(20 days)
Not Found
No
The document describes a system for voice and remote control of medical devices and digital documentation. It mentions capturing video but does not mention AI, ML, or any related concepts like training or test sets for algorithmic performance.
No
The device is an information management system that controls and manages medical device settings and captures digital documentation, rather than directly treating or diagnosing a medical condition.
No
The described intended use and device description focus on control and documentation of surgical equipment, not on diagnosing medical conditions.
No
The device description explicitly states it is a "network compatible hardware platform" and lists several hardware components including a console, handheld IR remote control, headset, and base station.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for controlling medical device settings and managing digital documentation. It does not mention analyzing biological samples or providing diagnostic information about a patient's health status.
- Device Description: The description focuses on hardware and software for controlling other medical devices and managing data. There is no mention of components or functions related to in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic, prognostic, or screening information
The device's function is primarily as a control and information management system for surgical equipment, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
GCJ; HRX
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
- 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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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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
1
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 Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|----------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person | Divya Sekar
Staff Regulatory Affairs Specialist
Phone: (408) 855-6244
Email: 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 Device
Control 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
4
- 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 System | ||
| with Wireless Device Control Capability | ||
| This Submission | SDC3 HD Information Management System with | |
| Wireless Device Control Capability | ||
| K160332 | ||
| Intended use: | ||
| 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. | Intended use: | |
| Same as subject device | ||
| Indications for Use: | ||
| Same as the Intended Use: | ||
| 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. | Indications for Use: | |
| The SDC3 is indicated for use with compatible endoscopic | ||
| and general surgery devices. SDC3 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. | ||
| SDC3 users are general surgeons, gynecologists, cardiac | ||
| surgeons, thoracic surgeons, plastic surgeons, orthopedic | ||
| Feature | Subject Device | Predicate Device |
| SDC3 HD Information Management System with | ||
| Wireless Device Control Capability | SDC3 HD Information | |
| Management System with Wireless | ||
| Device Control Capability | ||
| This Submission | K160332 | |
| Manufacturer | Stryker Endoscopy | |
| 5900 Optical Court | ||
| San Jose, CA 95138 | Same as subject device | |
| Principle of | ||
| Operation | Use of IR remote control for device control and RF | |
| communication for voice control of connected | ||
| devices | Same as subject device | |
| Documentation | ||
| functionalities | ||
| (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 for | ||
| recording purposes only (not for diagnosis or | ||
| treatment evaluation) | Same as subject device | |
| Device Control | ||
| User Interface | • Graphical User Interface on LCD touchscreen | |
| • Voice Recognition and Control via wireless | ||
| headset | ||
| • Device Control via IR Remote Control Device | ||
| Control and Camera Head directional keypad | Same as subject device | |
| Connection to | ||
| Controllable | ||
| Devices | • Wired connection to the console's device control | |
| ports via device control cable. | ||
| • Wired connection to Connected OR Spoke's | ||
| device control ports via device control cable. | ||
| • The console 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 the console. | Same as subject device | |
| Controllable | ||
| devices | Surgical Cameras, Light Sources, Insufflators, | |
| Pumps, RF and Shaver System, Wired/Wireless | ||
| Monitor, Ceiling Mounted Room Lights, Digital | ||
| Capture Device. | Same as subject device | |
| Operating | ||
| System | ||
| Software | Embedded Microsoft Windows 7 | Same as subject device |
| Electronic | ||
| Circuit Design | Custom Designed Chipset and capture card. | |
| CD/DVD drive: Included in Chassis | Same as subject device | |
| Video input and | ||
| output | On-board storage: Hard Disk Drive (HDD) only | |
| Input: S-Video, DVI, RGBHV | ||
| Output: S-Video, Composite, DVI, RGBHV | Same as subject device | |
| Data Transfer, | ||
| Documentation | ||
| and Storage | ||
| (Class I / Non- | ||
| Medical) | WLAN 802.11/g/n | |
| Frequency Range: 2.4GHz and 5 GHz | Same as subject device | |
| Feature | Subject Device | Predicate Device |
| SDC3 HD Information Management System with | ||
| Wireless Device Control Capability | SDC3 HD Information | |
| Management System with Wireless | ||
| Device Control Capability | ||
| This Submission | K160332 | |
| Wireless | ||
| Technology for | ||
| Device and | ||
| Voice Control | Wireless components used for device and voice | |
| control are Voice Control headset (DECT | ||
| technology), IR Remote (Infrared) and Connected | ||
| OR Spoke WiFi | Same as subject device | |
| Power Rating | 100-240VAC ~50/60 Hz, 4A/2A maximum | Same as subject device |
| Electrical | ||
| Safety | IEC 60601-1 | Same as subject device |
| EMC | IEC 60601-1-2 | Same as subject device |
5
Comparison of Technological Characteristics with the Predicate Device:
6
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.