(27 days)
No
The summary describes voice and remote control functionality, which is typically based on rule-based systems or simpler signal processing, not explicitly AI/ML. There is no mention of AI, ML, or related terms like deep learning or neural networks in the document.
No
The device is described as an "Information Management System with Device and Voice Control Package" that allows for voice and remote control of medical device settings and has digital documentation functionality. It does not exert a therapeutic effect on a patient.
No
The device is described as an "Information Management System" that allows for "voice control and remote control of medical device settings" and "has additional digital documentation functionality capture, transfer, store and display medical device data (non-medical device function)". It functions as a "Medical Device Data System (MDDS)" and controls other compatible devices, but it does not perform any diagnostic functions.
No
The device description explicitly states it is a "network compatible hardware platform" and lists hardware components like a "SDC4K Console," "software activation USB dongle," "handheld Infrared (IR) remote control," "wireless headset and base station," and "Connected OR Spoke."
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for controlling medical device settings and managing medical device data in an operating room setting. This is related to surgical procedures and equipment control, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on hardware and software for controlling other medical devices and managing data from them. It mentions Medical Device Data System (MDDS) functionalities, which are specifically excluded from the definition of an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis
- Reagents, calibrators, or controls used in laboratory testing
The device's function is to facilitate the operation and data management of other medical devices used during surgery. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The use of the SDC4K Information Management System with Device and Voice Control Package 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 Package 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 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 SDC4K Information Management System with Device and Voice Control Package is a network compatible hardware platform that carries out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.
The SDC4K Information Management System with Device and Voice Control Package consists of the following components:
-
- SDC4K Console which includes:
- a) Class I Medical Device Data System (MDDS) functionality
- b) Optional Device Control feature
- c) Optional Voice Control 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)
-
- Connected OR Spoke (Class I MDDS)
The SDC4K console carries out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as a standalone device. When upgraded with the Device Control and/or Voice Control package, the SDC4K Console extends its functionality to control compatible devices from its 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 SDC4K Information Management System with Device and Voice Control Package also provides compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the SDC4K is connected to the Spoke, Device Control can be extended to compatible devices connected to the Spoke.
Mentions image processing
N/A – No VIP feature
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:
- Electrical Safety: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 IEC 60601-1-6:2010+A1:2013+A2:2020 (Results: Pass)
- EMC: IEC 60601-1-2:2014+A1:2020 (Results: Pass)
- Software Validation & Verification: IEC 62304:2015 (Results: Pass)
- Usability: IEC 62366-1:2020 (Results: Pass)
- Performance - Bench: In accordance with device input specifications, user needs and intended use (Results: Pass)
Additionally, the subject device does not require clinical studies to support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Surgical Cameras: K132785, K182160, K200310, K202592, K210088, K211202, K212511
Light Sources: K142310, K151243, K173866, K182160, K191046, K192292, K202592, K210088, K211202
Insufflators: K063367, K170784, K201361
Pumps: K123441, K191259
RF and Shaver System: K071859
Wireless Monitor: K081995
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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February 9, 2022
Stryker Endoscopy Divva Sekar Senior Staff Regulatory Affairs Specialist 5900 Optical Ct. San Jose, California 95138
Re: K220108
Trade/Device Name: SDC4K Information Management System with Device and Voice Control Package Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, HRX Dated: January 11, 2022 Received: January 13, 2022
Dear Divya Sekar:
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 Mav 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/cfpm/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801 ): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220108
Device Name
SDC4K Information Management System with Device and Voice Control Package
Indications for Use (Describe)
The use of the SDC4K Information Management System with Device and Voice Control Package 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 Package 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 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K220108
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R.Part 807.92(c).
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Divya Sekar
Senior Staff Regulatory Affairs Specialist
Email: divya.sekar@stryker.com |
| Date Prepared: | January 11, 2022 |
Subject Device:
| Name of Device: | SDC4K Information Management System with Device and Voice Control Package |
|---|---|
| Common or Usual Name | Information Management System |
| Classification Name: | Laparoscope, General & Plastic Surgery (21 C.F.R. §876.1500) |
| Regulatory Class: | II |
| Product Code: | GCJ |
| Subsequent Product Code | HRX |
| 510(k) Review Panel: | General and Plastic Surgery |
Predicate Device:
| Connected OR Hub with Device and Voice Control | K212055 |
|---|---|
| ------------------------------------------------ | --------- |
NOTE: The predicate device has not been subject to a design-related recall.
4
K220108
Device Description:
The SDC4K Information Management System with Device and Voice Control Package is a network compatible hardware platform that carries out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.
The SDC4K Information Management System with Device and Voice Control Package consists of the following components:
-
- SDC4K Console which includes:
- a) Class I Medical Device Data System (MDDS) functionality
- b) Optional Device Control feature
- c) Optional Voice Control 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)
-
- Connected OR Spoke (Class I MDDS)
The SDC4K console carries out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as a standalone device. When upgraded with the Device Control and/or Voice Control package, the SDC4K Console extends its functionality to control compatible devices from its 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 SDC4K Information Management System with Device and Voice Control Package also provides compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the SDC4K is connected to the Spoke, Device Control can be extended to compatible devices connected to the Spoke.
