(57 days)
Not Found
Unknown
The document mentions an "enhanced image algorithm" for smoke detection and removal, which could potentially utilize AI/ML techniques, but the description is not specific enough to confirm. It does not explicitly mention AI, ML, or related terms like neural networks.
No
The device primarily focuses on controlling other medical devices, documenting data, and enhancing surgical images (smoke removal, smoke evacuation). It does not directly provide therapy to a patient.
No
Explanation: The device is described as a control system for medical devices and for documentation, not for diagnosing conditions or diseases. While it processes images to remove smoke, this is to enhance visualization during surgery, not for diagnostic interpretation.
No
The device description explicitly lists hardware components: "A Connected OR Hub Console a.", "A Device control package b.", and "A Voice control package C."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for controlling medical device settings, providing voice and remote control, and digital documentation of medical device data. None of these activities involve examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on controlling compatible devices, operating room documentation, and image processing for smoke removal. Again, this does not align with the definition of an IVD.
- No mention of biological samples or analysis: The text does not mention the collection, preparation, or analysis of any biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
- Focus on surgical equipment control and image processing: The primary functions described are related to controlling surgical equipment and processing surgical images, not diagnostic testing.
Therefore, based on the information provided, the Connected OR Hub with Device and Voice Control system is a medical device used in the operating room for control and documentation purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The use of the Connected OR Hub with Device and Voice Control system is to allow for remote 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 with Voice and Device 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 (Class I 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 is a medical device that allows the surgeon to control the state, selection, and settings of any compatible device attached to it. It also has operating room documentation functionalities (Class I device function) to electronically capture, transfer, store and display medical device data independently of the functions or parameters of the connected medical device.
The Connected OR Hub with Device and Voice Control consists of the following:
- A Connected OR Hub Console a.
- A Device control package b.
- A Voice control package C.
The Connected OR Hub with Device and Voice Control with the Video Image Processing (VIP) software feature incorporates and automates an enhanced image algorithm which detects and digitally removes smoke from surgical images; and, automates the detection and initiates smoke evacuation through compatible laparoscopic insufflator(s) during endoscopic procedures.
Mentions image processing
The Connected OR Hub with Device and Voice Control with the Video Image Processing (VIP) software feature incorporates and automates an enhanced image algorithm which detects and digitally removes smoke from surgical images; and, automates the detection and initiates smoke evacuation through compatible laparoscopic insufflator(s) during endoscopic procedures.
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:
Test: Software Validation & Verification, Method: IEC 62304:2015, Conclusion: PASS
Test: Usability, Method: IEC 62366-1:2015, Conclusion: PASS
Test: Electrical Safety, Method: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, Conclusion: PASS
Test: EMC, Method: IEC 60601-1-2:2014, Conclusion: PASS
Test: Performance - Bench, Method: In accordance with device input specifications and comparative testing to currently legally marketed device., Conclusion: PASS
NOTE: The Connected OR Hub with Device and Voice Control with the VIP feature does not require clinical studies to support the determination of substantial equivalence.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with a stylized image of a human figure. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it. The logo is clean and professional, reflecting the organization's role in regulating food and drugs.
July 28, 2020
Stryker Endoscopy Meagan Jones Principal Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95131
Re: K201434
Trade/Device Name: Connected OR Hub with Device and Voice Control Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 28, 2020 Received: June 1, 2020
Dear Meagan Jones:
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 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.
Digitally signed by Long H. Chen
Long H. Chen -S-S
Date: 2020.07.28 14:57:20 -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) K201434
Device Name
Connected OR Hub with Device and Voice Control
Indications for Use (Describe)
Intended use/Indications for Use:
The use of the Connected OR Hub with Device and Voice Control system is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other opersonnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 of safety and effectiveness information is being 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: | Meagan Jones
Principal Regulatory Affairs Specialist
Phone: (214) 701-2186
Email: meagan.jones@stryker.com |
| Date Prepared: | May 28, 2020 |
Subject Device:
| Name of Device: | Connected OR Hub with Device and Voice Control |
|---|---|
| Common or Usual Name | SDC4K Information Management System |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Regulation Number | 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(s):
| Stryker's Connected OR Hub with Device and Voice Control | K181258, K192172 |
|---|---|
| ZMED VP4000 Video Processor | K130929 |
NOTE: The predicate devices have not been subject to a design-related recall.
Device Description:
The Connected OR Hub with Device and Voice Control is a medical device that allows the surgeon to control the state, selection, and settings of any compatible device attached to it. It also has operating room documentation functionalities (Class I device function) to electronically capture, transfer, store and display medical device data independently of the functions or parameters of the connected medical device.
The Connected OR Hub with Device and Voice Control consists of the following:
4
- A Connected OR Hub Console a.
- A Device control package b.
- A Voice control package C.
The Connected OR Hub with Device and Voice Control with the Video Image Processing (VIP) software feature incorporates and automates an enhanced image algorithm which detects and digitally removes smoke from surgical images; and, automates the detection and initiates smoke evacuation through compatible laparoscopic insufflator(s) during endoscopic procedures.
