(30 days)
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.
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.
The provided document is a 510(k) premarket notification letter and a 510(k) summary for the FROG Forceps Valve (VAL1-F1-100). This device is an endoscope accessory and its clearance is based on substantial equivalence to a predicate device (JAZZ Forceps Valve (part of JAZZ Disposable Valve Kit) K210625).
The document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on bench testing, biocompatibility testing, and a comparison of technological characteristics to a predicate device.
Therefore, the requested information regarding acceptance criteria, performance data, sample sizes, expert involvement, ground truth establishment, and MRMC studies related to an AI device cannot be extracted from this document, as it pertains to a different type of medical device clearance (forceps valve, not AI/ML).
The information that can be extracted regarding the FROG Forceps Valve is as follows:
FROG Forceps Valve (VAL1-F1-100) Analysis:
This device is a physical accessory for endoscopes, not an AI/ML diagnostic or assistive tool. The performance evaluation is based on bench testing and biocompatibility, not on AI model performance metrics or human reader studies.
1. Table of acceptance criteria and the reported device performance:
The document states: "Additional performance specifications were evaluated against pre-defined acceptance criteria to demonstrate the effectiveness of the device over its stated 2-year shelf life." However, the specific acceptance criteria and the detailed reported performance values are NOT provided in this summary.
2. Sample sizes used for the test set and the data provenance:
- Bench Testing: The document states "Bench testing was conducted to confirm the compatibility of the subject device with Olympus scopes." and "Additional performance specifications were evaluated...". The specific sample sizes for these bench tests are not mentioned.
- Biocompatibility Testing: The document refers to consensus standards (ISO 10993-1, -5, -7, -10) and FDA guidance for biocompatibility. Specific sample sizes for these tests are not provided.
- Data Provenance: The tests are likely laboratory-based bench tests and biocompatibility assessments, not clinical data from patients. The manufacturer is FUJIFILM medwork GmbH, located in Höchstadt, Germany, implying the testing would likely be performed in a controlled laboratory environment. Retrospective or prospective classification is not applicable here as it's not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications:
- This is not applicable as the device is a physical medical device (forceps valve), not an AI/ML diagnostic. Ground truth (e.g., for diagnostic accuracy) is not established by human experts in the context of this device's performance evaluation for FDA clearance. Performance is assessed via engineering and biocompatibility testing.
4. Adjudication method for the test set:
- Not applicable for this type of device and performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was NOT done. This type of study is relevant for diagnostic AI tools where human readers' performance with and without AI assistance is evaluated. This document concerns a physical endoscope accessory.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- For biocompatibility: Adherence to ISO standards and FDA guidance for biological evaluation.
- For performance: Engineering specifications and functional requirements (e.g., tight seal, easy passage of devices, support suction function). The "ground truth" is based on the device's ability to meet these pre-defined engineering performance criteria.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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 JAZZDisposable Valve Kit) | FROG Forceps Valve(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 anendotherapy device, to prevent a leakor backflow of air and/or fluids, and toenable the suction function of aFUJIFILM gastrointestinal endoscope. | The forceps valve isintended to facilitatepassage of an endotherapydevice, to prevent leak orbackflow of air and/orfluids, and to enable thesuction function of aFUJIFILM or Olympusgastrointestinal endoscope. |
| Supplied Sterile | Yes, EO sterilized | No, used non-sterile |
| Single Use | Yes | Yes |
| Compatibility | FUJIFILM G7 Series | FUJIFILM G7 Series andOlympus 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.
§ 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.