(60 days)
To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.
The OverTube™ Endoscopic Access System is comprised of a single, polymer extrusion shaft reinforced with a metallic coil. The hub located at the proximal end of the device contains a cuff seal which can be inflated with air using a syringe to reduce loss of pressure when insufflation is used. The device is available in a single effective length of 27 cm with a tapered distal tip. The OverTube™ Endoscopic Access System will be delivered in a manner that a clinician may open one (1) OverTube per clinical procedure. The OverTube™ Endoscopic Access System will be provided in both sterile and non-sterile models. The sterile model is terminally sterilized by ethylene oxide (EO).
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the OverTube™ Endoscopic Access System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for the OverTube™ Endoscopic Access System. Instead, it states that "Performance testing was conducted on the OverTube™ Endoscopic Access System to establish substantial equivalence." The tests conducted are listed as:
- Insertion and removal force requirements
- Shaft deflection
- Leakage rate
- Bond strength
- Foreign body removal
- Biocompatibility (in accordance with ISO 10993-1:2009)
- Sterilization cycle validation (in accordance with ISO 11135-1:2007)
The document asserts that these tests "show that the differences between the OverTube™ Endoscopic Access System and predicate device do not raise any questions regarding its safety and effectiveness." This implies that the device performed comparably to, or within acceptable limits for, its predicate device for each of these parameters, thereby meeting the implicit acceptance criteria for substantial equivalence.
Since specific numerical acceptance criteria and reported performance values are not provided, the table below reflects what is stated in the document about the performance evaluation.
| Acceptance Criteria Category | Reported Device Performance/Evaluation |
|---|---|
| Functional Performance | Testing included: |
| - Insertion and removal force | |
| - Shaft deflection | |
| - Leakage rate | |
| - Bond strength | |
| - Foreign body removal | |
| (Implied: Performed equivalently to predicate or within acceptable ranges) | |
| Biocompatibility | Evaluated in accordance with ISO 10993-1:2009 |
| Sterilization | Validated in accordance with ISO 11135-1:2007 (for EO sterilization) |
| Overall Safety & Effectiveness | Differences from predicate do not raise any questions regarding safety and effectiveness. Device is determined to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the quantitative sample sizes for the performance tests (e.g., how many over-tubes were tested for insertion force or leakage rate). It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective. Given the nature of a 510(k) summary for a medical device that relies on substantial equivalence to a predicate, these tests are typically bench and/or in-vitro tests, not clinical studies involving patient data provenance from specific countries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For bench/functional testing of a device like an overtube, the "ground truth" is typically established by engineering specifications, standard test methods, and comparison to the predicate device's known performance, rather than expert clinical consensus on a test set.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the context of the described performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving expert reviews for ground truth establishment, which is not the type of study described here.
5. 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
This information is not applicable/provided. The device described is an endoscopic access system (a physical medical device), not an AI algorithm or a diagnostic tool that involves "human readers" interpreting output. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/provided. As mentioned above, this filing concerns a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the functional performance tests (insertion/removal force, shaft deflection, leakage, bond strength, foreign body removal), the "ground truth" would be the engineering specifications, established test methodologies, and the performance characteristics of the legally marketed predicate device (Guardus® Disposable Overtube). The goal was to demonstrate that the new device performs acceptably within these engineering and predicate-based parameters.
For biocompatibility, the ground truth is established by the requirements of ISO 10993-1:2009.
For sterilization, the ground truth is established by the requirements of ISO 11135-1:2007.
8. The Sample Size for the Training Set
This information is not applicable/provided. As this is a submission for a physical medical device based on substantial equivalence and performance testing, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reason as point 8.
§ 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.