(57 days)
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.
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.
The provided text describes a 510(k) premarket notification for the "Connected OR Hub with Device and Voice Control" and mentions its general performance testing. However, it does not contain the detailed information necessary to answer most of your specific questions about acceptance criteria, study methodologies, or ground truth establishment relevant to an AI/ML device.
This submission is primarily focused on demonstrating "substantial equivalence" of the device to legally marketed predicates based on design, intended use, principles of operation, technological characteristics, and safety features. While it mentions an "enhanced image algorithm which detects and digitally removes smoke from surgical images," the documentation does not delve into the specifics of how this algorithm (or any AI/ML component) was validated against defined performance criteria.
Here's an analysis based on the limited information available in the provided text, and what is missing:
The device being reviewed is primarily an OR integration system, not an AI/ML diagnostic or assistive device that would typically have the kind of acceptance criteria you're asking about. The mention of the "enhanced image algorithm which detects and digitally removes smoke from surgical images" is the closest it gets to an AI/ML-like function, but the provided text does not detail its validation as a separate component with specific performance metrics.
Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with reported device performance for an AI/ML component. The "Performance - Bench" test indicates "PASS" against "device input specifications and comparative testing to currently legally marketed device." This is a general statement, not specific to an AI/ML algorithm's performance metrics.
Missing Information for AI/ML Specifics:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on broad "PASS" results for standards compliance (IEC, ANSI/AAMI) and general bench testing, not specific performance metrics for an image processing algorithm.
- Sample sized used for the test set and the data provenance: Not specified for the image algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method for the test set: Not specified.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated. The document states, "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." This strongly implies no MRMC study was conducted specifically for the AI/ML-like image processing feature.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not detailed. While bench testing was done, the specific performance of the smoke detection/removal algorithm in isolation is not reported with quantitative metrics.
- The type of ground truth used: Not specified.
- The sample size for the training set: Not specified.
- How the ground truth for the training set was established: Not specified.
Summary of what is present:
- Device: Connected OR Hub with Device and Voice Control, including a Video Image Processing (VIP) software feature that "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."
- Regulatory Pathway: 510(k) Premarket Notification.
- Predicate Device: Stryker's Connected OR Hub with Device and Voice Control (K192172, K181258) and ZMED VP4000 Video Processor (K130929).
- Testing Conducted:
- 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
- Clinical Studies: "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." This is a key statement indicating that the detailed AI/ML validation metrics you're looking for were likely not part of this specific 510(k) submission process, as the agency determined it was substantially equivalent without needing such data for this particular feature in this context.
{0}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 Endoscopy5900 Optical CourtSan Jose, CA 95138 |
|---|---|
| Contact Person: | Meagan JonesPrincipal Regulatory Affairs SpecialistPhone: (214) 701-2186Email: 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 DeviceConnected OR Hub withDevice and Voice Control | Predicate Devices | ||
|---|---|---|---|---|
| Connected OR Hub with Voice and DeviceControl (primary predicate) | ZMED VP4000 VideoProcessor(secondary predicate) | |||
| SubmissionReference | Current submission | K192172, K181258 | K130929 | |
| Product Code | GCJ, HRX | Same as subjectdevice | LLZ | |
| Classification | Class II | Class II | Class II | |
