(29 days)
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM Diathermic Slitter (FlushKnife) is an electrosurgical instrument that removes tissue and controls bleeding by use of high-frequency ("HF") electrical current. The device is available with either a needle or ball tip slitter and comes in a variety of sizes.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device. It does not contain information about an AI/ML medical device or a clinical study with human subjects, therefore, most of the requested information cannot be extracted from the document. The document describes a Diathermic Slitter (FlushKnife) used for endoscopic treatments in the gastrointestinal tract. This is a physical, electrosurgical instrument, not an AI or software-based device.
Therefore, many of the requested fields related to AI/ML device performance, such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details, are not applicable to this document.
However, I can provide information based on the "Performance Data" section regarding the device's technical validation.
Here's what can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device met pre-defined acceptance criteria for all tests. Specific numerical acceptance criteria or performance metrics are not detailed in this summary; rather, it refers to compliance with standards and successful completion of tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety & Electromagnetic Compatibility | Device evaluated using ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-2-2:2017, and IEC 60601-2-18:2009. Met pre-defined acceptance criteria. |
| Biocompatibility | Device evaluated using ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, and ISO 10993-11:2017, in accordance with FDA guidance. Met pre-defined acceptance criteria. |
| Sterility | Device evaluated according to ISO 11135:2014 and FDA guidance "Submission and Review of Sterility Information...". Met pre-defined acceptance criteria. |
| Device Specific Testing (ISO 8600-1:2015) | Bench testing conducted to validate compatibility with submucosal injection agent. Met pre-defined acceptance criteria. |
| Additional Performance Testing (Bench Testing) | Maximum diameter of insertion portion, Working length, Slitter length, Conductivity, Liquid delivery amount. Met pre-defined acceptance criteria in all cases. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the performance tests. The document refers to "bench testing" and evaluations against standards, which typically involve a specified number of samples, but these numbers are not disclosed.
- Data Provenance: The testing appears to be conducted by the manufacturer as part of their submission for regulatory clearance. The document doesn't specify country of origin for data but states the manufacturer is FUJIFILM Corporation, located in Japan. The tests are described as "bench testing," implying a laboratory, likely prospective testing for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes a traditional electrosurgical device, not an AI/ML device that requires expert-established ground truth for image interpretation or diagnosis. Ground truth, in this context, refers to the physical properties and performance characteristics of the device being measured against engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this is not an AI/ML device relying on human interpretation, an adjudication method for test set ground truth is not relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/ML device and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or software device. Its performance is evaluated intrinsically as a physical piece of medical equipment.
7. The type of ground truth used
- Technical Specifications and Consensus Standards: The "ground truth" for this device's performance relies on its ability to meet engineering design specifications and comply with recognized consensus standards for electrical safety, biocompatibility, sterility, and device-specific functionalities (e.g., slitter length, conductivity). This is established through laboratory testing and verification against pre-defined performance metrics, rather than expert consensus on diagnostic interpretations or clinical outcomes data in a comparative study.
8. The sample size for the training set
- Not Applicable. This device uses traditional engineering principles, not machine learning, and therefore has no "training set."
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 4, 2022
FUJIFILM Corporation % Dhara Buch Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K220053
Trade/Device Name: Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KGE Dated: January 5, 2022 Received: January 6, 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) K220053
Device Name
FUJIFILM Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
Indications for Use (Describe)
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
| 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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510(k) Summary
FUJIFILM Corporation
FUJIFILM Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
Date: January 05, 2021
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan
Contact Person:
Dhara Buch Requlatory Affairs Specialist Phone: 781-824-2708 E-Mail: dhara.buch(@fujifilm.com
Identification of the Proposed Device:
| Device Name: | FUJIFILM Diathermic Slitter (FlushKnife) DK2620Jand DK2623JI |
|---|---|
| Common Name: | Electrosurgical Instruments |
| Product Code: | KGE |
| Device Class: | Class II |
| Classification: | Endoscopic electrosurgical unit and accessories |
| 21 C.F.R. § 876.4300 | |
| Review Panel: | Gastroenterology/Urology |
Predicate Device:
- FUJIFILM Diathermic Slitter FlushKnife (K171096)
Intended Use / Indications for Use:
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
Device Description:
FUJIFILM Diathermic Slitter (FlushKnife) is an electrosurgical instrument that removes tissue and controls bleeding by use of high-frequency ("HF") electrical current. The device is available with either a needle or ball tip slitter and comes in a variety of sizes.
