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

K161186 · Fujifilm Medical Systems U.S.A, Inc. · KGE · Jun 29, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K161186
• Device Name: Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
• Applicant: Fujifilm Medical Systems U.S.A, Inc.
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Jun 29, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Diathermic slitters (FlushKnife and ClutchCutter) are endoscopic electrosurgical instruments used for tissue cutting and coagulation within the digestive tract. Operated manually via a handle slider, the devices are inserted through specified endoscopes to deliver high-frequency electrical energy from an external electrosurgical generator to the target tissue. The FlushKnife features needle or ball-tip configurations for incision and dissection, while the ClutchCutter functions as a forceps-type device. These single-use devices are utilized by clinicians in endoscopic procedures to perform ablation, avulsion, and hemostasis. The output is the physical cutting or coagulation of tissue, which aids in therapeutic endoscopic interventions. The device modification involves a change in material (epoxy resin) compared to the predicate.

Clinical Evidence

Bench testing only. Testing included airtightness, insertion diameter, working length, slitter length, distal end shapes, and electrical resistance. All tests met pre-defined acceptance criteria.

Technological Characteristics

Monopolar electrosurgical instruments; single-use; manual operation via handle slider; includes water feed function (FlushKnife) and rotation function (ClutchCutter); materials include epoxy resin; compatible with standard endoscopes and electrosurgical generators.

Indications for Use

Indicated for ablation, incision, dissection, avulsion, cauterization, coagulation, and hemostasis of tissue within the digestive tract using high-frequency current via endoscope.

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

• Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter) (K151474)

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 image of three human profiles facing right, arranged in a stacked formation.

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

June 29, 2016

Fujifilm Medical Systems USA, Inc. Shraddha More Specialist, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470

Re: K161186

Trade/Device Name: Fujifilm Diathermic Slitter (flushknife), Fujifilm Diathermic Slitter (clutchcutter) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KGE Dated: June 16, 2016 Received: June 17, 2016

Dear Shraddha More,

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,

# 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

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

#### 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)

K161186

Device Name

Fuiifilm 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, 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.

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

"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."

FORM FDA 3881 (1/14)

Page 1 of 1 FDA

PSC Publishing Services [phone] EF

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

#### XII. 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:

Shraddha More Specialist, Regulatory Affairs and Quality Assurance Telephone: [phone] Ext. 522627 Facsimile: [phone] E-Mail [e-mail]

Date Prepared: April 26, 2016

#### Identification of the Proposed device:

| Proprietary/Trade Name: | Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter<br>(ClutchCutter) |
|-------------------------|-----------------------------------------------------------------------------------|
| 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) (K151474)

#### Purpose of the Special 510(k) notice:

The Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter) is a modification to Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter) (K151474).

#### Intended 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, coaqulation 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.

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

# Technological Characteristics:

Tables comparing the technological characteristics between FlushKnife and ClutchCutter and their respective predicate devices are shown below.

| | Predicate Device | Proposed Device |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Device Name | Fujifilm Diathermic Slitter<br>(FlushKnife) | Fujifilm Diathermic Slitter<br>(FlushKnife) |
| Device Models | DIATHERMIC SLITTER, MODEL<br>DK2618J -N10-, DK2618J -N15-,<br>DK2618J -N20-, DK2618J -N25-,<br>DK2618J -N30-, DK2618J -B15-,<br>DK2618J -B20-, DK2618J -B25-,<br>DK2618J -B30-, DK2623J -N15-,<br>DK2623J -N20-, DK2623J -B15-,<br>DK2623J -B20- | Same as predicate device |

