(68 days)
Not Found
No
The summary describes an information management system for controlling surgical devices and documentation, with no mention of AI or ML capabilities. The performance studies focus on device control, documentation, and voice recognition, not AI/ML model performance.
No.
The device is described as an "Information Management System" that allows surgeons to control compatible devices and capture/transfer medical device data. It does not directly provide therapy.
No
The device description indicates that the SDC3 system allows the surgeon to control other devices and has operating room documentation functionalities to capture, transfer, store, and display medical device data. It does not perform any diagnostic function.
No
The device description explicitly states it is a "system" that allows control of "compatible device attached to it," implying hardware components beyond just software. The performance studies also include testing for "device control performance" and "environmental performance evaluation," further suggesting hardware is part of the system.
Based on the provided information, the Stryker SDC3 HD Information Management System (SDC3) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the SDC3 is for use with compatible endoscopic and general surgery devices for visualization and documentation during surgical procedures. This involves direct interaction with the patient's body during surgery, not the examination of samples taken from the body.
- Device Description: The device description focuses on controlling other medical devices and providing documentation functionalities within the operating room. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
The SDC3 is a system designed to manage and document information during surgical procedures, acting as a control and recording hub for other surgical devices. This falls under the category of surgical support equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Stryker SDC3 HD Information Management System (SDC3) is intended 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 & 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, and urologists.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, HRX, KOG
Device Description
The Stryker SDC3 HD Information Management System (referred to as "SDC3 system" in the following sections) 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 any connected medical 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)
The SDC3 System was tested for performance in accordance with internal design specifications and with the applicable performance standards. Risk analysis was carried out in accordance with ISO 14971:2007; subsequently design verification activities and corresponding acceptance criteria were identified and performed in accordance to the risk analysis assessment. The performance testing for design verification and validation is as follows: Verification/validation testing for voice recognition performance; Verification/validation testing for device control performance; Verification/validation testing for digital documentation performance; Verification/validation testing for environmental performance evaluation. Electrical safety and electromagnetic compatibility testing was performed in accordance to IEC 60601-1:1988/A1:1991/A2:1995 and IEC 60601-1-2: 2001 + A1: 2004, respectively. Testing indicates that the SDC3 System conforms to the aforementioned voluntary standards. The software validation activities were performed in accordance with IEC 62304:2006 as well as the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", "Off-The-Shelf Software Use in Medical Devices", and "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software". The testing for the software verification and validation activities is as follows: Unit level testing; Integration level testing; System level testing and simulated use testing.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2015
Stryker Endoscopy % Underwriters Laboratories, Incorporated Mr. Ned Divine Senior Staff Engineer 333 Pfingsten Road Northbrook, IL 60062
Re: K121893
Trade/Device Name: Stryker SDC3 HD Information Management System (SDC3) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, HRX Dated (Date on orig SE ltr): August 17, 2012 Received (Date on orig SE ltr): August 21, 2012
Dear Mr. Divine,
This letter corrects our substantially equivalent letter of September 5, 2012.
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
1
Page 2 -
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 4
Traditional 510(k) Premarket Notification SDC3 HD Information Management System
INDICATIONS FOR USE STATEMENT
INDICATIONS FOR USE STATEMENT
Device Name: Stryker SDC3 HD Information Management System (SDC3)
KIS 1893 510{k} Number (if known): _
Indications for Use:
The Stryker SDC3 HD Information Management System (SDC3) is intended 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 & 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, and urologists.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD
Nil R.P. Ogden firmen
cal, Orthopedic.
510(k) Number K121893
Section 4, Page 1
3
k 12 1893 ps I of 3
stryker
SECTION 5
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information 1.