Comparison of Technological Characteristics:
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A comparison of technological characteristics between subject device and the predicate device is provided table below:
| Device Details | Predicate Device | Subject Device |
|---|---|---|
| Device Name | FUJIFILM Diathermic Slitter Knife | FUJIFILM Diathermic Slitter(FlushKnife) DK2620JI andDK2623JI |
| Model | MODEL DK2618J -N10-, DK2618J -N15-, DK2618J -N20-, DK2618J -N25-,DK2618J -N30-, DK2618J -B15-,DK2618J -B20-, DK2618J -B25-,DK2618J -B30-, DK2623J -N15-,DK2623J -N20-, DK2623J -B15-,DK2623J -B20- | MODEL DK2620JI N10-,DK2620JI -N15, DK2620JI -N20-, DK2620JI -N25-, DK2620JI -N30-, DK2620JI -B15-,DK2620JI -B20-, DK2620JI -B25-, DK2620JI -B30-,DK2623JI -N15-, DK2623JI -N20-, DK2623JI -B15-,DK2623JI -B20- |
| 510(k) number | K171096 | To be assigned |
| Product code | KGE | KGE |
| Manufacturer | FUJIFILM Corporation | FUJIFILM Corporation |
| Intended Use | This instrument is designed to be usedwith specified endoscopes to cut tissuewithin the digestive tract and using high-frequency current. Both of the ball tiptype and the needle type instrumentsare indicated for ablation, incision,dissection, avulsion, cauterization,coagulation and hemostasis of tissuewithin the digestive tract. | These products are used incombination with an applicableendoscope to perform theendoscopic treatments for thetarget site in the gastrointestinaltract, such as ablation, incision,dissection, cauterization,coagulation and avulsion oftissue and arrest of bleeding,and to inject saline orsubmucosal injection agent forendoscopic surgery into thesubmucosal layer in thegastrointestinal tract, which isexposed after dissection, underthe management of physicians inmedical facilities. |
| Slitter Length | 1.0/1.5/2.0/2.5/3.0mm (for DK2618Jseries)1.5/2.0mm (for DK2623J series) | Same as K171096 |
| Slitter Diameter | 0.5mm | Same as K171096 |
| Slitter Shape | Needle Type(With Ball Tip:-BXX-)(Without Ball Tip:-NXX-) | Same as K171096 |
| Maximum Diameterof Insertion Portion | 2.7mm | Same as K171096 |
| Water Feed Function | Yes | Same as K171096 |
| Method of Operation | Manually (handle slider) | Same as K171096 |
| Water supplyconnector | Yes, fixed | Yes, rotatable |
| Energy | Energy delivered from anelectrosurgical generator | Same as K171096 |
| Monopolar /Bipolar | Monopolar | Same as K171096 |
| Sterilization | Yes (Single Use Device) | Same as K171096 |
| CombinationTools | Endoscope, Electrosurgical generator,A Cord, Water supply unit | Endoscope, Electrosurgicalgenerator, A Cord |
| Injection agent | Saline and other sterile liquids | Saline, Eleview (K150852),ORISE Gel(K180068) |
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Performance Data:
Electrical safety and electromagnetic compatibility of the proposed device was evaluated using the following standards: ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-2-2:2017, and IEC 60601-2-18:2009.
Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, and ISO 10993-11:2017. 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.
Sterility of the proposed device was evaluated according to ISO 11135:2014 and the FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
Device specific testing was conducted using the following consensus standard: ISO 8600-1:2015. Bench testing was conducted to validate the compatibility of subject device with submucosal injection agent.
The proposed device met performance specifications in the following additional testing:
- Maximum diameter of insertion portion
- . Working length
- Slitter length
- Conductivity
- Liquid delivery amount ●
In all cases, the device met the pre-defined acceptance criteria for the test.
Conclusions:
The subject device shares the same intended use and similar indications as the predicate device (K171096).
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.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).