(81 days)
The Stryker Saphenous Vein Harvest Laparoscope is substantially equivalent to the Snowden Pencer Saphenous Vein Endoscope in intended use and is compatible for use with the Ethicon Subcu-Retractor for this purpose.
The Stryker Saphenous Vein Harvest Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of Stryker 5mm Laparoscopes, differing only in working length. Materials of construction coming into patient contact, including structural components and cannula components which are of stainless steel, plated brass, and anodized aluminum, joined with adhesives and braze alloys, are demonstrated to be bio-compatible per the Tripartite scheme, and/or ISO 10993 and G95-1. The optical system consisting of optical glass, adhesives and coated brass components for spacing and mounting, and light transmission fibers are identical to those currently used in Stryker cleared laparoscopes. Stryker Saphenous Vein Harvest laparoscopes are reusable, and sold non-sterile, and are validated for cleanability, disinfection and re-sterilization. Sterilization methods include 100% EtO, Cidex® and Steris® processes. Those endoscopes labeled as "Autoclavable" will be validated for durability, cleanability, and sterilizability under specified cycles per appropriate AAMI guidelines.
This document is a 510(k) premarket notification for a medical device, the Stryker Saphenous Vein Harvest Laparoscope. It is a declaration of substantial equivalence to existing devices and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've outlined for an AI/CAD system.
The provided text focuses on:
- Device Identification: Name, classification, sponsor.
- Substantial Equivalence Claim: The primary purpose of a 510(k) submission. It argues that the new device is "substantially equivalent" to legally marketed predicate devices (existing Stryker laparoscopes and the Snowden Pencer Saphenous Vein Endoscope).
- Justification for Equivalence: This includes comparing materials, construction, optical performance, safety, intended use, and compatibility with other devices.
- Biocompatibility: Statements about material biocompatibility per specific schemes and standards.
- Sterilization: Validation for cleanability, disinfection, and re-sterilization methods.
Therefore, I cannot extract the information requested in your numbered list from this document. This typically applies to performance studies for novel devices or AI/CAD systems, which are not detailed in this particular type of regulatory submission for a rigid endoscope.
§ 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.