(28 days)
None
No
The device description and performance studies focus on the physical properties, sterility, and biocompatibility of a single-use distal end cap for an endoscope. There is no mention of image processing, AI, ML, or any software-based functionality.
No
The device is described as an "atraumatic passage" assistant for endoscopes, not as a device that delivers therapy.
No
Explanation: The device is a distal end cap for an endoscope, designed to assist in providing atraumatic passage during endoscopic procedures. Its function is mechanical assistance during a procedure, not to diagnose a condition or disease.
No
The device description clearly states it is a "single use device" and a "distal end cap" that is "attached to the distal tip of a FUJIFILM ED-580XT duodenoscope." This indicates a physical, hardware component, not software. The performance studies also focus on physical properties like sterility, biocompatibility, 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 product is a "single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures." This describes a mechanical accessory used during an endoscopic procedure, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces its function as an attachment to an endoscope for mechanical assistance during a procedure and for facilitating reprocessing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is a single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures.
Do not use this product for any other purposes.
Product codes
FDT
Device Description
FUJIFILM Distal End Cap DC-08D is a single use device that is supplied sterile, eliminating the need for reprocessing prior to use. This distal end cap is designed to the distal tip of a FUJIFILM ED-580XT duodenoscope. After an endoscopic procedure, the DC-08D is detached to facilitate easier access to the distal elevator during reprocessing of the ED-580XT.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Sterility of the subject device was evaluated using the following consensus standards: ASTM F1980-16, ISO 11137-1:2006, ISO 11607-1:2019, ISO 11607-2:2019.
Biocompatibility of the subject device was evaluated using the following standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's quidance, "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.
Bench testing was conducted to demonstrate that the subject device is attached securely such that it will not detach during use.
The subject device was evaluated for conformance to ISO 8600-1:2015. Additional performance specifications were evaluated against pre-determined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
FUJIFILM Distal End Cap DC-07D (K191747)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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.
October 30, 2020
Fujifilm Corporation % Jeffrey Wan Senior Regulatory Affairs Specialist FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K203028
Trade/Device Name: FUJIFILM Distal End Cap Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT Dated: September 30, 2020 Received: October 2, 2020
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. You must comply with all the Act's
1
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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 Quality 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) | K203028 | ||
| Device Name | FUJIFILM Distal End Cap DC-08D | ||
| Indications for Use (Describe) | This product is a single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures. | ||
| Do not use this product for any other purposes. | |||
| 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. | |||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |||
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |||
| Department of Health and Human Services | |||
| Food and Drug Administration | |||
| Office of Chief Information Officer | |||
| Paperwork Reduction Act (PRA) Staff | |||
| PRAStaff@fda.hhs.gov | |||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." |
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary FUJIFILM Corporation Distal End Cap DC-08D
Date: September 30, 2020
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, Japan 258-8538
Contact Person:
Jeffrey Wan Senior Regulatory Affairs Specialist Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com
Identification of the Proposed Device:
| Device Name: | FUJIFILM Distal End Cap DC-08D |
|---|---|
| Common Name: | Endoscopic accessory |
| Device Class: | Class II |
| Classification Number: | 21 C.F.R. § 876.1500 |
| Classification Name: | Endoscope and accessories |
| Device Panel: | Gastroenterology/Urology |
Product Code Information:
| Product Code Name: | Duodenoscope and accessories, flexible/rigid |
|---|---|
| CFR Section: | 21 CFR 876.1500 |
| Product Code: | FDT |
Predicate Device:
- FUJIFILM Distal End Cap DC-07D (K191747) .
Intended Use / Indications for Use
This product is a single use distal end cap required to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures.
Do not use this product for any other purposes.
4
Device Description
FUJIFILM Distal End Cap DC-08D is a single use device that is supplied sterile, eliminating the need for reprocessing prior to use. This distal end cap is designed to the distal tip of a FUJIFILM ED-580XT duodenoscope. After an endoscopic procedure, the DC-08D is detached to facilitate easier access to the distal elevator during reprocessing of the ED-580XT.
Comparison of Technological Characteristics
The subject device FUJIFILM Distal End Cap DC-08D differs from the predicate device in the following modifications:
- DC-08D is supplied sterile, while DC-07D is supplied non-sterile and requires reprocessing . prior to use.
- Packaging change from non-sterile bag to sterile pouch
- . Material change
Performance Data
Sterility of the subject device was evaluated using the following consensus standards: ASTM F1980-16, ISO 11137-1:2006, ISO 11607-1:2019, ISO 11607-2:2019.
Biocompatibility of the subject device was evaluated using the following standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's quidance, "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.
Bench testing was conducted to demonstrate that the subject device is attached securely such that it will not detach during use.
The subject device was evaluated for conformance to ISO 8600-1:2015. Additional performance specifications were evaluated against pre-determined acceptance criteria.
Conclusions
The subject device DC-08D shares the same intended use and indications to the predicate device. Bench testing demonstrates that the subject device is as safe and effective as the predicate device. Thus, DC-08D is substantially equivalent to the listed predicate device.