Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control

K222079 · Stryker Endoscopy · GCJ · Oct 11, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K222079
• Device Name: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
• Applicant: Stryker Endoscopy
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Connected OR Hub with Device and Voice Control: The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other opersonnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device. SDC4K Information Management System with Device and Voice Control: The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

Device Story

Network-compatible hardware platforms (Connected OR Hub, SDC4K) serving as Medical Device Data Systems (MDDS). Inputs include touchscreen GUI commands, voice commands via wireless headset, and IR remote control signals. System processes these inputs to control settings of connected endoscopic/general surgery devices (cameras, light sources, insufflators, pumps). Features include digital documentation (capture/transfer/store/display data) and optional Video Image Processing (VIP) for smoke detection/evacuation and image enhancement. Used in operating rooms by surgeons/OR staff. Output is adjusted device state/settings and captured surgical data. Benefits include reduced manual device operation and improved communication efficiency in the OR.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (ANSI/AAMI ES60601-1), EMC (IEC 60601-1-2), software validation (IEC 62304), and usability (IEC 62366-1).

Technological Characteristics

Hardware platforms running Microsoft Windows 10. Connectivity via wired ports, Ethernet (to Connected OR Spoke), and wireless (WLAN 802.11a/b/g/n/ac, DECT for headset, IR for remote). Components include base console, device/voice control packages, and VIP package. Electrical safety per ANSI/AAMI ES60601-1; EMC per IEC 60601-1-2. Non-patient contacting.

Indications for Use

Indicated for surgeons and operating room personnel to remotely control or voice-control compatible medical device settings in an operating room environment, and to electronically capture, transfer, store, and display medical device data.

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

• Connected OR Hub with Device and Voice Control (K212055)
• SDC4K Information Management System with Device and Voice Control (K220108)

Submission Summary (Full Text)

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10/11/2022

Stryker Endoscopy Divya Sekar Senior Staff Regulatory Affairs Specialist 5900 Optical Ct San Jose, California 95138

Re: K222079

Trade/Device Name: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, HRX Dated: July 14, 2022 Received: July 15, 2022

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.

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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); 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 ([e-mail]) or phone [phone] 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

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# Indications for Use

### 510(k) Number (if known)

#### K222079

#### Device Name

Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control

#### Indications for Use (Describe)

Connected OR Hub with Device and Voice Control:

The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other opersonnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

### SDC4K Information Management System with Device and Voice Control

The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R.Part 807.92(c).

# 510(k) Number: K222079

## Submitter:

| Applicant: | Stryker Endoscopy<br>5900 Optical Court<br>San Jose, CA 95138 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Divya Sekar<br>Senior Staff Regulatory Affairs Specialist<br>Email: [e-mail]<br>Phone: [phone] |
| Date Prepared: | July 14, 2022 |

## Subject Device:

| Name of Device: | Connected OR Hub with Device and Voice Control;<br>SDC4K Information Management System with Device and Voice Control |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name | Information Management System |
| Classification Name: | Laparoscope, General & Plastic Surgery (21 C.F.R. §876.1500) |
| Regulatory Class: | II |
| Product Code: | GCJ |
| Subsequent Product Code | HRX |
| 510(k) Review Panel: | General and Plastic Surgery |

## Predicate Devices:

| Connected OR Hub with Device and Voice Control | K212055 |
|-------------------------------------------------------------------|---------|
| SDC4K Information Management System with Device and Voice Control | K220108 |

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

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## Device Description:

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components:

- 1) Base Console which includes:
- a) Class I Medical Device Data System (MDDS) functionalities
- b) Optional Device Control feature
- c) Optional Voice Control feature
- d) Optional Video Image Processing (VIP) feature
- 2) Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
- 3) Voice Control Package (software activation USB dongle and a wireless headset and base station)
- 4) Video Image Processing package (software activation USB dongle)
- 5) Connected OR Spoke (Class I MDDS)

The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control and/or Voice Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.

In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control also provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the Connected OR Hub with Device and Voice Control or SDC4K Information Management System with Device and Voice Control is connected to the Spoke, Device Control can be extended to compatible devices which are directly connected to the Spoke.

When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm, and removal of surgical smoke through a compatible insufflator.