| IntendedUse /Indications forUse | The use of the Connected ORHub with Device and VoiceControl system is to allow forvoice control and remotecontrol of medical devicesettings by surgeons oroperating room personnel,thereby eliminating the need tomanually operate thosedevices compatible with theConnected OR Hub withDevice and Voice Control orto rely on verbalcommunication between the | Same as subjectdevice. | The ZMED VP4000Video Processor isintended for use in anyapplication where aviewing device(fluoroscope, endoscope,laparoscope, etc.) andmonitor are incorporatedto aid in diagnosis andtreatment of a diseasesuch as an arthroscopyor cholecystectomy. | |
| Item | Subject Device | Predicate Devices | ||
| Connected OR Hub withDevice and Voice Control | Connected OR Hub with Voice and Device Control (primary predicate) | ZMED VP4000 Video Processor (secondary predicate) | ||
| surgeon and other operatingroom personnel in order toadjust the surgical equipment.It also has additional digitaldocumentation functionality toelectronically capture, transfer,store and display medicaldevice data (non-medicaldevice function), which isindependent of the functionsor parameters of any attachedStryker device. | ||||
| Manufacturer | Stryker | Same as subjectdevice | ZMED, Inc. | |
| Principles ofOperation | Use of IR remote control fordevice control and RFcommunication for voicecontrol of connected devices. | Same as subjectdevice. | Provides enhanced videocontrast mapping whichfacilitates bettervisualization of subtle(e.g. low contrast) imagefeatures | |
| Device Components | Connected OR Hub console Device Control Software Voice Control Software | Same as subjectdevice | VP4000 Video Processor(with enhanced imagingalgorithm) | |
| Feature(s) | SmokeDetection | Manual and automated | N/A – No smokedetection functionality | Not applicable - Nosmoke detectionfunctionality |
| EnhancedImaging | Manual and automated | Manual (throughZMED VP4000 Videoprocessor) | Automated enhancedimaging | |
| SmokeEvacuation | Manual and automated | Manual (throughDevice and Voicecontrol) | Not applicable - Nosmoke evacuationfunctionality. | |
| DocumentationFunctionalities (ClassI/Non-Medical Devicefunctionalities) | Capture, transfer and displayimage/video of variousformats for recording purposesonly (not for diagnosis ortreatment evaluation). | Same as subjectdevice | Not applicable - noClass I/Non-MedicalDevice functionalityincluded in Clarity. | |
| Device Control UserInterface | Capacitive touch Graphical User Interface on LCD touchscreen Voice Recognition and Control via wireless headset Device Control via IR Remote Control | Same as subjectdevice | Operation is requiredfrom outside sterile field.Front panel providesOn/Off and one-of-sixpreset selection controls,with additional buttons | |
| Item | Subject Device | Predicate Devices | ||
| Connected OR Hub withDevice and Voice Control | Connected OR Hubwith Voice and DeviceControl (primarypredicate) | ZMED VP4000 VideoProcessor(secondary predicate) | ||
| • Device Control via CameraHead directional keypad | for custom adjustment ofeach preset. | |||
| Connection toControllable Devices | Wired connection toConnected OR Hub's devicecontrol ports via devicecontrol cables.Connected OR Hub isconnected to masterConnected OR Spoke via anEthernet cable, while devicesat remote locations within thesame OR are connected to theslave Connected OR Spoke viadevice control cables. Themaster and slave Spokes act asthe wireless transfer mediumto transfer device control datato / from Connected OR Hub. | Same as subjectdevice | Not applicable – nodevices are controlledwith the Clarity Console.It is meant to beconnected into a videostream between a cameraand surgical display. | |
| Controllable Devices | Surgical Cameras, LightSources, Insufflators, Pumps,RF and Shaver System,Wireless Monitor | Same as subjectdevice. | Not applicable - Nocontrollable devices. | |
| Embedded SoftwareDesign | Embedded MicrosoftWindows 10 | Same as subjectdevice | Embedded software. | |
| Electronic CircuitDesign | Custom designed chipset,storage solution and CaptureCard.CD/DVD drive: Not includedin chassisOn-board storage: Hard DiskDrive (HDD) and Solid-StateDrive (SSD) | Same as subjectdevice | Custom design. | |
| Video Input andOutput | Input: DVI, RGBHV andHDMIOutput: DVI, HDMI | Same as subjectdevice. | Input: DVI,Output: DVI | |
| Power rating | 100-240VAC ~50/60 Hz,4A/2A maximum | Same as subjectdevice. | Same as subject device. | |
| Electrical Safety | IEC 60601-1 | Same as subjectdevice. | Same as subject device. | |
| Item | Subject DeviceConnected OR Hub withDevice and Voice Control | Predicate DevicesConnected OR Hubwith Voice and DeviceControl (primarypredicate) | ZMED VP4000 VideoProcessor(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 andA1:2012 | PASS |
| EMC | IEC 60601-1-2:2014 | PASS |
| Performance - Bench | In accordance with device input specificationsand comparative testing to currently legallymarketed 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.
§ 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.