(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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
December 11, 2019
FUJIFILM Corporation % Jeffrey Wan Senior Regulatory Affairs Specialist FUJIFILM Medical Systems U.S.A. Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K193123
Trade/Device Name: FUJIFILM Distal Cap Models 33-40 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS, FDF Dated: November 8, 2019 Received: November 12, 2019
Dear Jeffrey Wan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, PhD Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
FUJIFILM Distal Cap Models 33-40
Indications for Use (Describe)
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-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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510(k) SUMMARY FUJIFILM Distal Cap Models 33-40
Date: November 8, 2019
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Jeffrey Wan Senior Requlatory Affairs Specialist Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com
Identification of the Proposed Device:
| Proprietary/Trade Name: | FUJIFILM Distal Cap Models 33-40 |
|---|---|
| Common Name: | Endoscopic Accessory |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Classification: | Endoscope and accessories, 21 C.F.R. § 876.1500 |
| Product Codes: | FDS, FDF |
Predicate Device:
FUJIFILM Hood Models DH-28GR, DH-29CR, DH-30CR (K162749)
Intended Use / Indications for Use:
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.
Device Description:
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
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the surface of the endoscope. DH-33GR and DH-34CR also feature guide grooves to facilitate the use of endotherapy devices.
Technological Characteristics:
FUJIFILM Distal Cap Models 33-40 differ from the predicate devices DH-28GR, and DH-30CR in terms of technological characteristics. The subject and predicate devices share the same mode of operation and intended use.
A summary of major differences between the subject and predicate devices is provided as follows:
- Compatibility with applicable endoscopes
- Dimensional changes
- Introduction of guide grooves for DH-33GR and DH-34CR
- Expansion of storage and transportation conditions to a temperature range of -20°C to 60°C ● and a humidity range of 10 to 95% RH.
- . Material changes
Performance Data:
Sterility of the subject devices was evaluated using the following consensus standards: ISO 11135:2014 and ASTM F1980-16.
Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, and ISO 10993-10. Biocompatibility testing was performed in accordance with the FDA guidance—Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"—published June 16, 2016.
Storage and transportation testing was conducted on the subject devices to validate the expanded temperature and humidity ranges.
Bench testing was conducted to demonstrate that the subject devices are attached securely such that they will not detach during use.
Additional performance specifications were evaluated against pre-defined acceptance criteria.
Substantial Equivalence:
The subject devices FUJIFILM Distal Cap Models 33-40 are substantially equivalent to the predicate devices, FUJIFILM Hood Models DH-28GR, DH-29CR, and DH-30CR (K162749). The subject and predicate devices share the same intended use. Bench testing demonstrates that the differences in technological characteristics raise no new issues of safety or effectiveness. The change in materials was validated via biocompatibility testing. Thus, the subject devices are substantially equivalent to the predicate devices.
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Conclusions:
The subject devices FUJIFILM Distal Cap Models 33-40 are substantially equivalent to the predicate devices based on the same intended use and similar indications for use, technological characteristics, and materials.
§ 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.