(90 days)
No
The summary describes a standard medical video camera system and mentions integration with a voice-activated system, but there is no mention of AI or ML for image processing, analysis, or other functions.
No.
The device is described as a medical video camera system for endoscopic surgical procedures, providing visualization rather than therapy.
No
The device is a video camera system intended for endoscopic visualization during various surgical procedures. It provides imaging for guidance but does not perform diagnostic functions like analyzing images to identify pathology or aid in disease diagnosis.
No
The device description explicitly states the system consists of a camera control unit (CCU) and a camera head with an integral cable, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "endoscopic camera use in a variety of endoscopic surgical procedures." This involves visualizing internal structures during a surgical procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a camera system used for capturing video during surgery, not for analyzing biological samples.
The information provided consistently points to a device used for direct visualization during surgical procedures, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The Stryker Endoscopy Medical Video Camera System is intended for endoscopic camera use in a variety of endoscopic surgical procedures including orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery. Sterilization of the camera head and cable is required before use. The new Stryker camera will be capable of interfacing with the Hermes Operating Room Control Center (K973700) voice-activated system, with no impact on normal camera system operation
The Stryker Endoscopy 3-Chip Medical Video Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery where-ever a laparoscope/endoscope/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 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 ariery 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
Device Description
The Stryker Medical Video Camera System consists of a camera control unit (CCU) and a camera head with an integral cable that connects to the CCU.
The System is AC powered and is designed to meet international medical device standards (IEC 601-1, UL 2601, & CSA 22.2) to provide safe operation and eliminate or minimize the risk of fire, electrical shock, and electromagnetic interference that may be associated with it.
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 the Stryker Medical Video Camera 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)
Reference Device(s)
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
114 . 515 11 118156 - 15115 1.
Ontober 7, 1998
Premarket Notification 510(k) Safety and Effectiveness Summary
In accordance with 21 CFR section 807.92, Stryker Endoscopy is submitting the following safety and effectiveness summary.
Device Name:
Santa Clara, CA 9
Classification Name: Endoscopic Camera Common Name: Camera, Imaging system Proprietary Name: Model 888 Video Camera
Intended Use:
The Stryker Endoscopy Medical Video Camera System is intended for endoscopic camera use in a variety of endoscopic surgical procedures including orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery. Sterilization of the camera head and cable is required before use. The new Stryker camera will be capable of interfacing with the Hermes Operating Room Control Center (K973700) voice-activated system, with no impact on normal camera system operation
Device Description:
The Stryker Medical Video Camera System consists of a camera control unit (CCU) and a camera head with an integral cable that connects to the CCU.
The System is AC powered and is designed to meet international medical device standards (IEC 601-1, UL 2601, & CSA 22.2) to provide safe operation and eliminate or minimize the risk of fire, electrical shock, and electromagnetic interference that may be associated with it.
Equivalency:
The Stryker Endoscopy Medical Video Camera System is substantially equivalent to several other systems currently on the market, i.e., the Karl Storz Imaging Tricam Color Endoscopic Television System (K950862).
Overall, these differences represent improvements in safety and effectiveness among the predicate device and previous Stryker cameras. Any other differences would be of a cosmetic nature and not significant to safety and effectiveness
N. BertA
Rick Beutter Project Engineer Stryker Endoscopy
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 1999
Mr. Rick Beutter Project Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051
Re: K983566 Trade Name: Model 888 Video Camera Regulatory Class: II Product Code: GCJ Dated: October 7, 1998 Received: October 9, 1998
Dear Mr. Beutter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Rick Beutter
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
September 29, 1998
Page i of 1
K 98356 510(k , Number (if known): _
Device Name: Model 888 Video Camera
Indications for Use:
The Stryker Endoscopy 3-Chip Medical Video Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery where-ever a laparoscope/endoscope/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 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 ariery 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 the Stryker Medical Video Camera 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)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. 983566