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# Intended Use/Indications for Use:

| Subject Devices | Predicate Devices | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Connected OR Hub with Device and Voice Control;<br>SDC4K Information Management System with Device and<br>Voice Control | Connected OR Hub with<br>Device and Voice Control<br>(K212055) | SDC4K Information<br>Management System<br>with Device and Voice<br>Control (K220108) |
| NOTE 1: Connected OR Hub with Device and Voice Control and<br>SDC4K Information Management System with Device and Voice<br>Control have the same Intended Use/Indications for Use; only the<br>names of the device differ. | Same as subject device<br>(Connected OR Hub with<br>Device and Voice Control) | Same as subject device<br>(SDC4K Information<br>Management System<br>with Device and Voice<br>Control) |
| Connected OR Hub with Device and Voice Control:<br>The use of the Connected OR Hub with Device and Voice<br>Control is to allow for remote control and voice control of<br>medical device settings by surgeons or operating room personnel,<br>thereby eliminating the need to manually operate those devices<br>compatible with the Connected OR Hub or to rely on verbal<br>communication between the surgeon and other operating room<br>personnel in order to adjust the surgical equipment. It also has<br>additional digital documentation functionality to electronically<br>capture, transfer, store and display medical device data (non-<br>medical device function), which is independent of the functions<br>or parameters of any attached Stryker device. | | |
| SDC4K Information Management System with Device and<br>Voice Control:<br>The use of the SDC4K Information Management System with<br>Device and Voice Control is to allow for remote control and voice<br>control of medical device settings by surgeons or operating room<br>personnel, thereby eliminating the need to manually operate those<br>devices compatible with the SDC4K Information Management<br>System with Device and Voice Control or to rely on verbal<br>communication between the surgeon and other operating room<br>personnel in order to adjust the surgical equipment. It also has<br>additional digital documentation functionality to electronically<br>capture, transfer, store and display medical device data (non-<br>medical device function), which is independent of the functions<br>or parameters of any attached Stryker device. | | |

# Comparison of Technological Characteristics with the Predicate Device:

| Item | Subject Devices | Predicate Devices | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------|
| | Connected OR Hub with Device and Voice Control;<br>SDC4K Information Management System with Device and Voice Control | Connected OR Hub with Device and Voice Control (K212055) | SDC4K Information Management System with Device and Voice Control (K220108) |
| Manufacturer | Stryker | Same as subject device | Same as subject device |
| Principles of Operation | Use of IR remote control for device control and RF communication for voice control of connected devices. | Same as subject device | Same as subject device |
| Components | Console<br>Device Control Package<br>Voice Control Package | Same as subject device | Same as subject device |

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| Item | Subject Devices | Predicate Devices |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Connected OR Hub with Device and Voice Control;<br>SDC4K Information Management System with Device and Voice Control<br>Connected OR Spoke | Connected OR Hub with Device and Voice Control (K212055)<br>SDC4K Information Management System with Device and Voice Control (K220108) |
| Feature(s) | Documentation Functionalities (Class I/Non-Medical Device functionalities)<br>Gathering patient demographic data, Capture, Record, Transfer, Display image/video of various formats, Archiving information | Same as subject device |
| | Device Control<br>Remote control of compatible medical device settings | Same as subject device |
| | Voice Control<br>Voice control of compatible medical device settings | Same as subject device |
| | Video Image Processing (VIP)<br>Smoke Detection<br>Enhanced Imaging<br>Smoke Evacuation<br>(Connected OR Hub with Device and Voice Control only) | Not available. |
| Device Control User Interface | Capacitive Graphical User Interface on LCD touchscreen<br>Voice recognition and control via wireless headset<br>Device Control via IR remote control and camera head directional keypad | Same as subject device |
| Connection to Controllable Devices | Wired connection: The console's device control ports via device control cables.<br>Wireless connection: The console is connected to the master Connected OR Spoke via an Ethernet cable, while devices at remote locations within the same OR are connected to the slave Connected OR Spoke via device control cables. The master and slave Spoke act as the wireless transfer medium to transfer device control data to / from the console | Same as subject device |

