(30 days)
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection
The FUJIFILM Hood Models DH-106STL, DH-126STL, and DH-096ST are comprised of three main sections: an attaching portion, a distal portion, and a drain portion. The attaching portion is a wider diameter opening which is used to connect the hood to an applicable endoscope; a distal portion is the ending portion of the hood which tapers into narrower diameter opening, the drain slits on the distal portion form drain portion which prevent the fluids lodging on the surface of the endoscope.
The subject devices are used in combination with their respective applicable Fujifilm's endoscopes as shown in the table 7.1. All the applicable endoscopes marketed in USA are cleared under respective 510(k) notices.
The provided text describes a 510(k) submission for endoscopy hoods, which are physical accessories for endoscopes, not an AI/ML-driven medical device. Therefore, the information requested regarding acceptance criteria, study design for AI claims (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details), is not applicable to this submission.
The "device" in question (endoscopy hood) is a physical accessory without any computational or AI/ML components. The "performance data" mentioned refers to physical properties and conformity to standards for medical devices, not the performance of an algorithm.
Summary of Device and Performance Information Available in the Document:
The document concerns the Fujifilm Hood Models DH-106STL, DH-116STL, DH-126STL, and DH-096ST. These are endoscopy hoods intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Acceptance Criteria and Reported Device Performance (as inferred from the document for a physical device):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Device maintains field of view during endoscopic procedures when combined with compatible endoscopes. | The intended use is identical to the predicate device. The changes in dimensions and applicable endoscopes do not alter the intended use or fundamental technology. The device maintains the field of view during observation of the digestive tract. |
| Technological Characteristics Equivalence: Similar physical and material properties to the predicate. | - Manufacturer: Same as predicate (FUJIFILM corporation). |
- Outer Diameter: Slightly different from predicate due to shape changes (e.g., DH-106STL: 11.6mm vs. Predicate DH-28GR: 11.8mm).
- Maximum Diameter of Attaching Endoscope: Slightly different from predicate (e.g., DH-106STL: 15.3mm vs. Predicate DH-28GR: 15.5mm).
- Distance from the Tip: Shorter than predicate for versatility (e.g., DH-106STL: 6.0mm vs. Predicate DH-29CR: 7.0mm).
- Total Length: Shorter than predicate due to tip shortening (e.g., DH-116STL: 16.0mm vs. Predicate DH-29CR: 17.0mm).
- Combination Endoscope: Different specific endoscope models, but appropriate combinations set according to hood shape.
- How to Attach: Same method as predicate.
- Sterilization: EOG Sterilized (same as predicate).
- Reuse: Single Use (same as predicate).
- Material: Silicone rubber and Polycarbonate resin (same as predicate).
- Transport and Storage: Same environment parameters as predicate. |
| Safety and Effectiveness: Changes do not raise new safety or effectiveness issues. | "Performance data demonstrated that the FUJIFILM Hood Models DH-106STL, DH-116STL, DH-126STL, and DH-096ST have substantial equivalent performance to the predicate device Fujifilm Hood Model DH-28GR, DH-29CR and DH-30CR (K162749)."
"The differences in the dimensions between the subject devices and its predicate device raise no new issues of safety or effectiveness." |
| Compliance with Consensus Standards: Adherence to relevant industry standards. | Endoscope specific testing was conducted using ISO 8600-1:2015 and ISO 8600-4:2014. |
| Additional Testing for Physical Properties: Verified dimensional specifications. | Subject devices met performance specifications in additional testing for: - Outer diameter
- Maximum diameter of attaching endoscope
- Distance from the tip |
Details of Study that Proves the Device Meets Acceptance Criteria:
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A table of acceptance criteria and the reported device performance: See table above.
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Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device that uses "test sets" or "training sets" of data. The device is a physical accessory for endoscopes. The "performance data" refers to bench testing and comparison of physical characteristics against predicate devices and consensus standards. No patient data or images were used for evaluation of this device.
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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): Not applicable. "Ground truth" in the context of expert review of data is irrelevant for a physical endoscopy hood.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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. No "human readers" or "AI assistance" are involved with this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance relies on engineering specifications, material properties, and physical functionality, verified through bench testing and comparison to a legally marketed predicate device.
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The sample size for the training set: Not applicable.
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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.