(20 days)
The intended use of the SDC3 HD Information Management System with Wireless Device Control Capability 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 SDC3 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.
The SDC3 HD Information Management System with Wireless Device Control Capability is a network compatible hardware platform that allows the users to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly. The SDC3 HD Information Management System with Wireless Device Control Capability consists of the following: a. A SDC3 HD Information Management System console (Class I MDDS) 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 d. Connected OR Spoke (Class I MDDS)
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "SDC3 HD Information Management System with Wireless Device Control Capability". This submission argues for substantial equivalence to a predicate device (K160332).
Crucially, this document states that there are no performance studies or clinical trials conducted for this submission (K210584) because the changes are not related to design but to the indications for use, and a risk analysis concluded no new questions of safety and effectiveness were raised.
Therefore, I cannot provide details on the acceptance criteria, study design, sample sizes, expert ground truth establishment, or any other performance-related metrics as these studies were not performed for this 510(k) submission.
The document explicitly states:
"There are no design changes proposed nor necessary to support the change in indications for use. A risk analysis of the indications for use change concluded that the change in indications for use does not raise different questions of safety and effectiveness. Therefore, performance data are not necessary to evaluate the change in indications for use to a tool-type indications for use."
If performance data for the predicate device (K160332) were available, they would be in that submission's documentation. This document (K210584) only refers to a comparison of technological characteristics for substantial equivalence.
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March 18, 2021
Stryker Divya Sekar Staff Regulatory Affairs Specialist 5900 Ontical Ct San Jose, California 95138
Re: K210584
Trade/Device Name: SDC3 HD Information Management System with Wireless Device Control Capability Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 25, 2021 Received: February 26, 2021
Dear Divya Sekar:
We have reviewed vour 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/cfpmp/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.
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
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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
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Indications for Use
510(k) Number (if known) K210584
Device Name
SDC3 HD Information Management System with Wireless Device Control Capability
Indications for Use (Describe)
The intended use of the SDC3 HD Information Management System with Wireless Device Control Capability system is to allow for voice control and remote control of medical device settings by surgeons or operating room persomel, thereby eliminating the need to manually operate those devices compatible 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 capture, transfer, store and display medical device data (non-medical device function), which is incependent of the functions or parameters of any attached Stryker device.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
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510(k) Summary
Submitter:
| Applicant | Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138 |
|---|---|
| Contact Person | Divya SekarStaff Regulatory Affairs SpecialistPhone: (408) 855-6244Email: divya.sekar@stryker.com |
| Date Prepared | February 25, 2021 |
Subject Device:
The subject device is the SDC3 HD Information Management System with Wireless Device Control Capability:
| Name of Device | SDC3 HD Information Management System with Wireless DeviceControl Capability |
|---|---|
| Common or Usual Name | SDC3 HD Information Management System |
| Classification Name | Laparoscope, General and Plastic Surgery |
| Regulation number | 21 C.F.R. §876.1500 |
| Regulatory Class | Class II |
| Product Code | GCJ; HRX |
Predicate Device:
| Predicate Device | SDC3 HD Information Management System with Wireless Device Control Capability | K160332 |
|---|---|---|
| ------------------ | ------------------------------------------------------------------------------- | --------- |
NOTE: The predicate device has not been subject to a design-related recall.
Device Description:
The SDC3 HD Information Management System with Wireless Device Control Capability is a network compatible hardware platform that allows the users to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.
The SDC3 HD Information Management System with Wireless Device Control Capability consists of the following:
- a. A SDC3 HD Information Management System console (Class I MDDS)
- b. A Device Control Package (contains an optional software upgrade and a handheld Infrared (IR) remote control) - Class II
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- c. A Voice Control Package (contains an optional software upgrade and a headset and base station) – Class II
- d. Connected OR Spoke (Class I MDDS)
Intended Use / Indications for Use:
| Subject Device | Predicate Device | |
|---|---|---|
| SDC3 HD Information Management Systemwith Wireless Device Control CapabilityThis Submission | SDC3 HD Information Management System withWireless Device Control CapabilityK160332 | |
| Intended use:The intended use of the SDC3 HD InformationManagement System with Wireless Device ControlCapability system is to allow for voice control andremote control of medical device settings bysurgeons or operating room personnel, therebyeliminating the need to manually operate thosedevices compatible with the SDC3 with Device andVoice Control or to rely on verbal communicationbetween the surgeon and other operating roompersonnel in order to adjust the surgical equipment.It also has additional digital documentationfunctionality to electronically capture, transfer,store and display medical device data (non-medicaldevice function), which is independent of thefunctions or parameters of any attached Strykerdevice. | Intended use:Same as subject device | |
