(100 days)
No
The summary describes an information management system with device control capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on data transfer, storage, display, and control of compatible medical devices.
No
The device is an information management system with wireless device control capability, intended to provide centralized control of other medical devices and manage data. It does not directly provide a therapeutic effect.
No
The device description indicates that the SDC3 is an "Information Management System" that provides "convenient, centralized control of connected (wired and wireless), compatible medical devices." It accesses existing controls within other devices and is secondary to their built-in control interfaces. Its primary function is clearly stated as controlling other medical devices and managing information, rather than diagnosing conditions.
No
The device description explicitly states that the system consists of a "stand-alone console containing SDC3 software" and a "Universal Gateway System," which acts as a medium for data transfer. These components are hardware, not solely software.
Based on the provided information, the SDC3 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the SDC3 as being used with endoscopic and general surgery devices for visualization and control during surgical procedures. This is an in-vivo application (within a living organism), not an in-vitro application (outside of a living organism, typically in a lab setting).
- Device Description: The device description details a system for managing information and controlling other medical devices during surgery. It does not mention any components or functions related to testing biological samples or diagnosing conditions based on such tests.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as reagents, assays, sample handling, or analysis of biological specimens.
Therefore, the SDC3 is a surgical information management and control system, not an IVD.
N/A
Intended Use / 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 surgeons, ENT surgeons, and urologists.
Product codes
GCJ, HRX
Device Description
The proposed device is a modification of the Stryker SDC3 HD Information Management System (hereafter referred to as "predicate device", cleared under K121893) to add wired and wireless device control functionality via the Gateway. The wired device control feature (cleared under K121893) and the operating room documentation functionalities of electronically capturing, transferring, storing and displaying of medical device data (Class I device function) provided by the SDC3 remains the same compared to the predicate device. It should be noted that the device control functionality (both wired and wireless) of the proposed device only provides users with convenient, centralized control of connected (wired and wireless), compatible medical devices. The SDC3 accesses existing controls within each device and is secondary to the built-in control interface that is already on each device.
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
SDC3 users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
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)
Performance testing was conducted to ensure that the device functioned as intended and met design specifications, acceptance criteria and the content of the FDA guidance document "Radio Frequency Wireless Technology in Medical Devices."
Key results include verification of device/voice control of compatible devices via Gateway through SDC3's GUI, IR Remote, and supported Camera Head when devices are connected to Gateway; Verification of compatibility of SDC3 and Universal Gateway System and connection security; Verification of network security features; Verification of SDC3's ability to upload case data to an external server wirelessly under co-existence environment; Verification of latency of wireless device control data transmission under co-existence environment, as compared to an identical wired system, and data accuracy in a non-coexistence environment; Verification of accuracy and reliability of wireless device control data transmission under co-existence environment; and Verification of connection and disconnection times between SDC3 and Gateway. Design validation ensured expanded functionality of wireless device control met user needs and intended use under simulated use conditions.
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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2016
Stryker Endoscopy Ms. Angela Wong Staff Regulatory Affairs Analyst 5900 Optical Court San Jose, California 95138
Re: K160332
Trade/Device Name: Stryker 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, HRX Dated: April 15, 2016 Received: April 18, 2016
Dear Ms. Wong:
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. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Stryker SDC3 HD Information Management System with Wireless Device Control Capability
Indications for Use (Describe)
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, 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 anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery 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 surgeons, and urologists.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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Endoscopy
510(k) SUMMARY
1) General Information
| 510(k) Sponsor | Stryker Endoscopy |
|---|---|
| Address | 5900 Optical Court |
| San Jose, CA 95138 | |
| FDA Registration Number | 2936485 |
| Correspondence Person | Angela Wong |
| Staff Regulatory Affairs Analyst | |
| Stryker Endoscopy | |
| Contact Information | Email: angela.wong @ stryker.com |
| Phone: (408) 754-2737 | |
| Date Prepared | 4 February 2016 |
2) Device Identification
Proposed Device:
| Proprietary Name | Stryker SDC3 HD Information Management
System with Wireless Device Control Capability |
|-------------------------|------------------------------------------------------------------------------------------|
| Common Name | SDC3 HD Information Management System |
| Classification Name | Laparoscope, General and Plastic Surgery |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | GCJ |
| Subsequent Product Code | HRX |
| Regulatory Class | II |
Predicate Device:
| Proprietary Name | Stryker SDC3 HD Information Management System |
|---|---|
| Common Name | SDC3 HD Information Management System |
| Premarket Notification | K121893 |
| Classification Name | Laparoscope, General and Plastic Surgery |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | GCJ |
| Subsequent Product Code | HRX |
| Regulatory Class | II |
4
3) Device Description
The Stryker SDC3 HD Information Management System with wireless device control capability (herein referred to as 'proposed device') consists of the following:
-
- Stryker SDC3 HD Information Management System (SDC3) that consists of:
- a. A stand-alone console containing SDC3 software version 1.5 and above
- b. A device control package (contains optional software upgrade and a handheld Infrared (IR) remote control)
- c. A voice control package (contains optional software upgrade and a microphone/headset).