# Summary of differences between modified FlushKnife from its predicate device

| 510(k) Number | K151474 | Pending | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------|
| Intended Use | These instruments have been<br>designed to be used with specified<br>endoscopes to cut tissue using<br>high-frequency current within the<br>digestive tract. Both the ball tip<br>type and the needle type<br>instruments are indicated for<br>ablation, incision, dissection,<br>avulsion, cauterization,<br>coagulation and hemostasis of<br>tissue within the digestive tract. | Same as predicate device | |
| Technological<br>Characteristics | Slitter Length | 1.0/1.5/2.0/2.5/3.0mm (for<br>DK2618 series)<br>1.5/2.0mm (for DK2623 series) | Same as predicate device |
| | Slitter Shape | Needle Type<br>(With Ball Tip:-BXX-)<br>(Without Ball Tip:-NXX-) | Same as predicate device |
| | Maximum Diameter of<br>Insertion Portion | φ2.7 | Same as predicate device |
| | Working Length | 1800mm/2300mm | Same as predicate device |
| | Water Feed Function | Yes | Same as predicate device |
| | Method of Operation | Manually (handle slider) | Same as predicate device |
| Energy used or delivered | | energy delivered from a<br>electrosurgical generator | Same as predicate device |
| Monopolar/Bipolar | | Monopolar | Same as predicate device |
| Sterilization | | Yes (Single Use Device) | Same as predicate device |
| Biocompatibility | | Yes | Same as predicate device |
| Accessories | | None | Same as predicate device |
| Combination equipment | | Endoscope, Electrosurgical<br>generator, A Cord | Same as predicate device |

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

### Summary of differences between modified ClutchCutter from its predicate device

| | Predicate device | Proposed Device |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Device Name | Fujifilm Diathermic Slitter<br>(ClutchCutter) | Fujifilm Diathermic Slitter<br>(ClutchCutter) |
| Device Models | DP2618DT -35-, DP2618DT -50- | Same as predicate device |
| 510(k) Number | K151474 | Pending |
| Intended Use | These instruments have been<br>designed to be used with<br>specified endoscopes to cut<br>tissue using high-frequency<br>current within the digestive tract.<br>These instruments are indicated<br>for ablation, incision, dissection,<br>avulsion, cauterization,<br>coagulation and hemostasis of<br>tissue within the digestive tract. | Same as predicate device |

| Technological<br>Characteristics | Slitter Shape | Forceps Type | Same as predicate device |
|----------------------------------|------------------------------------------|------------------------------------------------------|--------------------------|
| | Maximum Diameter<br>of Insertion Portion | φ2.7 | Same as predicate device |
| | Working Length | 1800mm | Same as predicate device |
| | Slitter Portion<br>Rotation Function | Yes | Same as predicate device |
| | Method of Operation | Manually (handle slider) | Same as predicate device |
| Energy used or delivered | | energy delivered from a<br>electrosurgical generator | Same as predicate device |
| Monopolar/Bipolar | | Monopolar | Same as predicate device |
| Sterilization | | Yes (Single Use Device) | Same as predicate device |
| Biocompatibility | | Yes | Same as predicate device |
| Accessories | | None | Same as predicate device |
| Combination equipment | | Endoscope, Electrosurgical<br>generator, A Cord | Same as predicate device |

### Performance Data

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

# FlushKnife

- . Airtightness
- Maximum diameter of insertion portion .
- Working length .
- Slitter Portion length
- . Electrical resistance

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

# ClutchCutter

- . Working length:
- Maximum diameter of insertion portion ●
- . Distal end shapes
- . Electrical resistance

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

## Substantial Equivalence

The company's proposed device, FlushKnife and ClutchCutter have the same intended use as the previously cleared predicate FlushKnife and ClutchCutter (K151474). In addition, the proposed device, FlushKnife and ClutchCutter has same indications, technological characteristics, and principles of operation as its predicate. Although there are minor differences between the proposed device and its predicate device, namely modification in material (epoxy resin), those differences do not raise new questions of safety or efficacy. The minor change done in the material would not raise any new or additional questions in of safety or effectiveness of the proposed device. Thus, the proposed device, FlushKnife and ClutchCutter, is substantially equivalent to its predicate device.