Traditional 510(k) Premarket Notification:
SDC3 HD Information Management System
510(k) Sponsor: | Stryker Endoscopy |
---|---|
Address: | 5900 Optical Court |
San Jose, CA 95138 | |
FDA Registration Number: | 2936485 |
Correspondence person: | Lifei Liu, RAC |
Senior Regulatory Affairs Analyst | |
Stryker Endoscopy | |
Email: lifei.liu@stryker.com | |
Phone: (408) 754-2315 |
2. Device Identification
Proposed Device:
Proprietary Name: | Stryker SDC3 HD Information Management System |
---|---|
Classification Name: | Laparoscope, General and Plastic Surgery |
Regulation Number: | 21 CFR 876.1500 |
Product Code: | GCJ |
Subsequent Product Codes: | HRX, KOG |
Regulatory Class: | II |
Predicate Device:
Proprietary Name: | Stryker SIDNE™ System |
---|---|
Premarket Notification | K022393 |
Classification Name: | Laparoscope, General and Plastic Surgery |
Regulation Number: | 21 CFR 876.1500 |
Product Code: | GCJ |
Subsequent Product Codes: | HRX, KOG |
Regulatory Class: | II |
3. Device Description
The Stryker SDC3 HD Information Management System (referred to as "SDC3 system" in the following sections) 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 any connected medical device.
4. Indications for Use
The SDC3 system is intended 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
4
Image /page/4/Picture/18 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and connected, giving the word a dynamic and modern appearance. The color of the text is black, contrasting with the white background.
Traditional 510(k) Premarket Notification: SDC3 HD Information Management System
SECTION 5
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 hysterectorny. laparoscopic & 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.
The Indications for Use for the SDC3 system is identical to the Indications for Use previously cleared for the Stryker SIDNE™ System (K022393).
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.
The only difference between the Intended Use of the SDC3 system and the Stryker SIDNE™ System is the addition of digital documentation functionality (Class I device function) to the SDC3 system. Addition of such functionality does not render SDC3 system exceeding the limitations set forth in 21 CFR 876.1500, nor does it impact the safety and effectiveness for the intended use of device control. As a result, the Intended Use of the SDC3 system and the Stryker SIDNE™ System is deemed to be the same based on FDA guidance "510/k) 'Substantial Equivalence' Decision Making Process".+
thttp://www.fda.goy/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/Pre marketSubmissions/PremarketNotification510k/ucm134783.htm
6. Technological Comparison
The SDC3 system has similar hardware as the predicate device, uses the same communication protocols as the predicate device, employs the same voice recognition technology and controls the same types of connected devices as the predicate device. Therefore, the SDC3 has the same technological characteristics as the predicate device in the following areas:
- Operating principle
- Software architecture
- Electrical characteristics ●
- . Mechanical characteristics
- . Communication characteristics
5
K121893
pg 3 of 3
Image /page/5/Picture/1 description: The image contains the Stryker logo. The logo is in black and consists of the word "stryker" in a bold, sans-serif font. Below the main logo, the words "Stryker Endoscopy" are written in a smaller, sans-serif font.
SECTION 5
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- Performance characteristics ●
- Compatibility with controllable devices as listed in the product labeling ●
- Energy source
Traditional 510(k) Premarket Notification:
SDC3 HD Information Management System
- Material (no patient contacting material) ●
7. Performance Testing
The SDC3 System was tested for performance in accordance with internal design specifications and with the applicable performance standards. Risk analysis was carried out in accordance with ISO 14971:2007; subsequently design verification activities and corresponding acceptance criteria were identified and performed in accordance to the risk analysis assessment. The performance testing for design verification and validation is as follows:
- Verification/validation testing for voice recognition performance ●
- . Verification/validation testing for device control performance
- Verification/validation testing for digital documentation performance ●
- Verification/validation testing for environmental performance evaluation ●
Electrical safety and electromagnetic compatibility testing was performed in accordance to IEC 60601-1:1988/A1:1991/A2:1995 and IEC 60601-1-2: 2001 + A1: 2004, respectively. Testing indicates that the SDC3 System conforms to the aforementioned voluntary standards.
The software validation activities were performed in accordance with IEC 62304:2006 as well as the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", "Off-The-Shelf Software Use in Medical Devices", and "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Softwore". The testing for the software verification and validation activities is as follows:
- Unit level testing .
- Integration level testing ●
- System level testing and simulated use testing .
-
- Conclusion
The SDC3 system has the following similarities as compared to its predicated device:
- Identical indications for use, .
- . Same Intended Use
- Same technological characteristics ●
In conclusion, the Stryker SDC3 system raises no new questions of safety and effectiveness as compared to its predicate device. Therefore, the SDC3 system is substantially equivalent to the predicate device the Stryker SIDNE™ system.