-
- The Universal Gateway System (Gateway) (acts as a medium for transferring medical device and non-medical device data).
The proposed device is a modification of the Stryker SDC3 HD Information Management System (hereafter referred to as "predicate device", cleared under K121893) to add wired and wireless device control functionality via the Gateway. The wired device control feature (cleared under K121893) and the operating room documentation functionalities of electronically capturing, transferring, storing and displaying of medical device data (Class I device function) provided by the SDC3 remains the same compared to the predicate device. It should be noted that the device control functionality (both wired and wireless) of the proposed device only provides users with convenient, centralized control of connected (wired and wireless), compatible medical devices. The SDC3 accesses existing controls within each device and is secondary to the built-in control interface that is already on each device.
| Wireless
technology and
| functions | Universal Gateway System Wireless Module: Wireless Technology : 2.4GHz 802.11n (Wi-Fi) wireless radio. |
|---|---|
| RF Frequencies | |
| and Maximum | |
| output powers | Universal Gateway System Wireless Module: RF Frequencies 802.11n (ISM band): 2.412 - 2.484 GHz Maximum Output Power 802.11n: 14.5 dBm +/- 1.5 dB Range at Maximum Output Power 100+ feet depending on a number of factors |
| Wireless Quality of | |
| Service | The wireless quality of service needed for wireless device control is the same quality of service that is currently offered by wired device control. Therefore, the Quality of Service |
The table below summarizes the wireless technology of the proposed device.
5
| | | (QoS) metrics considered for the proposed device accounted
for the latency, data rate, accuracy, and communication
reliability required to achieve equivalent performance as
compared to the wired device control. |
|--------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Security | | It is recommended that the user use WPA2-Enterprise with
AES encryption for Wi-Fi security. |
| Alarm Signals | | No alarm signals are transmitted wirelessly in the proposed
device. The SDC3 monitors its connection to each Gateway.
If a connection to a given Gateway is dropped, an audible
alert will be issued by the SDC3 for each compatible device
that is connected to that Gateway. |
| Connection to
other wireless
devices | | No other wireless products or devices are able to establish a
wireless device control connection. This is enforced by the
proposed device security measures. |
4) Indication 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 surgeons, ENT surgeons, and urologists.
5) Intended Use
The intended use of the SDC3 system is to allow for voice control and remote control of medical device settings by the surgeons or operating room personnel, thereby eliminating the need of manual operation of those devices compatible with SDC3, or relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment. It also has an 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.
6
6) Comparison of Technological Characteristics with the Predicate Device
The Stryker SDC3 HD Information Management System (SDC3) with wireless device control capability (herein referred to as the proposed device) has the same technological characteristics and design as the predicate device except for the addition of wired and wireless device control functionality via the Gateway. The addition of wired and wireless device control functionality is achieved via a software update to allow the predicate device to be compatible with Universal Gateway System (Gateway), which act as a medium for the SDC3 to transfer device control data wired and wirelessly.
All other technological characteristics of the proposed device are identical to the predicate device. The proposed device uses the same hardware and communication protocols, employs the same voice recognition technology, and is compatible with the same types of controllable devices as listed in the predicate device's product labeling.
