(178 days)
Not Found
No
The summary mentions "Voice Recognition Performance" and "Voice Accuracy Benchmark" which are functionalities that could be implemented using AI/ML, but the summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no further details about the voice control technology that would confirm the use of AI/ML. The focus of the device description is on control and documentation functionalities.
No.
The device is described as a control hub for compatible endoscopic and general surgery devices, allowing surgeons to control device settings and offering documentation functionalities. It does not directly provide therapy; rather, it facilitates the control and operation of other devices that may be therapeutic.
No
The device description and intended use indicate it is an operating room hub for controlling other surgical devices and documenting data, not for diagnosing medical conditions.
No
The device description explicitly states that the Connected OR Hub consists of a console, a device control package (including an IR remote control), and a voice control package (including a headset and base station), all of which are hardware components.
Based on the provided information, the ConnectedOR Hub is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used with compatible endoscopic and general surgery devices for visualization and control during surgical procedures. This is a direct interaction with the patient's body during surgery, not the examination of specimens in vitro (outside the body).
- Device Description: The description focuses on controlling surgical devices, managing data related to those devices, and providing voice control for the surgeon. It does not mention any components or functionalities related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in those specimens
- Providing diagnostic information based on laboratory analysis
The ConnectedOR Hub is a surgical control and information management system used during surgical procedures, which falls under the category of surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The ConnectedOR Hub is indicated for use with compatible endoscopic and general surgery devices. The ConnectedOR Hub can be used in general laparoscopy, nasopharyngoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectory, laparoscopic 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. ConnectedOR Hub users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, HRX
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 (also referred to as proposed device in the following sections) consists of the following:
- a. A Connected OR Hub console
- b. A Device control package (contains an optional software upgrade and a handheld Infrared (IR) remote control)
- c. A Voice control package (contains an optional software upgrade and a headset and base station)
The proposed device is the latest iteration of the Stryker SDC3 HD Information Management System with wireless device control (hereafter referred to as "predicate device", cleared under K160332). The device and voice control features of the proposed device are identical to the predicate device. The operating room documentation functionalities of electronically capturing, transferring, storing and displaying medical device data (Class I device functions) independently of the functions or parameters of any connected medical device remain similar to the predicate device. The proposed device accesses existing controls within each device and is secondary to the built-in control interface that is already on each device which is identical to the predicate device
Although the device and voice control characteristics of the proposed device remain the same as compared to the predicate device, the operating system and the hardware were altered significantly leading to the need for a traditional submission per the FDA guidance Deciding When to Submit a 510(k) for a Change to an Existing Device and Deciding When to Submit a 510(k) for a Software Change to an Existing Device. This submission hence focuses on providing data regarding substantial equivalence of the proposed device (Stryker Connected OR Hub with Device and Voice Control) to the predicate device (Stryker SDC3 HD Information Management System with wireless device and voice control)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ConnectedOR Hub users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
The intended 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 the surgeons or operating room personnel, thereby eliminating the need of manual operation of those devices compatible with the Connected OR Hub, or relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests Performed:
- Device and Voice Control performance: Verified if the performance of device and voice control functionalities with compatible devices is in accordance with device performance specifications.
- Compatibility with Connected OR Spoke: Verified if proposed device was compatible with Connected OR Spoke in accordance with device performance specification.
- Environmental performance: The functionality of the product was verified for the specified operating temperature and humidity range.
- Video Compatibility: Verified if the Connected OR Hub is compatible with supported Cameras, Monitors, and peripherals that the Stryker customers use in the field.
- Memory Profiling and Performance: Verified if the performance and system response times of the Class II Medical Device functionality (Voice and Device Control functionality) while the Connected OR Hub's Class I documentation functionalities is in use are in accordance with device performance specifications.
- Voice Recognition Performance: Verified if the voice recognition performance of the proposed system when voice commands are issued to the system in accordance with device performance specification.
- Voice Accuracy Benchmark: Verified if the voice recognition accuracy of the proposed system when voice commands are issued to the proposed system are equivalent or better to the predicate system.
- Wireless technology performance: Verified the performance and coexistence of the wireless technology in the proposed device in accordance with AAMI TIR 69:2017, ANSI C63.27:2017 and FDA guidance document Radio Frequency Wireless Technology in Medical Devices.
