(45 days)
The Gateway Advantage Y-Adapter is intended to prevent irrigant backflow while securing urological devices during procedures. Irrigation may also be connected to the side port of the device. The Y-Adapter is supplied in a sealed pouch and is intended for single use only.
The Gateway Advantage Y - Adapter has four main components; 1) a rotatable male luer fitting; 2) a Y-Adapter body; 3) a thumb screw Tuohy-Borst valve; and 4) a blue luer seal with female proximal end. The body has two lumens: a straight lumen and an adjoining curved lumen. The straight lumen tapers to an inner diameter of 3 mm (9 F) minimum, and the adjoining curved lumen tapers to an inner diameter of 2.413 mm (7 F) minimum. The adjoining curved lumen is terminated at the proximal end with a blue luer seal and the straight lumen of the Y-Adapter body has a Tuohy-Borst valve. Both valve and seal are intended to prevent irrigant backflow and secure urological devices. The blue luer seal has a female proximal end intended for use with irrigant tubing with a male luer connection. The distal end of the straight lumen has a rotating male luer which attaches to the scope.
The provided text describes a traditional 510(k) submission for a medical device called the "Gateway™ Advantage Y-Adapter". This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing of physical and functional characteristics, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested criteria, which are typical for studies involving AI or diagnostic performance, are not applicable in this context.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Leak Resistance with Urologic Device | Equivalence to predicate device | Passed - Demonstrates equivalence |
| Leak Resistance After Removal of Urologic Device | Equivalence to predicate device | Passed - Demonstrates equivalence |
| Tuohy-Borst - Acceptance of Multiple Exchanges | Equivalence to predicate device | Passed - Demonstrates equivalence |
| Luer Seal Acceptance of Multiple Exchanges | Equivalence to predicate device | Passed - Demonstrates equivalence |
| Securing Device Removal Force | Equivalence to predicate device | Passed - Demonstrates equivalence |
Note: The document states "The results of the performance testing demonstrate equivalence of the Gateway Advantage Y-Adapter to the predicate Sureseal II Endoscopic Valve." This implies that the acceptance criteria for each test were met if the device performed comparably to the predicate device within acceptable tolerances for these functional parameters.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for each performance test. It only mentions "samples aged at T=0" and "Accelerated Aging" samples.
- Data Provenance: The tests are described as "Performance Testing (Bench Evaluation)" and were conducted by Boston Scientific. This indicates in-vitro (benchtop) testing, not human or animal data. The origin would be the testing laboratories of Boston Scientific. The data is prospective in the sense that the tests were designed and executed to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is a mechanical adapter, and its performance (e.g., leak resistance, securing force) is assessed through engineering and functional bench testing, not by expert interpretation of images or patient data to establish a "ground truth" in a diagnostic context.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving subjective interpretations (e.g., radiology reads) to resolve discrepancies. Bench testing involves quantifiable measurements that are compared against predefined specifications or predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. MRMC studies are designed to compare the performance of multiple readers (human or AI) across multiple cases, typically in diagnostic imaging or clinical decision-making. This submission is for a mechanical medical device and involves no human readers in an interpretive capacity or AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a mechanical adapter, not an algorithm or AI system.
7. Type of Ground Truth Used
- Not applicable for diagnostic ground truth. For this device, the "ground truth" for its performance is established by engineering specifications and functional testing results compared against the predicate device's known performance characteristics. For example, a "leak resistance" test would have objective measurement criteria for what constitutes a leak and what levels are acceptable, often based on industry standards or the predicate's performance.
8. Sample Size for the Training Set
- Not applicable. This device does not involve a training set as it is not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set.
§ 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.