(258 days)
The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endscopic procedures such as mucosal resection.
The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR 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 document is a 510(k) premarket notification for FUJIFILM Hood Models DH-28GR, DH-29CR, and DH-30CR. It primarily focuses on demonstrating substantial equivalence to a predicate device, FUJIFILM Hood Model DH-17EN (K143556), rather than outlining specific acceptance criteria in the context of device performance metrics and a detailed study proving performance against those metrics in the way one might typically see for AI/ML devices.
Instead, the document details performance data that supports the substantial equivalence, particularly concerning changes in dimensions, material, and sterility status compared to the predicate device.
Here's an analysis based on the information provided, framed to address your requested points where applicable, and highlighting what is not present (which is most of the detailed information expected for an AI/ML device performance study):
1. Table of Acceptance Criteria and Reported Device Performance
The term "acceptance criteria" is not used in the document for specific performance thresholds. Instead, the document discusses meeting "performance specifications" or demonstrating "substantially equivalent performance" to the predicate device. The performance data presented focuses on verifying that changes to the device (dimensions, material, sterility) do not negatively impact its safety and effectiveness compared to the predicate.
| Category | Acceptance Criteria (Implied/Stated as "Met Performance Specifications" or "Equivalent") | Reported Device Performance (as stated in the document) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 series (ISO 10993-1, -5, -7, -10) | Evaluated using specified ISO standards; no new concerns. |
| Sterilization | Compliance with ISO 11135:2014 and ASTM F1980-07:2011 | Evaluated according to specified standards; successfully validated. |
| Endoscope Specific | Compliance with ISO 8600-1:2015 and ISO 8600-4:2014 | Conducted using specified ISO standards. |
| Dimensional | Outer diameter consistent with design. | Met performance specifications. |
| Maximum diameter of attaching endoscope consistent with design. | Met performance specifications. | |
| Inner diameter of distal end consistent with design. | Met performance specifications. | |
| Inner diameter of attaching portion consistent with design. | Met performance specifications. | |
| Distance from the tip consistent with design. | Met performance specifications. | |
| Residual EO/ECH | Concentrations are safe. | Successfully validated for residual EO and ECH concentrations. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described appears to be bench testing or in vitro assessments of device properties rather than a clinical study with patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided as this is not a study involving expert review for ground truth establishment. The performance data relates to physical and material properties and compliance with engineering and sterilization standards.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a test set requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided. This device is an accessory for endoscopes, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
This information is not applicable and not provided. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as it applies to AI/ML device performance (e.g., expert consensus, pathology, outcomes data) is not relevant to this 510(k) submission. The "ground truth" in this context would be the established engineering specifications, material properties, and regulatory standards.
8. Sample Size for the Training Set
This information is not applicable and not provided. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
Summary of the Study (as described in the document):
The "study" described in the 510(k) submission is a series of bench tests and evaluations aimed at demonstrating that the new FUJIFILM Hood Models DH-28GR, DH-29CR, and DH-30CR are substantially equivalent to the predicate device, FUJIFILM Hood Model DH-17EN. The focus is on showing that changes in dimensions, material composition, and the introduction of a sterile presentation do not introduce new questions of safety or effectiveness.
The performance data included:
- Biocompatibility testing according to ISO 10993 standards.
- Sterilization validation according to ISO 11135 and ASTM F1980.
- Endoscope-specific testing according to ISO 8600 standards.
- Verification of specific dimensions (outer diameter, max diameter of attaching endoscope, inner diameter of distal end, inner diameter of attaching portion, distance from the tip) against performance specifications.
The document concludes that these tests demonstrated substantially equivalent performance to the predicate device, supporting the claim that the new device models are as safe and effective as the previously cleared 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.