Connected OR Hub with Device and Voice Control

K192172 · Stryker · GCJ · Sep 9, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K192172
• Device Name: Connected OR Hub with Device and Voice Control
• Applicant: Stryker
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 9, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The use of the Connected OR Hub with Device and Voice Control system 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 operating room personnel 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.

Device Story

System acts as central interface for operating room equipment; enables voice and remote control of compatible medical devices. Inputs include voice commands via headset/base station and IR signals from handheld remote. Transforms inputs into control signals for connected surgical equipment; eliminates manual adjustment or verbal coordination between staff. Also provides digital documentation (capture, transfer, store, display) of medical device data. Used in OR by surgeons and staff. Output allows hands-free or remote adjustment of surgical settings; improves workflow efficiency and reduces reliance on verbal communication. Does not contact patients.

Clinical Evidence

No clinical data. Performance testing not required due to lack of design changes and risk analysis confirming no new safety or effectiveness issues.

Technological Characteristics

Console-based system with IR remote and voice control headset/base station. Uses WLAN 802.11a/b/g/n/ac (2.4GHz/5.2GHz) for non-medical data. No patient-contacting materials. Software-based control architecture. Energy source: electrical.

Indications for Use

Indicated for use by surgeons and operating room personnel to provide voice and remote control of compatible medical devices, eliminating manual operation or verbal communication for equipment adjustment. Includes digital documentation functionality for capturing, transferring, storing, and displaying 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

• Stryker Connected OR Hub with Device and Voice Control (K181258)

Submission Summary (Full Text)

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September 9, 2019

Stryker Endoscopy Meagan Jones Principal Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138

Re: K192172

Trade/Device Name: Connected OR Hub 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: August 9, 2019 Received: August 12, 2019

Dear Meagan Jones:

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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) K192172

#### Device Name

Connected OR Hub with Device and Voice Control

Indications for Use (Describe)

Indications for Use:

The use of the Connected OR Hub with Device and Voice Control system 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary As required by 21 C.F.R Part 807.92(c)

### Submitter:

| Applicant | Stryker Endoscopy<br>5900 Optical Court<br>San Jose, CA 95138 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------|
| FDA Registration number | 2936485 |
| Contact Person | Meagan Jones<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | September 3, 2019 |

#### Subject Device:

| Name of Device | Connected OR Hub with Device and Voice Control | |
|-------------------------|------------------------------------------------|--|
| Common or Usual Name | SDC 4k Information Management System | |
| Classification Name | Laparoscope, General and Plastic Surgery | |
| Regulation number | 21 CFR 876.1500 | |
| Regulatory Class | Class II | |
| Product Code | GCJ | |
| Subsequent Product Code | HRX | |

#### Predicate Device:

| Name of Device | Stryker Connected OR Hub with Device and Voice Control, | |
|----------------|---------------------------------------------------------|--|
| | K181258 | |

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

#### Device Description:

The Connected OR Hub with Device and Voice Control is a medical device that allows the surgeon to control the state, selection, and settings of any compatible device attached to it. It also has operating room documentation functionalities (Class I device function) to electronically capture, transfer, store and display medical device data independently of the functions or parameters of the connected medical device.

The Connected OR Hub with Device and Voice Control consists of the following:

- a. A Connected OR Hub console (MDDS device)

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- b. A Device control package (contains an optional software upgrade and a handheld Infrared (IR) remote control) - Class II
- c. A Voice control package (contains an optional software upgrade and a headset and base station) - Class II

### Intended Use:

The use of the Connected OR Hub with Device and Voice Control system 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 operating room personnel 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.

#### Indications for Use:

The use of the Connected OR Hub with Device and Voice Control system 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 operating room personnel 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.

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

The proposed device uses the same device control communication protocols as the predicate device, employs the same voice recognition software engine and controls the same types of connected devices as the predicate device. The Connected OR Hub has similar technological characteristics as the predicate device in the following areas:

- . Operating principle
- Software architecture
- Electrical characteristics .
- . Mechanical characteristics
- . Communication characteristics
- . Performance characteristics
- Compatibility with controllable devices as listed in the product labeling ●
- . Energy source
- . Material (no patient contacting material)

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In accordance with 21 CFR807.92 (a) (6), a summary of the differences between the proposed and predicate device is provided in the Table below. A complete comparison of the technological characteristics between the proposed and predicate devices is provided in Section 12-Substantial Equivalence Discussion.

