(90 days)
Not Found
No
The summary describes voice and remote control functionality and data management, but does not mention AI or ML in the device description, intended use, or performance studies. While voice recognition could potentially use ML, the summary does not provide any indication that it does.
No
The device is designed for controlling other medical devices and managing data, not for direct therapeutic intervention on a patient.
No
The device is described as a system for voice and remote control of medical device settings and for digital documentation of medical device data. It explicitly states that its documentation functionality is a "non-medical device function" and that the device carries out "Medical Device Data System (MDDS) functionalities." MDDS devices do not acquire or interpret diagnostic data. There is no indication that the device performs any diagnostic function, rather it controls other medical devices.
No
The device description explicitly states that the device consists of "network compatible hardware platforms" and lists several hardware components like a "Base Console," "USB dongle," "handheld Infrared (IR) remote control," and "wireless headset and base station."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The intended use and device description clearly state that the Connected OR Hub and SDC4K Information Management System are used for:
- Voice and remote control of medical device settings during surgery.
- Digital documentation of medical device data.
- Medical Device Data System (MDDS) functionalities.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from a patient. Its function is related to controlling and managing other medical devices and their data within the operating room environment.
Therefore, the device's purpose and functionality do not align with the definition of an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
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 compatible connected 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
- c) Optional Voice 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 and/or Voice Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices. The Connected OR Hub and SDC4K centrally manage foot pedal assignments for the Surgical Drill System and Ultrasonic Aspirator System handpieces, utilizing device or voice control inputs from the systems or directly from the connected foot pedal.
In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control also provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the Connected OR Hub with Device and Voice Control or SDC4K Information Management System with Device and Voice Control is connected to the Spoke, Device Control can be extended to compatible devices which are directly connected to the Spoke. Ethernet-compatible devices are connected to the Secondary Spoke via an ethernet cable/switch.
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)
- Electrical Safety: In accordance with FDA-recognized voluntary consensus standard IEC 60601-1:2020 (19-49), Pass.
- EMC: In accordance with FDA-recognized voluntary consensus standard IEC 60601-1-2:2014+A1:2020 (19-36), Pass.
- Wireless Technology: In accordance with FDA-recognized voluntary consensus standard AAMI TIR69:2017/(R2020) (19-22) and ANSI C63.27:2017 (19-29), Pass.
- Reprocessing: In accordance with FDA-recognized voluntary consensus standard ISO 17664-2:2021 (14-579), AAMI TIR12:2020 and AAMI TIR 30: 2011, Pass.
- Software Verification and Validation: In accordance with FDA-recognized voluntary consensus standard IEC 62304:2006+A1:2015 (13-79), Pass.
- Cybersecurity: In accordance with FDA Guidance for Industry and Staff - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 2023), Pass.
- Usability: In accordance with FDA-recognized voluntary consensus standard IEC 62366-1:2015+AMD1:2020 (5-129), Pass.
- Performance - Bench: In accordance with device input specifications, user needs and intended uses: Video Compatibility, Environmental Compatibility, Voice Recognition Performance, System Design Validation, Pass.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 15, 2024
Stryker Endoscopy Sekar Divya Principal Regulatory Affairs Specialist 5900 Optical Ct San Jose, California 95138
Re: K241401
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: May 16, 2024 Received: May 17, 2024
Dear Sekar Divya:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long H. Chen -S Digitally signed by Long H.Chen -S
Date: 2024.08.15 14:20:11 -04'00'
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) K241401
Device Name
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Indications for Use (Describe)
Connected OR Hub with Device and Voice Control:
The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other 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.
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
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R Part 807.92(c).
