Diathermic Slitter (FlushKnife) DK2618J and DK2623J are intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The devices are indicated for ablation, incision, dissection, avulsion, coagulation and hemostasis of tissue within the digestive tract.

Device Description

Diathermic Slitter (FlushKnife) is sterile and intended for single used electrosurgical instruments that remove tissue and control bleeding by use of high-frequency ("HF") electrical current. The device is comprised of a proximal handle with slider that is connected to a flexible resin tube. The flexible resin tube covers and insulates the operation wire and slitter (when retracted). The operation wire controls the mechanical function of and delivers high frequency (HF) electrical current to the slitter. The proximal end of the operation wire is connected to the slider, which allows the operator to manually control the extension and retraction of the distal end of the operation wire connects to the slitter, which is located at the distal tip of the device. The device connects to a HF electrosurgical power supply unit by an active cord ("A-Cord") connector. HF electrical current generated by a HF electrosurgical power supply unit flows to the slitter from the HF electrosurgical power supply unit via the A-cord, the A-cord connector, and the operation wire. The distal tip of the device is inserted through the forceps channel of the specified endoscope. Once inserted, the operator can extend the slitter from the tip of the endoscope using the slitter is extended to the target site of a patient. Cleavage, resection, incision, ablation, hemostasis, coagulation, or excision of tissue is achieved by delivering HF current to the target tissue through the slitter. The device is provided sterile for single-use only. The device can supply sterile water or fluids to its distal end target site via a water/fluid supply channel. The port for the water/fluid supply channel is located on the handle at the proximal end of the device. The sterile water or fluid also aids in the removal of debris, blood and extraneous material from the distal end of the device or a target site. To supply sterile water or fluid to the distal end target site, a syringe filled with water or fluid is connected to the water/fluid inlet at the proximal handle. Besides a syringe, alternate delivery methods can also be used to supply sterile water or fluid to the distal end target site of the device.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Fujifilm Diathermic Slitter (FlushKnife)," which is a modified version of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device, especially regarding a minor modification: the addition of compatible sterile fluids and alternate delivery systems.

Here's an analysis of the acceptance criteria and study information provided, focusing on what's explicitly stated and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a detailed table with specific numerical acceptance criteria and a corresponding reported performance for each criterion. It mentions categories of performance testing but does not quantify them.

Acceptance Criteria Category	Reported Device Performance
Fluid supply	The device met the pre-defined acceptance criteria for the test.
Temperature rise	The device met the pre-defined acceptance criteria for the test.
Dielectric voltage	The device met the pre-defined acceptance criteria for the test.
Durability	The device met the pre-defined acceptance criteria for the test.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text states "Fujifilm conducted the following performance testing," but no details about sample sizes or the origin of the test data (e.g., country of origin, retrospective/prospective) are mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/provided. The performance testing described (fluid supply, temperature rise, dielectric voltage, durability) are engineering/functional tests, not tests that require expert-established ground truth related to clinical outcomes or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As above, the tests mentioned are functional performance tests, not clinical evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is an electrosurgical instrument for cutting tissue, not an imaging or diagnostic device that would typically involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone performance" for an algorithm does not apply to this device. This is a physical electrosurgical instrument, not an AI or algorithmic device. The performance tests described (fluid supply, temperature rise, dielectric voltage, durability) are inherent to the device's physical function.

7. The Type of Ground Truth Used

The ground truth for the performance tests would be established through engineering specifications and standards relevant to medical device safety and performance. For example:

Fluid supply: Met predefined flow rates or delivery volumes.
Temperature rise: Stayed within safe operating temperature limits.
Dielectric voltage: Withstood specified voltage without breakdown.
Durability: Maintained functional integrity after a specified number of uses or cycles.

These are not "expert consensus," "pathology," or "outcomes data" in the typical clinical sense, but rather objective measurements against established engineering benchmarks.

8. The Sample Size for the Training Set

This information is not applicable/provided. As this is a physical medical instrument and not an AI or machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the same reason as point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 9, 2017

FUJIFILM Medical Systems U.S.A., Inc. Jeffrey Wan Specialist, Regulatory Affairs 10 High Point Drive Wayne, NJ 07470

Re: K171096

Trade/Device Name: Fujifilm Diathermic Slitter (FlushKnife) Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KGE Dated: April 11, 2017 Received: April 13, 2017

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. 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.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K171096

Device Name

Fujifilm Diathermic Slitter (FlushKnife)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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FORM FDA 3881 (1/14)

Page 1 of 1 FDA

PSC Publishing Services (301) 443-6740 EF

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XV. 510(K) SUMMARY

Submitter's Information

FUJIFILM Medical Systems U.S.A., Inc. Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293

Contact Person:

Jeffrey Wan Specialist, Regulatory Affairs Telephone: (973) 709-2219 Ext. 522219 Facsimile: (973) 633-8818 E-Mail: jeffrey.wan@fujifilm.com

Date Prepared: May 8, 2017

Identification of the Proposed Device:

Proprietary/Trade Name:	Fujifilm Diathermic Slitter (FlushKnife)
Common Name:	Electrosurgical Instruments
Device Class:	Class II
Review Panel:	Gastroenterology/Urology

Classification Information:

Endoscopic electrosurgical unit and accessories 21 C.F.R. § 876.4300 Product Code: KGE

Predicate Device:

Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter) (K161186)

Purpose of the Special 510(k) notice:

The Diathermic Slitter (FlushKnife) is a modification to Diathermic Slitter (FlushKnife) (K161186).

