(70 days)
The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.
The EndoChoice water bottle cap system is a sterile disposable device designed to fit commercially available sterile water bottles for providing sterile water during endoscopic procedures. The water bottle cap system is designed with a clip that is placed on the tubing to stop water flow from the water bottle when the endoscope is not in use.
The device attaches via a connector to the air/water port of an endoscope. The water bottle cap itself is attached to a standard sterile water bottle. Air supplied from the processor unit then pressurizes the water bottle, providing water flow when then air/water valve of the endoscope is depressed. Some models provide a feature that provides an option to use a CO2 air source. Instructions state that the device is to be used by trained endoscopy professionals.
This FDA 510(k) premarket notification describes a medical device, the "EndoChoice Water Bottle Cap System," and makes a case for its substantial equivalence to a legally marketed predicate device. However, it does not contain the kind of detailed information about acceptance criteria and a study that proves the device meets them, as requested in your prompt.
Here's why and what information is available:
This document is a 510(k) submission, which is a premarket notification demonstrating that the device is at least as safe and effective as a legally marketed predicate device. It typically relies on comparing the new device to an existing one (the predicate) and showing that any differences do not raise new questions of safety or effectiveness. This is different from a PMA (Premarket Approval) which requires clinical trials to demonstrate safety and effectiveness for novel devices.
Therefore, the document does not provide:
- A table of acceptance criteria and reported device performance in terms of specific metrics like sensitivity, specificity, accuracy, etc.
- Sample sizes used for a test set, data provenance, ground truth establishment for an AI/diagnostic device.
- The number of experts or their qualifications for ground truth.
- Adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Ground truth type for a diagnostic device.
- Training set sample size or how its ground truth was established.
What the document does provide, and how it relates to proving safety and effectiveness for this type of device (an accessory for endoscopes):
1. Acceptance Criteria and Device Performance (Implicit):
For this device, the "acceptance criteria" are implicitly tied to demonstrating that the modified device performs comparably to the predicate device and meets safety standards, particularly concerning its function in supplying sterile water and biocompatibility.
| Acceptance Criteria (Implicit from provided text) | Reported Device Performance |
|---|---|
| Functional Performance: Maintain intended function of supplying sterile water during endoscopic procedures. | "Benchtop functional performance testing, post-aging" was completed; "All test results passed." |
| Biocompatibility: Meet safety standards for patient-contacting materials. | "Biocompatibility testing in conformance with ISO 10993-1" was completed; "All test results passed." |
| Sterility: Maintain sterility until use. | Sterilization method (Ethylene Oxide) is unchanged from the predicate. |
| Compatibility: Remain compatible with existing endoscopes and water bottles. | Compatibility with Olympus 140, 160, 180, and Fuse Endoscopes is unchanged. Compatible with Standard 33 mm water bottle caps (unchanged). |
| Substantial Equivalence: Differences from predicate do not raise new issues of safety or effectiveness. | Conclusion states: "The modified EndoChoice Water Bottle Cap System is equivalent to the legally marketed predicate device. It is the same or equivalent in terms of design, intended use, materials, and labeling." |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not specified quantitatively. The "benchtop functional performance testing" and "biocompatibility testing" would have involved a certain number of device units, but this specific number is not disclosed in the summary.
- Data Provenance: The testing was "non-clinical testing" and "benchtop," meaning it was conducted in a laboratory/engineering environment, not on human patients. The country of origin for the testing facilities is not specified but would typically be where the manufacturer (EndoChoice, Inc. in Alpharetta, GA) conducts its R&D or uses contract labs. It is prospective testing performed on the modified device.
3. Number of Experts and Qualifications for Ground Truth:
- For this type of device, "ground truth" isn't established by medical experts in the way it would be for an AI diagnostic device. Instead, the "truth" is determined by engineering and material science standards (e.g., a pump correctly delivers water, a material does not cause a toxic reaction).
- The experts involved would be engineers, material scientists, and quality control personnel who conducted and evaluated the benchtop and biocompatibility tests. Their specific number and qualifications are not mentioned in this summary but are implicit to the conduct of these types of tests under regulatory standards.
4. Adjudication Method:
- Not applicable in the context of this 510(k) submission for a non-diagnostic accessory. Test results would be objectively measured against predefined engineering specifications and ISO standards; there's no "adjudication" by multiple human reviewers for interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the device (often AI) is intended to assist or replace that interpretation. The EndoChoice Water Bottle Cap System is a physical accessory, not an interpretive diagnostic tool.
6. Standalone (Algorithm Only) Performance:
- No, a standalone performance study in the context of an algorithm or AI was not done. This device does not contain an algorithm or AI. It is a mechanical accessory.
7. Type of Ground Truth Used:
- For functional performance, the "ground truth" is adherence to engineering specifications for flow rate, pressure capability, leak prevention, and durability (post-aging). This is determined by objective physical measurements against established design requirements.
- For biocompatibility, the "ground truth" is conformance to ISO 10993-1 standards, meaning the materials do not elicit an unacceptable biological response. This is determined by specified laboratory tests (e.g., cytotoxicity, sensitization, irritation).
8. Sample Size for the Training Set:
- Not applicable. There is no AI or algorithm that requires a "training set" for this device.
9. How the Ground Truth for the Training Set was Established:
- 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.