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| Item | Subject Devices | | Predicate Devices | |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------|--|
| | Connected OR Hub with Device and<br>Voice Control;<br>SDC4K Information Management<br>System with Device and Voice<br>Control | Connected OR Hub with<br>Device and Voice Control<br>(K212055) | SDC4K Information<br>Management System<br>with Device and Voice<br>Control (K220108) | |
| Controllable Devices | Stryker Devices: Class II Devices<br>Surgical Cameras (K132785, K182160,<br>K200310, K202592, K210088,<br>K211202, K212511, K214046,<br>K220895)<br>Light Sources (K142310, K151243,<br>K173866, K182160, K191046,<br>K192292, K02592, K210088,<br>K211202, K214046)<br>Insufflators (K063367, K170784,<br>K201361)<br>Pumps (K123441, K191259)<br>RF and Shaver System (K071859)<br>Wireless Monitor (K081995) | Same as subject device | Same as subject device | |
| | Class I/ II 510(k) exempt devices<br>Ceiling Mounted Room Lights (Class<br>II, Product Code: FSY) | | | |
| | Wired Monitor (Class I device) | | | |
| Hardware and Software Architecture | | | | |
| Embedded Software Design | Microsoft Windows 10 | Same as subject device | Same as subject device | |
| Electronic Circuit Design | Custom designed chipset, storage<br>solution and Capture Card.<br>CD/DVD drive: Not included in chassis<br>On-board storage: Hard Disk Drive<br>(HDD) and Solid-State Drive (SSD) | Same as subject device | Same as subject device | |
| Video Input and Output | (Connected OR Hub with Device and<br>Voice Control)<br>Input: DVI, RGBHV and HDMI<br>Output: DVI, HDMI<br>(SDC4K Information Management<br>System with Device and Voice Control)<br>Input: HDMI<br>Output: HDMI | Same as subject device | Input: HDMI<br>Output: HDMI | |
| Communication Protocol | DCM, SIDNE, SFB | SIDNE, SFB | SIDNE, SFB | |
| Wireless Technology | | | | |
| Data Transfer,<br>Documentation and Storage<br>(Class I/Non-Medical<br>functionality) | Wireless Standard: WLAN<br>802.11a/b/g/n/ac<br>Frequency: 2.4GHz and 5GHz | Same as subject device | Same as subject device | |
| Wireless technology for<br>Device and Voice Control | Voice Control headset (DECT<br>technology), IR Remote (Infrared) and<br>Connected OR Spoke (WiFi) | Same as subject device | Same as subject device | |
| Item | Subject Devices | Predicate Devices | | |
| | Connected OR Hub with Device and Voice Control;<br>SDC4K Information Management System with Device and Voice Control | Connected OR Hub with Device and Voice Control (K212055) | SDC4K Information Management System with Device and Voice Control (K220108) | |
| Electrical Safety/ EMC | | | | |
| Power rating | 100-240VAC ~50/60 Hz, 4A/2A maximum | Same as subject device | Same as subject device | |
| Electrical Safety | ANSI/AAMI ES60601-1 | Same as subject device | Same as subject device | |
| EMC | IEC 60601-1-2 | Same as subject device | Same as subject device | |

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## Performance Data:

Testing was completed in accordance with the following:

| Test | Method | Results |
|------------------------------------|------------------------------------------------------------------------------------|---------|
| Electrical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012<br>IEC 60601-1-6:2010+A1:2013+A2:2020 | Pass |
| EMC | IEC 60601-1-2:2014+A1:2020 | Pass |
| Software Validation & Verification | IEC 62304:2015 | Pass |
| Usability | IEC 62366-1:2020 | Pass |
| Performance - Bench | In accordance with device input specifications, user needs and<br>intended use | Pass |

NOTE: The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control is not patient contacting; therefore, biocompatibility testing is not required to support the determination of substantial equivalence. Additionally, the subject devices do not require clinical studies to support the determination of substantial equivalence.

### Conclusions:

The modifications to the subject devices do not raise new types of questions regarding safety and effectiveness compared to the predicate devices, and performance testing demonstrates that differences between the subject and predicate devices do not negatively impact the safety and effectiveness of the subject devices compared to the predicates and when they are used for the proposed indications for use. The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control subject devices in this 510(k) are considered to be substantially equivalent to the predicate devices K212055 and K220108.