(51 days)
The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.
Stryker's SPY Laparoscope is part of Stryker's rigid endoscope product portfolio. Stryker's SPY Laparoscopes are tubular optical instruments used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Laparoscope transmits light in both the visible and near infrared spectrum to illuminate and image the anatomy, then forms and relays the image of the surgical site to a camera system for processing and display.
The provided text describes the regulatory clearance of the SPY Laparoscope by the FDA, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria related to its clinical effectiveness or diagnostic accuracy. The "Performance Testing" section details various engineering and biological tests (electrical safety, packaging, biocompatibility, cleaning & disinfection, sterilization, and bench performance related to optical and mechanical verification), but these are primarily for safety and functional verification, not clinical performance or diagnostic accuracy.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for clinical effectiveness or diagnostic accuracy.
- Sample size used for the test set and data provenance for clinical performance studies.
- Number of experts and their qualifications for establishing ground truth for clinical performance.
- Adjudication method for clinical performance.
- Multi-reader multi-case (MRMC) comparative effectiveness study details or effect size.
- Standalone (algorithm only) performance details.
- Type of ground truth used for clinical performance (e.g., pathology, outcomes data).
- Sample size for the training set for clinical performance.
- How ground truth for the training set was established for clinical performance.
The document focuses on demonstrating substantial equivalence to a predicate device (Stryker AIM System, K210088) through comparisons of design, intended use, principles of operation, and a battery of standard safety and functional tests. This is typical for a 510(k) submission, where the focus is on showing similarity to an already legally marketed device rather than proving novel clinical efficacy or diagnostic accuracy.
§ 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.