(29 days)
Not Found
No
The document describes a passive mechanical device (distal cap) and its intended use, materials, and performance testing related to sterility, biocompatibility, storage, and attachment security. There is no mention of image processing, AI, ML, or any software-driven functionality.
No
The device is described as maintaining the field of view during endoscopic procedures or observation of the digestive tract. While some models feature guide grooves for "endotherapy devices," the device itself is not presented as providing therapy. Its primary function is observational or supportive for other procedures, not therapeutic.
No
The device is described as an accessory (distal cap) used with endoscopes to maintain the field of view during endoscopic procedures or observation of the digestive tract. It facilitates viewing but does not perform diagnostic functions itself.
No
The device description explicitly states the device is comprised of physical components (attaching portion and distal portion) and mentions physical characteristics like drain slits and guide grooves. Performance studies also focus on physical properties like sterility, biocompatibility, storage, transportation, and secure attachment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the distal caps are used in combination with endoscopes to maintain the field of view during endoscopic procedures or observation of the digestive tract. This is a mechanical function performed in vivo (within the body) during a medical procedure.
- Device Description: The description details the physical components and features of the distal caps, which are designed for attachment to an endoscope.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease. The device does not perform any diagnostic testing on biological samples.
The device is a medical device used during an endoscopic procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
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-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.
Product codes (comma separated list FDA assigned to the subject device)
FDS, FDF
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 the surface of the endoscope. DH-33GR and DH-34CR also feature guide grooves to facilitate the use of endotherapy devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Digestive tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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.