(168 days)
Not Found
No
The document describes voice control and device control based on user input (voice commands, IR remote, touchscreen). While voice recognition can sometimes involve ML, the description here focuses on the control aspect and doesn't mention any learning, adaptation, or complex pattern recognition beyond interpreting direct commands. The image processing mentioned is described as an "enhanced image algorithm" and smoke removal, which doesn't necessarily imply AI/ML. There is no mention of AI, ML, or related terms like deep learning or neural networks.
No
The device is described as a control system for other medical devices and a Medical Device Data System (MDDS), which manages data and device settings. It does not directly provide therapy or affect the body's structure or function for treatment. Its function is to facilitate the operation and documentation of other medical devices.
No
The device is described as a system for voice and remote control of medical device settings, and for documentation of medical device data. It does not provide any diagnostic information about a patient's health condition.
No
The device description explicitly states it is a "network compatible hardware platform" and lists hardware components like the "Connected OR Hub Console" and "Connected OR Spoke". While it includes software features, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for controlling and documenting settings of medical devices in the operating room. It focuses on workflow efficiency and data management, not on analyzing biological samples or providing diagnostic information about a patient's health status.
- Device Description: The description details a hardware platform with functionalities for device control, voice control, and data management (MDDS). It does not mention any components or processes related to in vitro testing of samples.
- Lack of IVD Indicators: There are no mentions of analyzing biological samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD device.
The device functions as a control and data management system for other medical devices within the operating room environment.
N/A
Intended Use / 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.
Product codes
GCJ, HRX
Device Description
The Connected OR Hub with Device and Voice Control is a network compatible hardware platform that carries 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 consists of the following components:
-
- The Connected OR Hub Console which includes:
- a. Class I Medical Device Data System (MDDS) functionality
- b. Device Control package (optional software feature and a handheld Infrared (IR) remote control)
- c. Voice Control package (optional software feature and a headset and base station)
- d. Video Imaging Process (VIP) package (optional software feature)
-
- Connected OR Spoke (Class I MDDS)
The Connected OR Hub console carries out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as a standalone device. When upgraded with the Device Control and/or Voice Control package, the Connected OR Hub Console extends its functionality to control compatible devices from its touchscreen graphical user interface (GUI), spoke commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). In addition, the Device and Voice Control package also provide compatibility with the Connected OR Spoke which is a standalone Class I Medical Device Data System. Once the Connected OR Hub is connected to the Spoke, Device Control can be extended to compatible devices connected directly to the Spoke. When upgraded with the Video Image Processing package, the Connected OR Hub automates an enhanced image algorithm and removal of surgical smoke through a compatible insufflator.
Mentions image processing
Yes
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
surgeons or operating room personnel
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: Bench Performance Testing
Sample Size: Not specified
Key Results: Testing was completed in accordance with device input specifications, user needs and intended uses. Results: Pass
Study Type: Electrical Safety
Method: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012
Results: Pass
Study Type: EMC
Method: IEC 60601-1-2:2014
Results: Pass
Study Type: Software Validation & Verification
Method: IEC 62304:2015
Results: Pass
Study Type: Usability
Method: IEC 62366-1:2015
Results: Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the acronym "FDA" is displayed in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder blue font. Below that, the word "ADMINISTRATION" is written in a smaller blue font.
December 16, 2021
Stryker Endoscopy Eugene Perelshteyn Senior Regulatory Affairs Specialist 5900 Optical Ct San Jose, California 95138
Re: K212055
Trade/Device Name: Connected OR Hub with Voice Control Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 30, 2021 Received: July 1, 2021
Dear Eugene Perelshteyn:
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.
1
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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K212055
Device Name
Connected OR Hub with Device and Voice Control
Indications for Use (Describe)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K212055
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R.Part 807.92(c).
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eugene Perelshteyn
Senior Regulatory Affairs Specialist
Phone: (469) 470-4312
Email: Eugene.Perelshteyn@stryker.com |
| Date Prepared: | June 30, 2021 |
Subject Device:
| Name of Device: | Connected OR Hub 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 Device:
| Connected OR Hub with Device and Voice Control | K201434, K192172, K181258 |
|---|---|
| ------------------------------------------------ | --------------------------- |
NOTE: The predicate device has not been subject to a design-related recall.
