2017<br>EN ISO 15883-2:2009 | Pass |
| Sterilization | AAMI TIR12:2020<br>AAMI ST79:2017<br>ISO 17664:2017<br>ISO 14937:2009<br>ISO 17665-1:2006 | Pass |
| Software | IEC 62304:2006/AMD1:2015 | Pass |
| Usability | IEC 62366-1:2020 | Pass |
| Performance - Bench | In accordance with design input specifications | Pass |
| Performance - Animal | In accordance with device user needs | 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.