510(k) Number: K241401
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Divya Sekar
Principal Regulatory Affairs Specialist
Email: divya.sekar@stryker.com
Phone: 408-754-2473 |
| Date Prepared: | August 14, 2024 |
Subject Device:
| Name of Device: | Connected OR Hub with Device and Voice Control;
SDC4K Information Management System with Device and Voice Control |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name | Endoscope and accessories |
| Classification Name: | Laparoscope, General & Plastic Surgery (21 C.F.R. §876.1500) |
| Subsequent Classification Name: | Arthroscope, Orthopedic (21 C.F.R. §888.1100) |
| Regulatory Class: | II |
| Product Code: | GCJ |
| Subsequent Product Code | HRX |
| 510(k) Review Panel: | General and Plastic Surgery |
Predicate Devices:
| Connected OR Hub with Device and Voice Control | K232157 (primary) |
|---|---|
| SDC4K Information Management System with Device and Voice Control | K230886, K222079 |
NOTE: The predicate devices have not been subject to a design-related recall.
4
Device Description:
The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected 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
- c) Optional Voice 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 and/or Voice Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices. The Connected OR Hub and SDC4K centrally manage foot pedal assignments for the Surgical Drill System and Ultrasonic Aspirator System handpieces, utilizing device or voice control inputs from the systems or directly from the connected foot pedal.
In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control also provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the Connected OR Hub with Device and Voice Control or SDC4K Information Management System with Device and Voice Control is connected to the Spoke, Device Control can be extended to compatible devices which are directly connected to the Spoke. Ethernet-compatible devices are connected to the Secondary Spoke via an ethernet cable/switch.
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.
5
Intended Use/Indications for Use:
| Subject Devices | Predicate Devices |
|---|---|
| Connected OR Hub with Device and Voice Control; | |
| SDC4K Information Management System with Device and Voice Control | Connected OR Hub with Device and |
| Voice Control; | |
| SDC4K Information Management | |
| System with Device and Voice Control | |
| NOTE: Connected OR Hub with Device and Voice Control and SDC4K | |
| Information Management System with Device and Voice Control have the | |
| same Intended Use/Indications for Use; only the names of the device differ. | |
| Connected OR Hub with Device and Voice Control: | |
| The use of the Connected OR Hub with Device and Voice Control is to allow | |
| for remote control and 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 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. | K232157 (primary), K230886, K222079 |
| Same as subject device (Connected OR | |
| Hub with Device and Voice Control) | |
| 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 remote control and voice 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. |
Comparison of Technological Characteristics with the Predicate Device:
| Item | Subject Devices | Predicate Devices | |
|---|---|---|---|
| Connected OR Hub with Device and Voice | |||
| Control; SDC4K Information Management | |||
| System with Device and Voice Control | Connected OR Hub with Device and Voice | ||
| Control; SDC4K Information | |||
| Management System with Device and | |||
| Voice Control | |||
| Manufacturer | Stryker | Same as subject devices | |
| Submission Reference | Current Submission | K232157 (primary), K230886, K222079 | |
| Principles of Operation | Use of IR remote control for device control | ||
| and RF communication for voice control of | |||
| connected devices. | Same as subject devices | ||
| Device Components | Console (Connected OR Hub & SDC4K) Device Control Package Voice Control Package Connected OR Hub VIP Package Connected OR Spoke | Same as subject devices | |
| Item | Subject Devices | ||
| Connected OR Hub with Device and Voice Control; SDC4K Information Management | |||
| System with Device and Voice Control | Predicate Devices | ||
| Connected OR Hub with Device and Voice Control; SDC4K Information | |||
| Management System with Device and | |||