- Electrical Safety: In accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).
- EMC Testing: In accordance with IEC60601-1-2 Edition 4.0 2014-02.
- Usability: Product was designed and tested per IEC 60601-1-6 Edition 3.1 2013-10 and ANSI/AAMI/IEC 62366-1:2015.
- System validation and simulated user testing: Validated system performance in accordance with defined user needs and device performance specifications.
- Software Validation & Verification: In accordance with IEC 62304 and FDA Guidance Document Principles of Software Validation.
- Cybersecurity verification and Network scan: In accordance with device performance specifications, cybersecurity risk assessment and FDA guidance documents - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Results: All tests passed.
NOTE: The Connected OR Hub with Device and Voice Control does not require clinical studies to support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
November 5, 2018
Stryker Jay Nayar Staff Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138
Re: K181258
Trade/Device Name: ConnectedOR 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: September 26, 2018 Received: September 28, 2018
Dear Jay Nayar:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows a digital signature. The signature is from Long H. Chen -S. The date of the signature is 2018.11.05, and the time is 14:30:52 -05'00'.
Date: 2018.11.05
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181258
Device Name
ConnectedOR Hub with Device and Voice Control
Indications for Use (Describe)
The ConnectedOR Hub is indicated for use with compatible endoscopic and general surgery devices. The ConnectedOR Hub can be used in general laparoscopy, nasopharyngoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectory, laparoscopic 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. ConnectedOR Hub users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5. 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
General Information:
| 510(k) Sponsor: | Stryker Endoscopy |
|---|---|
| Address | 5900 Optical Court |
| San Jose, CA 95138 | |
| FDA Registration Number | 2936485 |
| Contact Information | April Malmborg |
| Director, Regulatory Affairs | |
| Phone: 408-754-2473 | |
| Email: april.malmborg@stryker.com | |
| Date Prepared | 11/02/2018 |
Device Identification:
Proposed Device:
| Trade Name | Connected OR Hub with Device and Voice Control |
|---|---|
| Common Name | SDC 4K Information Management System |
| Regulatory Class | II |
| Classification Name | Laparoscope, General and Plastic Surgery |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | GCJ |
| Subsequent Product Code | HRX |
Predicate Device:
| Trade Name | Stryker SDC3 HD Information Management System with
Wireless Device Control Capability |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Common Name | SDC3 HD Information Management System |
| Regulatory Class | II |
| Classification Name | Laparoscope, General and Plastic Surgery |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | GCJ |
| Subsequent Product Code | HRX |
| This device has not been subjected to a design-related recall | |
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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 (also referred to as proposed device in the following sections) consists of the following:
- a. A Connected OR Hub console
- b. A Device control package (contains an optional software upgrade and a handheld Infrared (IR) remote control)
- c. A Voice control package (contains an optional software upgrade and a headset and base station)
The proposed device is the latest iteration of the Stryker SDC3 HD Information Management System with wireless device control (hereafter referred to as "predicate device", cleared under K160332). The device and voice control features of the proposed device are identical to the predicate device. The operating room documentation functionalities of electronically capturing, transferring, storing and displaying medical device data (Class I device functions) independently of the functions or parameters of any connected medical device remain similar to the predicate device. The proposed device accesses existing controls within each device and is secondary to the built-in control interface that is already on each device which is identical to the predicate device
Although the device and voice control characteristics of the proposed device remain the same as compared to the predicate device, the operating system and the hardware were altered significantly leading to the need for a traditional submission per the FDA guidance Deciding When to Submit a 510(k) for a Change to an Existing Device and Deciding When to Submit a 510(k) for a Software Change to an Existing Device. This submission hence focuses on providing data regarding substantial equivalence of the proposed device (Stryker Connected OR Hub with Device and Voice Control) to the predicate device (Stryker SDC3 HD Information Management System with wireless device and voice control)
Indications for Use:
This submission is not proposing any changes from the indications cleared for the predicate device.
The Connected OR Hub is indicated for use with compatible endoscopic and general surgery devices. The Connected OR Hub can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic
5
lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder 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. Connected OR Hub users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
Intended Use:
This submission is not proposing any changes from the intended uses cleared for the predicate device.
