(262 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard electrosurgical device and does not mention any AI or ML capabilities.
Yes.
The device is intended for medical purposes such as ablation, incision, dissection, avulsion, cauterization, coagulation, and hemostasis of tissue within the digestive tract, all of which are considered therapeutic actions.
No
This device is an electrosurgical instrument used for therapeutic procedures like cutting, ablation, and coagulation of tissue, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components, including an electrode, operation wire, tube, slider, handle, and connector. It also describes the physical mechanism of action and connection to an electrosurgical power supply unit.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Diathermic Slitter is an electrosurgical instrument used within the digestive tract to cut and control bleeding of tissue in situ. It directly interacts with tissue inside the body.
- Intended Use: The intended use describes procedures performed directly on tissue within the digestive tract, not the analysis of samples taken from the body.
The device is a surgical instrument used for therapeutic procedures, not for diagnostic testing of samples.
N/A
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
KGE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 (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
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.
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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: (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 Systems |
| Corporation | ||
| K092309 | Single Use Electrosurgical Knife Series, Model | |
| KD-610L, KD611L, KD620LR, KD630L, KF640L | Olympus Medical Systems | |
| 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
Description | OLYMPUS
MEDICAL
SYSTEMS
CORPORATION
Single Use | OLYMPUS
MEDICAL
SYSTEMS
CORPORATION | FUJIFILM Medical Systems U.S.A., Inc.,
FlushKnife and ClutchCutter
(Subject Device) | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electrosurgical
Knife Series,
(K092309
Predicate Device) | Electrosurgical
Hemostatic
Forceps Series,
(K062517
Predicate Device) | FlushKnife | ClutchCutter |
| Intended
Use /
Indications
for Use | This instrument
has been
designed to be
used with
Olympus
endoscopes and
electrosurgical
units to cut tissue
within the
digestive tract and
using high-
frequency current. | This instrument
has been
designed to be
used with
Olympus
endoscopes to
cauterize,
coaqulate and
perform
hemostasis using
high-frequency
current within the
digestive tract. | 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. |
| Models | Model KD-610L,
KD-620LR | Model FD-410LR | 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
DP2618DT-35-,
DP2618DT -50- |
| Device | OLYMPUS
MEDICAL
SYSTEMS
CORPORATION
Single Use | OLYMPUS
MEDICAL
SYSTEMS
CORPORATION
Electrosurgical | FUJIFILM Medical Systems U.S.A., Inc.,
FlushKnife and ClutchCutter
(Subject Device) | |
| Description | Electrosurgical
Knife Series,
(K092309
Predicate Device) | Hemostatic
Forceps Series,
(K062517
Predicate Device) | FlushKnife | ClutchCutter |
| Slitter Shape | Needle Type with
Ball Tip (KD-
610L), Needle
Type with hook
portion (KD-
620LR) | Forceps type | Needle Type
(With Ball Tip:-BXX-)
(Without Ball Tip:-NXX-) | Forceps type |
| Slitter
Length | 4.0 mm (KD-
610L), 4.5 mm
(KD-620LR) | Not Applicable | 1.0/1.5/2.0/2.5/3.0mm (for
DK2618 series)
1.5/2.0mm (for DK2623
series) | Not Applicable |
| Maximum
Diameter of
Insertion
Portion | $\phi$2.6 | $\phi$2.75 | $\phi$2.7 | $\phi$2.7 |
| Working
Length | 1650mm | 1650 mm | 1800mm/2300mm | 1800 mm |
| Water Feed
Function | None | Not Applicable | Yes | Not Applicable |
| Method of
Operation | Manually (handle
slider) | Manually (handle
slider) | Manually (handle slider) | Manually (handle
slider) |
| Energy | energy delivered
from an
electrosurgical
generator | energy delivered
from an
electrosurgical
generator | energy delivered from an
electrosurgical generator | energy delivered
from an
electrosurgical
generator |
| Monopolar /
Bipolar | Monopolar | Monopolar | Monopolar | Monopolar |
| Sterilization | Yes (Single Use
Device) | Yes (Single Use
Device) | Yes (Single Use Device) | Yes (Single Use
Device) |
| Combination
Tools | Endoscope,
Electrosurgical
generator, A Cord | Endoscope,
Electrosurgical
generator, A Cord | Endoscope,
Electrosurgical generator,
A Cord | Endoscope,
Electrosurgical
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.