(63 days)
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.
The Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter) are electrosurgical instruments intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The FlushKnife has needle or ball tip shapes and varying slitter lengths and working lengths. The ClutchCutter has a forceps type slitter shape and a working length of 1800mm. Both devices have a water feed function, are operated manually via a handle slider, use monopolar energy delivered from an electrosurgical generator, are single-use devices, and are biocompatible.
The provided text is a 510(k) premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a clinical study or effectiveness study with human readers.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable or not provided in this document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document states that "In all cases, the device met the pre-defined acceptance criteria for the test." However, the specific acceptance criteria values are not detailed in this summary for each test. The tests performed were:
| Test Performed (FlushKnife) | Reported Device Performance |
|---|---|
| Airtightness | Met pre-defined acceptance criteria |
| Maximum diameter of insertion portion | Met pre-defined acceptance criteria |
| Working length | Met pre-defined acceptance criteria |
| Slitter Portion length | Met pre-defined acceptance criteria |
| Electrical resistance | Met pre-defined acceptance criteria |
| Test Performed (ClutchCutter) | Reported Device Performance |
|---|---|
| Working length | Met pre-defined acceptance criteria |
| Maximum diameter of insertion portion | Met pre-defined acceptance criteria |
| Distal end shapes | Met pre-defined acceptance criteria |
| Electrical resistance | Met pre-defined acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies mentioned are engineering/performance testing, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the tests were performance testing of physical device attributes, not diagnostic performance requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for physical device performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a physical medical device (electrosurgical slitter), not an AI-powered diagnostic tool, so this type of study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests, the "ground truth" would be established engineering specifications and measurement standards. For example, "Working length" would have a defined specification, and the device's measured length would be compared against it. This is not explicitly detailed in the summary, but it's inherent to engineering performance testing.
8. The sample size for the training set
This information is not applicable as there is no training set for an AI or algorithm in this context.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an AI or algorithm in this context.
Summary of the Device and its Review:
The document describes a Special 510(k) for the Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter). The purpose of this submission is to address a minor modification (change in material - epoxy resin) to an already cleared predicate device (K151474). The core argument for substantial equivalence is that the intended use, indications, technological characteristics, and principles of operation remain the same as the predicate device. The performance tests conducted (e.g., airtightness, working length, electrical resistance) were to ensure that the modified device performs equivalently to the predicate and met pre-defined acceptance criteria. The document concludes that these minor differences do not raise new questions of safety or efficacy.
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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
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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,
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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FORM FDA 3881 (1/14)
Page 1 of 1 FDA
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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, 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- | Same as predicate device |
Summary of differences between modified FlushKnife from its predicate device
| 510(k) Number | K151474 | Pending | |
|---|---|---|---|
| Intended Use | These instruments have beendesigned to be used with specifiedendoscopes to cut tissue usinghigh-frequency current within thedigestive tract. Both the ball tiptype and the needle typeinstruments are indicated forablation, incision, dissection,avulsion, cauterization,coagulation and hemostasis oftissue within the digestive tract. | Same as predicate device | |
| TechnologicalCharacteristics | Slitter Length | 1.0/1.5/2.0/2.5/3.0mm (forDK2618 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 ofInsertion 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 aelectrosurgical 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, Electrosurgicalgenerator, 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 beendesigned to be used withspecified endoscopes to cuttissue using high-frequencycurrent within the digestive tract.These instruments are indicatedfor ablation, incision, dissection,avulsion, cauterization,coagulation and hemostasis oftissue within the digestive tract. | Same as predicate device |
| TechnologicalCharacteristics | Slitter Shape | Forceps Type | Same as predicate device |
|---|---|---|---|
| Maximum Diameterof Insertion Portion | φ2.7 | Same as predicate device | |
| Working Length | 1800mm | Same as predicate device | |
| Slitter PortionRotation Function | Yes | Same as predicate device | |
| Method of Operation | Manually (handle slider) | Same as predicate device | |
| Energy used or delivered | energy delivered from aelectrosurgical 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, Electrosurgicalgenerator, 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
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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.
§ 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).