(244 days)
The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.
The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.
The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).
The Defendo Pentax Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single-use valves designed to be used on the Pentax endoscopes as accessories. The specific valves include the Defendo Pentax Single Use Air/Water Valve, the Defendo Pentax Single Use Suction Valve, the Defendo Pentax Single Use Biopsy Valve, and the Endogator Pentax Single Use Connector.
The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.
The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.
The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.
The Connector allows attachment between the irrigation tubset via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water jet valve.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.
The provided text describes a 510(k) premarket notification for a set of single-use endoscopy valves. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with acceptance criteria for device performance. Therefore, the document does not contain the detailed information typically found in a study proving a device meets specific performance acceptance criteria, such as clinical effectiveness or diagnostic accuracy.
The document discusses non-clinical performance testing to support substantial equivalence, but these tests are not presented as meeting specific clinical acceptance criteria or performed as a comparative effectiveness study with human readers or standalone algorithm performance.
Here's an attempt to answer your questions based on the available information, noting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not use the term "acceptance criteria" for clinical performance. Instead, it describes non-clinical performance testing conducted to demonstrate the safety and effectiveness of the device as substantially equivalent to predicate devices. The "reported device performance" are the results of these non-clinical tests.
| Device Component | Test Performed | Implicit "Acceptance Criteria" (Substantial Equivalence) | Reported Performance (Implied "Met") |
|---|---|---|---|
| Air/Water Valve | Gas (Air and CO2) flow rate | Comparable flow rates to predicate device or within acceptable range for intended function. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Water flow rate | Comparable flow rates to predicate device or within acceptable range for intended function. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Backflow prevention | Effective prevention of backflow, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Sonic Weld Break Testing) | Forces within acceptable ergonomic and functional range, comparable to predicate. Structural integrity maintained. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Valve Operation / Procedure Duration Test | Consistent and reliable operation throughout simulated procedure duration, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Suction Valve | Suction Bypass | Effective suction bypass, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Suction Rate (water and soil) | Effective suction of water and soil at rates comparable to predicate device or within acceptable range for intended function. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Sonic Weld Break Testing) | Forces within acceptable ergonomic and functional range, comparable to predicate. Structural integrity maintained. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Valve Operation / Procedure Duration Test | Consistent and reliable operation throughout simulated procedure duration, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Biopsy Valve | Leak Testing | Minimal or no leakage, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Insufflation Testing | Effective maintenance of insufflation, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Auxiliary Waterjet (Connector) | Flow Durability Testing | Durable flow comparable to predicate, capable of extended use as intended. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Check Valve Functionality (Back Flow Prevention) | Effective backflow prevention, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Mechanical Strength Testing | Adequate mechanical strength for intended use, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| All Devices | Packaging Testing (ISO 11607/ASTM 4169) | Packaging maintains sterile barrier after shipping/transit, demonstrating sterility assurance. | Testing completed; packaging maintains sterile barrier. |
| All Devices | Biocompatibility (ISO 10993) | Patient-contacting portions of the device are biocompatible. | Test results show the subject devices are biocompatible. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for individual non-clinical tests (e.g., how many valves were tested for flow rate or mechanical properties). It refers to "testing" as being performed on "the subject device."
The data provenance is from non-clinical performance testing conducted by the manufacturer, Medivators (A Subsidiary of STERIS Corporation), located in Conroe, TX 77303, USA. These are laboratory-based tests, not clinical data from patients.
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 to this 510(k) submission. The "ground truth" concept is typically relevant for studies involving diagnostic accuracy or clinical outcomes where human expert assessment is needed. This submission relies on engineering and laboratory testing for functional performance and safety.
4. Adjudication Method for the Test Set
This information is not applicable to this 510(k) submission. Adjudication methods (like 2+1 or 3+1) are used in clinical trials to establish a definitive diagnosis or outcome, often from multiple expert opinions. The testing mentioned here is non-clinical and lab-based.
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. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices, often involving AI. The devices described here are single-use endoscopic valves, which are mechanical accessories, not diagnostic imaging devices or AI tools.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. Standalone algorithm performance is relevant for AI-based devices. The devices described here are mechanical endoscopic accessories.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document speaks of "non-clinical performance testing" and "biocompatibility assessment" to demonstrate substantial equivalence to predicate devices. The "ground truth," in this context, would be the established functional performance characteristics and safety profiles of the predicate devices, along with relevant engineering standards and regulatory requirements. It is based on engineering benchmarks, physical measurements, and internationally recognized standards (e.g., ISO 10993 for biocompatibility, ISO 11607/ASTM 4169 for packaging).
8. The Sample Size for the Training Set
This information is not applicable. A "training set" refers to data used to train machine learning algorithms. The devices described are mechanical accessories and do not involve AI or machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in 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.