Intended Use/Indications for Use:
| Subject Device | Predicate Device |
|---|---|
| SDC4K Information Management System with Device and Voice Control | |
| Package | Connected OR Hub with Device and |
| Voice Control (K212055) | |
| The use of the SDC4K Information Management System with Device and Voice Control package 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. | |
| NOTE: Intended use and Indications for Use are the same. | Same as subject device |
5
| Item | Subject Device | Predicate Device | |
|---|---|---|---|
| SDC4K Information Management System with Device | |||
| and Voice Control Package | Connected OR Hub with Device | ||
| and Voice Control (K212055) | |||
| Manufacturer | Stryker | Same as subject device. | |
| Principles of Operation | Use of IR remote control for device control and RF | ||
| communication for voice control of connected devices. | Same as subject device. | ||
| Device Components | SDC4K console | ||
| Device Control Package | |||
| Voice Control Package | |||
| Connected OR Spoke | Connected OR Hub console | ||
| Device Control Package | |||
| Voice Control Package | |||
| Connected OR Spoke | |||
| Feature(s) | Documentation | ||
| Functionalities | |||
| (Class I/Non- | |||
| Medical Device | |||
| functionalities) | Gathering patient demographic data, | ||
| Capture, | |||
| Record, | |||
| Transfer, | |||
| Display image/video of various formats, | |||
| Archiving information | Same as subject device | ||
| Device Control | Remote control of compatible medical device settings | Same as subject device | |
| Voice Control | Voice control of compatible medical device settings | Same as subject device | |
| Video Image | |||
| Processing | |||
| (VIP) | N/A – No VIP feature | Smoke Detection | |
| Enhanced Imaging | |||
| Smoke Evacuation | |||
| Device Control User | |||
| Interface | Capacitive Graphical User Interface on LCD touchscreen | ||
| Voice Recognition and Control via wireless headset | |||
| Device Control via IR Remote Control | |||
| Device Control via Camera Head directional keypad | Same as subject device | ||
| Connection to Controllable | |||
| Devices | Wired connection: SDC4K's device control ports via | ||
| device control cables. |
Wireless connection: SDC4K is connected to the master
Connected OR Spoke via an Ethernet cable, while devices
at remote locations within the same OR are connected to
the slave Connected OR Spoke via device control cables.
The master and slave Spoke act as the wireless transfer
medium to transfer device control data to / from SDC4K. | Same as subject device |
| | Controllable Devices | Stryker Devices: Class II Devices
Surgical Cameras (K132785, K182160, K200310,
K202592, K210088, K211202, K212511)
Light Sources (K142310, K151243, K173866, K182160,
K191046, K192292, K202592, K210088, K211202)
Insufflators (K063367, K170784, K201361)
RF and Shaver System (K071859)
Wireless Monitor (K081995)
Class I/ II 510(k) exempt devices
Ceiling Mounted Room Lights (Class II) | Same as subject device. |
| Item | Subject Device | Predicate Device | |
| | SDC4K Information Management System with Device
and Voice Control Package | Connected OR Hub with Device
and Voice Control (K212055) | |
| Hardware and Software Architecture | | | |
| 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 | Input: HDMI
Output: HDMI | Input: DVI, RGBHV and HDMI
Output: DVI, HDMI | |
| Wireless Technology | | | |
| Data Transfer,
Documentation and Storage
(Class I/Non-Medical
functionality) | Wireless Standard: WLAN 802.11a/b/g/n/ac
Frequency: 2.4GHz and 5GHz | Same as subject device. | |
| Wireless technology for
Device and Voice Control | Wireless components used for device and voice control
are Voice Control headset (DECT technology), IR
Remote (Infrared) and Connected OR Spoke (WiFi) | Same as subject device. | |
| Electrical Safety/ EMC | | | |
| Power rating | 100-240VAC ~50/60 Hz, 4A/2A maximum | Same as subject device. | |
| Electrical Safety | ANSI/AAMI ES60601-1 | Same as subject device. | |
| EMC | IEC 60601-1-2 | Same as subject device. | |
Comparison of Technological Characteristics with the Predicate Device:
6
Performance Data:
Testing was completed in accordance with the following:
| Test | Method | Results |
|---|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 | |
| IEC 60601-1-6:2010+A1:2013+A2:2020 | Pass | |
| EMC | IEC 60601-1-2:2014+A1:2020 | Pass |
| Software Validation & Verification | IEC 62304:2015 | Pass |
| Usability | IEC 62366-1:2020 | Pass |
| Performance - Bench | In accordance with device input specifications, user needs and intended use | Pass |
NOTE: The SDC4K Information Management System with Device and Voice Control Package is not patient contacting; therefore, biocompatibility testing is not required to support the determination of substantial equivalence. Additionally, the subject device does not require clinical studies to support the determination of substantial equivalence.
Conclusions:
The SDC4K Information Management System with Device and Voice Control Package is substantially equivalent in design, intended use, principles of operation, technological characteristics, and safety features to the predicate device. There are no different questions of safety and/or effectiveness introduced by the SDC4K Information Management System with Device and Voice Control Package.