(29 days)
Not Found
Unknown
While the device includes voice control and image processing, the description does not explicitly mention the use of AI or ML algorithms for these functions. The image processing is described as an "image enhancing algorithm" and "removal of surgical smoke," which could be rule-based or traditional image processing techniques rather than ML. The voice control is described as processing "spoken commands," which could also be achieved through non-ML methods. Without further detail, it's not possible to definitively confirm the presence of AI/ML.
No
The device is described as a platform for controlling other medical devices and for data management. While it interacts with medical devices used in therapeutic procedures, it does not itself perform a therapeutic function by treating or diagnosing a disease or condition. Its primary functions are control and data handling.
No
The device is described as a system for remote and voice control of medical device settings and for digital documentation of medical device data. It explicitly states that its data capture, transfer, storage, and display functionality is a "non-medical device function" and independent of the functions or parameters of any attached medical device. Its primary purpose is to facilitate the operation and management of other medical devices, not to diagnose medical conditions or provide diagnostic information. While it has an optional Video Image Processing feature which automates an image enhancing algorithm, this is for improving visual clarity during surgery, not for diagnostic interpretation.
No
The device description explicitly states that the device consists of "network compatible hardware platforms" and lists several hardware components including a "Base Console", "software activation USB dongle", "handheld Infrared (IR) remote control", and "wireless headset and base station".
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary function described is the control of medical device settings (voice and remote) and digital documentation of medical device data. This relates to the operation and management of surgical equipment, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The components and functionalities described are focused on hardware platforms for controlling other medical devices and managing data from them. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD Characteristics: The text 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 specimens
- Providing information for diagnosis, monitoring, or treatment based on specimen analysis
The device's function is centered around the control and data management of other medical devices used in the operating room. While it plays a role in the surgical workflow, it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for 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 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.
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 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 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 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:
- Base Console which includes:
a) Medical Device Data System (MDDS) functionalities
b) Optional Device Control feature
- d) Optional Video Image Processing (VIP) feature
-
- Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
-
- Voice Control Package (software activation USB dongle and a wireless headset and base station)
-
- Video Image Processing package (software activation USB dongle)
- Connected OR Spoke (MDDS)
The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Non-medical function) and can be marketed as standalone devices. When upgraded with the Device 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 provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone 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.
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, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was designed and developed in accordance with applicable requirements and stablish performance and safety of the subject devices (Connected OR Hub with Device and Voice Control and SDC4K information Management System with Device and Voice Control). These include software function testing executed in accordance with IEC 62304:2015, Medical device software - Software ife-cycle processes (FDA recognized voluntary consensus standard: 13-79) as well as EMC and Electrical Safety testing in accordance with IEC 60601-1-22014+A1:2020, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance – Colateral standard: Electromagnetic disturbances – Requirements and Tests (FDA-recognized voluntary consensus standard: 19-36) and IEC TR 60601-4-2 Edition 1.0 2016-05, Medical Electrical Equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems (FDArecognized voluntary consensus standard: 19-19), IEC 60601-1 Edition 3.2 2020-08 Consolidated Version equipment -Part 1: General requirements for basic satety and essential performance (FDA recognized voluntary consensus standard: 19-49) and IEC 60601-1-6:2010+A1:2013+A2:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (FDA-recognized voluntary consensus standard: 5-132). Verification and validation testing successfully completed demonstrated that the device conform with recognized safety standards, design input specifications, user needs and intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 18, 2023
Stryker Corporation Lauren Bentley Sr. Manager, Regulatory Affairs 5900 Optical Ct San Jose, California 95138
Re: K232157
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 19, 2023 Received: July 20, 2023
Dear Lauren Bentley:
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.
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Mark Trumbore -S Mark Trumbore -S
Date: 2023.08.18 15:10:05 -04'00'
Mark Trumbore
Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team 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:
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 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.
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 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.
3
510(k) Summary
Prepared on: 2023-07-20
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Stryker Corporation |
|---|---|
| Applicant Address | 5900 Optical Ct San Jose CA 95138 United States |
| Applicant Contact Telephone | (408) 754-2473 |
| Applicant Contact | Ms. Janki Bhatt |
| Applicant Contact Email | janki.bhatt@stryker.com |
| Correspondent Name | Stryker Corporation |
| Correspondent Address | 5900 Optical Ct San Jose CA 95138 United States |
| Correspondent Contact Telephone | (484) 985-0736 |
| Correspondent Contact | Ms. Lauren Bentley |
| Correspondent Contact Email | lauren.bentley@stryker.com |
21 CFR 807.92(a)(2)
| Device Trade Name | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control |
|---|---|
| Common Name | Endoscope and accessories |
| Classification Name | Laparoscope, General & Plastic Surgery |
| Regulation Number | 876.1500 |
| Product Code | GCJ |
21 CFR 807.92(a)(3)
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K230886 | Connected OR Hub with Device and Voice Control; SDC4K Information | GCJ |
21 CFR 807.92(a)(4)
Device Description Summary
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 controlThe Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components:
the state, selection, and settings of comected endoscopic and general surgery devices both wired and wirelessly.
- Base Console which includes:
a) Medical Device Data System (MDDS) functionalities
b) Optional Device Control feature
4
- d) Optional Video Image Processing (VIP) feature
-
- Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
-
- Voice Control Package (software activation USB dongle and a wireless headset and base station)
-
- Video Image Processing package (software activation USB dongle)
- Connected OR Spoke (MDDS)
The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GU), 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 provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone 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.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
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 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.
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 of medical device settings by surgeons or opersonnel, 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 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 Comparison
The subject devices, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control have the same indications for use and intended use as the predicate devices.
Technological Comparison
The subject devices and the predicate devices (Connected OR Hub with Device Control and SDC4K information Management System with Device and Voice Control) have the same technological characteristics (i.e., principles of operation, components, features, user interface, controllable devices, software design, video input and output, communication protocol(s), wireless technology and electrical safety/EMC/with the exception of the Connected OR Hub and SDC4K Consoles' internal hardware components. The subject devices' internal hardware was replaced with similar components that provide the same functionality, hence considered similar in technology.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical testing was designed and developed in accordance with applicable requirements and stablish performance and safety of the subject devices (Connected OR Hub with Device and Voice Control and SDC4K information Management System with Device and Voice Control). These include software function testing executed in accordance with IEC 62304:2015, Medical device software - Software ife-cycle processes (FDA recognized voluntary consensus standard: 13-79) as well as EMC and Electrical Safety testing in accordance with IEC 60601-1-22014+A1:2020, Medical Electrical Equipment - Part 1-2: General requirements for basic
5
safety and essential performance – Colateral standard: Electromagnetic disturbances – Requirements and Tests (FDA-recognized voluntary consensus standard: 19-36) and IEC TR 60601-4-2 Edition 1.0 2016-05, Medical Electrical Equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems (FDArecognized voluntary consensus standard: 19-19), IEC 60601-1 Edition 3.2 2020-08 Consolidated Version equipment -Part 1: General requirements for basic satety and essential performance (FDA recognized voluntary consensus standard: 19-49) and IEC 60601-1-6:2010+A1:2013+A2:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (FDA-recognized voluntary consensus standard: 5-132). Verification and validation testing successfully completed demonstrated that the device conform with recognized safety standards, design input specifications, user needs and intended uses.
The subject devices do not require clinical studies to support the determination of substantial equivalence.
The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device Control are the same or similar in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are the same or similar with respect to safety and effectiveness to the legally marketed predicate devices.