| Voice Control | |||
| Feature(s) | Documentation | ||
| Functionalities | |||
| (Non-Medical | |||
| Device | |||
| functionalities) | Gathering patient demographic data, Capture, | ||
| Record, Transfer, Display image/video of | |||
| various formats, Archiving information | Same as subject devices | ||
| Device Control | Remote control of compatible medical device | ||
| settings | Same as subject devices | ||
| Voice Control | Voice control of compatible medical device | ||
| settings | Same as subject devices | ||
| Video Image | |||
| Processing (VIP) | Smoke Detection Enhanced Imaging Smoke Evacuation NOTE: The VIP feature is not available on the | ||
| SDC4K. | Same as subject devices | ||
| Device Control User | |||
| Interface | Capacitive Graphical User Interface on | ||
| LCD touchscreen Voice recognition and control via | |||
| wireless headset Device Control via IR remote control and | |||
| camera head directional keypad | Same as subject devices | ||
| Connection to Controllable | |||
| Devices | Wired connection: | ||
| Using USB port: The controllable devices | |||
| are connected to the console's USB | |||
| port(s) via USB cable. Using SORN port: The Connected OR Spoke is | |||
| connected to the console's SORN | |||
| port via ethernet cable, while the | |||
| controllable devices are connected to | |||
| the Connected OR Spoke via USB | |||
| and/or firewire cables. The controllable devices are | |||
| connected to the console's SORN | |||
| port via ethernet cable/switch. | Wired connection: | ||
| Using USB port: The controllable | |||
| devices are connected to the console's | |||
| USB port(s) via USB cable. Using SORN port: The Connected OR Spoke is | |||
| connected to the console's | |||
| SORN port via ethernet cable, | |||
| while the controllable devices | |||
| are connected to the Connected | |||
| OR Spoke via USB and/or | |||
| firewire cables. | |||
| Wireless connection: | |||
| The primary Connected OR spoke is | |||
| connected to the console's SORN port via | |||
| an ethernet cable, while controllable | |||
| devices at remote locations within the | |||
| same OR are connected to the secondary | |||
| Connected OR Spoke via USB and/or | |||
| firewire cables. Ethernet- compatible | |||
| devices are connected to the Secondary | |||
| Spoke via an ethernet cable/switch. The | |||
| primary and secondary Spoke act as the | |||
| wireless transfer medium to transfer | |||
| device control data to / from the console. | Wireless connection: | ||
| The primary Connected OR spoke is | |||
| connected to the console's SORN port | |||
| via an ethernet cable, while controllable | |||
| devices at remote locations within the | |||
| same OR are connected to the secondary | |||
| Connected OR Spoke via device control | |||
| cables. The primary and secondary | |||
| Spoke act as the wireless transfer | |||
| medium to transfer device control data to | |||
| / from the console. | |||
| Item | Subject Devices | Predicate Devices | |
| Connected OR Hub with Device and Voice | |||
| Control; SDC4K Information Management | |||
| System with Device and Voice Control | Connected OR Hub with Device and Voice | ||
| Control; SDC4K Information | |||
| Management System with Device and | |||
| Voice Control | |||
| Controllable Devices | Class II Devices: | ||
| ● Surgical Cameras (K132785, K211202, | |||
| K212511, K214046, K231854, K233327, | |||
| K240174) | |||
| ● Light Sources (K142310, K151243, | |||
| K192292, K214046, K221611, K231854) | |||
| ● Insufflators (K063367, K170784, | |||
| K201361) | |||
| ● Irrigation Pumps (K123441, K191259) | |||
| ● RF Probes and Shaver System (K071859, | |||
| K160050, K171391) | |||
| ● Wireless Monitor (K081995) | |||
| ● Surgical Drill System (K171840) | Class II Devices: | ||
| ● Surgical Cameras (K132785, K211202, | |||
| K212511, K214046, K231854, | |||
| K233327, K240174) | |||
| ● Light Sources (K142310, K151243, | |||
| K192292, K214046, K221611, | |||
| K231854) | |||
| ● Insufflators (K063367, K170784, | |||
| K201361) | |||
| ● Irrigation Pumps (K123441, K191259) | |||
| ● RF Probes and Shaver System | |||
| (K071859, K160050, K171391) | |||
| ● Wireless Monitor (K081995) | |||
| Unclassified Devices: | |||
| ● Ultrasonic Aspirator System (K213824, | |||
| K190070) | Class I/ II 510(k) exempt devices: | ||
