K Number
K111997
Date Cleared
2012-04-06

(268 days)

Product Code
Regulation Number
876.1500
Panel
GU
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Image1 GI CCU is to be used in conjunction with a light source and endoscope by physician/endoscopist to provide optical visualization via a video monitor for endoscopic observation and image recording during diagnostic and therapeutic procedures of the upper/lower digestive tract.

Device Description

The Image1 GI CCU consists of two components: the camera control unit and a keyboard. The Image1 GI CCU is used in conjunction of a videoscope and a light source, which transmit the video signals to camera control unit (image processor) to provide optical visualization via a video monitor.

AI/ML Overview

The provided 510(k) summary for the KARL STORZ Endoscopy America, Inc. Image1 GI CCU does not contain the detailed information requested regarding acceptance criteria and study results.

This summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a different regulatory pathway than providing detailed performance data against specific acceptance criteria. Substantial equivalence generally means proving that the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

Here's why the requested information is not present in the provided text:

  • Acceptance Criteria and Reported Device Performance: The document states, "Internal safety and performance testing are performed to ensure the safety and efficacy of the device." However, it does not outline specific acceptance criteria (e.g., image resolution, color accuracy, latency thresholds) nor does it report the quantitative results of these tests.
  • Sample Size and Data Provenance: No information is provided about the sample sizes of any test sets or the origin of the data (e.g., country, retrospective/prospective).
  • Number and Qualifications of Experts for Ground Truth: There is no mention of experts or ground truth establishment for any test data.
  • Adjudication Method: Not applicable as no expert review of test data is described.
  • Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is not mentioned. The device is a camera control unit, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be relevant in this context.
  • Standalone Performance: The concept of "standalone performance" (algorithm only) is not applicable here as the device is a hardware component (camera control unit) for endoscopy, not a standalone algorithm.
  • Type of Ground Truth: Not applicable as no ground truth data is discussed.
  • Training Set Sample Size and Ground Truth Establishment for Training Set: Not applicable as this is not an AI/machine learning device that requires a training set.

In summary, the provided document serves as a 510(k) premarket notification emphasizing substantial equivalence, not a detailed technical report demonstrating device performance against quantitative acceptance criteria through clinical or technical studies with data and expert involvement.

To get the type of information requested, one would typically look for a more detailed Technical File, Design History File, or specific performance testing reports, which are usually proprietary and not publicly disclosed in the 510(k) summary.

§ 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.