(317 days)
K# 991444
Not Found
Yes
The device description explicitly states the intent is to allow for "voice control of medical device settings". Voice control systems often utilize AI/ML for speech recognition and natural language processing. While not explicitly stated as "AI" or "ML", the described functionality strongly suggests the use of these technologies.
No
The device is described as a control system for surgical equipment, enabling voice control of settings rather than directly treating a medical condition.
No
The device description states that the Stryker Sidne™ System is designed to allow the surgeon to control the state, selection, and settings of surgical equipment, primarily through voice control. Its intended use is for various endoscopic and general surgeries where it aids in visualizing the surgical field and manipulating equipment. There is no mention of the device performing any diagnostic functions, such as identifying diseases, conditions, or analyzing patient data for diagnostic purposes.
No
The device description explicitly states it is a "medical device" and describes its function as controlling "surgical equipment" and being "networked with" existing devices. While it utilizes voice control, the description implies interaction with and control of physical hardware (surgical equipment), which is not characteristic of a software-only medical device. The predicate device also appears to be a control center, suggesting a hardware component.
Based on the provided information, the Stryker Sidne™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description of the Stryker Sidne™ System clearly state its purpose is to control surgical equipment during various endoscopic and general surgeries. It interacts with surgical devices and the operating room environment, not with patient specimens.
- The description focuses on controlling surgical equipment via voice commands. This is a functional control system for surgical procedures, not a diagnostic test performed on biological samples.
Therefore, the Stryker Sidne™ System falls under the category of a surgical control system, not an in vitro diagnostic device.
No
The provided text explicitly states "Control Plan Authorized (PCCP) and relevant text Not Found". Therefore, there is no language indicating FDA review, approval, or clearance of a PCCP for this device.
Intended Use / Indications for Use
The Stryker Sidne™ System is indicated for use with compatible endoscopic and general surgery devices. The Stryker Sidne™ System can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope fendoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectorny, laparoscopic hemia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder anthroscopy, small joint anthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectorny, 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.
Product codes
GCJ, HRX
Device Description
The Stryker Sidne™ System is a medical device that is designed to allow the surgeon to control the state, selection, and settings of the surgical equipment it Is networked with. Sidne™ is compatible with existing devices that are HERMES OR Control Center compatible.
The intent of the Sidne™ Control Center is to allow for voice control of medical device settings by the surgeon or operating room personnel, thereby eliminating the need for manual operation of those devices compatible with Sidne™ , or relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
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
The users of Sidne™ 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K# 991444
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling a person embracing another person. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Endoscopy Mr. Kiran Javadekar Senior Design Engineer 5900 Optical Court San Jose, CA 95138
JUL 2 7 2015
Re: K022393 Trade/Device Name: MerdocTM System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, HRX Dated (Date on orig SE ltr): March 31, 2003 Received (Date on orig SE ltr): April 1, 2003
Dear Mr. Javadekar,
This letter corrects our substantially equivalent letter of June 5, 2003.
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/ResourcesforYou/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
June 3, 2003
510(k) Number (if known): K022393
Device Name: Sidne ™
Indications for Use:
The Stryker Sidne™ System is indicated for use with compatible endoscopic and general surgery devices. The Stryker Sidne™ System can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope fendoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectorny, laparoscopic hemia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder anthroscopy, small joint anthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectorny, 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. The users of Sidne™ are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
Division Sign-Off) (Division of General, Restorative
510(k) Number K022393
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
p.3
Stryker Endoscopy Sidne™ System 510(k) submission
3
JUN - 5 2003
ax 1408) 754-250
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Classification Name: | Laparoscope, General and Plastic Surgery |
|---|---|
| Common and Usual Name: | Sidne™ |
| Proprietary Name: | Sidne™ System |
This 510(k) summary and effectiveness is being submitted in accordance with requirements of SMDA 1990
The Sidne™ System is substantially equivalent in safety and efficacy as the currently marketed HERMES OR Control Center. The HERMES OR Control Center was cleared under 510K# 991444
The Stryker Sidne™ System is a medical device that is designed to allow the surgeon to control the state, selection, and settings of the surgical equipment it Is networked with. Sidne™ is compatible with existing devices that are HERMES OR Control Center compatible.
The intent of the Sidne™ Control Center is to allow for voice control of medical device settings by the surgeon or operating room personnel, thereby eliminating the need for manual operation of those devices compatible with Sidne™ , or relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment. The Sidne™ System is intended for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope lendoscope/arthroscope is indicated for use.
The Sidne™ System conforms to the following voluntary standards: EN 60601-1-1 Medical Electrical Equipment Part 1: General Requirements for Safety; EN 60601-1-1 Collateral Standard: Safety Requirements for Medical Electrical Systems; EN 60601-1-2 Collateral Standard: Electromagnetic Compatiblity - Requirements and Tesls; EN 60601-1-4 Collateral Standard: Programmable Electrical Medical Systems.
The technological differences between the Stryker Sidne™ System and the predicate HERMES device do not raise new issues of safety and efficacy of the predicate device. Therefore, the Stryker Sidne™ System is substantially equivalent to the currently marketed Computer Motion HERMES™ OR Control Center.
jivadikar
Kıran Javadekar Senior Design Engineer Stryker Endoscopy
Date: 6/03/2003
Stryker Endoscopy Sidne™ System 510(k) submission