(26 days)
The SaberScope5 Laparoscope is intended to be used in diagnostic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.
The Articulating Xenoscope™ System is being renamed the SaberScope5 Laparoscope. The subject device contains two separate functioning components. First is the single-use, sterile SaberScope5 Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 90° articulating tip, 10 - 36 cm long shaft, and high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. The second is the XenoBox™, which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Xenocor® SaberScope5 Laparoscope, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table (Table 2) between the predicate device (Articulating Xenoscope™ Laparoscope, K193315) and the subject device (SaberScope5 Laparoscope). The acceptance criteria implicitly are that the subject device's performance attributes are "Same" as the predicate device or demonstrate equivalent performance, with some notable differences.
| Attribute | Predicate Device Performance (K193315) | SaberScope5 Laparoscope Performance | Acceptance Criteria Met? | Notes |
|---|---|---|---|---|
| Indications for Use | Diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. | Same | Yes | Maintained same Indications for Use. |
| Classification Info. | GCJ, GCQ, HET; Class II | Same | Yes | Maintained same classification. |
| Single Use | Yes | Same | Yes | |
| Sterile | Provided Sterile (EO gas) | Same | Yes | |
| Prescription | Yes | Same | Yes | |
| Anatomical Access | Thoracic and abdominal body cavities, hollow organs, and canals, including female reproductive organs. | Same | Yes | |
| Fundamental Scientific Technology | Imaging sensor that sends digital video, converted to HDMI by Xenobox. | Same as predicate with the additional manual focus capability | Yes (with enhancement) | The addition of manual focus is highlighted as an improvement, not a deviation from acceptance. |
| Part No. | XSA-0-0510, XSA-0-0536 | Same | Yes | These are the model numbers for existing lengths. |
| Design | 0° camera angle, 5 mm rigid shaft, articulating tip with fixed focus. | Same, but with manual focus buttons on handle | Yes (with enhancement) | The addition of manual focus buttons is an enhancement. |
| Shaft Diameter (OD) | 5 mm | Same | Yes | |
| Shaft Tip | Articulating Tip (± 90°) | Same | Yes | |
| Shaft Lengths | 10 cm, 36 cm | Same | Yes | |
| Shaft Material | Carbon Fiber, covered with heat shrink sheathing | Same | Yes | |
| Field of View | 65°-75° (Nominal 69º) | Same | Yes | |
| HD Resolution | 1080p | Same | Yes | |
| Camera Focus | Fixed Focus | 3-10cm | Yes (improved) | This is a key difference. The SaberScope5 moves from "Fixed Focus" to a "3-10cm" focus range, which implies user-adjustable focus. The associated design change is the addition of focus control buttons. This is presented as an improvement that meets acceptance. |
| Focus Control Buttons | N/A | 3 buttons: forward (manual mode), backward (manual mode), manual/auto toggle | N/A | This is a new feature introduced in the SaberScope5. It's not a "met" or "not met" criteria against the predicate, but a feature leading to the "3-10cm" focus range. |
| Frame Rate | 30 fps | Same | Yes | |
| Exposure/Gain Control | Automatic (no user adjustments) | Same | Yes | |
| **Latency ( |
§ 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.