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, cauterization, coagulation and hemostasis of tissue within the digestive tract.

Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The device is indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.

Device Description

The Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter) (the "devices") are electrosurgical instruments that remove tissue and control bleeding by use of high-frequency ("HF") electrical current. The devices are provided sterile for single-use only. The devices are provided in various models (described below), but each is comprised of the following major components:

The FlushKnife and ClutchCutter consist of the following major components:

· Slitter Electrode at distal tip of the device that performs ablation, incision, dissection, avulsion, cauterization, coagulation, and hemostasis of tissue via delivery of HF electrical current.
Operation wire Inner wire of the device that connects the handle and slider control to the slitter, facilitates manual control of slitter position, and delivers the HF electrical current to the slitter.
· Tube Flexible resin tube that is inserted into body cavities and insulates operation wire carrying the HF electrical current.
Slider Portion of handle that extends and retracts the slitter portion from the distal end of the tube (FlushKnife) or opens and closes slitter jaws (ClutchCutter) by means of the operation wire.
· Handle Proximal end of the device that provides for user control.
· Active Cord ("A-Cord") Connector Used to connect the device to the electrosurgical power supply unit via an A-cord.

The devices are 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 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 of the slitter (for the FlushKnife) or open and close (ClutchCutter) of the slitter Jaws. The distal end of the operation wire connects to the slitter, which is located at the distal tip of the device.

The devices connect to a HF electrosurgical power supply unit by an active cord ("A-Cord") connector. HF electrical current generated by HF electrosurgical power supply unit flows to the slitter from the HF electrosurgical power supply unit via 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 (FlushKnife) or opens and closes slitter jaws (ClutchCutter) 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for electrosurgical instruments (Fujifilm Diathermic Slitter FlushKnife and ClutchCutter). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on performance studies with human-in-the-loop or standalone AI.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/human comparative effectiveness study.

The performance data mentioned in the document are related to safety and effectiveness through compliance with recognized consensus standards (biocompatibility, sterilization, EMC, electrical safety, as well as standards related to packaging and shelf life) and bench testing, primarily to demonstrate that the new device is as safe and effective as the predicate devices.

Here's why the requested information cannot be extracted:

Acceptance Criteria & Reported Device Performance (Table 1): The document does not define specific performance metrics (e.g., sensitivity, specificity, accuracy, or other clinical outcomes) as acceptance criteria for the device's function that would typically be evaluated in an AI-related study. Instead, it compares the technological characteristics of the subject device to predicate devices to establish substantial equivalence.
Sample Size for Test Set & Data Provenance: This information is not explicitly provided because the studies conducted are primarily bench tests and compliance assessments against standards, not clinical performance studies with a "test set" of patient data.
Number of Experts & Qualifications / Adjudication Method: These points are relevant for studies determining ground truth in diagnostic or AI applications. The document describes electrosurgical instruments, not a diagnostic or AI device that requires expert review for ground truth.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that such a study was performed. The device is an electrosurgical tool, not an AI-assisted diagnostic system where human readers would be evaluated with and without AI assistance.
Standalone Performance (Algorithm Only): The device is a physical electrosurgical instrument; there is no mention of an associated algorithm or AI component that would have standalone performance.
Type of Ground Truth Used: "Ground truth" in the context of this document is related to the physical and electrical safety and performance of the instrument as measured by engineering and material standards, not clinical ground truth derived from expert consensus, pathology, or outcomes data in a diagnostic sense.
Sample Size for Training Set & How Ground Truth for Training Set was Established: These concepts are entirely absent as the device is not an AI/machine learning product.

In summary, the provided text describes a submission for an electrosurgical instrument, not a device involving AI or complex clinical diagnostic performance metrics as typically seen in AI/ML medical device submissions.