Intended Use:

Device Description:

Diathermic Slitter (FlushKnife) is sterile and intended for single used electrosurgical instruments that remove tissue and control bleeding by use of high-frequency ("HF") electrical current.

The device is comprised of a proximal handle with slider that is connected to a flexible resin tube. The flexible resin tube covers and insulates the operation wire and slitter (when retracted). The

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operation wire controls the mechanical function of and delivers high frequency (HF) electrical current to the slitter. The proximal end of the operation wire is connected to the slider, which allows the operator to manually control the extension and retraction of the sistal end of the operation wire connects to the slitter, which is located at the distal tip of the device.

The device connects to a HF electrosurgical power supply unit by an active cord ("A-Cord") connector. HF electrical current generated by a HF electrosurgical power supply unit flows to the slitter from the HF electrosurgical power supply unit via the A-cord, the A-cord connector, and the operation wire.

The distal tip of the device is inserted through the forceps channel of the specified endoscope. Once inserted, the operator can extend the slitter from the tip of the endoscope using the slitter is extended to the target site of a patient. Cleavage, resection, incision, ablation, hemostasis, coagulation, or excision of tissue is achieved by delivering HF current to the target tissue through the slitter.

The device is provided sterile for single-use only.

The device can supply sterile water or fluids to its distal end target site via a water/fluid supply channel. The port for the water/fluid supply channel is located on the handle at the proximal end of the device. The sterile water or fluid also aids in the removal of debris, blood and extraneous material from the distal end of the device or a target site.

To supply sterile water or fluid to the distal end target site, a syringe filled with water or fluid is connected to the water/fluid inlet at the proximal handle.

Besides a syringe, alternate delivery methods can also be used to supply sterile water or fluid to the distal end target site of the device.

Technological Characteristics:

A table comparing the technological characteristics between FlushKnife and the predicate devices is shown below.

	Predicate Device	Proposed Device
Device Name	Fujifilm Diathermic Slitter(FlushKnife)	Fujifilm Diathermic Slitter(FlushKnife)
Device Models	DIATHERMIC SLITTER, MODELDK2618J -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-	Same as predicate device
510(k) Number	K161186	Pending
	Intended Use	These instruments have beendesigned to be used with specifiedendoscopes to cut tissue usinghigh-frequency current within thedigestive tract. Both the ball tiptype and the needle typeinstruments are indicated forablation, incision, dissection,avulsion, cauterization,coagulation and hemostasis oftissue within the digestive tract.	Same as predicate device

TechnologicalCharacteristics	Slitter Length	1.0/1.5/2.0/2.5/3.0mm (forDK2618 series)1.5/2.0mm (for DK2623 series)	Same as predicate device
	Slitter Diameter	0.5mm	Same as predicate device
	Slitter Shape	Needle Type(With Ball Tip:-BXX-)(Without Ball Tip:-NXX-)	Same as predicate device
	Maximum Diameter ofInsertion Portion	2.7mm	Same as predicate device
	Working Length	1800mm/2300mm	Same as predicate device
	Method of Operation	Manually (handle slider)	Same as predicate device
Energy used or delivered		energy delivered from aelectrosurgical generator	Same as predicate device
Monopolar/Bipolar		Monopolar	Same as predicate device
Sterilization		Yes (Single Use Device)	Same as predicate device
Combination equipment		EndoscopeElectrosurgical generatorA CordSyringe	EndoscopeElectrosurgical generatorA CordSyringePump
Compatible fluids		Sterile water	Sterile water and other sterilefluids
Material of Insertion Portion		Stainless steelCeramicsFluorine resinFluorine coatingSilver brazing filler metal	Same as predicate device

Summary of differences between modified FlushKnife from its predicate device

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Performance Data

Fujifilm conducted the following performance testing on the proposed device FlushKnife to ensure that the modified device performs equivalently to the predicate device:

Fluid supply ●
Temperature rise .
Dielectric voltage ●
Durability .

In all cases, the device met the pre-defined acceptance criteria for the test.

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Substantial Equivalence

The company's FlushKnife has the same intended use as the previously cleared predicate FlushKnife (K161186). In addition, the proposed device FlushKnife has the same intended use, indications for use, technological characteristics, and principles of operation as its predicate. Although there is a minor difference between the proposed device and its predicate device, namely the addition of compatible sterile fluids and alternate delivery systems, this difference does not raise new or additional questions of safety or effectiveness of the proposed device. Thus, the proposed device FlushKnife is substantially equivalent to its predicate device.

Regulation Number and Section

§ 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).