(82 days)
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the colonoscope to maintain central positioning within the lumen and help control the endoscope's view field and/or endoscope positioning.
The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC ("SPARKC") inflation pump. The G-EYE® Colonoscope includes a reprocessable, reusable balloon (the G-EYE® balloon) that is attached to a standard, commercially available colonoscope which is remanufactured by Smart Medical to include the balloon at its bending section. The installation of the balloon onto the standard colonoscope is considered remanufacturing of the standard colonoscope by Smart Medical, which assumes responsibility for the final device including the G-EYE® balloon and the remanufactured colonoscope. The G-EYE® balloon is inflated by the dedicated SPARKC inflation system, which enables automatic control of the required balloon pressure in one of several user-selected, systemcontrolled pressure levels such that the balloon conforms to the colonic lumen diameter. The G-EYE® Colonoscope is advanced by the endoscopist with the balloon deflated, which essentially preserves the standard colonoscope's diameter and insertion technique. At the cecum, the balloon is inflated to engage the colon walls, and the colonoscope is then withdrawn by the endoscopist using standard withdrawal technique. Withdrawal of the inflated balloon mechanically straightens the colonic folds and anatomic flexures, centers the colonoscope optics within the colonic lumen, and minimizes uncontrolled bowel slippage during withdrawal, therefore maintaining the endoscope's field of view
The provided text describes a 510(k) premarket notification for the G-EYE® System, aiming to demonstrate its substantial equivalence to a previously cleared predicate device. The submission focuses on expanding the range of compatible endoscope models and affirms that this change does not raise new questions of safety or effectiveness.
While the document details various nonclinical tests conducted to support substantial equivalence (reprocessing validation, biocompatibility, software verification/validation, electrical safety, and verification bench testing), it does not provide a table of specific acceptance criteria or reported device performance for these tests in a quantifiable manner. It merely states that "Each of these tests met its acceptance criteria, supporting substantial equivalence to the predicate."
Furthermore, the document mentions the availability of clinical data from five studies involving approximately 4500 subjects, stating that these studies "demonstrated that the device functioned as intended, with no serious device-related adverse events" and "facilitates visualization of the colonic mucosa surface area." However, it does not present the specific acceptance criteria or the study results for these clinical studies in a way that directly addresses quantitative performance metrics or comparative effectiveness.
Given the information provided in the input, it is not possible to fully address all parts of your request. The response below will focus on what can be extracted from the text.
Acceptance Criteria and Device Performance Study for the G-EYE® System
The provided 510(k) summary focuses on demonstrating substantial equivalence of the G-EYE® System to its predicate (K202469), primarily for expanding the range of compatible endoscope models. The study details included are largely general statements confirming that various tests met their acceptance criteria, rather than specific quantitative performance figures.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, a detailed table with quantifiable acceptance criteria and reported device performance cannot be generated. The document states that various tests "met its acceptance criteria" but does not specify these criteria or the test results numerically.
| Acceptance Criteria Category | Acceptance Criteria (as stated or inferred) | Reported Device Performance (as stated or inferred) |
|---|---|---|
| Reprocessing Validation | Consistent with FDA guidance. | "Met its acceptance criteria." (Specific data not provided) |
| Biocompatibility | Established in accordance with ISO 10993-1. | "Met its acceptance criteria." (Specific data not provided) |
| Software Verification & Validation | Software performs as intended. | "Demonstrated that the software performs as intended." (Specific data not provided) |
| Electrical Safety & EMC | Passing in accordance with IEC 60601-1 and IEC 60601-1-2. | "Results were passing." (Specific data not provided) |
| Verification Bench Testing (SPARKC & G-EYE® Colonoscope) | Operational and functional testing requirements met. | "Met its acceptance criteria." (Specific data not provided) |
| Clinical Performance (General) | Functions as intended, no serious device-related adverse events, facilitates visualization of colonic mucosa. | "Demonstrated that the device functioned as intended, with no serious device-related adverse events. In addition, the studies demonstrated that the device served its intended function, and that the mechanical straightening of the colonic flexures provided by the G-EYE® System facilitates visualization of the colonic mucosa surface area." (No quantitative metrics provided) |
2. Sample Size Used for the Test Set and Data Provenance
- Nonclinical Test Sets: The sample sizes for the specific nonclinical tests (reprocessing, biocompatibility, software, electrical safety, bench testing) are not specified in the document.
- Clinical Data: "In total, the studies included approximately 4500 subjects."
- Data Provenance: The document does not specify the country of origin for the clinical data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The document refers to "clinical studies" but does not detail how ground truth was established within those studies, nor does it mention the number or qualifications of experts involved in establishing ground truth for any test set (clinical or nonclinical).
4. Adjudication Method for the Test Set
- The document does not provide details on any adjudication methods used for the test sets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- The document does not explicitly state that an MRMC comparative effectiveness study was done regarding human readers improving with AI vs. without AI assistance. The focus is on the device's mechanical function (balloon) rather than an AI component assisting human readers. The text mentions "clinical studies" but does not describe them in the context of MRMC studies or effect sizes for human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The G-EYE® System, as described, is a mechanical device that enhances visualization during colonoscopy. It incorporates a balloon and inflation system. There is no mention of an AI algorithm or standalone algorithm performance in the provided text.
7. The Type of Ground Truth Used
- For the nonclinical tests (reprocessing, biocompatibility, software, electrical safety, bench testing), the "ground truth" seems to be defined by adherence to established standards and company-defined acceptance criteria.
- For the clinical data, the "ground truth" for reported outcomes appears to be clinical observation ("device functioned as intended," "no serious device-related adverse events," "facilitates visualization of the colonic mucosa surface area"). There is no explicit mention of pathology, expert consensus, or specific outcomes data as "ground truth" for quantitative performance metrics.
8. The Sample Size for the Training Set
- The document describes a 510(k) submission for a medical device (colonoscope system) that has been previously cleared, and the current submission expands compatibility. It does not mention a "training set" in the context of machine learning or AI models. Therefore, a sample size for a training set is not applicable or provided.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" for an AI/ML model is not mentioned, this question is not applicable based on the provided text.
§ 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.