(67 days)
The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.
The Schoelly FSC 2 is a camera hand piece with built-in LED illumination intended to be used with Schoelly endoscopes. The light source provides illumination to the area under endoscopic examination. The compact camera component attaches to the proximal eyepiece of the endoscope via the Flexilock connector. Optically captured images are transferred to the camera. converted to an electrical signal, and amplified for output to accessories such as a computer.
The provided text is a 510(k) Summary for a medical device called "FSC 2," which is an endoscope camera and illumination system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The submission explicitly states "Performance: NA" for both the device and its predicate, indicating that a dedicated performance study for clinical efficacy, as typically understood for AI/algorithm devices, was not performed or deemed necessary for this type of device.
Here's a breakdown of the information that can be extracted from the provided text, along with notes on what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated or Implied) | Reported Device Performance |
|---|---|
| General Design: Camera with LED lamp type | Camera with LED lamp type |
| Intended Use: Provide illumination and video visualization of optical images in conjunction with endoscopic devices. | "Use in conjunction with endoscopic devices to provide illumination and video visualization of optical images" |
| Target Population: Any patient population | Any patient population |
| Anatomical Sites: Any where endoscopic devices are used | Any where endoscopic devices are used |
| Where Used: Hospitals, clinics, and physician offices | Hospitals, clinics, and physician offices |
| Biocompatibility: NA - no patient contacting surfaces | NA - no patient contacting surfaces |
| Sterility: NA - non-sterile | NA - non-sterile |
| Electrical Safety: Conforms with IEC 60601-1 | Conforms with IEC 60601-1 |
| Mechanical Safety: NA | NA |
| Performance: Substantially equivalent to predicate device K053412 (FSC 50 MH/50 MHC) in terms of general design and technology, indication for use, and function. | Substantially Equivalent to FSC 50 MH/50 MHC (K053412) |
Study that proves the device meets the acceptance criteria:
The "study" presented is a comparison to a predicate device (Schoelly FSC 50MH K053412) to demonstrate substantial equivalence, rather than a clinical performance study with specific device-centric acceptance criteria. The basis for meeting the criteria is the direct comparison of features and adherence to recognized standards for safety where applicable.
Information Not Available in the Provided Text:
- Sample size used for the test set and the data provenance: Not applicable. No test set for algorithm performance was mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set for algorithm performance or ground truth establishment was mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI/algorithm-based interpretive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware component.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This device is not an AI/algorithm-based interpretive tool.
- How the ground truth for the training set was established: Not applicable. This device is not an AI/algorithm-based interpretive tool.
§ 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.