The intended 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 the surgeons or operating room personnel, thereby eliminating the need of manual operation of those devices compatible with the Connected OR Hub, or relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment. It also has an additional digital documentation functionality to electronically capture, transfer, store and display medical device data (Class I device function), which is independent of the functions or parameters of any attached device.
Comparison of Technological Characteristics with the Predicate Device:
The Connected OR Hub with Device and Voice Control has the same technological characteristics and design as the predicate with the exception of the software operating system and internal hardware components. The software and hardware were upgraded to support product sustainment, higher processing speeds and higher video resolution. All other technological characteristics of the proposed device are the predicate. 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 principles ●
- Software architecture ●
- Electrical characteristics
- Mechanical characteristics
- Communication characteristics
- Performance characteristics ●
- . Compatibility with controllable devices as listed in the product labeling
- Energy source
- Materials (no patient contacting materials) ●
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Image /page/6/Picture/1 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 the logo for Stryker Corporation, a medical technology company.
A complete comparison of technological characteristics between the proposed and predicate devices is provided in Section 14- Substantial Equivalence Discussion.
Summary of Non-Clinical Testing Performed:
| Test | Method | Results |
|---|---|---|
| Device and | ||
| Voice Control | ||
| performance | Verified if the performance of device and voice control | |
| functionalities with compatible devices is in accordance with | ||
| device performance specifications. | Pass | |
| Compatibility | ||
| with Connected | ||
| OR Spoke | Verified if proposed device was compatible with Connected | |
| OR Spoke in accordance with device performance | ||
| specification. | Pass | |
| Environmental | ||
| performance | The functionality of the product was verified for the specified | |
| operating temperature and humidity range. | Pass | |
| Video | ||
| Compatibility | Verified if the Connected OR Hub is compatible with | |
| supported Cameras, Monitors, and peripherals that the Stryker | ||
| customers use in the field. | Pass | |
| Memory | ||
| Profiling and | ||
| Performance | Verified if the performance and system response times of the | |
| Class II Medical Device functionality (Voice and Device | ||
| Control functionality) while the Connected OR Hub's Class I | ||
| documentation functionalities is in use are in accordance with | ||
| device performance specifications. | Pass | |
| Voice | ||
| Recognition | ||
| Performance | Verified if the voice recognition performance of the proposed | |
| system when voice commands are issued to the system in | ||
| accordance with device performance specification. | Pass | |
| Voice Accuracy | ||
| Benchmark | Verified if the voice recognition accuracy of the proposed | |
| system when voice commands are issued to the proposed | ||
| system are equivalent or better to the predicate system. | Pass | |
| Wireless | ||
| technology | ||
| performance | Verified the performance and coexistence of the wireless | |
| technology in the proposed device in accordance with AAMI | ||
| TIR 69:2017, ANSI C63.27:2017 and FDA guidance | ||
| document Radio Frequency Wireless Technology in Medical | ||
| Devices. | Pass | |
| Electrical Safety | In accordance with ANSI/AAMI ES60601-1:2005/(R)2012 | |
| and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | ||
| (Consolidated Text) | Pass | |
| EMC Testing | In accordance with IEC60601-1-2 Edition 4.0 2014-02 | Pass |
| Usability | Product was designed and tested per IEC 60601-1-6 Edition | |
| 3.1 2013-10 and ANSI/AAMI/IEC 62366-1:2015 | Pass | |
| System | ||
| validation and | ||
| simulated user | ||
| testing | Validated system performance in accordance with defined user | |
| needs and device performance specifications | Pass | |
| Software | ||
| Validation & | ||
| Verification | In accordance with IEC 62304 and FDA Guidance Document | |
| Principles of Software Validation | Pass | |
| Test | Method | Results |
| Cybersecurity | ||
| verification and | ||
| Network scan | In accordance with device performance specifications, cybersecurity risk assessment and FDA guidance documents - | |
| Content of Premarket Submissions for Management of | ||
| Cybersecurity in Medical Devices | Pass |
7
sti
NOTE: The Connected OR Hub with Device and Voice Control does not require clinical studies to support the determination of substantial equivalence.
Conclusion:
Based upon the indications for use, intended use, technological characteristic, performance testing and comparison to the predicate device, the Stryker Connected OR Hub with Device and Voice Control raises no new questions of safety and effectiveness as compared to the predicate device.