(149 days)
The DEFENDO™ Y-Opsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.
The DEFENDO™Y-Opsy Irrigator is a sterile, disposable, single patient use, biopsy valve with a side port backflow valve for irrigation. It provides access for endoscopic device passage, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy channel during endoscopic procedures. The backflow valve prevents the potential of cross contamination between patients the device's diaphragm (slit) minimizes leakage from the biopsv channel while reducing the healthcare professional's exposure to biomaterials as endoscopy instruments are withdrawn.
Here's an analysis of the acceptance criteria and supporting studies for the DEFENDO™ Y-Opsy Irrigator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparative bench testing rather than defining explicit acceptance criteria for novel performance claims. The "acceptance criteria" are implied by the performance of the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance (DEFENDO™ Y-Opsy Irrigator) |
|---|---|
| Flow Rate: Equivalent or greater than the Endogator® System Y-Connector (K092429) (for irrigation functionality). | Demonstrated equivalent or greater flow rate than the predicate Endogator System Y-Connector (K092429) when tested with two separate manufacturers' endoscopes. |
| Functional Equivalence: Equivalent performance to the DEFENDO™ Biopsy Valve (K090851) across five functional criteria. | Demonstrated equivalent performance to the DEFENDO™ Biopsy Valve (K090851) across five functional criteria. |
| Leakage during biopsy sample withdrawal/bowel irrigation: No evidence of fluid leakage. | 100% of tested DEFENDO™ Y-Opsy Irrigators showed no evidence of fluid leakage during sample biopsy or bowel irrigation. |
| Pressure maintenance during bowel insufflation: Maintain at least 10 psi with no leakage. | 100% of tested DEFENDO™ Y-Opsy Irrigators maintained a pressure of at least 10 psi with no leakage. |
2. Sample Size Used for the Test Set and Data Provenance:
- Flow Rate Study: The sample size for the devices tested in the flow rate study is not explicitly stated, only that it utilized "two separate manufacturers' endoscopes." The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
- Functional Criteria Study: The sample size for the devices tested in the functional criteria study is not explicitly stated. The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
- Leak Testing: The sample size for the leak testing is described as "100% of the DEFENDO™ Y-Opsy Irrigators tested." The exact number (e.g., N=X) is not provided, but implies a comprehensive test of a batch. The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
- Country of Origin: Not specified but implicitly conducted by Byrne Medical Inc. in Conroe, Texas, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This device is a medical accessory, and the "ground truth" for its performance is established through measurable physical properties (flow rate, leakage, functional criteria) through bench testing, not by expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the evaluation is based on objective bench testing measurements, not expert review or adjudication of subjective data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic imaging device or an AI-assisted device that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical medical device, not an algorithm or software. The performance studies are standalone to the device itself.
7. The Type of Ground Truth Used:
The ground truth used for these studies is based on:
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate devices (Byrne Medical Endogator® System Y-Connector and Byrne Medical DEFENDO™ Biopsy Valve).
- Objective Bench Test Measurements: Quantifiable measurements such as flow rate (volume over time) and pressure capabilities, as well as qualitative assessments of functional equivalence during simulated use.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of 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.