In accordance with 21 CFR807.92 (a) (6), a summary of the differences between the proposed and predicate device is provided in Table 5.1. A complete comparison of technological characteristics between the proposed and predicate devices is provided in Section 12 - Substantial Equivalence Discussion.
| Feature/
Functions | Proposed Devices | Predicate Devices
(K121893) |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wireless
Device
Control | Wireless Technology:
2.4GHz 802.11n (Wi-Fi) wireless radio. RF Frequencies:
802.11 n (ISM band): 2.412 - 2.484 GHz Maximum Output Power
802.11 n: 14.5 dBm +/- 1.5 dB Range at Maximum Output Power
100+ feet depending on a number of factors | Not available |
| Connection
to
Compatible
Controllable
Devices | Wired connection to SDC3's device control ports via device control cable. Wired connection to Gateway device control ports via device control cable. | Wired connection to SDC3's device control ports via device control cable. |
| Controllable
Devices | Same type of currently marketed devices as
predicate device.
A complete compatible devices list is provided
under Section 12 – Substantial Equivalence
Discussion. | Compatible controllable
devices include legacy and
currently marketed devices.
A complete compatible
devices list is provided under
Section 12 – Substantial
Equivalence Discussion. |
Table 5.1: Differences between the Proposed and Predicate Devices
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7) Performance Testing
The Stryker SDC3 HD Information Management System with wireless device control capability was tested for performance in accordance with internal design specifications, applicable performance standards and FDA guidance documents. Risk analysis was carried out in accordance with ISO 14971:2007 - Medical Devices - Application of Risk Management to Medical Devices; subsequently design verification/validation activities and corresponding acceptance criteria were identified and performed in accordance to the risk analysis assessment.
Electrical safety and electromagnetic compatibility testing was performed in accordance with the standards listed below. Testing indicates that the proposed device conforms to these standards.
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009(R)2012 and ● A2:2010/(R)2012 (Consolidated Text) - Medical Electrical Equipment - Part 1 : General Requirements for Basic Safety and Essential Performance
- . IEC60601-1-2:2007 - Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
Software was developed, tested, and verified per IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes as well as FDA guidance documents:
- Guidance for the Content of Premarket Submissions for Software Contained ● in Medical Devices
- Content of Premarket Submissions for Management of Cybersecurity in . Medical Devices
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf . Software Use in Medical Devices
The software for this device was classified as "moderate" level of concern, since a failure or latent flaw in the software could result in minor injury to the patient or operator.
Performance testing was conducted to ensure that the device functioned as intended and met design specifications, acceptance criteria and the content of the FDA guidance document "Radio Frequency Wireless Technology in Medical Devices." Table 5.2 summarized performance verification and validation data provided within this submission.
8
| Test | Test Description |
|---|---|
| SDC3 and Gateway Software Device | |
| Control Verification | Verified device/voice control of |
| compatible devices via Gateway through | |
| SDC3's GUI, IR Remote, and supported | |
| Camera Head when the devices are | |
| connected to Gateway. | |
| SDC3 and Gateway Connectivity | |
| Software Verification | Verified the compatibility of SDC3 with |
| Universal Gateway System and the | |
| connection security between the SDC3 | |
| and the Universal Gateway System. | |
| Software Network Security | |
| Verification | Verified network security features of the |
| SDC3. | |
| Wireless Co-existence Verification | |
| Test | Verified SDC3's ability to upload case |
| data to an external server wirelessly under | |
| co-existence environment. | |
| Benchmarking Test | Verified latency of wireless device control |
| data transmission under co-existence | |
| environment, as compared to an identical | |
| wired system. Also verified the data | |
| accuracy in a non-coexistence | |
| environment. | |
| SDC3 and Gateway Accuracy and | |
| Reliability Coexistence Report. | Verified accuracy and reliability of |
| wireless device control data transmission | |
| under co-existence environment. | |
| Timing Test | Verified that the connection and |
| disconnection times between the SDC3 | |
| and the Gateway meet the specification. | |
| Design Validation | Validated expanded functionality of |
| wireless device control to ensure defined | |
| user needs and intended use are met under | |
| simulated use conditions |
Table 5.2: Performance Verification and Validation Summary
8) Conclusion
Based on the indications for use, intended use, technological characteristics, performance testing and comparison to the predicate device, the Stryker SDC3 HD Information Management System with wireless device control capability raises no new questions of safety and effectiveness as compared to the predicate device.