| Indications for Use:Same as the Intended Use:The intended use of the SDC3 HD InformationManagement System with Wireless Device ControlCapability system is to allow for voice control andremote control of medical device settings bysurgeons or operating room personnel, therebyeliminating the need to manually operate thosedevices compatible with the SDC3 with Device andVoice Control or to rely on verbal communicationbetween the surgeon and other operating roompersonnel in order to adjust the surgical equipment.It also has additional digital documentationfunctionality to electronically capture, transfer,store and display medical device data (non-medicaldevice function), which is independent of thefunctions or parameters of any attached Strykerdevice. | Indications for Use:The SDC3 is indicated for use with compatible endoscopicand general surgery devices. SDC3 can be used in generallaparoscopy, nasopharyngoscopy, ear endoscopy,sinuscopy, and plastic surgery wherever a laparoscope,endoscope, or an arthroscope is indicated for use. A fewexamples of the more common endoscopic surgeries arelaparoscopic cholecystectomy, laparoscopic hernia repair,laparoscopic appendectomy, laparoscopic pelvic lymphnode dissection, laparoscopically assisted hysterectomy,laparoscopic and thorascopic anterior spinal fusion,anterior cruciate ligament reconstruction, kneearthroscopy, shoulder arthroscopy, small joint arthroscopy,decompression fixation, wedge resection, lung biopsy,pleural biopsy, dorsal sympathectomy, pleurodesis,internal mammary artery dissection for coronary arterybypass, coronary artery bypass grafting where endoscopicvisualization is indicated and examination of the evacuatedcardiac chamber during performance of valve replacement.SDC3 users are general surgeons, gynecologists, cardiacsurgeons, thoracic surgeons, plastic surgeons, orthopedic | |
| Feature | Subject Device | Predicate Device |
| SDC3 HD Information Management System withWireless Device Control Capability | SDC3 HD InformationManagement System with WirelessDevice Control Capability | |
| This Submission | K160332 | |
| Manufacturer | Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138 | Same as subject device |
| Principle ofOperation | Use of IR remote control for device control and RFcommunication for voice control of connecteddevices | Same as subject device |
| Documentationfunctionalities(Class I /Non-medical) | • Capture image/ video from live input video;• Support image/video transfer to multiple media;• Display image/ video on LCD touch screen forrecording purposes only (not for diagnosis ortreatment evaluation) | Same as subject device |
| Device ControlUser Interface | • Graphical User Interface on LCD touchscreen• Voice Recognition and Control via wirelessheadset• Device Control via IR Remote Control DeviceControl and Camera Head directional keypad | Same as subject device |
| Connection toControllableDevices | • Wired connection to the console's device controlports via device control cable.• Wired connection to Connected OR Spoke'sdevice control ports via device control cable.• The console is connected to master Connected ORSpoke via an Ethernet cable, while devices atremote locations within the same OR areconnected to the slave Connected OR Spoke viadevice control cables. The master and slaveSpokes act as the wireless transfer medium totransfer device control data to / from the console. | Same as subject device |
| Controllabledevices | Surgical Cameras, Light Sources, Insufflators,Pumps, RF and Shaver System, Wired/WirelessMonitor, Ceiling Mounted Room Lights, DigitalCapture Device. | Same as subject device |
| OperatingSystemSoftware | Embedded Microsoft Windows 7 | Same as subject device |
| ElectronicCircuit Design | Custom Designed Chipset and capture card.CD/DVD drive: Included in Chassis | Same as subject device |
| Video input andoutput | On-board storage: Hard Disk Drive (HDD) onlyInput: S-Video, DVI, RGBHVOutput: S-Video, Composite, DVI, RGBHV | Same as subject device |
| Data Transfer,Documentationand Storage(Class I / Non-Medical) | WLAN 802.11/g/nFrequency Range: 2.4GHz and 5 GHz | Same as subject device |
| Feature | Subject Device | Predicate Device |
| SDC3 HD Information Management System withWireless Device Control Capability | SDC3 HD InformationManagement System with WirelessDevice Control Capability | |
| This Submission | K160332 | |
| WirelessTechnology forDevice andVoice Control | Wireless components used for device and voicecontrol are Voice Control headset (DECTtechnology), IR Remote (Infrared) and ConnectedOR Spoke WiFi | Same as subject device |
| Power Rating | 100-240VAC ~50/60 Hz, 4A/2A maximum | Same as subject device |
| ElectricalSafety | IEC 60601-1 | Same as subject device |
| EMC | IEC 60601-1-2 | Same as subject device |
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Comparison of Technological Characteristics with the Predicate Device:
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Performance Testing:
There are no design changes proposed nor necessary to support the change in indications for use. A risk analysis of the indications for use change concluded that the change in indications for use does not raise different questions of safety and effectiveness. Therefore, performance data are not necessary to evaluate the change in indications for use to a tool-type indications for use.
Conclusions:
The SDC3 HD Information Management System with Wireless Device Control Capability 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 effectiveness introduced by the modified SDC3 HD Information Management System with Wireless Device Control Capability when used as instructed.
§ 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.