(63 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of the device for cutting tissue using high-frequency current. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies are focused on physical and electrical characteristics, not algorithmic performance.
Yes
The device is used for cutting, ablating, dissecting, coagulating, and achieving hemostasis of tissue within the digestive tract, all of which are therapeutic interventions.
No
Explanation: The device is an electrosurgical instrument used to cut, ablate, incise, dissect, avulse, coagulate, and hemostasize tissue. These are therapeutic actions, not diagnostic ones.
No
The device description clearly indicates it is a physical electrosurgical instrument with a handle, slitter shapes, working lengths, and a water feed function, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) outside of the body. Their purpose is to provide information about a person's health status, diagnose diseases, or monitor treatments.
- This device is an electrosurgical instrument used within the digestive tract to cut and manipulate tissue. It directly interacts with tissue inside the body using high-frequency current.
The description clearly indicates that the device is used for surgical procedures within the digestive tract, not for analyzing samples in a laboratory setting.
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
KGE
Device Description
The Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter) are electrosurgical instruments. The FlushKnife has models with varying slitter lengths (1.0/1.5/2.0/2.5/3.0mm for DK2618 series; 1.5/2.0mm for DK2623 series), needle shape (with or without ball tip), maximum insertion portion diameter of φ2.7, and working lengths of 1800mm/2300mm. It also features a water feed function. The ClutchCutter has a forceps type slitter shape, maximum insertion portion diameter of φ2.7, working length of 1800mm, and a slitter portion rotation function. Both devices are operated manually via a handle slider, deliver energy from an electrosurgical generator, are monopolar, single-use, and biocompatible. They are used with an endoscope, electrosurgical generator, and an A Cord. The subject device is a modification of the predicate device, specifically a minor change in the material (epoxy resin).
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)
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 performance tests:
- Airtightness
- Maximum diameter of insertion portion
- Working length
- Slitter Portion length
- Electrical resistance
ClutchCutter performance tests:
- 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.
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 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 (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,
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)
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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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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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: (973) 686-2627 Ext. 522627 Facsimile: (973) 633-8818 E-Mail smore@fujifilm.com
Date Prepared: April 26, 2016
Identification of the Proposed device:
| Proprietary/Trade Name: | Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter
(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.
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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 | |
| (FlushKnife) | Fujifilm Diathermic Slitter | |
| (FlushKnife) | ||
| Device Models | DIATHERMIC SLITTER, 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- | 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 | ||
| designed to be used with specified | |||
| endoscopes to cut tissue using | |||
| high-frequency current within the | |||
| digestive tract. Both the ball tip | |||
| type and the needle type | |||
| instruments are indicated for | |||
| ablation, incision, dissection, | |||
| avulsion, cauterization, | |||
| coagulation and hemostasis of | |||
| tissue within the digestive tract. | Same as predicate device | ||
| Technological | |||
| Characteristics | Slitter Length | 1.0/1.5/2.0/2.5/3.0mm (for | |
| DK2618 series) | |||
| 1.5/2.0mm (for DK2623 series) | Same as predicate device | ||
| Slitter Shape | Needle Type | ||
| (With Ball Tip:-BXX-) | |||
| (Without Ball Tip:-NXX-) | Same as predicate device | ||
| Maximum Diameter of | |||
| 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 | ||
| 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 | ||
| generator, A Cord | Same as predicate device |
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Summary of differences between modified ClutchCutter from its predicate device
| Predicate device | Proposed Device | |
|---|---|---|
| Device Name | Fujifilm Diathermic Slitter | |
| (ClutchCutter) | Fujifilm Diathermic Slitter | |
| (ClutchCutter) | ||
| Device Models | DP2618DT -35-, DP2618DT -50- | Same as predicate device |
| 510(k) Number | K151474 | Pending |
| Intended Use | These instruments have been | |
| designed to be used with | ||
| specified endoscopes to cut | ||
| tissue using high-frequency | ||
| current within the digestive tract. | ||
| These instruments are indicated | ||
| for ablation, incision, dissection, | ||
| avulsion, cauterization, | ||
| coagulation and hemostasis of | ||
| tissue within the digestive tract. | Same as predicate device |
| Technological
| Characteristics | Slitter Shape | Forceps Type | Same as predicate device |
|---|---|---|---|
| Maximum Diameter | |||
| of Insertion Portion | φ2.7 | Same as predicate device | |
| Working Length | 1800mm | Same as predicate device | |
| Slitter Portion | |||
| 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 | ||
| 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 | ||
| 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.