(151 days)
The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera and Quantum 5000 Light Source that is used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cheleeystectomy, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion, 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. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
The HERMES Operating Room Control Center is a computer-driven system whose basic function is offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control. The intended use of the HERMES OR Control Center is a Voice Control system whose function is to allow for simplified and direct control of Stryker Endoscopy 882 Camera and Quantum 5000 Light Source settings by the surgeon, thereby eliminating the necessity of using multiple input interfaces now common in the operating room, or relying upon verbal communications between the surgeon and other personnel in the OR in order to adjust Stryker Endoscopy 882 Camera and Quantum 5000 Light Source.
The provided text is a 510(k) Premarket Notification for the HERMES OR Control Center System. This type of document is for regulatory clearance of medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than reporting on a clinical study with detailed performance metrics and acceptance criteria in the way a research paper would.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth used (e.g., pathology, outcomes data)
- Sample size for the training set
- How ground truth for the training set was established
Instead, the document focuses on:
- Device identification and intended use: The HERMES OR Control Center is a computer-driven system offering voice control for Stryker Endoscopy 882 Camera and Quantum 5000 Light Source settings. It's intended to simplify control and eliminate the need for multiple input interfaces or verbal communication to adjust settings during various endoscopic procedures like laparoscopy, thoracoscopy, and sinuscopy.
- Substantial equivalence: The device is claimed to be substantially equivalent to AESOP 510(k)'s K931783 and K960655, Model 882 Camera: K820624, and Quantum 5000 Light Source: K961971. This is the primary method of demonstrating safety and effectiveness for a 510(k) submission.
- Compliance with standards: The HERMES OR Control Center was designed and tested to several international and national standards for medical electrical equipment, including IEC 601-1, UL 2601-1, EMC Directive European Union 89/336/EEC, and CAN/CSA-C22.2. It also mentions "HERMES System Functional Test Requirements," but does not detail these requirements or results.
- Regulatory clearance: The FDA reviewed the 510(k) notification and determined the device to be substantially equivalent for the stated indications for use, thereby permitting it to be marketed.
In summary, this regulatory document for the HERMES OR Control Center does not provide the kind of detailed performance study information with explicit acceptance criteria, ground truth, and reader studies that would be found in a clinical trial report or a scientific publication. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices and compliance with relevant safety standards.
§ 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.