(90 days)
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.
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.
The provided text is a 510(k) premarket notification for the Stryker Endoscopy Model 888 Video Camera. It focuses on establishing substantial equivalence to a predicate device based on intended use and technical characteristics, rather than presenting a formal study with acceptance criteria and performance metrics in the way a clinical study for a drug or a novel AI diagnostic would.
Therefore, many of the requested categories are not applicable or not explicitly stated in this type of submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Meets international medical device standards (IEC 601-1, UL 2601, & CSA 22.2) to minimize risks of fire, electrical shock, and electromagnetic interference. | The system is designed to meet these standards. (No specific test results or performance metrics are provided in this summary, but compliance with these standards would indicate acceptable safety performance). |
| Effectiveness/Functionality: Intended for endoscopic camera use in a variety of surgical procedures. | Substantially equivalent to the Karl Storz Imaging Tricam Color Endoscopic Television System (K950862). The "differences represent improvements in safety and effectiveness" compared to the predicate and previous Stryker cameras. The new camera will be capable of interfacing with the Hermes Operating Room Control Center with "no impact on normal camera system operation." |
| Intended Use: Supports general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, plastic surgery, and various common endoscopic surgeries where an endoscope/arthroscope is indicated. | The device is presented as suitable for these indications and users (general surgeons, gynecologists, cardiac surgeons, etc.). |
Important Note: This 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device. This process typically relies on comparing intended use, technological characteristics, and performance data if available, to show that the new device is as safe and effective as the predicate. It does not usually involve setting new, independent acceptance criteria and then conducting a novel study against those criteria in the same way a new drug or a novel AI algorithm might. The "performance" here is largely inferred from the equivalence claim and compliance with relevant standards.
Regarding the specific study questions:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not explicitly stated. This document does not describe a clinical performance study with a test set of data. The "study" mentioned is the comparison for substantial equivalence.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not explicitly stated. No ground truth establishment by experts for a test set is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not explicitly stated. No test set requiring annotation or adjudication is mentioned.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a hardware device (video camera), not an AI-powered diagnostic. An MRMC study is not relevant to this submission.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device; standalone algorithm performance is not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not explicitly stated. For a medical video camera, ground truth typically relates to image quality and functionality, which would be assessed through technical specifications and usability evaluations, rather than a clinical ground truth like pathology for a diagnostic device.
- 8. The sample size for the training set
- Not applicable / Not explicitly stated. No training set for an algorithm is relevant to this submission.
- 9. How the ground truth for the training set was established
- Not applicable / Not explicitly stated. No training set is relevant.
§ 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.