(111 days)
The EndoSmart Bottle is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
Endo Smart Bottle is designed to be attached to an endoscope, to help supply water, air/CO2. The device consists of a connector cap, a water bottle, a threaded cap, a small tube, and a male luer. The main function of the subject device is -
- . To provide water for rinsing the lens.
- To provide air or CO2 to insufflate the anatomical lumen, to help the end user to see . the inner wall more clearly.
Similar to its predicate device, the subject device is provided sterile to the end user, fabricated from plastics, and elastomers, intended for daily (24 hour) multi-patient use and must be discarded daily. Both the subject device and its predicate device do not come in direct contact with patients.
This document is a 510(k) summary for the Medivators Endo Smart Bottle, an endoscopic irrigation/suction system. It primarily focuses on demonstrating substantial equivalence to a predicate device, the Endo Smart Cap. The document describes the device, its intended use, and non-clinical performance data to support its safety and effectiveness.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, it lists types of performance tests designed to demonstrate equivalence to the predicate device. The "reported device performance" is described qualitatively as having passed these tests, indicating equivalence.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Qualitative) |
|---|---|
| Lens Rinsing Function | Performed equivalently to predicate |
| Insufflation Function | Performed equivalently to predicate |
| Safety (Design Verification) | Performed equivalently to predicate |
| Cytotoxicity Evaluation | Met biocompatibility requirements |
| Intracutaneous Irritation Test | Met biocompatibility requirements |
| Sensitization | Met biocompatibility requirements |
| Functional Testing (Shelf-life) | Maintained function over shelf-life |
| Dye Penetration Testing (Shelf-life) | Maintained integrity over shelf-life |
| Peel Strength Testing (Shelf-life) | Maintained integrity over shelf-life |
| Visual Seal Inspection (Shelf-life) | Maintained integrity over shelf-life |
| Sterilization Validation | Met sterility requirements |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on the specific sample sizes used for each non-clinical performance test (e.g., how many bottles were tested for lens rinsing function). It also does not mention data provenance (country of origin or retrospective/prospective nature) as these are non-clinical engineering and bench tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable. The evaluations described are "Design Verification," "Biocompatibility," "Shelf-life validation," and "Sterilization validation," which are engineering and laboratory tests based on established standards and protocols, not expert consensus on medical interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the tests are non-clinical engineering and laboratory tests, not clinical performance studies requiring adjudication of results.
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
No such study was conducted or is mentioned. This product is a physical medical device (endoscopic irrigation/suction system) and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a manual accessory for an endoscope and does not involve algorithms or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests would be defined by established engineering and biological standards, specifications, and test methodologies relevant to medical device performance (e.g., maintaining specific flow rates, successfully clearing a lens, demonstrating no cytotoxic effects, maintaining sterile barrier integrity). It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This is not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this device.
§ 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.