(28 days)
Not Found
No
The summary describes a simple mechanical accessory (a distal cap) for an endoscope, with no mention of image processing, AI, ML, or any software-based functionality. The performance studies focus on sterility, biocompatibility, and secure attachment, not algorithmic performance.
No.
The device is intended to maintain the field of view during endoscopic procedures, which is a diagnostic or procedural aid, not a direct therapeutic action on the patient.
No
The device is described as an accessory used to maintain the field of view during endoscopic procedures, not to diagnose a condition.
No
The device description explicitly states that the device is a "pre-sterilized, single-use accessory" that is "attached to the tip of an applicable FUJIFILM double balloon endoscope." This indicates a physical, hardware component, not a software-only device. The performance studies also focus on sterility, biocompatibility, and secure attachment, which are characteristic of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "maintain the field of view during endoscopic procedures." This is a mechanical function to aid in visualization during a procedure, not to perform a diagnostic test on a sample taken from the body.
- Device Description: The device is described as an accessory that attaches to an endoscope to maintain a clear view. This aligns with a surgical or procedural aid, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely to improve visualization during an endoscopic procedure.
N/A
Intended Use / Indications for Use
Distal Cap Models DH-32EN and DH-17EN2 are intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
FDS, FDF
Device Description
Distal Cap Models DH-32EN and DH-17EN2 are pre-sterilized, single-use accessories that are attached to the tip of an applicable FUJIFILM double balloon endoscope to maintain a clear, unobstructed field of view during endoscopic procedures.
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 (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, ISO 11607-1:2019, ASTM F1980-16.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's guidance, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," published September 4, 2020.
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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August 19, 2021
FUJIFILM Corporation % Jeffrey Wan Manager, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K212296
Trade/Device Name: Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF, FDS Dated: July 21, 2021 Received: July 22, 2021
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 control's 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,
for
Shanil P. Haugen, Ph.D. 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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Indications for Use
510(k) Number (if known) K212296
Device Name
Distal Cap Models DH-32EN and DH-17EN2
Indications for Use (Describe)
Distal Cap Models DH-32EN and DH-17EN2 are intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Production/Use for 21 CFR 511.1 Subject Drugs |
|---|
| □ Compounding/Manufacturing for 21 CFR 511.4 Subject Drugs |
X 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 Corporation Distal Cap Models DH-32EN and DH-17EN2
Date: July 21, 2021
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan
Contact Person:
Jeffrey Wan Manager, Regulatory Affairs Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com
Identification of the Proposed Device:
| Device Name: | Distal Cap Models DH-32EN and DH-17EN2 |
|---|---|
| Common Name: | Endoscopic Accessory |
| Device Class: | Class II |
| Classification Number: | 21 C.F.R. § 876.1500 |
| Classification Name: | Endoscope and accessories |
| Device Panel: | Gastroentereology/Urology |
| Product Code: | FDS, FDF |
Predicate Devices:
- . Distal Cap Model DH-39CZ (K193123)
Intended Use / Indications for Use
Distal Cap Models DH-32EN and DH-17EN2 are intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.
Device Description
Distal Cap Models DH-32EN and DH-17EN2 are pre-sterilized, single-use accessories that are attached to the tip of an applicable FUJIFILM double balloon endoscope to maintain a clear, unobstructed field of view during endoscopic procedures.
4
Comparison of Technological Characteristics
A comparison of technological characteristics between DH-32EN and DH-17EN2 and the predicate DH-39CZ is provided below:
| | Subject Device #1
DH-32EN | Subject Device #2
DH-17EN2 | Predicate Device
DH-39CZ |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | To be assigned | To be assigned | K193123 |
| Product code | FDF, FDS | FDF, FDS | FDF, FDS |
| Manufacturer | FUJIFILM Corporation | FUJIFILM Corporation | FUJIFILM Corporation |
| Intended Use | Distal Cap Models DH-
32EN and DH-17EN2
are intended to be used
in combination with the
dedicated endoscope to
maintain the field of view
during endoscopic
procedures. | Distal Cap Models DH-
32EN and DH-17EN2
are intended to be used
in combination with the
dedicated endoscope to
maintain the field of view
during endoscopic
procedures. | This hood is intended to
be used in combination
with compatible
endoscopes to maintain
the field of view during
observation of the
digestive tract |
| Outer
diameter | 9.7±0.2mm | 11.5±0.2mm | 14.2±0.5mm |
| Maximum
diameter of
compatible
endoscope | 13.3mm | 17.8mm | 18.2mm |
| Total length | 9.1mm | 8.0mm | 12.0mm |
| Distance from
the tip | 1.3mm | 1.5mm | 2.0mm |
| Compatible
endoscopes | EN-580T
El-580BT | EN-580T
EI-580BT | EC-600HL |
| Sterile method | EO | EO | EO |
| Single use | Yes | Yes | Yes |
Performance Data
Sterility of the subject devices was evaluated using the following consensus standards: ISO 11135:2014, ISO 11607-1:2019, ASTM F1980-16.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's guidance, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," published September 4, 2020.
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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.
Conclusions
The subject devices Distal Cap Models DH-32EN and DH-17EN2 share the same intended use and similar indications to the predicate device. Bench testing demonstrates that the subject devices are as safe and effective as the predicate device. Thus, Distal Cap Models DH-32EN and DH-17EN2 are substantially equivalent to the listed predicate device.