| ● Ceiling Mounted Room Lights (Class II, | |||
| Product Code: FSY) | |||
| Class I/ II 510(k) exempt devices: | |||
| ● Ceiling Mounted Room Lights (Class II, | |||
| Product Code: FSY) | |||
| ● Wired Monitor (Class I device) | ● Wired Monitor (Class I device) | ||
| Embedded Software Design | 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 | (Connected OR Hub with Device and Voice | ||
| Control) | |||
| Input: DVI, RGBHV and HDMI | |||
| Output: DVI, HDMI |
(SDC4K Information Management System
with Device and Voice Control)
Input: HDMI
Output: HDMI | Same as subject device | |
| Communication Protocol(s) | Wired: SIDNE, DCM
Wireless: DCM, SIDNE, SFB | Same as subject device | |
| Data Transfer,
Documentation and Storage
(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 | ● Voice Control headset (DECT
technology)
● IR Remote (Infrared)
● Connected OR Spoke (WiFi) | Same as subject device | |
| 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 | |
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Summary of technological characteristics:
The subject and the predicate devices (Connected OR Hub with Device and Voice Control and SDC4K information Management System with Device and Voice Control) have the same following technological characteristics (i.e., Principles of operation, Components, User interface, Software design, Circuit design, Video input and output, Communication protocol(s), Wireless technology and Electrical safety / EMC) except for the inter device communication with additional Stryker devices via ethernet-based communication.
Description of nonclinical and clinical tests:
The subject devices (Connected OR Hub with Device and Voice Control and SDC4K information Management System with Device and Voice Control) have been evaluated and conform with recognized standards, device input specifications, user needs and intended uses. A summary of testing is provided in the table below:
| Test | Method | Results |
|---|---|---|
| Electrical Safety | • In accordance with FDA-recognized voluntary consensus standard IEC | |
| 60601-1:2020 (19-49) | Pass | |
| EMC | • In accordance with FDA-recognized voluntary consensus standard IEC | |
| 60601-1-2:2014+A1:2020 (19-36) | Pass | |
| Wireless Technology | • In accordance with FDA-recognized voluntary consensus standard | |
| AAMI TIR69:2017/(R2020) (19-22) | ||
| • In accordance with FDA-recognized voluntary consensus standard | ||
| ANSI C63.27:2017 (19-29) | Pass | |
| Reprocessing | • In accordance with FDA-recognized voluntary consensus standard ISO | |
| 17664-2:2021 (14-579) | ||
| • In accordance with AAMI TIR12:2020 | ||
| • In accordance with AAMI TIR 30: 2011 | Pass | |
| Software Verification | ||
| and Validation | • In accordance with FDA-recognized voluntary consensus standard IEC | |
| 62304:2006+A1:2015 (13-79) | Pass | |
| Cybersecurity | • In accordance with FDA Guidance for Industry and Staff - | |
| Cybersecurity in Medical Devices: Quality System Considerations and | ||
| Content of Premarket Submissions (September 2023) | Pass | |
| Usability | • In accordance with FDA-recognized voluntary consensus standard IEC | |
| 62366-1:2015+AMD1:2020 (5-129) | Pass | |
| Performance - Bench | • In accordance with device input specifications, user needs and intended | |
| uses: | ||
| • Video Compatibility | ||
| • Environmental Compatibility | ||
| • Voice Recognition Performance | ||
| • System Design Validation | Pass |
NOTE: The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control is not patient contacting; therefore, biocompatibility testing is not required to support the determination of substantial equivalence.
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Conclusion:
The modifications to the subject devices do not raise new types of questions regarding safety and effectiveness compared to the predicate devices, and performance testing demonstrates that differences between the subject and predicate devices do not negatively impact the safety and effectiveness of the subject devices compared to the predicates when they are used for the proposed indications for use. The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control subject devices in this 510(k) are substantially equivalent to the predicate devices K232157 (primary), K230886, K222079 for the proposed indications for use.