(28 days)
Not Found
No
The document describes voice and remote control functionality and data capture, but does not mention AI or ML, nor does it describe any learning or adaptive capabilities.
No
The device is described as a control system for medical device settings and documentation, not as directly delivering therapy.
No
The device is described as a control system for medical device settings and a documentation system for medical device data. It does not perform any diagnostic functions by evaluating medical conditions or diseases.
No
The device description explicitly lists hardware components: a Connected OR Hub console, a handheld Infrared (IR) remote control, and a headset and base station.
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 "voice control and remote control of medical device settings by surgeons or operating room personnel". This involves controlling the operation of other medical devices within the operating room.
- Device Description: The description reinforces this by stating it "allows the surgeon to control the state, selection, and settings of any compatible device attached to it."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for these purposes.
The device's function is focused on controlling and documenting the operation of other medical devices in a surgical setting, which is not the function of an IVD.
N/A
Intended Use / Indications for 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 surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, HRX
Device Description
The Connected OR Hub with Device and Voice Control 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. A Connected OR Hub console (MDDS device)
- b. A Device control package (contains an optional software upgrade and a handheld Infrared (IR) remote control) - Class II
- c. A Voice control package (contains an optional software upgrade and a headset and base station) - Class II
Mentions image processing
Not Found
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)
There are no significant design changes to the device leading to or because of the indications for use change. A risk analysis of the indications for use change concluded that the change in indication for use does not raise new issues of safety and effectiveness. Therefore, performance data are not necessary to evaluate the change in indications to a tool type indication.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services (HHS) seal on the left and the FDA acronym and name on the right. The HHS seal is a stylized depiction of a caduceus, while the FDA name is written in blue, with the acronym "FDA" in a larger font size than the rest of the name.
September 9, 2019
Stryker Endoscopy Meagan Jones Principal Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138
Re: K192172
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, HRX Dated: August 9, 2019 Received: August 12, 2019
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.
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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.
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
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Indications for Use
510(k) Number (if known) K192172
Device Name
Connected OR Hub with Device and Voice Control
Indications for Use (Describe)
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 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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510(k) Summary As required by 21 C.F.R Part 807.92(c)
Submitter:
| Applicant | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------|
| FDA Registration number | 2936485 |
| Contact Person | Meagan Jones
Principal Regulatory Affairs Specialist
Phone: (214) 701-2186
Email: meagan.jones@stryker.com |
| Date Prepared | September 3, 2019 |
Subject Device:
| Name of Device | Connected OR Hub with Device and Voice Control | |
|---|---|---|
| Common or Usual Name | SDC 4k Information Management System | |
| Classification Name | Laparoscope, General and Plastic Surgery | |
| Regulation number | 21 CFR 876.1500 | |
| Regulatory Class | Class II | |
| Product Code | GCJ | |
| Subsequent Product Code | HRX |
Predicate Device:
| Name of Device | Stryker Connected OR Hub with Device and Voice Control, | |
|---|---|---|
| K181258 |
Note: The predicate device has 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:
- a. A Connected OR Hub console (MDDS device)
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- b. A Device control package (contains an optional software upgrade and a handheld Infrared (IR) remote control) - Class II
- c. A Voice control package (contains an optional software upgrade and a headset and base station) - Class II
Intended 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 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.
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 surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.
Comparison of Technological Characteristics with the Predicate Device:
The proposed device uses the same device control communication protocols as the predicate device, employs the same voice recognition software engine and controls the same types of connected devices as the predicate device. The Connected OR Hub has similar technological characteristics as the predicate device in the following areas:
- . Operating principle
- Software architecture
- Electrical characteristics .
- . Mechanical characteristics
- . Communication characteristics
- . Performance characteristics
- Compatibility with controllable devices as listed in the product labeling ●
- . Energy source
- . Material (no patient contacting material)
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In accordance with 21 CFR807.92 (a) (6), a summary of the differences between the proposed and predicate device is provided in the Table below. A complete comparison of the technological characteristics between the proposed and predicate devices is provided in Section 12-Substantial Equivalence Discussion.
| Feature | Subject Device - Connected
OR Hub with Device and
Voice Control | Predicate Device - Connected
OR Hub with Device and
Voice Control, K181258 |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Stryker Endoscopy | Same as subject device |
| Submission Reference | Current Submission | K181258 |
| Intended use statement | The intended 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
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 device. | Same as subject device |
| Feature | Subject Device - Connected
OR Hub with Device and
Voice Control | Predicate Device - Connected
OR Hub with Device and
Voice Control, K181258 |
| Indications for Use Statement | The intended 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
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 device. | The Connected OR Hub is
indicated for use with
compatible endoscopic and
general surgery devices. The
Connected OR Hub can be used
in general laparoscopy,
nasopharyngoscopy, ear
endoscopy, sinuscopy, and
plastic surgery wherever a
laparoscope, endoscope, or an
arthroscope is indicated for use.
A few examples of the more
common endoscopic surgeries
are laparoscopic
cholecystectomy, laparoscopic
hernia repair, laparoscopic
appendectomy, laparoscopic
pelvic lymph node dissection,
laparoscopically assisted
hysterectomy, laparoscopic and
thorascopic anterior spinal
fusion, anterior cruciate
ligament reconstruction, knee
arthroscopy, shoulder
arthroscopy, small joint
arthroscopy, decompression
fixation, wedge resection, lung
biopsy, pleural biopsy, dorsal
sympathectomy, pleurodesis,
internal mammary artery
dissection for coronary artery
bypass, coronary artery bypass
grafting where endoscopic
visualization is indicated and
examination of the evacuated
cardiac chamber during
performance of valve
replacement. Connected OR
Hub users are general surgeons,
gynecologists, cardiac surgeons,
thoracic surgeons, plastic
surgeons, orthopedic surgeons,
ENT surgeons, and urologists. |
| Operating Principles | Use of IR remote control for
device control and RF
communication for voice control
of connected devices. | Same as subject device |
| Feature | Subject Device - Connected OR Hub with Device and Voice Control | Predicate Device - Connected OR Hub with Device and Voice Control, K181258 |
| Hardware and Software Architecture | No changes to hardware and software architecture for subject device from predicate device. | Same as subject device |
| Wireless technology
(for Class I and non-medical device functionality only) | Wireless Standard: WLAN 802.11a/b/g/n/ac
Frequency: 2.4GHz and 5.2Ghz | Same as subject device |
| Controllable devices | No changes to list of compatible devices between subject device and predicate device. See Section 12, Substantial Equivalence Discussion for complete list. | Same as subject device |
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Performance Testing:
There are no significant design changes to the device leading to or because of the indications for use change. A risk analysis of the indications for use change concluded that the change in indication for use does not raise new issues of safety and effectiveness. Therefore, performance data are not necessary to evaluate the change in indications to a tool type indication.
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 device. There are no new issues of safety and/or effectiveness introduced by the subject device when used as instructed.