(34 days)
The Defendo Fujifilm 700 Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.
This device is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.
The Defendo Fujifilm 700 Single Use Cleaning Adapter is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Fujifilm endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The Defendo Fujifilm 700 Single Use Cleaning Adapter assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.
This document is a 510(k) premarket notification from the FDA for a medical device. It is not a study demonstrating the performance of an AI/ML powered device. Most of the requested information regarding AI/ML study design and results is therefore not applicable.
The device is the "Defendo Fujifilm 700 Single Use Cleaning Adapter," which is a non-sterile, single-use disposable valve intended to pre-clean endoscope air/water channels post-procedure. The submission is a "Special 510(k)" to obtain clearance for a non-sterile version of a previously cleared sterile device (K232329).
Here's the relevant information based on the provided text, with explanations why certain points are not applicable:
1. A table of acceptance criteria and the reported device performance
The document provides a summary table of non-clinical performance testing. The "Acceptance Criteria" column consistently states "Meet acceptance criteria" without detailing the specific numeric or qualitative thresholds for each test. However, the "Results" column consistently states "Pass," indicating that the device met these (undisclosed) criteria for all tests.
| Testing Conducted | Acceptance Criteria | Results |
|---|---|---|
| Button cycling/external leak | Meet acceptance criteria | Pass |
| Water Flow Rate | Meet acceptance criteria | Pass |
| Air Flow Rate | Meet acceptance criteria | Pass |
| Cap breakage strength | Meet acceptance criteria | Pass |
| Force to depress | Meet acceptance criteria | Pass |
| Backpressure Hold Test | Meet acceptance criteria | Pass |
| Force to Attach | Meet acceptance criteria | Pass |
| ASTM D4169 Ship Test | Meet acceptance criteria | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size for any of the non-clinical tests conducted.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given that these are benchtop "non-clinical" performance tests for a physical device, the concepts of retrospective/prospective clinical data or patient data provenance do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The device is a mechanical cleaning adapter, not an AI/ML-powered diagnostic tool. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant to its performance testing. The "truth" here is objective physical measurements and functional performance as per engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is not a study requiring expert adjudication of clinical findings.
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/ML device, nor is it a clinical study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance testing consists of engineering specifications, material properties, and functional requirements (e.g., specific flow rates, force thresholds, leak prevention). It is established through physical measurements and bench testing against predefined criteria, not against clinical expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set for an AI/ML model.
§ 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.