(29 days)
Distal Cap Models DH-33GR, DH-34CR, and DH-40GR are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Distal Cap Models DH-35GZ, DH-37CZ, DH-38CZ, and DH-39CZ are intended to be used in combination with compatible endoscopes to maintain the field of view during observation of the digestive tract.
FUJIFILM Distal Cap Models 33-40 are comprised of an attaching portion and a distal portion. DH-33GR, DH-34CR, DH-35GZ, and DH-40GR feature drain slits, which prevent fluids from lodging on the surface of the endoscope. DH-33GR and DH-34CR also feature guide grooves to facilitate the use of endotherapy devices.
This document is a 510(k) premarket notification for FUJIFILM Distal Cap Models 33-40. It describes the device, its intended use, and performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document provides a general statement about performance data, but does not provide a specific table of acceptance criteria and reported device performance for each criterion. It mentions:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterility | Evaluated using ISO 11135:2014 and ASTM F1980-16. |
| Biocompatibility | Evaluated using ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, and ISO 10993-10; testing in accordance with FDA guidance. |
| Storage & Transportation | Conducted to validate expanded temperature (-20°C to 60°C) and humidity (10 to 95% RH) ranges. |
| Secure Attachment | Bench testing conducted to demonstrate secure attachment during use. |
| Additional Performance | Evaluated against "pre-defined acceptance criteria." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the tests. It refers to "bench testing" and "evaluations" but does not quantify the number of units or tests performed.
The document mentions FUJIFILM Corporation is located in Japan (798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan), implying the testing or at least the device development originated from there. It does not explicitly state whether the data is retrospective or prospective, but based on the context of a 510(k) submission, it would typically involve prospective testing conducted for regulatory purposes.
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 question is not applicable to the provided document. The device in question is a physical endoscope accessory (distal cap). The "ground truth" for its performance relates to objective physical and biological properties (sterility, biocompatibility, secure attachment, durability), not to diagnostic accuracy involving expert interpretation of images or clinical outcomes that would require physician feedback on a "ground truth" established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnostic accuracy, particularly in imaging or clinical assessments. The performance data for this device is based on technical and biological laboratory testing.
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 question is not applicable. The device is an endoscope accessory, not an AI-powered diagnostic system or a device that directly enhances human reader performance in a diagnostic task. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical accessory, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" in the traditional sense of a diagnostic reference standard is not directly applicable here. For the tests mentioned:
- Sterility: The "ground truth" would be established by the absence of viable microorganisms, as measured by standardized microbiological tests (e.g., Sterility Assurance Level as per ISO 11135).
- Biocompatibility: The "ground truth" would be established by the absence of cytotoxic, sensitizing, or irritating effects as per ISO 10993 standards.
- Secure Attachment: The "ground truth" would be the device remaining securely attached under simulated use conditions, determined by bench testing against engineering specifications.
- Storage and Transportation: The "ground truth" would be the device maintaining its integrity and functionality after exposure to specified temperature and humidity extremes, determined by physical inspection and functional tests.
8. The sample size for the training set
This question is not applicable. The device is a hardware accessory, not a machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable, as 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.