| Feature | Subject Device - Connected<br>OR Hub with Device and<br>Voice Control | Predicate Device - Connected<br>OR Hub with Device and<br>Voice Control, K181258 |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Stryker Endoscopy | Same as subject device |
| Submission Reference | Current Submission | K181258 |
| Intended use statement | The intended use of the<br>Connected OR Hub with Device<br>and Voice Control system is to<br>allow for voice control and<br>remote control of medical<br>device settings by surgeons or<br>operating room personnel,<br>thereby eliminating the need to<br>manually operate those devices<br>compatible with the Connected<br>OR Hub with Device and Voice<br>Control or to rely on verbal<br>communication between the<br>surgeon and other operating<br>room personnel in order to<br>adjust the surgical equipment. It<br>also has additional digital<br>documentation functionality to<br>electronically capture, transfer,<br>store and display medical device<br>data (Class I device function),<br>which is independent of the<br>functions or parameters of any<br>attached device. | Same as subject device |
| Feature | Subject Device - Connected<br>OR Hub with Device and<br>Voice Control | Predicate Device - Connected<br>OR Hub with Device and<br>Voice Control, K181258 |
| Indications for Use Statement | The intended use of the<br>Connected OR Hub with Device<br>and Voice Control system is to<br>allow for voice control and<br>remote control of medical<br>device settings by surgeons or<br>operating room personnel,<br>thereby eliminating the need to<br>manually operate those devices<br>compatible with the Connected<br>OR Hub with Device and Voice<br>Control or to rely on verbal<br>communication between the<br>surgeon and other operating<br>room personnel in order to<br>adjust the surgical equipment. It<br>also has additional digital<br>documentation functionality to<br>electronically capture, transfer,<br>store and display medical device<br>data (Class I device function),<br>which is independent of the<br>functions or parameters of any<br>attached device. | The Connected OR Hub is<br>indicated for use with<br>compatible endoscopic and<br>general surgery devices. The<br>Connected OR Hub can be used<br>in general laparoscopy,<br>nasopharyngoscopy, ear<br>endoscopy, sinuscopy, and<br>plastic surgery wherever a<br>laparoscope, endoscope, or an<br>arthroscope is indicated for use.<br>A few examples of the more<br>common endoscopic surgeries<br>are laparoscopic<br>cholecystectomy, laparoscopic<br>hernia repair, laparoscopic<br>appendectomy, laparoscopic<br>pelvic lymph node dissection,<br>laparoscopically assisted<br>hysterectomy, laparoscopic and<br>thorascopic anterior spinal<br>fusion, anterior cruciate<br>ligament reconstruction, knee<br>arthroscopy, shoulder<br>arthroscopy, small joint<br>arthroscopy, decompression<br>fixation, wedge resection, lung<br>biopsy, pleural biopsy, dorsal<br>sympathectomy, pleurodesis,<br>internal mammary artery<br>dissection for coronary artery<br>bypass, coronary artery bypass<br>grafting where endoscopic<br>visualization is indicated and<br>examination of the evacuated<br>cardiac chamber during<br>performance of valve<br>replacement. Connected OR<br>Hub users are general surgeons,<br>gynecologists, cardiac surgeons,<br>thoracic surgeons, plastic<br>surgeons, orthopedic surgeons,<br>ENT surgeons, and urologists. |
| Operating Principles | Use of IR remote control for<br>device control and RF<br>communication for voice control<br>of connected devices. | Same as subject device |
| Feature | Subject Device - Connected OR Hub with Device and Voice Control | Predicate Device - Connected OR Hub with Device and Voice Control, K181258 |
| Hardware and Software Architecture | No changes to hardware and software architecture for subject device from predicate device. | Same as subject device |
| Wireless technology<br>(for Class I and non-medical device functionality only) | Wireless Standard: WLAN 802.11a/b/g/n/ac<br>Frequency: 2.4GHz and 5.2Ghz | Same as subject device |
| Controllable devices | No changes to list of compatible devices between subject device and predicate device. See Section 12, Substantial Equivalence Discussion for complete list. | Same as subject device |

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## Performance Testing:

There are no significant design changes to the device leading to or because of the indications for use change. A risk analysis of the indications for use change concluded that the change in indication for use does not raise new issues of safety and effectiveness. Therefore, performance data are not necessary to evaluate the change in indications to a tool type indication.

### Conclusions:

The Connected OR Hub with Device and Voice Control is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the subject device when used as instructed.