The forceps valve is intended to facilitate passage of an endotherapy device, to prevent leak or back flow of air and/or fluids, and to enable the suction function of a FUJIFILM or Olympus gastrointestinal endoscope.
Device Story
FROG Forceps Valve (VAL1-F1-100) is a single-use endoscope channel accessory; attaches to biopsy port of FUJIFILM or Olympus gastrointestinal endoscopes. Device forms tight seal; prevents leakage of biomaterial; facilitates passage of endotherapy instruments; maintains suction function. Used in hospital/clinic settings by physicians/endoscopy staff. Output is mechanical interface; enables clinical procedure performance; benefits patient by maintaining endoscopic system integrity and preventing fluid/air leakage during intervention.
Clinical Evidence
Bench testing only. Biocompatibility testing performed per ISO 10993-1, -5, -7, -10. Bench testing confirmed compatibility with Olympus endoscopes and effectiveness over 2-year shelf life. Bioburden testing conducted per USP 61.
Technological Characteristics
Single-use, non-sterile endoscope channel accessory. Material biocompatibility per ISO 10993 standards. Mechanical seal design for biopsy port. Compatible with FUJIFILM G7 series and Olympus GI endoscopes. 2-year shelf life.
Indications for Use
Indicated for use with FUJIFILM or Olympus gastrointestinal endoscopes to facilitate endotherapy device passage, prevent air/fluid leakage or backflow, and enable suction during endoscopic procedures.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
JAZZ Forceps Valve (part of JAZZ Disposable Valve Kit) (K210625)
Submission Summary (Full Text)
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June 1, 2022
FUJIFILM medwork GmbH % Dhara Buch Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K221264
> Trade/Device Name: FROG Forceps Valve (VAL1-F1-100) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: April 29, 2022 Received: May 2, 2022
Dear Dhara Buch:
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
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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, 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) K221264
Device Name FROG Forceps Valve VAL1-F1-100
Indications for Use (Describe)
The forceps valve is intended to facilitate passage of an endotherapy device, to prevent leak or back flow of air and/or fluids, and to enable the suction function of a FUJIFILM or Olympus gastrointestinal endoscope.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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K221264 Page 1 of 3
# 510(k) Summary
# FUJIFILM medwork GmbH
#### FROG Forceps Valve (VAL1-F1-100)
Date: April 29, 2022
### Submitter's Information:
FUJIFILM medwork GmbH Medworkring 1 91315 Höchstadt, Germany
#### Contact Person:
Dhara Buch Regulatory Affairs Specialist Phone: 781-824-2708 E-Mail: dhara.buch@fujifilm.com
#### ldentification of the Proposed Device:
| Device Name: | FROG Forceps Valve (VAL1-F1-100) |
|------------------------|----------------------------------|
| Common Name: | Endoscope Channel Accessory |
| Product Code: | ODC |
| Device Class: | Class II |
| Classification: | Endoscope and accessories |
| Classification Number: | 21 C.F.R. § 876.1500 |
| Review Panel: | Gastroenterology/Urology |
#### Predicate Device:
- JAZZ Forceps Valve (part of JAZZ Disposable Valve Kit) (K210625) ●
#### Intended Use / Indications for Use:
The forceps valve is intended to facilitate passage of an endotherapy device, to prevent leak or backflow of air and/or fluids, and to enable the suction function of a FUJIFILM or Olympus gastrointestinal endoscope.
#### Device Description:
The FROG forceps valve forms a tight seal with the biopsy port to prevent leakage of biomaterial, provide easy passage of endotherapy devices, and support the suction function.
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# Comparison of Technological Characteristics:
A comparison of technological characteristics between the subject device and the predicate device is provided in the table below:
| Device Details | Predicate Device | Subject Device |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | JAZZ Forceps Valve (part of JAZZ<br>Disposable Valve Kit) | FROG Forceps Valve<br>(VAL1-F1-100) |
| 510(k) number | K210625 | To be assigned |
| Product code | ODC | ODC |
| Classification | II | II |
| Regulation Number | 21CFR § 876.1500 | 21CFR § 876.1500 |
| Manufacturer | FUJIFILM medwork GmbH | FUJIFILM medwork GmbH |
| Intended Use | The JAZZ Forceps Valve is intended to facilitate passage of an<br>endotherapy device, to prevent a leak<br>or backflow of air and/or fluids, and to<br>enable the suction function of a<br>FUJIFILM gastrointestinal endoscope. | The forceps valve is<br>intended to facilitate<br>passage of an endotherapy<br>device, to prevent leak or<br>backflow of air and/or<br>fluids, and to enable the<br>suction function of a<br>FUJIFILM or Olympus<br>gastrointestinal endoscope. |
| Supplied Sterile | Yes, EO sterilized | No, used non-sterile |
| Single Use | Yes | Yes |
| Compatibility | FUJIFILM G7 Series | FUJIFILM G7 Series and<br>Olympus GI Endoscopes |
| Environment of Use | Hospital and/or clinics | Hospital and/or clinics |
| Shelf life | 3 years | 2 years |
# Performance Data:
The proposed device was adopted into the biocompatibility testing of the predicate device 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
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medical devices - Part 1: Evaluation and testing within a risk management process,"" published September 4, 2020.
Bench testing was conducted to confirm the compatibility of the subject device with Olympus scopes.
Additional performance specifications were evaluated against pre-defined acceptance criteria to demonstrate the effectiveness of the device over its stated 2-year shelf life.
Bioburden testing was conducted according to USP 61.
## Conclusions:
The subject device shares the same intended use and similar indications as the predicate device (K210625).
Bench testing demonstrates that the subject device is as safe and effective as the predicate device. Thus, subject device is substantially equivalent to the predicate device.
