(88 days)
Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals
S 41 & S 41 S Video Imaging Systems
This 510(k) summary for the SOPRO S 41 & S 41 S Video Imaging Systems does not contain the detailed study information, acceptance criteria, or performance data that would typically be required to answer your request.
Medical devices are categorized into different classes based on their risk: Class I (low risk, general controls), Class II (moderate risk, general controls and special controls), and Class III (high risk, premarket approval). The SOPRO S 41 & S 41 S Video Imaging System falls under Class II with product code GCJ, which is for an endoscope and accessories.
For Class II devices, a 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device already legally marketed. This often means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate device. For devices like the video imaging system described, the key aspects for substantial equivalence usually revolve around:
- Imaging quality: Resolution, illumination, color accuracy, field of view.
- Safety: Electrical safety, biocompatibility of materials in contact with the patient (if applicable for parts of the system), mechanical integrity.
- Functionality: Compatibility with endoscopes, recording capabilities, ease of use.
Since the submission relies on substantial equivalence and does not detail a de novo clinical study, the information you've requested is largely absent from this document. The document states: "The design of the S 41 & S41S is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the sames, SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device." This indicates that the manufacturer is asserting equivalence based on similarity rather than presenting a detailed performance study with specific acceptance criteria that they tested against.
Therefore, I cannot provide the information you requested based solely on the provided text.
Specifically, the following details are not available in the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The submission states the device is "virtually identical" and "specifications very similar" to predicate devices, implying performance would be similar but no specific criteria or measurements are given.
- Sample sized used for the test set and the data provenance: No test set is mentioned for a performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a video imaging system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as a training set for a performance algorithm is not relevant here.
- How the ground truth for the training set was established: Not applicable.
To obtain such details, one would typically need access to the full 510(k) submission, including any performance testing documentation referenced or included, which is not part of this summary letter.
§ 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.