4
K212055
Device Description:
The Connected OR Hub with Device and Voice Control is a network compatible hardware platform that carries 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 consists of the following components:
-
- The Connected OR Hub Console which includes:
- a. Class I Medical Device Data System (MDDS) functionality
- b. Device Control package (optional software feature and a handheld Infrared (IR) remote control)
- c. Voice Control package (optional software feature and a headset and base station)
- d. Video Imaging Process (VIP) package (optional software feature)
-
- Connected OR Spoke (Class I MDDS)
The Connected OR Hub console carries out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as a standalone device. When upgraded with the Device Control and/or Voice Control package, the Connected OR Hub Console extends its functionality to control compatible devices from its touchscreen graphical user interface (GUI), spoke commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). In addition, the Device and Voice Control package also provide compatibility with the Connected OR Spoke which is a standalone Class I Medical Device Data System. Once the Connected OR Hub is connected to the Spoke, Device Control can be extended to compatible devices connected directly to the Spoke. When upgraded with the Video Image Processing package, the Connected OR Hub automates an enhanced image algorithm and removal of surgical smoke through a compatible insufflator.
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.
5
| Item | Subject Device
Connected OR Hub with Device and Voice Control | Predicate Device
Connected OR Hub with Device
and Voice Control (K201434) |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Manufacturer | Stryker | 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. |
| Device Components | Connected OR Hub console
Device Control Software
Voice Control Software
Connected OR Spoke | Same as subject device |
| Feature(s) Documentation
Functionalities
(Class I/Non-Medical Device
functionalities) | Gathering patient demographic data,
Capture,
Record,
Transfer,
Display image/video of various formats,
Archiving information | Same as subject device |
| Device Control | Remote control of compatible medical device settings | Same as subject device |
| Voice Control | Voice control of compatible medical device settings | Same as subject device |
| Video Image
Processing
(VIP) | Smoke Detection
Enhanced Imaging
Smoke Evacuation | Same as subject device |
| Device Control User
Interface | Capacitive touch Graphical User Interface on LCD
touchscreen
Voice Recognition and Control via wireless headset
Device Control via IR Remote Control
Device Control via Camera Head directional keypad | Same as subject device |
| Connection to Controllable
Devices | Wired connection: Connected OR Hub's device control ports via device control cables.
Wireless connection: Connected OR Hub is connected to 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 Spokes act as the wireless transfer medium to transfer device control data to / from Connected OB Hub | Same as subject device |
| Item | Subject Device | Predicate Device |
| | Connected OR Hub with Device and Voice Control | Connected OR Hub with Device
and Voice Control (K201434) |
| Controllable Devices | Stryker Devices: Class II Devices
Surgical Cameras (K132785, K182160, K200310,
K202592, K210088)
Light Sources (K142310, K151243, K173866, K182160,
K191046, K192292, K202592, K210088)
Insufflators (K063367, K170784, K201361)
Pumps (K123441)
RF and Shaver System (K071859)
Wireless Monitor (K081995)
Class I/ II 510(k) exempt devices
Ceiling Mounted Room Lights
(Class II, Product Code: FSY)
Wired Monitor (Class I device) | Same as subject device. |
| Hardware and Software Architecture | | |
| Embedded Software Design | Embedded Microsoft Windows 10 | Same as subject device |
| Electronic Circuit Design | Custom designed chipset, storage solution and Capture
Card.
CD/DVD drive: Not included in chassis
On-board storage: Hard Disk Drive (HDD) and Solid-
State Drive (SSD) | Same as subject device |
| Video Input and Output | Input: DVI, RGBHV and HDMI
Output: DVI, HDMI | Same as subject device |
| Wireless Technology | | |
| Data Transfer,
Documentation and Storage
(Class I/Non-Medical
functionality) | Wireless Standard: WLAN
802.11a/b/g/n/ac
Frequency: 2.4GHz and 5GHz | Same as subject device. |
| Wireless technology for
Device and Voice Control | Wireless components used for device and voice control
are Voice Control headset (DECT technology), IR
Remote (Infrared) and Connected OR Spoke WiFi | Same as subject device. |
| Electrical Safety/ EMC | | |
| Power rating | 100-240VAC ~50/60 Hz, 4A/2A maximum | Same as subject device. |
| Electrical Safety | ANSI/AAMI ES60601-1 | Same as subject device. |
| EMC | IEC 60601-1-2 | Same as subject device. |
Comparison of Technological Characteristics with the Predicate Device:
6
7
Performance Data:
| Test | Method | Results |
|---|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 | Pass |
| EMC | IEC 60601-1-2:2014 | Pass |
| Software | ||
| Validation & | ||
| Verification | IEC 62304:2015 | Pass |
| Usability | IEC 62366-1:2015 | Pass |
| Performance – | ||
| Bench | In accordance with device input specifications, user | |
| needs and intended uses | Pass |
Testing was completed in accordance with the following:
NOTE: The Connected OR Hub with Device and Voice Control is not patient contacting; therefore, biocompatibility testing is not required to support the determination of substantial equivalence.
NOTE: The Connected OR Hub with Device and Voice Control does not require clinical studies to support the determination of substantial equivalence.
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 different questions of safety and/or effectiveness introduced by the Connected OR Hub with Device and Voice Control.