(140 days)
The 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, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Single Use Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).
The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel postprocedure, and not to be used during a patient procedure.
The Defendo Fujifilm 700 Single-Use Valves Set consists of a family of ready-to-use, sterile, single-use valves designed to be used on the Fujifilm 700 series GI endoscopes as accessories. The specific valves that are the subject of this 510(k) include the Defendo Fujifilm 700 Single-Use Air/Water Valve, the Defendo Fujifilm 700 Single-Use Suction Valve, the Defendo Fujifilm 700 Single Use Biopsy Valve, the Endogator Fujifilm 700 Connector, and the Defendo Fujifilm 700 Cleaning Adapter.
The provided text describes the acceptance criteria and the study conducted for Medivators' Defendo Fujifilm 700 Single-Use Valves Set, which includes several types of valves and a cleaning adapter. It's important to note that this submission is for accessories to endoscopes, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions related to AI/SaMD (like ground truth, expert adjudication, MRMC studies, training set details) are not applicable to this type of device clearance.
The study focuses on demonstrating the substantial equivalence of these new single-use accessories to existing predicate devices, primarily through engineering and performance testing, and biocompatibility.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerically reported device performance against those criteria in a summary format. Instead, it describes various "Non-Clinical Performance Testing" conducted for each component (Air/Water Valve, Suction Valve, Biopsy Valve, Auxiliary Waterjet Valve (Connector), Cleaning Adapter). The conclusion states that the "subject device has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use," implying that all tests performed achieved their respective pass/fail criteria.
However, we can infer the types of acceptance criteria from the performed tests:
| Device Component | Type of Testing and Implied Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|---|
| Air/Water Valve | - Gas (Air and CO2) flow rate testing: Likely to ensure sufficient airflow for insufflation. |
- Water flow rate testing: Likely to ensure sufficient water flow for lens washing.
- Backflow prevention testing: To prevent backflow of contents.
- Mechanical testing:
- Depression Force
- Valve Application Force
- Valve Removal Force
- Force to Disassemble via Axial Pull
(Ensures proper function, insertion, removal, and integrity).
- Valve Operation / Procedure Duration Test: To ensure durability and consistent performance throughout a typical endoscopic procedure duration. | Met criteria (Substantially Equivalent) |
| Suction Valve | - Suction Bypass: To ensure proper suction path. - Suction Rate (water and soil): To demonstrate adequate aspiration capability.
- Mechanical testing:
- Depression Force
- Valve Application Force
- Valve Removal Force
- Force to Disassemble via Axial Pull
(Ensures proper function, insertion, removal, and integrity).
- Valve Operation / Procedure Duration Test: To ensure durability and consistent performance throughout a typical endoscopic procedure duration. | Met criteria (Substantially Equivalent) |
| Biopsy Valve | - Workability / Instrument Access Testing: To ensure smooth passage and exchange of endoscopic instruments. - Slit Length / Dimensional Stability: To maintain proper sealing and instrument passage.
- Confirmatory testing: To ensure continued performance as intended, especially given the change in sterility status compared to a prior predicate. | Met criteria (Substantially Equivalent) |
| Auxiliary Waterjet Valve (Connector) | - Flow Rate / Durability Testing: To ensure adequate irrigation flow and sustained performance. - Backflow Prevention Test: To prevent backflow. | Met criteria (Substantially Equivalent) |
| Cleaning Adapter | - Gas Flow Rate: To ensure proper air channel cleaning. - Water Flow Rate: To ensure proper water channel cleaning.
- Mechanical Testing:
- Depression Force
- Adapter Application Force
- Adapter Removal Force
(Ensures proper function, insertion, and removal).
- Button Cycling / Durability Testing: To ensure repeated functional use for pre-cleaning. | Met criteria (Substantially Equivalent) |
| Packaging | - ISO 11607/ASTM 4169 testing: To ensure sterile barrier maintenance after shipping/transit. | Met criteria (Sterile Barrier Maintained) |
| Biocompatibility | - ISO 10993-1 assessment: "Biocompatibility testing conducted on the patient-contacting portions... in accordance with the ISO 10993 standard." "The test result shows that the subject devices are biocompatible." | Met criteria (Biocompatible) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (N) for each of the performance tests. It states that "Non-clinical performance testing was performed on the subject device to support the substantial equivalence determination."
Data provenance: The testing was performed by Medivators (A Subsidiary of STERIS Corporation) in Conroe, Texas, USA. It's engineering performance test data, not patient data, so "country of origin of the data" in the sense of patient demographics is not applicable. The data is retrospective based on the tests performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a 510(k) submission for physical medical device accessories (valves, connectors, adapters), not an AI/software device that requires human expert review for "ground truth" establishment from medical images or clinical data. The "ground truth" for these performance tests is based on engineering specifications, physical measurements, and functional requirements.
4. Adjudication method for the test set
Not applicable, as this is related to expert consensus for AI/SaMD ground truth, which is not relevant for this device.
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
Not applicable. This is not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD.
7. The type of ground truth used
The "ground truth" for the performance of these physical accessories is defined by established engineering and functional specifications, industry standards (e.g., ISO 11607 for packaging, ISO 10993 for biocompatibility), and the performance of the legally marketed predicate devices. The tests verify that the subject devices meet these specifications for safe and effective use.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 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.