Summary

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

February 18, 2016

Fujifilm Medical System U.S.A., Inc. Mary Moore Senior Director, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470

Re: K151474

Trade/Device Name: Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KGE Dated: January 8, 2016 Received: January 8, 2016

Dear Mary Moore,

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. 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

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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 yours,

Herbert P. Lerner -S

for 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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Indications for Use

510(k) Number (if known) K151474

Device Name

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

Indications for Use (Describe)

Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to cut tissue using highfrequency current within the digestive tract. The device is incision, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.

Type of Use (Select one or both, as applicable)
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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 Medical Systems U.S.A., Inc.'s

Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter)

Date Prepared: June 1, 2015

Sponsor's Information:

FUJIFILM Medical Systems U.S.A., Inc. Endoscopy Division 10 High Point Drive Wayne, NJ 07470

Contact Person:

Mary K. Moore Senior Director, Regulatory Affairs and Quality Assurance Telephone: (973) 686-2498 Facsimile: (973) 686-2616 E-Mail: mkmoore@fujifilm.com

Name of Device

Proprietary Name:	Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter(ClutchCutter)
Common or Usual Name:	Electrosurgical Instruments
Device Class:	Class II
Review Panel:	Gastroenterology and urology

Classification Information:

Endoscopic Electrosurgical Unit and Accessories; 21 C.F.R. § 876.4300 Product Code: KGE

Predicate Devices

510(K) Number	Device Trade Name	Manufacturer
K062517	Electrosurgical Hemostatic Forceps Series	Olympus Medical SystemsCorporation
K092309	Single Use Electrosurgical Knife Series, ModelKD-610L, KD611L, KD620LR, KD630L, KF640L	Olympus Medical SystemsCorporation

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Intended Use / Indications for Use

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.

Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The device is indicated for ablation, incision, dissection, avulsion, coagulation and hemostasis of tissue within the digestive tract.

Device Description

The FlushKnife and ClutchCutter consist of the following major components:

· Slitter Electrode at distal tip of the device that performs ablation, incision, dissection, avulsion, cauterization, coagulation, and hemostasis of tissue via delivery of HF electrical current.
Operation wire Inner wire of the device that connects the handle and slider control to the slitter, facilitates manual control of slitter position, and delivers the HF electrical current to the slitter.
· Tube Flexible resin tube that is inserted into body cavities and insulates operation wire carrying the HF electrical current.
Slider Portion of handle that extends and retracts the slitter portion from the distal end of the tube (FlushKnife) or opens and closes slitter jaws (ClutchCutter) by means of the operation wire.
· Handle Proximal end of the device that provides for user control.
· Active Cord ("A-Cord") Connector Used to connect the device to the electrosurgical power supply unit via an A-cord.

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Technological Characteristics

A table comparing the technological characteristics between FlushKnife and ClutchCutter and their Predicate Devices is shown below.

