Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

K151474 · Fujifilm Medical System U.S.A., Inc. · KGE · Feb 18, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K151474
• Device Name: Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Feb 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Electrosurgical instruments for endoscopic tissue management; FlushKnife and ClutchCutter models. Input: high-frequency (HF) electrical current from external electrosurgical generator. Operation: device inserted through endoscope forceps channel; operator uses proximal handle slider to extend/retract slitter electrode (FlushKnife) or open/close slitter jaws (ClutchCutter); HF current delivered via internal operation wire to distal tip for tissue cutting, coagulation, or hemostasis. Used in clinical settings by physicians. Output: mechanical tissue manipulation and thermal tissue effect. Benefits: enables precise endoscopic resection and bleeding control. Single-use, sterile.

Clinical Evidence

Bench testing only. Evaluated per ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ISO 8600-1, ISO 10993 (biocompatibility), ISO 11135-1 (sterilization), and packaging/shelf-life standards (ASTM 1980, ISO 11607).

Technological Characteristics

Monopolar electrosurgical instruments. Components: slitter electrode, operation wire, flexible resin tube, handle with slider, A-Cord connector. FlushKnife: needle-type (ball tip or non-ball tip). ClutchCutter: forceps-type. Energy: HF electrosurgical generator. Sterilization: sterile, single-use. Standards: ANSI/AAMI ES60601-1:2005, IEC 60601-1-2:2007, IEC 60601-2-2:2009, IEC 60601-2-18:2009, ISO 10993-1:2009, ISO 11135-1:2007, ISO 8600-1:2013, ASTM 1980:2007, ISO 11607-1/2:2006.

Indications for Use

Indicated for patients requiring endoscopic tissue ablation, incision, dissection, avulsion, coagulation, and hemostasis within the digestive tract using high-frequency electrosurgical current.

Regulatory Classification

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.

Predicate Devices

• Electrosurgical Hemostatic Forceps Series (K062517)
• Single Use Electrosurgical Knife Series, Model KD-610L, KD611L, KD620LR, KD630L, KF640L (K092309)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other.

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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 (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 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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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: [phone] Facsimile: [phone] E-Mail: [e-mail]

#### Name of Device

| Proprietary Name: | Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter<br>(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 Systems<br>Corporation |
| K092309 | Single Use Electrosurgical Knife Series, Model<br>KD-610L, KD611L, KD620LR, KD630L, KF640L | Olympus Medical Systems<br>Corporation |

{4}------------------------------------------------

# 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 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.

{5}------------------------------------------------

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.

## Technological Characteristics

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

| Device<br>Description | OLYMPUS<br>MEDICAL<br>SYSTEMS<br>CORPORATION<br>Single Use | OLYMPUS<br>MEDICAL<br>SYSTEMS<br>CORPORATION | FUJIFILM Medical Systems U.S.A., Inc.,<br>FlushKnife and ClutchCutter<br>(Subject Device) | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electrosurgical<br>Knife Series,<br>(K092309<br>Predicate Device) | Electrosurgical<br>Hemostatic<br>Forceps Series,<br>(K062517<br>Predicate Device) | FlushKnife | ClutchCutter |
| Intended<br>Use /<br>Indications<br>for Use | This instrument<br>has been<br>designed to be<br>used with<br>Olympus<br>endoscopes and<br>electrosurgical<br>units to cut tissue<br>within the<br>digestive tract and<br>using high-<br>frequency current. | This instrument<br>has been<br>designed to be<br>used with<br>Olympus<br>endoscopes to<br>cauterize,<br>coaqulate and<br>perform<br>hemostasis using<br>high-frequency<br>current within the<br>digestive tract. | Diathermic Slitter<br>(FlushKnife) DK2618J<br>and DK2623J are<br>intended to be used with<br>specified endoscopes to<br>cut tissue using high-<br>frequency current within<br>the digestive tract. The<br>devices are indicated for<br>ablation, incision,<br>dissection, avulsion,<br>cauterization, coagulation<br>and hemostasis of tissue<br>within the digestive tract. | Diathermic Slitter<br>(ClutchCutter)<br>DP2618DT is<br>intended to be<br>used with<br>specified<br>endoscopes to cut<br>tissue using high-<br>frequency current<br>within the<br>digestive tract.<br>The device is<br>indicated for<br>ablation, incision,<br>dissection,<br>avulsion,<br>cauterization,<br>coagulation and<br>hemostasis of<br>tissue within the<br>digestive tract. |
| Models | Model KD-610L,<br>KD-620LR | Model FD-410LR | Model<br>DK2618J -N10-, DK2618J<br>-N15-, DK2618J -N20-,<br>DK2618J -N25-, DK2618J<br>-N30-, DK2618J -B15-,<br>DK2618J -B20-,<br>DK2618J -B25-, DK2618J<br>-B30-, DK2623J -N15-,<br>DK2623J -N20-, DK2623J<br>-B15-, DK2623J -B20- | Model<br>DP2618DT-35-,<br>DP2618DT -50- |
| Device | OLYMPUS<br>MEDICAL<br>SYSTEMS<br>CORPORATION<br>Single Use | OLYMPUS<br>MEDICAL<br>SYSTEMS<br>CORPORATION<br>Electrosurgical | FUJIFILM Medical Systems U.S.A., Inc.,<br>FlushKnife and ClutchCutter<br>(Subject Device) | |
| Description | Electrosurgical<br>Knife Series,<br>(K092309<br>Predicate Device) | Hemostatic<br>Forceps Series,<br>(K062517<br>Predicate Device) | FlushKnife | ClutchCutter |
| Slitter Shape | Needle Type with<br>Ball Tip (KD-<br>610L), Needle<br>Type with hook<br>portion (KD-<br>620LR) | Forceps type | Needle Type<br>(With Ball Tip:-BXX-)<br>(Without Ball Tip:-NXX-) | Forceps type |
| Slitter<br>Length | 4.0 mm (KD-<br>610L), 4.5 mm<br>(KD-620LR) | Not Applicable | 1.0/1.5/2.0/2.5/3.0mm (for<br>DK2618 series)<br>1.5/2.0mm (for DK2623<br>series) | Not Applicable |
| Maximum<br>Diameter of<br>Insertion<br>Portion | \$\phi\$2.6 | \$\phi\$2.75 | \$\phi\$2.7 | \$\phi\$2.7 |
| Working<br>Length | 1650mm | 1650 mm | 1800mm/2300mm | 1800 mm |
| Water Feed<br>Function | None | Not Applicable | Yes | Not Applicable |
| Method of<br>Operation | Manually (handle<br>slider) | Manually (handle<br>slider) | Manually (handle slider) | Manually (handle<br>slider) |
| Energy | energy delivered<br>from an<br>electrosurgical<br>generator | energy delivered<br>from an<br>electrosurgical<br>generator | energy delivered from an<br>electrosurgical generator | energy delivered<br>from an<br>electrosurgical<br>generator |
| Monopolar /<br>Bipolar | Monopolar | Monopolar | Monopolar | Monopolar |
| Sterilization | Yes (Single Use<br>Device) | Yes (Single Use<br>Device) | Yes (Single Use Device) | Yes (Single Use<br>Device) |
| Combination<br>Tools | Endoscope,<br>Electrosurgical<br>generator, A Cord | Endoscope,<br>Electrosurgical<br>generator, A Cord | Endoscope,<br>Electrosurgical generator,<br>A Cord | Endoscope,<br>Electrosurgical<br>generator, A Cord |

{6}------------------------------------------------

#### 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.

{7}------------------------------------------------

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.