Indications for Use:
The use of the Connected OR Hub with Voice and Device Control system is to allow for remote 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 with Voice and Device 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 (Class I device function), which is independent of the functions or parameters of any attached Stryker device.
| Item | Subject Device
Connected OR Hub with
Device and Voice Control | Predicate Devices | | |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| | | Connected OR Hub with Voice and Device
Control (primary predicate) | ZMED VP4000 Video
Processor
(secondary predicate) | |
| Submission
Reference | Current submission | K192172, K181258 | K130929 | |
| Product Code | GCJ, HRX | Same as subject
device | LLZ | |
| Classification | Class II | Class II | Class II | |
| Intended
Use /Indications for
Use | The use of the Connected OR
Hub with Device and Voice
Control system is to allow for
voice control and remote
control of medical device
settings by surgeons or
operating room personnel,
thereby eliminating the need to
manually operate those
devices compatible with the
Connected OR Hub with
Device and Voice Control or
to rely on verbal
communication between the | Same as subject
device. | The ZMED VP4000
Video Processor is
intended for use in any
application where a
viewing device
(fluoroscope, endoscope,
laparoscope, etc.) and
monitor are incorporated
to aid in diagnosis and
treatment of a disease
such as an arthroscopy
or cholecystectomy. | |
| Item | Subject Device | Predicate Devices | | |
| | Connected OR Hub with
Device and Voice Control | Connected OR Hub with Voice and Device Control (primary predicate) | ZMED VP4000 Video Processor (secondary predicate) | |
| | 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. | | | |
| Manufacturer | Stryker | Same as subject
device | ZMED, Inc. | |
| Principles of
Operation | Use of IR remote control for
device control and RF
communication for voice
control of connected devices. | Same as subject
device. | Provides enhanced video
contrast mapping which
facilitates better
visualization of subtle
(e.g. low contrast) image
features | |
| Device Components | Connected OR Hub console Device Control Software Voice Control Software | Same as subject
device | VP4000 Video Processor
(with enhanced imaging
algorithm) | |
| Feature(s) | Smoke
Detection
| Manual and automated | N/A – No smoke
detection functionality | Not applicable - No
smoke detection
functionality |
| | Enhanced
Imaging | Manual and automated | Manual (through
ZMED VP4000 Video
processor) | Automated enhanced
imaging |
| | Smoke
Evacuation | Manual and automated | Manual (through
Device and Voice
control) | Not applicable - No
smoke evacuation
functionality. |
| Documentation
Functionalities (Class
I/Non-Medical Device
functionalities) | Capture, transfer and display
image/video of various
formats for recording purposes
only (not for diagnosis or
treatment evaluation). | Same as subject
device | Not applicable - no
Class I/Non-Medical
Device functionality
included in Clarity. | |
| Device Control User
Interface | Capacitive touch Graphical User Interface on LCD touchscreen Voice Recognition and Control via wireless headset Device Control via IR Remote Control | Same as subject
device | Operation is required
from outside sterile field.
Front panel provides
On/Off and one-of-six
preset selection controls,
with additional buttons | |
| Item | Subject Device | Predicate Devices | | |
| | Connected OR Hub with
Device and Voice Control | Connected OR Hub
with Voice and Device
Control (primary
predicate) | ZMED VP4000 Video
Processor
(secondary predicate) | |
| | • Device Control via Camera
Head directional keypad | | for custom adjustment of
each preset. | |
| Connection to
Controllable Devices | Wired connection to
Connected OR Hub's device
control ports via device
control cables.
Connected OR Hub is
connected to master
Connected OR Spoke via an
Ethernet cable, while devices
at remote locations within the
same OR are connected to the
slave Connected OR Spoke via
device control cables. The
master and slave Spokes act as
the wireless transfer medium
to transfer device control data
to / from Connected OR Hub. | Same as subject
device | Not applicable – no
devices are controlled
with the Clarity Console.
It is meant to be
connected into a video
stream between a camera
and surgical display. | |
| Controllable Devices | Surgical Cameras, Light
Sources, Insufflators, Pumps,
RF and Shaver System,
Wireless Monitor | Same as subject
device. | Not applicable - No
controllable devices. | |
| Embedded Software
Design | Embedded Microsoft
Windows 10 | Same as subject
device | Embedded software. | |
| 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 | Custom design. | |
| Video Input and
Output | Input: DVI, RGBHV and
HDMI
Output: DVI, HDMI | Same as subject
device. | Input: DVI,
Output: DVI | |
| Power rating | 100-240VAC ~50/60 Hz,
4A/2A maximum | Same as subject
device. | Same as subject device. | |
| Electrical Safety | IEC 60601-1 | Same as subject
device. | Same as subject device. | |
| Item | Subject Device
Connected OR Hub with
Device and Voice Control | Predicate Devices
Connected OR Hub
with Voice and Device
Control (primary
predicate) | ZMED VP4000 Video
Processor
(secondary predicate) | |
| EMC | IEC 60601-1-2 | Same as subject device. | Same as subject device. | |
Comparison of Technological Characteristics with the Predicate Device:
5
6
7
Performance Data:
Testing was completed in accordance with the following:
| Test | Method | Conclusion |
|---|---|---|
| Software Validation & | ||
| Verification | IEC 62304:2015 | PASS |
| Usability | IEC 62366-1:2015 | PASS |
| Electrical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 and | |
| A1:2012 | PASS | |
| EMC | IEC 60601-1-2:2014 | PASS |
| Performance - Bench | In accordance with device input specifications | |
| and comparative testing to currently legally | ||
| marketed device. | PASS |
NOTE: The Connected OR Hub with Device and Voice Control with the VIP feature does not require clinical studies to support the determination of substantial equivalence.
Conclusions:
The Connected OR Hub with Device and Voice Control is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. There are no new issues of safety and/or effectiveness introduced by the Connected OR Hub with Device and Voice Control.