(82 days)
Not Found
No
The description focuses on voice and remote control, data capture, and basic image processing, without mentioning AI or ML algorithms for decision-making, pattern recognition, or learning.
No
The device is used to control other medical devices and manage data, not to directly treat a medical condition.
No
Explanation: The document describes the device as a system for controlling medical device settings and documenting data, primarily through voice and remote control. It does not mention any function related to diagnosing medical conditions. The "Medical Device Data System (MDDS) functionalities" are described as Class I device functions or non-medical functions, which typically involve data storage and transfer, not diagnosis.
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," "wireless headset and base station," and "Connected OR Spoke."
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the device is for controlling medical device settings and providing digital documentation functionality. It focuses on the operation and management of surgical equipment and data, not on the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a hardware platform with functionalities for controlling medical devices, voice control, and data management. It mentions Medical Device Data System (MDDS) functionalities, which are related to data transfer and storage, not in vitro testing.
- No mention of in vitro testing: There is no mention of analyzing biological samples, reagents, or any processes associated with in vitro diagnostics.
The device's function is centered around controlling and managing surgical equipment and associated data within the operating room environment. This falls outside the scope of an IVD, which is used to perform tests on samples taken from the body to diagnose diseases or conditions.
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 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 compatible 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) Class I 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 (Class I MDDS)
The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or 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.
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 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.
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)
Testing was completed in accordance with the following:
Software functional verification (Device and Voice Control with Spoke) - Pass
Network Security - Pass
Memory Profiling and Performance - Pass
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 & Drug Administration (FDA). On the left is the Department of Health & 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.
June 21, 2023
Stryker Endoscopy Lauren Bentley Senior Manager, Regulatory Affair 5900 Optical Ct San Jose, California 95138
Re: K230886
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: March 31, 2023 Received: March 31, 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); 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.
Image /page/1/Picture/5 description: The image shows the name "Mark Trumbore -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Mark Trumbore -S Date: 2023.06.21 13:37:52 -04:00'". This indicates that the document was digitally signed by Mark Trumbore on June 21, 2023 at 13:37:52 with a time zone offset of -04:00.
Mark Trumbore, 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)
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 opersonnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub or to rely on verbal communication between and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, 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 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) | |||
|---|---|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | │ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510K Summary
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lauren Bentley
Sr. Manager, Regulatory Affairs
Email: lauren.bentley@stryker.com
Phone: (408) 754-2473 |
| Date Prepared: | March 31, 2023 |
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 | 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 Devices:
| Manufacturer | Device Name | 510(K) Number |
|---|---|---|
| Stryker | ||
| Endoscopy | Connected OR Hub with Device and Voice Control; | |
| SDC4K Information Management System with Device | ||
| and Voice Control | K222079 |
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 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) Class I 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 (Class I MDDS)
The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or 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.
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 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.
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 (K222079) | ||
| 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 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. | Same as subject devices | |
| 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 of | ||
| parameters of any attached Stryker device. | ||
| Item | Subject Devices | Predicate Devices |
| Manufacturer | 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 |
| Submission Reference | Stryker | Same as subject devices |
| Principles of Operation | Current Submission | K222079 |
| Components | Use of IR remote control for device control and RF communication for voice control of connected devices. | Same as subject devices |
| Console (Connected OR Hub & SDC4K) Device Control Package Voice Control Package Connected OR Hub VIP Package Connected OR Spoke | Same as subject devices | |
| 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 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: The console's device control ports via device control cables. |
Wireless connection: The console is connected to the primary Connected OR Spoke via an Ethernet cable, while 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 | Same as subject devices. |
| 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 | Stryker Devices: Class II Devices
Surgical Cameras (K132785, K182160,
K200310, K202592, K210088, K211202,
K212511, K214046, K220895, K222130,
K230216)Light Sources (K142310, K151243,
K173866, K182160, K191046, K192292,
K202592, K210088, K211202, K214046,
K221611)Insufflators (K063367, K170784,
K201361)Pumps (K123441, K191259)RF Probes and Shaver System (K071859,
K121855, K160050, K171391)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 |
| 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 chassisOn-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 | Wired: SIDNE, DCM
Wireless: SIDNE, SFB |
| Data Transfer,
Documentation and Storage
(Class I/Non-Medical
functionality) | Wireless Standard: WLAN
802.11a/b/g/n/acFrequency: 2.4GHz and 5GHz | Same as subject device |
| Item | Subject Devices | Predicate Devices |
| 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 |
6
Comparison of Technological Characteristics with the Predicate Device:
7
8
Performance Data:
Testing was completed in accordance with the following:
| Summary of Testing Utilizing Well-Established Methods | ||
|---|---|---|
| Test | Method | Results |
| Software | Software functional verification (Device and Voice Control with Spoke) | Pass |
| Performance | Network Security | Pass |
| Testing - Bench | Memory Profiling and Performance | Pass |
NOTE: The Connected OR Hub and SDC4K Information Management Systems with Device and Voice Control Packages are not patient contacting; therefore, biocompatibility testing is not required to support the determination of substantial equivalence.
NOTE: The Connected OR Hub and SDC4K Information Management Systems with Device and Voice Control Packages do not require clinical studies to support the determination of substantial equivalence.
Conclusions:
The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice 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.