DeviceDescription	OLYMPUSMEDICALSYSTEMSCORPORATIONSingle Use	OLYMPUSMEDICALSYSTEMSCORPORATION	FUJIFILM Medical Systems U.S.A., Inc.,FlushKnife and ClutchCutter(Subject Device)
	ElectrosurgicalKnife Series,(K092309Predicate Device)	ElectrosurgicalHemostaticForceps Series,(K062517Predicate Device)	FlushKnife	ClutchCutter
IntendedUse /Indicationsfor Use	This instrumenthas beendesigned to beused withOlympusendoscopes andelectrosurgicalunits to cut tissuewithin thedigestive tract andusing high-frequency current.	This instrumenthas beendesigned to beused withOlympusendoscopes tocauterize,coaqulate andperformhemostasis usinghigh-frequencycurrent within thedigestive tract.	Diathermic Slitter(FlushKnife) DK2618Jand DK2623J areintended to be used withspecified endoscopes tocut tissue using high-frequency current withinthe digestive tract. Thedevices are indicated forablation, incision,dissection, avulsion,cauterization, coagulationand hemostasis of tissuewithin the digestive tract.	Diathermic Slitter(ClutchCutter)DP2618DT isintended to beused withspecifiedendoscopes to cuttissue using high-frequency currentwithin thedigestive tract.The device isindicated forablation, incision,dissection,avulsion,cauterization,coagulation andhemostasis oftissue within thedigestive tract.
Models	Model KD-610L,KD-620LR	Model FD-410LR	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-	ModelDP2618DT-35-,DP2618DT -50-
Device	OLYMPUSMEDICALSYSTEMSCORPORATIONSingle Use	OLYMPUSMEDICALSYSTEMSCORPORATIONElectrosurgical	FUJIFILM Medical Systems U.S.A., Inc.,FlushKnife and ClutchCutter(Subject Device)
Description	ElectrosurgicalKnife Series,(K092309Predicate Device)	HemostaticForceps Series,(K062517Predicate Device)	FlushKnife	ClutchCutter
Slitter Shape	Needle Type withBall Tip (KD-610L), NeedleType with hookportion (KD-620LR)	Forceps type	Needle Type(With Ball Tip:-BXX-)(Without Ball Tip:-NXX-)	Forceps type
SlitterLength	4.0 mm (KD-610L), 4.5 mm(KD-620LR)	Not Applicable	1.0/1.5/2.0/2.5/3.0mm (forDK2618 series)1.5/2.0mm (for DK2623series)	Not Applicable
MaximumDiameter ofInsertionPortion	$\phi$2.6	$\phi$2.75	$\phi$2.7	$\phi$2.7
WorkingLength	1650mm	1650 mm	1800mm/2300mm	1800 mm
Water FeedFunction	None	Not Applicable	Yes	Not Applicable
Method ofOperation	Manually (handleslider)	Manually (handleslider)	Manually (handle slider)	Manually (handleslider)
Energy	energy deliveredfrom anelectrosurgicalgenerator	energy deliveredfrom anelectrosurgicalgenerator	energy delivered from anelectrosurgical generator	energy deliveredfrom anelectrosurgicalgenerator
Monopolar /Bipolar	Monopolar	Monopolar	Monopolar	Monopolar
Sterilization	Yes (Single UseDevice)	Yes (Single UseDevice)	Yes (Single Use Device)	Yes (Single UseDevice)
CombinationTools	Endoscope,Electrosurgicalgenerator, A Cord	Endoscope,Electrosurgicalgenerator, A Cord	Endoscope,Electrosurgical generator,A Cord	Endoscope,Electrosurgicalgenerator, A Cord

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Performance Data

EMC and electrical safety of the subject devices were evaluated using the following consensus standards: ANSI/AAMI ES60601-1:2005; IEC 60601-1-2:2007; IEC 60601-2-2:2009; and IEC 60601-2-18:2009.

Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-7:2008; ISO 10993-10:2010.

Sterilization of the subject devices were evaluated according to the following consensus standards: ISO 11135-1:2007 and ISO 10993-7:2008.

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Testing specific to the subject devices was conducted per ISO 8600-1:2013.

Subject devices conformed to the following additional standards related to packaging and shelf life:

ASTM 1980:2007 .
. ISO 11607-1:2006
. ISO 11607-2:2006

Substantial Equivalence

The Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter) are as safe and effective as the Single Use Electrosurgical Knife (K092309) and the Electrosurgical Hemostatic Forceps Series (K062517). The FlushKnife and ClutchCutter have the same intended uses and similar indications, technological characteristics, and principles of operation as their predicate devices. The minor technological differences between the FlushKnife and their predicate devices raise no new issues of safety or new concerns of effectiveness. Performance data demonstrate that the FlushKnife and ClutchCutter are as safe and effective as the Single Use Electrosurgical Knife and the Electrosurqical Hemostatic Forceps Series. Thus, the FlushKnife and ClutchCutter have substantially equivalent performance to their predicate devices.

Conclusions

The subject devices are substantially equivalent to the predicates based on intended use/indications for use and technological characteristics. The minor technological differences between the FlushKnife and ClutchCutter and their predicate devices raise no new questions of safety or new concerns of effectiveness. Bench testing data demonstrated that the FlushKnife and ClutchCutter have substantially equivalent performance to the predicates.

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).